Attachment C
Management of the Installation
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TABLE OF CONTENTS
1 SITE MANAGEMENT & CONTROL ........................................................ 1
2 ENVIRONMENTAL MANAGEMENT SYSTEM ........................................ 2
3 CALIBRATION & MAINTENANCE SYSTEMS ........................................ 3
4 HOURS OF OPERATION ......................................................................... 3
5 FIT AND PROPER PERSON ................................................................... 4
ISO 14001 Certificate
ISO 50001 Certificate
ISO 18001 Certificate
EHS Policy
Energy Policy
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1 Site Management & Control
Senior management at the AbbVie facility in Cork is as follows:
Mairéad Dunne – Site Director
John Gallagher – Business Excellence Manager
Pauline Morrison – Human Resources Manager
Gary Crowley – Site Engineering Manager
Peter Power – Supply Chain Manager
Jim McGrath – Finance Manager
Liz Tolan – Head of Quality
Éanna Ó Maitiú – Technical Operations Manager
The management structure at the company incorporating the Environmental,
Health & Safety Department (EHS) is detailed in Figure 1.
Figure 1: EHS Department Structure at AbbVie
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The EHS&E Manager is supported by an extensive team of EHS specialists.
Independent expertise will be continually engaged for specific tasks related to
the sites environmental responsibilities (e.g. environmental monitoring and
emissions, maintenance) and certification/auditing requirements (e.g. ISO
14001, ISO 50001, OHSAS 18001 etc.).
2 Environmental Management System
AbbVie operates an Environmental Management System in accordance with
International Standard ISO 14001 Environmental Management. A copy of the
latest accreditation certificate No. 2009/764 is included with this attachment.
AbbVie prepares an annual Environmental Management Programme, which is
fully integrated into the site management system. Targets are set, for between
one and five years, for the programme objectives. At the end of each year the
progress against the targets is formally reviewed at senior management level.
The programmes are adjusted as required in the light of ongoing experience
and advances in knowledge and technology. Targets and goals in the
programmes are set to ensure that resources and systems are put in place to
achieve the targets. The success of the programme is measured by the
effectiveness of the systems installed, as well as results in meeting targets. A
copy of the Annual Environmental Report is made available on request to the
general public.
It is the responsibility of the EHS&E Manager and the site Energy
Champion/CEM to ensure that operations under their control are measured
and monitored. Although the overall management responsibility has been
defined, other managers and key influencers are also assigned responsibility
for components of the systems.
Internal audits are conducted by AbbVie staff throughout the year, with each
area of the operation undergoing a detailed environmental, health and safety
audit by the EHS Department on an annual basis. The Site Leadership Team
annually review the EMS, to ensure its continuing suitability, adequacy and
effectiveness. The management review addresses the possible need for
changes to Environmental, Health and Safety Policy, environmental objectives
and other elements of the environmental management system, in the light of
environmental management system audit results, changing circumstances
and the commitment to continual improvement.
A copy of the AbbVie Environment, Health & Safety Policy and the AbbVie
Energy Policy are included with this attachment. The EHS Manual for the site
is available on request.
AbbVie is also certified as complying with the requirements of OHSAS 18001.
OHSAS 18001 is an international specification which defines a set of
requirements for a comprehensive Occupational Health and Safety
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Management System specification, designed to enable organisations to
manage both their operational risks and improve their performance. A copy of
the certificate is appended to this attachment.
AbbVie also operates an Energy Management System in accordance with
International Standard ISO 50001 Energy Management. A copy of the latest
accreditation certificate is included with this attachment.
3 Calibration & Maintenance Systems
AbbVie has established standard procedures and schedules for the inspection
and calibration of environmental control, abatement and treatment equipment
at the facility.
4 Hours of Operation
The plant operates a combination of days, 24-hours, five and seven day operations. There is a 24-hour security presence on-site at all times.
The plant is in operation at all times of the year. Some parts of the facility
may be subject to short duration shutdown periods for maintenance activities.
These generally occur in the summertime. The plant may opt to cease
operations for short periods such as Christmas or New Year. In all cases there
will be a full time security presence on-site with back up call in systems in the
unlikely event of an incident occurring during these times.
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5 Fit and Proper Person
No employees of AbbVie have been convicted of any offence under the EPA
Acts 1992 and 2003, the Waste Management Act 1996 (as amended), the
Local Government (Water Pollution) Acts 1977 and 1990 or the Air Pollution
Act 1987.
Details of the qualifications, technical knowledge and experience of the
relevant AbbVie employees are given below:
Name Title Role/Responsibility
at AbbVie
Qualifications Years’ Experience
in Environmental
Role
Jens
Buchwald
EHS
Manager
Environmental and
Health & Safety
Management of
Cork Site
Master's degree, Safety
and Environmental
Engineering
Degree Qualified
Environmental, Health
and Safety Professional
with Additional
qualifications in Pollution
Control, Fire Safety,
Waste and Dangerous
Goods.
Over 17 years’
industry experience
across the chemical,
medical device and
pharma industry in
the UK, Germany
and Ireland.
Gary
Crowley
Engineering
Manager
Site Engineering
Manager with
responsibility for the
Engineering and
EHSE functions
MEng, Process Safety
Engineering
MSc, Chemistry
Diploma, Health, Safety
& Welfare at Work
Over 8 years EHS
experience
Provide information to show that the person is likely to be in a position to meet
any financial commitments or liabilities that may have been or will be entered
into or incurred in carrying on the activity to which the application relates or in
consequence of ceasing to carry out that activity.
Attachment K to the main application contains the Decommissioning
Management Plan for the facility. An appropriate financial instrument will be
put in place in due course.
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ISO14001 Certificate
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This is t o certify that the
Environmental Management System Of
AbbVie Cork At
IDA Industrial Estate, Carrigtwohill, Co. Cork
Has been assessed by Certification Europe and deemed to comply w ith the requirements of
ISO 14001:2004 This certificate is val id for the activities specified below:
The manufacture of pharmaceutical products.
Certification of Registrat ion remains the property of Certification Europe Ltd. The val id ity of th is Certificate is maintained o n the condition t hat t he Management System is assessed throug h an
o n-going surveillance program me and continues to adeq uately meet the requ irements of t he standard. To verify this certi f icate valid ity please con tact us at [email protected]
Date of initial cer tification: 7th October 2009 This cert ificate is valid until: 6th October 2018
Chief Executive: Michael Brophy Chairman: Padraic A. W hite
~.c a~-t;_ Signature. ________ _
Client Registration No.: 2009/764 Certificate Reference No.: A/7
Date of certificate issue: 21st October 2015
ISO
CERTIFICATION EUROPE •
Cert1f1cat1on l:urope Ltd Block 20A Beckett Way, Park West Business Park. Dublin 12. Ireland info<ii,certificationeurooe com
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ISO 50001 Certificate
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This is to certify that the
Energy Management System Of
AbbVie Cork At
IDA Industrial Estate, Carrigtwohill, Co. Cork
Has been assessed by Certification Europe and deemed to comply with the requirement s of
ISO 50001:2011 This certificate is valid for the activities specified below:
The electricity, gas, transport, and water used within the boundaries of the AbbVie Cork site.
Certification of Registration remains the property of Certification Europe Ltd. The validity of this Certificate is maintained on the condition that the Management System is assessed through an
on-going surveillance programme and continues to adequately meet the requ irements of the standard . To verify this certificate validity please contact us at info@certificat ioneurope.com
Date of initial certification: 14 t h July 2010 This certificate is valid until: 13th July 2019
Chief Executive: Michael Brophy Chairman: Padraic A. White
.,so lia ~~2~L
.. EUROPE
Certification Europe Ltd Block 20A Beckett Way, Park West Business Park, Dublin 12, Ireland info@certificat ioneurooe.com
~ .c. a~t;_ Signature. ________ _
Cl ient Registration No.: 2010/ 1038 Certi ficate Reference No.: A/ 7
Date of Certificate issue: 4th August 2016
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ISO 18001 Certificate
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This is to certify that the
Occupational Health & Safety Management System
Of
AbbVie Cork At
IDA Industrial Estate, Carrigtwohi ll, Co. Cork
Has been assessed b y Certificatio n Europe and deemed t o comply w ith the requirements of
OHSAS 18001:2007 This certifi cat e is valid for the acti vities spec ified below:
The manufacture of pharmaceutical products.
Cert ification of Registration remains the property of Certification Europe Ltd. The va lidity of this Certificate is maintained on the condi tion that the Management System is assessed through an
on-going surveillance programme and continues to adequately meet the requirements of the standard. To verify th is certificate validity p lease contact us at [email protected]
Date of initial certification: 7'h October 2009 This certificate is valid unti l: 61h October 2018
Chief Executive: Michael Brophy
s;gnature, ~~ Chairman: Padraic A. White
~,c O.~i{_ Signature. ___ _ _ ___ _
OHSAS
CERTIFICATIO N EUROPE
Cerlif,coliori Europe Ltd Block 20A Beckett Way, Park West Business Park. Dublin 12, Ireland info<a:cert1f1catiooeurooe com
Client Registration No .: 2009/765 Certificate Reference No.: A/6
Date of Cert if icate issue: 21st October 2015
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EHS Policy
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Environmental, Health & Safety Policy
AbbVie (Fournier Laboratories Ireland Ltd.) is a Pharmaceutical Manufacturing and Scale-up Facility dedicated to the supply of Commercial and Clinical Products that enable Abb Vie to deliver a consistent stream of innovative products and therapies that solve serious health issues and have a remarkable impact on people's lives. AbbVie is committed to having a positive impact on societies around the world.
The company considers the safeguarding of the Safety, Health and Welfare of any Worker under the Control of the Organization while performing work or work-related activities and operations; and any Interested Party; person or organisation, that can affect, be affected by, or perceive itself to be affected
by a decision or activity, to be a management priority.
The site policy objectives will be driven by the environmental principles of prevention, reduction, re
use and re-cycle and all reasonable and practicable steps will be taken to provide a safe and healthy environment in addition to safe systems of work. It is therefore the responsibility of AbbVie and all its
employees to adhere to this policy and published global operating policies. In particular AbbVie will conform to the following practices in so far as reasonably practicable:-
• Our Responsible Care policy is a key element in our commitment to Sustainable Development and
Prevention of Pollution. One of our core objectives is to Encourage Energy Efficiency via ongoing management of our key energy aspects and supporting programs. These principles will be driven by top managements' Demonstration of Leadership and the Participation of Workers in the decisionmaking processes
• We are cognizant of our Compliance Obligations through our systematic management of all applicable local, national and international Regulations that relate to Health, Safety and the Environment.
• We are committed to developing a deeper understanding of the Context Of the Organisation, whilst continuing to develop and supply products that, throughout their life-cycle, involve minimum risk to human beings and the environment, while best meeting the needs of our customers.
• We are committed to managing our sites and transportation of our products in such a way as to avoid harm to communities and to our employees, and to minimize the impact of these activities on the environment. We are committed to the Prevention oflnjury and Ill Health at all stages of our processes.
• We are committed to keeping all stakeholders informed of health, safety and environmental issues, and to engage in dialogue with them in a spirit of openness and mutual respect.
• We encourage our joint-ventures, suppliers, sub-contractors and customers to adopt a policy comparable to ours in relation to health, safety and the environment.
• Continual Improvement is a fundamental element of this policy.
This policy is fully supported by Management at all levels of our Organisation and will be reviewed at least annually and u~dirrth:e-seYelopment of Management Objectives, Targets and Programmes.
LQ \ -___________________________ Q: _________ ,
Mairead Dunne, Site Director
Abb Vie Operations Cork
Date
Reference: AbbVie Management Standard - MOO.AV AbbVie Environment, Health and Safety Policy, Clause 4.2 - ISO 14001: 2004 & OHSAS 18001: 2007 and Clause 4.3 - ISO 50001: 2011 & The AbbVie EHS Commitment Policy Statement.
abbvie
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Energy Policy
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Energy Policy
AbbVie (Fournier Laboratories Ireland Ltd) is a pharmaceutical manufacturing facility.
The company acknowledges its duty to ensure that all of its activities are conducted in a responsible and safe manner. It is therefore the responsibility of AbbVie, and all its employees, to adhere to this policy. We have put in place our EnMS in accordance with ISO 50001 standard which is the frame work for setting and review of Energy objectives and targets.
This policy applies to all employees, visitors and contractors. Individual influence and impact on energy procurement, use and conservation will be defined and the appropriate roles, responsibilities and appropriate endorsement and training will be facilitated by senior management.
Management will provide the necessary information and resources to the Energy Committee when and where realistic and achievable opportunities for improvement are identified and the outcomes validated through recognised and auditable measuring protocols.
In particular AbbVie will conform to the following practices in so far as reasonably practicable:
• We have fully endorsed this policy and are fully committed to the entirety of the Energy Management System and Standard within the scope and boundaries of the policy.
• In line with our local and corporate commitment to Operational Excellence we are committed to achieving improved energy performance in all areas.
• Our Responsible Care policy is a key element in our commitment to Sustainable Development and Prevention of Pollution. It applies to all management units and to all employees. One of our core objectives is to Encourage Energy Efficiency via ongoing management of our key energy aspects and supporting programs.
• We are committed to complying with all applicable local, organisational, national and international Regulations and other Requirements that relate to energy aspects and management.
• We are committed to keeping all stakeholders informed on all energy issues, and to engage in dialogue with them in a spirit of openness and mutual respect.
• We encourage our joint-ventures, suppliers, sub-contractors and customers to adopt a policy comparable to ours in relation to energy management and fully support the purchase of energy efficient goods and services.
• We are committed to the availability of resources and information to achieve objectives and targets; these resources may be comprised of the provision of fully competent personnel.
• Continual Improvement in energy performance is a fundamental element of this policy.
This policy is fully supported by management at all levels of our organization and will be reviewed at least annually and used in the development of management objectives, targets and programs.
~ _(ALL _ _ .:;?.:)_~_ Mairead Dunne, Site Director
AbbVie Operations Cork
. _J _ -st __ .t/1 A(c_,, V'\ I lo Date
Reference: ENOO.AV AbbVie Energy Policy, ISO 50001: 201 l(E) Energy Management Standard: Clause 4.3 Energy Policy
abbvie
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Attachment D
Site Operational Description
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TABLE OF CONTENTS:
1 MANUFACTURING ACTIVITIES ON-SITE .............................................. 1
1.1 Site History .......................................................................................... 1
1.2 Company History ................................................................................ 2
1.3 Existing Operations ............................................................................ 3
2 DESCRIPTION OF UNIT OPERATIONS ................................................. 4
2.1 Material Purchasing ............................................................................ 4
2.2 Receipt into Warehouse ..................................................................... 5
2.3 Sampling/Testing by Quality Control ................................................ 6
2.4 Dispensing ........................................................................................... 6
2.5 Milling ................................................................................................... 7
2.6 Granulation .......................................................................................... 7
2.7 Sieving/Sifting ..................................................................................... 8
2.8 Blending ............................................................................................... 9
2.9 Compression ....................................................................................... 9
2.10 Coating ............................................................................................... 10
2.11 Packing .............................................................................................. 10
2.12 Receipt into Warehouse ................................................................... 11
3 PROPOSED PROCESSES .................................................................... 12
4 DESCRIPTION OF PROPOSED UNIT OPERATIONS .......................... 13
4.1 Material Purchasing .......................................................................... 13
4.2 Receipt into Warehouse ................................................................... 13
4.3 Sampling/Testing by Quality Control .............................................. 14
4.4 Dispensing ......................................................................................... 15
4.5 Blending ............................................................................................. 15
4.6 Cooling ............................................................................................... 16
4.7 Milling ................................................................................................. 16
4.8 Compression ..................................................................................... 17
4.9 Film Coating ...................................................................................... 17
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4.10 Blending of the Coated Tablets ....................................................... 18
4.11 Sieving ............................................................................................... 18
4.12 Encapsulation .................................................................................... 19
4.13 Packing .............................................................................................. 19
4.14 Receipt into Warehouse ................................................................... 20
5 CLEAN-IN-PLACE (CIP) OPERATIONS ............................................... 21
6 PROCESS EFFLUENT ABATEMENT ................................................... 21
7 EMISSIONS TO ATMOSPHERE ABATEMENT .................................... 22
7.1 Thermal Oxidiser (TO) ....................................................................... 22
7.2 Dust Control Systems ....................................................................... 22
8 PROCESS CONTROL SYSTEM ............................................................ 23
9 MONITORING ........................................................................................ 23
10 WATER SUPPLY SYSTEM ................................................................ 23
11 STORMWATER MANAGEMENT/ FIREWATER AND SPILL
MANAGEMENT ............................................................................................. 24
12 FIRE WATER SUPPLY SYSTEM ....................................................... 25
13 SCALE-UP FACILITY ......................................................................... 26
13.1 Description ........................................................................................ 26
13.2 Emissions .......................................................................................... 26
14 LABORATORY FACILITIES ON-SITE ............................................... 27
14.1 Description ........................................................................................ 27
14.2 Emissions .......................................................................................... 27
15 NOISE ................................................................................................. 28
16 WASTE ............................................................................................... 29
17 ACCIDENT PREVENTION ................................................................. 29
18 CESSATION OF ACTIVITIES ............................................................. 30
19 BAT ..................................................................................................... 31
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1
1 Manufacturing Activities On-Site
1.1 Site History
AbbVie have been operating the plant since 2013. An overview of the site
history since greenfield development is as follows:
The IDA Industrial Estate was first developed in the 1970’s before which time
the site was used for agricultural purposes. The first commercial activity on
the existing AbbVie site began in 1978, when the site was first developed by
Island Pharmaceuticals for blending and packaging of powder form
pharmaceuticals. Jouvenal Manufacturing took over the site in 1987 and
began production of their anti-biotic nasal sprays in 1988.
In 1997 the site was purchased by the American pharmaceutical company
Warner Lambert. In 2000, the American global pharmaceutical corporation
Pfizer acquired Warner-Lambert. Between 2000 and 2001 the site was
reportedly not used by Pfizer.
In 2001, the site was acquired by Fournier Laboratories. Having secured
planning permission, Fournier began construction of Manufacturing and R&D
facilities in 2002. The site completed production commissioning and went into
full production in May 2004.
In 2005, Fournier Laboratories was acquired by the Belgian chemical
company Solvay. During 2006, there was significant investment and two new
production facilities were constructed. This included the construction of a two-
storey extension to existing manufacturing building comprising of production
and plant space, alterations to the existing gowning suite and associated
works including drainage, hard-standings, bunds, extension to car parking and
roadways and the provision of footpaths.
In 2007 there was an extension to the existing research and development
laboratory building.
In 2010, the American worldwide health care company Abbott Laboratories
completed the acquisition of Solvay Pharmaceuticals, including the Fournier
Laboratories facility in Cork.
In 2013, AbbVie was founded as a global biopharmaceutical company with
focus and capabilities to address some of the world’s greatest health
challenges. AbbVie is a research-based specialty biopharmaceuticals
company with a broad portfolio of medicines, including leadership in
immunology and virology, and a pipeline of breakthrough therapies.
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1.2 Company History
AbbVie Inc. is a global, research-based biopharmaceutical company formed in
2013 following the separation from Abbott.
AbbVie (previously Abbott) has had a presence in Ireland since 1973.
AbbVie are 25,000 people in 170 countries focused on developing new
products and new ways to help people manage some of the most serious
health conditions.
“We are scientists, researchers, communicators, manufacturing
specialists, and regulatory experts. We also are parents, brothers,
sisters, friends, community leaders, volunteers, and more. We have a lot
in common with the people we serve, and we come together every day
to create, discover, and deliver new ways to improve people's health.”
With its 125-year history, the company’s mission is to use its expertise,
dedicated people and unique approach to innovation to develop and market
advanced therapies that address some of the world’s most complex and
serious diseases.
A New Beginning
On January 1, 2013, AbbVie became an independent company as a result of
the distribution by Abbott Laboratories (Abbott) of 100 percent of the
outstanding common stock of AbbVie to Abbott’s shareholders.
AbbVie was incorporated in Delaware on April 10, 2012 and is comprised of
Abbott’s former research-based pharmaceuticals business.
AbbVie’s Registration Statement on Form 10 was declared effective by the
U.S. Securities and Exchange Commission on December 7, 2012.
AbbVie’s common stock began trading ‘‘regular-way’’ under the ticker symbol
‘‘ABBV’’ on the New York Stock Exchange on January 2, 2013.
AbbVie is a global biopharmaceutical company with the focus and capabilities
to address some of the world's greatest health challenges.
AbbVie has the stability, resources, expertise, and passion to discover,
develop, and bring to market ground-breaking science to solve the biggest
health problems that face the world today and tomorrow.
AbbVie is ……
Focused - on developing leading-edge therapies and innovations.
Passionate - AbbVie have the commitment, expertise, and capabilities
to provide life-changing products to patients who need them most.
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Making a Difference - AbbVie combines deep understanding of patient
needs and disease states to deliver treatments that have an impact on
peoples' lives.
The team in Cork is dedicated, talented and adaptable.
1.3 Existing Operations
AbbVie is a research-based specialty global biopharmaceuticals facility. The
facility currently manufactures solid oral dose products for human use at
commercial scale. These products are used to treat a range of therapeutic
areas such as; High Cholesterol, HIV and Hepatitis C. The site also operates
a 1/10th scale-up facility.
The site operates an Environmental Management System certified to ISO
14001, Health and Safety Management System certified to OHSAS 18001
and Energy Management System certified to ISO 50001.
The products currently manufactured on-site are as follows:
1. TriCor (Cholesterol Treatment)
2. TriLipix (Cholesterol Treatment)
3. Cholib (Cholesterol Treatment)
4. Kaletra (HIV Treatment)
5. Viekirax (Hepatitis C Treatment)
6. Aluvia (HIV-1 Treatment)
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2 Description of Unit Operations
The processes employed on-site include milling, blending, granulation, drying,
sieving, tableting, coating and packaging. In general, the product type being
manufactured will also dictate the nature of emissions to the environment,
however there will be typical emissions arising from each unit operation. Such
emissions are summarised in the following unit operation descriptions.
The manufacturing operations may vary depending on the product
specifications, but in general the manufacture of pharmaceutical tablets at the
AbbVie facility comprise the following unit operations.
Material Purchasing
Receipt to Warehouse
Sampling and Testing
Dispensing
Milling
Granulation
Sieving
Blending
Compression into tablets
Coating of tablets
Packing
Receipt into Warehouse
2.1 Material Purchasing
2.1.1 Description
The site Master Scheduler receives a consolidated finished product demand
from the planning centres and external customers. This demand is loaded in
to SAP (the in-process control system) and a Materials Requirement Plan
(MRP) is generated. The MRP will generate requirements per individual
material or component and Purchase Requisitions are generated. The
purchasing department reviews the requisitions and converts them to
Purchase Orders on a monthly basis.
The purchase orders are placed with the approved vendors and the materials
are delivered in accordance with the agreed lead times. Once the material
arrives at the plant it is goods receipted by the warehouse personnel in
accordance with approved cGMP procedures. Materials are sampled as
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required by the Quality Control sampling procedure and once the materials
have been confirmed to meet the required specifications the materials are
approved for use. Once the materials have been successfully goods
receipted the vendor payment process is completed.
An Approved Suppliers List (ASL) is maintained and materials may only be
purchased from approved suppliers. These suppliers are managed through
the Supplier Management Programme and are audited in accordance with this
programme.
2.1.2 Emissions
Air
There will be no significant emissions to air from this operation.
Sewer
There will be no significant emissions to sewer from this operation.
Waste
Waste paper may arise occasionally which will be disposed of as non-
hazardous waste and recycled were possible.
2.2 Receipt into Warehouse
2.2.1 Description
On receipt of delivery the material is received into the warehouse. It is visually
inspected by the Warehouse Operator. The Warehouse Operator enters the
material details onto SAP and labels the material as per Goods Receipt from
Suppliers procedure.
2.2.2 Emissions
Air
There will be no significant emissions to air from this operation.
Sewer
There will be no significant emissions to sewer from this operation.
Waste
Waste arising will primarily be solid in nature comprising hazardous waste
such as damaged materials and non-hazardous fractions of packaging waste.
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2.3 Sampling/Testing by Quality Control
2.3.1 Description
The material is sampled by the Quality Control department in accordance with
Sampling of Raw Materials procedure. The material is tested and assigned a
status in accordance with the Receipt, Testing & Approval of Samples in the
QC Laboratory procedure. Once the material is assigned a status by the
Quality Department, the material is placed in the appropriate location.
2.3.2 Emissions
Air
Air emissions primarily arise in laboratories from fume hoods and similar
systems. All emissions arising are vented to atmosphere as minor emission
points.
Sewer
There will be emissions to sewer from the laboratory operations, including
glassware washers, sinks, etc.
Waste
Waste arising will primarily be hazardous liquid waste including solvent waste,
laboratory chemicals etc. and also solid waste including empty laboratory
containers and bottles, laboratory utensils (pipettes etc.) testing materials etc.
this waste is collected and transported off site for treatment. Non-hazardous
waste including packaging waste and administrative waste will also occur.
2.4 Dispensing
2.4.1 Description
The material is now available to be dispensed. Dispensing is carried out in
accordance with general dispensing procedure. The residual weight (where
applicable) is calculated, and attached to the container.
2.4.2 Emissions
Air
The operation is conducted in a closed environment to contain any dust
emissions arising, which are then directed to the general dust collection
system for that processing area, subject to HEPA filtration and vented to
atmosphere via a designated main emission point.
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Sewer
During cleaning operations, wastewater is discharged to the process
wastewater drainage system in accordance with the conditions of the current
DTS Licence.
Waste
Waste raw materials may occasionally arise, for on-site collection and
storage, prior to disposal as hazardous solid waste.
2.5 Milling
2.5.1 Description
The dispensed extrudate is milled in the mill in accordance with the
appropriate procedure to reduce the particle size.
2.5.2 Emissions
Air
The milling process is conducted in a closed environment to contain any dust
emissions arising, which are then directed to the general dust collection
system for that processing area, subject to HEPA filtration and vented to
atmosphere via a designated main emission point.
Sewer
Wastewater emissions will arise following rinsing of the milling equipment
which are directed to the process wastewater system on-site and discharged
in accordance with the conditions of the DTS Licence.
Waste
Waste raw materials may occasionally arise, for on-site collection and
storage, prior to disposal as hazardous solid waste.
2.6 Granulation
2.6.1 Description
At this stage the Granulation Feed Dispersion is granulated using a Fluid Bed
Dryer. The Granulation Feed Dispersion is coated onto Lactose using the
Fluid Bed Dryer. The resulting granulate is tested for water content to ensure
the correct specification is achieved.
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2.6.2 Emissions
Air
The granulation process is conducted in a closed environment to contain any
dust emissions arising, which are then directed to the general dust collection
system for that processing area, subject to HEPA filtration and vented to
atmosphere via a designated main emission point.
Sewer
Wastewater emissions will arise following rinsing of the granulation equipment
which are directed to the process wastewater system on-site and discharged
in accordance with the conditions of the DTS Licence.
Waste
Waste raw materials may occasionally arise, for on-site collection and
storage, prior to disposal as hazardous solid waste.
2.7 Sieving/Sifting
2.7.1 Description
A portion of the milled extrudate along with the dispensed quantities of other
required raw materials are sieved or sifted and then combined with the
remaining milled extrudate.
2.7.2 Emissions
Air
The operation is conducted in a closed environment to contain any dust
emissions arising, which are then directed to the general dust collection
system for that processing area, subject to HEPA filtration and vented to
atmosphere via a designated main emission point. There will be no fugitive
emissions to air due to the controlled environment.
Sewer
During cleaning operations, wastewater is discharged to the process
wastewater drainage system in accordance with the conditions of the DTS
Licence.
Waste
A portion of the milled extrudate along with the dispensed quantities of other
required raw materials are sieved or sifted and then combined with the
remaining milled extrudate.
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2.8 Blending
2.8.1 Description
The mixture is charged to an IBC and then blended with extranular excipients
to afford blended material suitable for compression into a matrix tablet. The
Blend is then weighed.
2.8.2 Emissions
Air
This operation is conducted within a closed environment to contain any dust
emissions arising. These emissions are then directed to the general dust
collection system for that processing area, subject to HEPA filtration and
vented to atmosphere via a designated main emission point. There will be no
fugitive emissions to air due to the controlled environment.
Sewer
Vessel rinses generate washwaters, which are directed to the process
wastewater system on-site and discharged in accordance with the conditions
of the DTS Licence.
Waste
Waste raw materials may occasionally arise, for on-site collection and
storage, prior to disposal as hazardous solid waste.
2.9 Compression
2.9.1 Description
This blend is then compressed to form uncoated tablets. Tests for weight
(individual and average), hardness, thickness and visual are performed on the
uncoated tablets to ensure they are of the correct quality.
2.9.2 Emissions
Air
All air emission arising vented to the atmosphere via HEPA filtration.
Sewer
There are no direct emissions arising from the compression stage.
Waste
There may be small quantities of waste tablet dusts arising, for subsequent
handling and disposal off-site as hazardous waste.
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2.10 Coating
2.10.1 Description
The uncoated tablets are coated in accordance with the relevant procedural
method. The tablets are tested for mass and are also visually inspected during
the coating process.
2.10.2 Emissions
Air
These emissions are then directed to the general dust collection system for
that processing area, subject to HEPA filtration and vented to atmosphere via
a designated main emission point. There will be no fugitive emissions to air
due to the controlled environment.
Sewer
Equipment and coating pans cleaning rinses will generate wash waters which
are directed to the process wastewater system on-site and discharged in
accordance with the conditions of the DTS Licence.
Waste
There may be small quantities of waste tablets arising, for subsequent
handling and disposal off-site as hazardous waste.
2.11 Packing
2.11.1 Description
The Finished Product tablets or capsules are packed in accordance with
packaging procedures.
2.11.2 Emissions
Air
All emissions arising in the packaging area are vented via general dust
collection systems, prior to emitting to atmosphere via designated main
emission points, and HEPA filtration.
Sewer
There are no emissions to sewer from the packaging operations.
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Waste
Waste arising will primarily be solid in nature comprising hazardous waste
such as damaged Finished Product and non-hazardous fractions of packaging
waste.
2.12 Receipt into Warehouse
2.12.1 Description
The finished products are received into the warehouse.
2.12.2 Emissions
Air
There will be no significant emissions to air from this operation.
Sewer
There will be no significant emissions to sewer from this operation.
Waste
Waste paper may arise occasionally which will be disposed of as non-
hazardous waste and recycled were possible.
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3 Proposed Processes
The application for an Industrial Emissions (IE) licence from the EPA is
necessary to facilitate the production of a new product line, Creon DR (DR
stands for delayed release i.e. the active ingredient is released gradually into
the body). Creon DR is used in Pancreatic Enzyme Replacement Therapy
(PERT) to treat cases involving Exocrine Pancreatic Insufficiency (EPI) due to
Cystic Fibrosis (CF), Chronic Pancreatitis (CP) and other conditions.
Unit operations for this new product line will be similar to those currently used
for existing product which include milling, blending, granulation, drying,
sieving, tableting, coating and packaging. The production of Creon DR will
differ from existing operations insofar as the process requires the use of the
organic solvent Acetone. The volumes of Acetone required annually for the
production of Creon DR has prompted the IE application process.
The manufacture of Creon DR tablets will comprise the following unit
operations:
Material Purchasing
Receipt to Warehouse
Sampling and Testing
Dispensing
Blending
Cooling
Milling of Particles
Compression into Tablets
Solvent Coating of Tablets
Blending of Coated Tablets
Encapsulation into Oral Dose Specification Capsules
Packing
Receipt into Warehouse
The unit operations associated in the Creon DR production process are
described in more detail below.
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4 Description of Proposed Unit Operations
4.1 Material Purchasing
4.1.1 Description
The site Master Scheduler receives a consolidated finished product demand
from the planning centres and external customers. This demand is loaded in
to SAP and a Materials Requirement Plan (MRP) is generated. The MRP will
generate requirements per individual material or component and Purchase
Requisitions are generated. The purchasing department reviews the
requisitions and converts them to Purchase Orders on a monthly basis.
The purchase orders are placed with the approved vendors and the materials
are delivered in accordance with the agreed lead times. Once the material
arrives at the plant it is goods receipted by the warehouse personnel in
accordance with approved cGMP procedures. Materials are sampled as
required by the Quality Control sampling procedure and once the materials
have been confirmed to meet the required specifications the materials are
approved for use. Once the materials have been successfully goods
receipted the vendor payment process is completed.
An Approved Suppliers List (ASL) is maintained and materials may only be
purchased from approved suppliers. These suppliers are managed through
the Supplier Management Programme and are audited in accordance with this
programme.
4.1.2 Emissions
Air
There will be no significant emissions to air from this operation.
Sewer
There will be no significant emissions to sewer from this operation.
Waste
Waste paper may arise occasionally which will be disposed of as non-
hazardous waste and recycled were possible.
4.2 Receipt into Warehouse
4.2.1 Description
On receipt of delivery the material is received into the warehouse. It is visually
inspected by the Warehouse Operator. The Warehouse Operator enters the
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material details onto SAP and labels the material as per Goods Receipt from
Suppliers procedure.
4.2.2 Emissions
Air
There will be no significant emissions to air from this operation.
Sewer
There will be no significant emissions to sewer from this operation.
Waste
Waste arising will primarily be solid in nature comprising hazardous waste
such as damaged materials and non-hazardous fractions of packaging waste.
4.3 Sampling/Testing by Quality Control
4.3.1 Description
The material is sampled by the Quality Control department in accordance with
Sampling of Raw Materials procedure. The material is tested and assigned a
status in accordance with the Receipt, Testing & Approval of Samples in the
QC Laboratory procedure. Once the material is assigned a status by the
Quality Department, the material is placed in the appropriate location.
4.3.2 Emissions
Air
Air emissions primarily arise in laboratories from fume hoods and similar
systems. All emissions arising are vented to atmosphere as minor emission
points.
Sewer
There will be emissions to sewer from the laboratory operations, including
glassware washers, sinks, etc.
Waste
Waste arising will primarily be hazardous liquid waste including solvent waste,
laboratory chemicals etc. and also solid waste including empty laboratory
containers and bottles, laboratory utensils (pipettes etc.) testing materials etc.
this waste is collected and transported off site for treatment. Non-hazardous
waste including packaging waste and administrative waste will also occur.
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4.4 Dispensing
4.4.1 Description
The material is now available to be dispensed. Dispensing is carried out in
accordance with general dispensing procedure. The residual weight (where
applicable) is calculated, and attached to the container.
4.4.2 Emissions
Air
The operation is conducted in a closed environment to contain any dust
emissions arising, which are then directed to the general dust collection
system for that processing area, subject to HEPA filtration and vented to
atmosphere via a designated main emission point.
Sewer
During cleaning operations, wastewater will be discharged to the process
wastewater drainage system in accordance with the conditions of the IE
Licence.
Waste
Waste raw materials may occasionally arise, for on-site collection and
storage, prior to disposal as hazardous solid waste.
4.5 Blending
4.5.1 Description
Different batches of API and PEG 4000 powder are charged to Conical Screw
Blender, and mixed to get a homogenous mixture of PEG and API enzyme
activity throughout.
4.5.2 Emissions
Air
The blending process is conducted in a closed environment to contain any
dust emissions arising, which are then directed to the general dust collection
system for that processing area, subject to HEPA filtration and vented to
atmosphere via a designated main emission point.
Sewer
Wastewater emissions will arise following rinsing of the blending equipment
which will be directed to the process effluent system on-site and discharged in
accordance with the conditions of the IE Licence.
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Waste
Waste raw materials may occasionally arise, for on-site collection and
storage, prior to disposal as hazardous solid waste.
4.6 Cooling
4.6.1 Description
The material is cooled to room temperature and discharged into containers.
4.6.2 Emissions
Air
There will be no significant emissions to air from this operation.
Sewer
There will be no significant emissions to sewer from this operation.
Waste
Waste raw materials may occasionally arise, for on-site collection and
storage, prior to disposal as hazardous solid waste.
4.7 Milling
4.7.1 Description
The granules are then milled to a particle size suitable for compression.
During the milling process the temperature is controlled to below the melting
point of the Polyethylene Glycol (PEG).
4.7.2 Emissions
Air
The milling process is conducted in a closed environment to contain any dust
emissions arising, which are then directed to the general dust collection
system for that processing area, subject to HEPA filtration and vented to
atmosphere via a designated main emission point.
Sewer
Wastewater emissions will arise following rinsing of the milling equipment
which are directed to the process wastewater system on-site and discharged
in accordance with the conditions of the IE Licence.
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Waste
Waste raw materials may occasionally arise, for on-site collection and
storage, prior to disposal as hazardous solid waste.
4.8 Compression
The milled granules are compressed into minitabs using a rotary tablet press.
4.8.1 Emissions
Air
The compression process is conducted in a closed environment to contain
any dust emissions arising, which are then directed to the general dust
collection system for that processing area, subject to HEPA filtration and
vented to atmosphere via a designated main emission point.
Sewer
Wastewater emissions will arise following rinsing of the press which are
directed to the process wastewater system on-site and discharged in
accordance with the conditions of the IE Licence.
Waste
Waste raw materials may occasionally arise, for on-site collection and
storage, prior to disposal as hazardous solid waste.
4.9 Film Coating
4.9.1 Description
The coating dispersion is manufactured by dissolving Hypromellose Phthalate
in Acetone in a mixing vessel. After complete dissolution of Hypromellose
Phthalate in Acetone the other coating components are added to the polymer
solution in the container. The minitabs are then coated with the enteric coating
solution using Wurster type coater. The coating is performed in multiple
sublots.
The pre-prepared solution is applied to the fluidized bed, using spray nozzles.
The coated pellets are dried in the coater and are discharged into containers.
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4.9.2 Emissions
Air
The coated pellets are heated to remove the Acetone from the coated pellets.
Volatised Acetone is directed to the Thermal Oxidiser where it is chemically
oxidized to form CO2 and H2O.
Sewer
Equipment and container cleaning rinses will generate wash waters which are
directed to the process wastewater system on-site and discharged in
accordance with the conditions of the IE Licence.
Waste
Equipment cleaning wipes and cleaning waste products will be collected and
handled as hazardous waste. Initial cleanings are disposed as solid
hazardous waste.
4.10 Blending of the Coated Tablets
4.10.1 Description
The dried coated pellets are transferred to the mixer, to produce a
homogenous batch.
4.10.2 Emissions
Air
Dust extraction is provided for emissions arising. As the material is now at the
final product stages, emissions arising are considered negligible.
Sewer
There are no direct emissions to sewer arising from the tablet sorting process.
Waste
Solid waste comprising reject tablets can arise for disposal as hazardous
waste.
4.11 Sieving
4.11.1 Description
The dried enteric coated pellets are separated by using a tumbling sieving
machine with screens to remove any broken / twinned tablets. The sieved
minitabs are sampled, tested for enzyme activity and stored in containers.
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4.11.2 Emissions
Air
Dust extraction is provided for emissions arising. As the material is now at the
final product stages, emissions arising are considered negligible.
Sewer
There are no direct emissions to sewer arising from the tablet sorting process.
Waste
Solid waste comprising reject tablets can arise for disposal as hazardous
waste.
4.12 Encapsulation
4.12.1 Description
The Pancrelipase delayed-release pellets are encapsulated into hard gelatin
capsules on an encapsulator. The target fill weight for a particular batch is
calculate based actual lipase activity in the batch, calculated as a ratio of the
target lipse activity for that dose
Finally, the capsules produced are packed (in-process capsule storage) in
polyethylene bags, which are placed in disposable high density polyethylene
containers.
4.12.2 Emissions
Air
Dust extraction is provided for emissions arising. As the material is now at the
final product stages, emissions arising are considered negligible.
Sewer
There are no direct emissions to sewer arising from the tablet sorting process.
Waste
Solid waste comprising reject tablets can arise for disposal as hazardous
waste.
4.13 Packing
4.13.1 Description
The Finished Product tablets or capsules are packed in accordance with
packaging procedures.
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4.13.2 Emissions
Air
All emissions arising in the packaging area are vented via general dust
collection systems, prior to emitting to atmosphere via designated main
emission points, and HEPA filtration.
Sewer
There are no emissions to sewer from the packaging operations.
Waste
Waste arising will primarily be solid in nature comprising hazardous waste
such as damaged Finished Product and non-hazardous fractions of packaging
waste.
4.14 Receipt into Warehouse
4.14.1 Description
The finished products are received into the warehouse.
4.14.2 Emissions
Air
There will be no significant emissions to air from this operation.
Sewer
There will be no significant emissions to sewer from this operation.
Waste
Waste paper may arise occasionally which will be disposed of as non-
hazardous waste and recycled were possible.
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5 Clean-in-place (CIP) Operations
All process effluent generated at the site is generated by washing of process
vessels, mostly automatic washes (referred to as CIP). CIP washes are
preceded by a flush. IBCs and some parts of equipment are washed manually
in dedicated washing areas.
Certain washes use only hot water, whereas other washes use Oxonia
(sterilising agent) in addition to hot water or CIP95 (a detergent based on
alkali and complexing agents). The cleaning of certain equipment does not
generate a wastewater discharge to sewer. There is no firm schedule or
timing for washing of equipment. Some tanks are washed every day, however
most of the CIP washes takes place after a production run.
Effluent arising from CIP activities will undergo preliminary treatment on-site
comprising load balancing, pH correction and temperature correction prior to
discharge via sewer to the Carrigtwohill Waste Water Treatment Plant
(WWTP).
6 Process Effluent Abatement
The AbbVie facility has an effluent treatment system on-site. The site’s
effluent management system consists of an automated pH neutralisation
system including a balancing tank at the effluent outflow point.
In addition, there is a system for solids separation and removal from the
process effluent stream (lamella clarifier). However, this system is not in
operation as the suspended solids in the effluent are within the limits of the
sites current Discharge License; Licence Number (Reg. Ref.): IW-DTS-
685667-0.
More details information regarding process effluent abatement is presented in
attachment F, Treatment, Abatement & Control Systems.
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7 Emissions to Atmosphere Abatement
In accordance with the requirements of BAT (Best Available Techniques),
AbbVie ensures that preventative measures are taken against atmospheric
pollution and that suitable abatement technologies are implemented to reduce
the impact on the environment.
7.1 Thermal Oxidiser (TO)
The new Creon DR development will result in the installation of a Thermal
Oxidiser (TO) for the abatement of solvent emissions. This thermal oxidiser
will be used for the destruction of solvent fume emissions which are collected
from the Creon DR production building. This abatement system is in line with
the Best Available Techniques (BAT) as outlined in Section 5.2.3 of the 2006
‘Best available techniques for the manufacture of organic fine chemicals’
document. The emissions from this unit will be continuously monitored by a
fixed continuous emissions monitoring system (CEMS) for key parameters to
be agreed with the Agency.
7.2 Dust Control Systems
It is proposed to use HEPA filters to abate particulate matter from main
emission sources. The efficiency of these filters is >99.95% and filter
performance is verified by way of integrity testing (ISO 14644-3:2005).
The Engineering Department is responsible for supervising the integrity
testing of HEPA filters, Air Flow Velocity Measurements and non-specific air
borne particle counts. Testing, review and interpretation of the results is the
responsibility of the approved contractor and the Engineering Department.
Furthermore, spare filter elements and panels are maintained on-site at all
times.
Emissions to Atmosphere and process effluent emissions are detailed in
Section E of the main application.
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8 Process Control System
The Building Management System at AbbVie is used to control the heating,
ventilation and air conditioning (HVAC) equipment serving production areas,
corridors, packaging rooms, offices and utilities buildings. This includes
control of air handling units, heat exchangers, extract fans and some ancillary
equipment.
The system is also used as a utilities tool for monitoring and troubleshooting
various items of equipment. Analogue and digital data can be taken from
almost any equipment containing electronic control equipment and can be
forwarded to the BMS system for remote monitoring and alarm reporting.
9 Monitoring
AbbVie will implement a programme to ensure that all emissions are
monitored in accordance with IE licence requirements. Details of monitoring
points and methodologies are included in section F.2 of the application.
10 Water Supply System
Potable water supply to the facility is provided exclusively by the public water
supply connection to the IDA Business Park water main which is supplied by
Irish Water. There is no water used up in the process, so the water intake
approximates discharged water volumes. All waste water is discharged into
the sewer. There are no discharge points directly to surface water or ground.
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11 Stormwater Management/ Firewater and Spill
Management
All production will take place exclusively within the production buildings and
loading and unloading of materials will only take place on designated hard-
standing areas.
Under the IE Licence AbbVie will be required to implement and maintain an
Environmental Management Programme (EMP) which will include detailed
measures for the prevention of pollutant release to the storm water drainage
system. Preventative measures which are in place at the AbbVie site include
full secondary containment (bunding) of all internal and external vessels
containing potentially polluting materials. These preventative measures will be
applied to all proposed new infrastructure as required, in the form of either
local bunding, or remote bunding. All bunds and underground process
infrastructure will be integrity tested every 3 years.
Procedures are in place for the use, handling and storage of all chemicals on-
site to ensure that the risk of spills is minimised. Training is provided to staff in
relation to the handling and storage of all chemicals on-site to ensure the risk
of spills is minimised.
Regular routine maintenance programmes are in place for the process
equipment, environmental process equipment, continuous monitors,
laboratory equipment and sampling equipment.
The emergency response teams are also trained in containment measures
with respect to spillages including procedures for containment including; use
of spill kits, spill cleaning and safe disposal of clean-up materials.
Storage areas, production facilities and roadways will have impervious
surfaces, which will drain to collection systems. Plant and vehicles serviced
regularly to minimise leaks. Fuels and lubricant will be stored in designated
bunded areas and refuelling of plant will only be permitted in controlled areas
only.
A fire-water risk assessment recently undertaken has concluded that, based
on the assessment and the EPA’s Guidance Note, firewater retention facilities
for the AbbVie site are not required. For more information, refer to the
Firewater Risk Assessment included in Attachment J of this application.
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12 Fire Water Supply System
The existing fire hydrants are supplied via a 200mm Local Authority ductile
iron water main that enters the existing campus at two locations.
The current fire suppression system comprises:
Firewater holding tank 500m3;
2 x Firewater pumps (5.68m3/min): Diesel Fire Pump & Electric Fire Pump;
Automatic Sprinkler System fed by a 500m3 firewater fighting tank (covers all areas of the site, except Chemstore and Waste store buildings);
7 x fire hydrants (H 1 to H7);
150 mm firewater main; and
Fire extinguishers throughout all areas of the site.
It is AbbVie’s policy that, in the event of a fire, the safe-guarding of life takes
precedence over all other matters. AbbVie provides Emergency Response
Teams (ERT) training to all core ERT team members and conduct emergency
drills bi-annually. In the event of a fire, the Emergency Response Plan is
implemented. The plan addresses in depth the actions to be taken in the
event of a fire; gas release; bomb threat; chemical spillage and environmental
incident. It is site policy that there is always an Emergency Response Team
and Leader available to respond to an accident or incident. In the event of a
fire, the primary objectives are extinguishment and containment. Fire
detection, fire protection and firefighting equipment is provided on-site and
maintained in accordance with recognised standards.
The site is serviced by Midleton Fire Brigade, based at Market Green,
Midleton, which is approximately 10 kilometres from the site. In the event of a
fire alarm being raised, travel time from this fire station to AbbVie would be
estimated to be approximately 10 minutes depending on traffic. The site’s
Emergency Response Plan states that it is responsibility of the “site incident
controller” to alert emergency services. Members of Midleton fire station have
visited AbbVie to familiarise themselves with the layout of the facility, location
of services and to offer general advice to management. The AbbVie site
operates 24/5, however there is a 24/7 security presence at the site.
Once an IE licence has been issued, in the event of an accident or incident,
AbbVie will be required to notify as appropriate; the EPA, Local Authority, Fire
Service, Health Service Executive, Gardaí, Health and Safety Authority,
Fisheries Board, Sanitary Authority, Food Safety Authority and/or Harbour
Masters, of all incidents relating to the environment. Approval and guidance
from the EPA will be sought prior to the disposal of materials and retained fire
water.
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13 Scale-Up Facility
13.1 Description
AbbVie is currently operating a 1/10th size scale-up facility to trial the
production of Creon DR.
13.2 Emissions
Air
Particulate matter, including API particulate is generated during the process.
Emissions from the Coater are abated using a HEPA filter. The Mill and
Extruder have vents but are not currently filtered. The Tablet Press and
Encapsulator are vented and filtered.
Sewer
Waste water will be assessed against licence limits before discharge to sewer.
CIP wash water is collected in IBCs for disposal by an approved waste
contractor.
Waste
Waste Acetone Solution is collected separately in drums for disposal by an
approved waste contractor.
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14 Laboratory Facilities On-site
14.1 Description
There are a number of laboratories at the AbbVie facility, which are involved in
quality control, quality assurance testing activities and product development.
Typical laboratory analyses comprise determination of raw material purity,
product assay and dissolution rate test, tests for chemical impurities and
measurement of physical characteristics.
14.2 Emissions
Air
Air emissions primarily arise in laboratories from fume hoods and similar
systems. All emissions arising are vented to atmosphere as minor emission
points.
Sewer
There will be emissions to sewer from the laboratory operations, including
glassware washers, sinks, etc.
Waste
Waste arising will primarily be hazardous liquid waste including solvent waste,
laboratory chemicals etc. and also solid waste including empty laboratory
containers and bottles, laboratory utensils (pipettes etc.) testing materials etc.
this waste is collected and transported off site for treatment. Non-hazardous
waste including packaging waste and administrative waste will also occur.
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15 Noise
There have been no issues with noise from the AbbVie facility in recent years.
The activities at this plant operate in accordance with strict environmental
controls and AbbVie demonstrates compliance with these by continuing to
satisfy compliance with the international environmental standard ISO14001.
Along with this, and as part of previous planning conditions, AbbVie is subject
to various environmental conditions as issued by Cork County Council (CCC).
To satisfy one of the requirements of ISO14001 AbbVie is required to carry
out an environmental noise survey at the facility. The purpose of this survey is
to measure the noise levels from the site and assess them against the noise
criteria detailed in their planning conditions.
Condition 6 of a previous planning condition, which relates to noise, stipulates
noise criteria which the facility must adhere to.
“Noise levels emanating from the proposed development when
measured at the site boundaries shall not exceed 55dBA (15 Minute
Leq) between 0800 hours and 2000 hours Monday to Friday inclusive,
and shall not exceed 45dBA (15 minute Leq) at any other time.
Measurements shall be made in accordance with ISO recommendation
R.1996/1 “Acoustics – Description and Measurement of Environmental
Noise, Part 1: Basic Quantities and Procedures.” At no time shall the
noise generated on-site result in an increase in noise level of more than
10dBA above background levels at the boundaries of adjoining
premises. Background noise level shall be interpreted as the mean
minimum sound level at the relevant place and time in the absence of
noise from the premises the subject of the application.
If noise contains a discrete, continuous tone (whine, hiss, screech, hum
etc.), or if there are distinctive impulses in the noise (bangs, clicks,
clatters or thumps), or if the noise is irregular enough in character to
attract attention, a penalty of +5dBA will be applied to the measured
noise level and this increased level shall be used in checking
compliance with the specified levels.”
Previous noise surveys have noted that, in several instances, noise levels at
the site boundary have exceeded the 45dBA limit stipulated in Condition 6.
However, in accordance with the EPA’s document, Guidance Note for Noise:
Licence Applications, Surveys and Assessments in relation to Schedules
Activities (NG4), these areas are classed as non-sensitive locations as they
are not residential. The AbbVie facility is located next to neighbouring
industrial facilities who also contribute to the noise emissions in the immediate
area. Previous noise surveys have advised that in order to provide a more
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reasonable assessment of the noise impact from the facility; noise emissions
from AbbVie should be assessed at the nearest noise sensitive location
(NSL). The closest NSL to the AbbVie facility is the Castle Lake residential
estate which lies approximately 200m to the east. This approach would also
satisfy the methodology in NG4.
AbbVie has never received any complaints relating to noise, or otherwise, and
can demonstrate satisfactorily that noise has never been an issue at the
Carrigtwohill facility.
New equipment suppliers are advised of the noise limits in NG4 and that any
new equipment being installed must meet those limits. Therefore, it is
expected that the existing limits will be met once any new equipment
associated with this application is installed.
16 Waste
Solid and liquid waste (hazardous and non-hazardous) is disposed or recycled
by licensed waste contractors as agreed with the Agency. A full record of all
waste taken off site is maintained in accordance with the national and
European waste legislation.
For more information regarding waste management, refer to Attachment H:
Materials Handling.
17 Accident Prevention
The Emergency Response Plan contains information on the measures in
operation to reduce the impact of an accidental emission or spillage. The
Emergency Response Plan also includes the provisions for response to
accidental emissions and emergency situations which arise outside of normal
working hours i.e. night-time, weekends and holidays. Site Management will
update the Emergency Response Plan to ensure it is adequate to cover any
new equipment installed. It is not anticipated that there will be any significant
additional accident prevention measures to be undertaken in relation to this
development.
For more information regarding Accident Prevention and Emergency
Response procedures, refer to Attachment J: Accident Prevention and
Emergency Response.
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18 Cessation of Activities
AbbVie has prepared a Decommissioning Management Plan as part of its
Industrial Emissions licence application, to ensure that in the event of a
sudden closure, the site would no longer pose a risk to the environment.
Should circumstances arise whereby it becomes necessary to shut down the
facility, then AbbVie would, at a minimum, implement the Decommissioning
Management Plan to ensure that any negative environmental impact is
avoided. The overall strategy of the Plan is to bring the facility to an
environmentally inert state. AbbVie does not intend to remove all equipment,
structures or systems from the site other than certain specialist equipment.
Once of the plant and/or equipment has been decommissioned and
decontaminated, it will then be tested to ensure there is no risk of
environmental pollution remaining. It is proposed that, following
implementation of the Decommissioning Management Plan, the facility would
be decommissioned to a state whereby it would remain suitable for future
industrial use and its condition would not pose a risk to the public.
The Decommissioning Management Plan will be reviewed annually and
updated as required. A copy of the DMP for the AbbVie facility is included in
Attachment K of this application.
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19 BAT
BAT stands for the Best Available Technique. BAT for a particular sector is
defined in the EU BREF (BAT Reference) document. Attachment I.8 of the
application addresses in detail how the facility intends to comply with BAT.
Where a BAT Conclusions document has not been issued by the Commission
(as is the case for the facility in question) then the ‘BAT Conclusions’ chapter
of the relevant BREF should be consulted. As advised by the EPA, in this
case the relevant BAT and BREF documents are as follows:
‘BAT Guidance Note on Best Available Techniques for Solvent Use in
Coating, Cleaning and Degreasing’, EPA, 2008.
‘Reference Document on Best Available Techniques on Surface
Treatment Using Organic Solvents’, EU IPPC Bureau, 2007.
‘Reference Document on Best Available Techniques in Common Waste
Water and Waste Gas Treatment / Management Systems in the Chemical
Sector’ EU IPPC Bureau, 2003.
‘Reference Document on Best Available Techniques for Energy
Efficiency’ EU IPPC Bureau, 2009.
‘Reference Document on the General Principles of Monitoring’ EU IPPC
Bureau, 2003.
‘Reference Document on Best Available Techniques on Emissions from
Storage’ EU IPPC Bureau, 2006.
AbbVie was found to comply with all relevant BAT requirements.
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