consent of copyright owner required for any other use. non ... · copy of the annual environmental...

Attachment A.1

Non-Technical Summary

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TABLE OF CONTENTS

1 OVERVIEW .............................................................................................. 1

1.1 AbbVie Cork – Current Profile ............................................................ 2

1.2 Site Location ........................................................................................ 3

1.3 Characteristics of the Site .................................................................. 3

1.4 Environmental Management .............................................................. 4

1.5 Occupants/Staffing ............................................................................. 4

1.6 Existing Permissions .......................................................................... 5

1.7 Company History ................................................................................ 5

1.8 Site History .......................................................................................... 7

1.9 Requirement for an IE Licence ........................................................... 8

2 NEW DEVELOPMENTS ........................................................................... 9

3 BEST AVAILABLE TECHNIQUES ........................................................ 10

4 FACILITY OPERATIONS ....................................................................... 11

5 ENVIRONMENTAL IMPACTS ............................................................... 12

6 RAW MATERIALS AND PRODUCT ...................................................... 16

6.1 Materials ............................................................................................. 16

6.2 Products ............................................................................................. 17

7 EMISSIONS TO ATMOSPHERE ............................................................ 18

7.1 Boiler Emissions ............................................................................... 18

7.2 Main Emissions ................................................................................. 18

7.3 Minor Emissions ............................................................................... 19

7.4 Fugitive & Potential Emissions ........................................................ 19

7.5 Control & Abatement Technology ................................................... 20

7.6 Assessment of Impact of Atmospheric Emissions ........................ 21

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8 EMISSIONS TO SEWER ........................................................................ 22

8.1 Process Emissions ........................................................................... 22

8.1.1 Process Effluent Treatment .......................................................... 22

8.1.2 Assessment of Impact of Emissions to Sewer/Waters ............... 23

8.2 Sanitary Emissions ........................................................................... 23

9 EMISSIONS TO SURFACE WATER ..................................................... 23

10 EMISSIONS TO GROUND ..................................................................... 24

11 NOISE EMISSIONS ................................................................................ 25

12 WASTE ................................................................................................... 26

12.1 Waste Segregation ............................................................................ 26

13 SAMPLING AND MONITORING ............................................................ 27

14 ENERGY EFFICIENCY .......................................................................... 27

15 CONTAINMENT OF ACCIDENTAL SPILLAGES & EMISSIONS ......... 28

16 EMERGENCY RESPONSE .................................................................... 28

17 DECOMMISSIONING ............................................................................. 29

Site Layout Map

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1 Overview

AbbVie (Fournier Laboratories Ireland Ltd.) is a biopharmaceutical tablet

manufacturing and scale-up development facility located in the IDA Industrial

Estate in Carrigtwohill, Co. Cork.

The operation is a modern bulk tablet finish facility, manufacturing solid and

capsule formulation using state-of-the-art technology. The facility specialises

in Active Pharmaceutical Ingredient (API) particle size reduction resulting in

lower dosage formulations. The highly sophisticated technology on-site

enables delivery of products and processes from small scale clinical trial

supply to larger commercial manufacturing. API is not manufactured at the

Carrigtwohill facility. AbbVie’s focus is on developing medicines that can

provide strong clinical performance, measurable patient benefit and economic

value, particularly in areas where there is significant need, such as hepatitis

C, neuroscience, immunology, oncology, chronic kidney disease,

cardiovascular disease and women’s health.

Operations are based on formulation activities, consisting of blending of raw

materials, granulation, drying and coating processes, with subsequent filling

and packaging operations and product distribution from the site. Most of the

raw materials used for production are solids (powder or granules) which are

mixed with purified water.

The company is committed to a cleaner, healthier environment and

acknowledges its duty to ensure that all activities are conducted in an

environmentally responsible manner. The site’s EHS&E policy objectives are

driven by the environmental principles of prevention, reduction, re-use and re-

cycle.

The existing development has a total building area of approximately 14,000m2

over two stories. The total site area at AbbVie is c. 5 ha. The total

hardstanding area of the site, including buildings’ roofs, roads and paved

ground, is c. 2 ha.

The principal buildings on-site at present are identified below:

Production buildings;

Up-scale facility (process development);

Laboratory;

Product warehouse for storing finished products (currently under

construction – due for completion Q1 2017);

Offices and canteen;

Waste store building;

Chemstore building;

Boiler room;

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Effluent treatment facility;

Fire pump house;

Electrical switch-rooms.

The site layout is shown in Drawing A1, with the main features identified.

1.1 AbbVie Cork – Current Profile

The historical focus of the Cork facility has been the pharmaceutical

manufacture of oral solid dosage products for a variety of markets including

the US and EU.

AbbVie Cork’s product lines are comprised of traditional blending, tableting

and encapsulation of pharmaceuticals.

Almost 150 people (including contractors) work at this drug product facility

which has a capacity of 2 billion tablets per year, depending on the tablet

configuration.

AbbVie Cork’s historical production profile has relied on the manufacture of

TriCor and Trilipix drugs for the treatment of dyslipidaemia. These products

are already off patent and Group sales have reduced dramatically over the

last number of years; $2.1bn in 2012 to $179m in 2015, due to other generic

substitutes on the market.

The demand for these traditional products is projected to continue to diminish

over the next 3 years due to:

Products coming off patent and the resultant increased competition

from “generic substitutes”;

Advancements in manufacturing;

Advancements in pharmaceutical and biologic technologies.

To continue to be relevant and strategically important, the Cork site needs to

move from a dependence on traditional oral solid dose facility and identify new

opportunities for growth.

The future growth of AbbVie Inc. will be based on innovative high value

products to treat unmet conditions. The strategic plan for the Corporation is

currently to double its revenue in the next number of years. This will create

significant growth opportunities for those manufacturing sites that are

strategically aligned with its corporate philosophy.

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1.2 Site Location

The AbbVie facility is located in the IDA Business Park in Carrigtwohill. This

development is situated approximately 1 km west of Carrigtwohill town, in the

townland of Anngrove. The IDA Business Park is located to the north of the

N25 road, which can be accessed via the R624 intersection at Cobh Cross.

The facility is generally well screened from the surrounding residences. The

nearest residences are in the Castle Lake residential estate which lies

approximately 200m to the east of the AbbVie site. The Glounthaune-Midleton

railway line bounds the site to the north.

Carrigtwohill is located approximately 10km to the east of Cork city and 6km

to the west of Midleton. It is to the north of the N25 dual carriageway section

known as the East Cork [or Eastern] Parkway, which provides a first class

road corridor between Cork City and Midleton.

The site location map is shown in Attachment B.2.

1.3 Characteristics of the Site

The topography of the site is generally flat for the most part with an average

ground level varying from 6.5m AOD along the front southern boundary

increasing to 7.5m AOD around the Main Production Building. There is an

embankment located along the rear of the Main Production Building that

decreases in gradient towards the northern boundary line. The ground level

rises from an average level of 7.5m AOD to 12.5m AOD along the top of the

embankment over a horizontal distance of 4.7m and rises further to 20m AOD

from the top of the embankment to the boundary line of the existing campus.

The finished floor level of the main facility is given as 7.79m AOD.

Apart from the relatively steep embankment located towards the rear of the

site, there are no other notable site topographical features above ground on

the site.

The bedrock geology in the area consists of Dinantian Lower Impure

Limestones and Dinantian Pure Unbedded Limestones. Groundwater

vulnerability is classified as High (on a scale of Low, Moderate, High, and

Extreme) and is located on a gravel aquifer which has been classified as

Regionally Important - Karstified (diffuse) (Rkd). In general, groundwater is

assumed to follow the local topographical gradient, migrating southward and

ultimately discharging to Cork Harbour.

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The closest waterbody is a stream (Tibbotstown 010) which runs north to

south through the IDA industrial estate (within 100m of the site) from

Anngrove to join the Slatty Water at Slatty Bridge, 800 m south of the site.

The site discharges pre-treated process effluent to Irish Water Sewer. Surface

water is discharged, via the local authority network, to the Slatty River Estuary

(Slatty Water) which in turn feeds into the Great Island Channel, part of Cork

Harbour.

1.4 Environmental Management

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.

AbbVie is committed to implementing and employing the highest EHS

standards. Environmental awareness is a priority of the company.

The Environmental Health & Safety (EHS) Manager and EHS Department

ensures that day-to-day operations of the facility are conducted while

minimising risk of harm to humans and the environment.

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.

1.5 Occupants/Staffing

Approximately 135 permanent staff are currently employed at AbbVie. Staff

numbers may increase to 175-195 by 2020-2021 following commissioning and

commencement of commercial operations in the new Creon DR Production

building. In addition to the permanent staff, approximately 30-40 contract staff

are routinely on-site supporting projects and commercial volume. The plant

operates a combination of days, 24-hours, five and seven day operations.

AbbVie has a 24-hour security presence on-site at all times. Access to the

facility is controlled via secured access gates.

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1.6 Existing Permissions

The site’s activities, in terms of effluent management and the resulting

wastewater discharges, are deemed appropriate to be licenced under Section

16 of the Local Government (Water Pollution) Acts 1977 to 2007. The site

currently operates under a Discharge to Sewer License from Irish Water;

Licence Number (Reg. Ref.): IW-DTS-685667-01. Previous to this, the site

operated under a Trade Effluent Licence issued by Cork County Council

(Licence No. W.P (S) 09/05).

1.7 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.

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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.

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.

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1.8 Site History

The IDA Industrial Estate was first developed in the 1970’s before which time

the site was used for agricultural purposes. The first activity on the existing

AbbVie site was in 1978, when the site was 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 used by Pfizer for storage.

In 2001, the site was acquired by Fournier Pharma. Having secured planning

permission, Fournier expanded the site in 2002 through the addition of a

tabletting plant including; production, R&D facilities, warehousing, staff &

office areas, laboratory, services, security & utility buildings, storage tanks and

associated works. The site completed commissioning and went into full

production of Fenofibrate tablets in May 2004.

In 2005, Fournier Pharma was acquired by the Belgian chemical company

Solvay Pharmaceuticals. 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 facilities 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 becomes an independent company.

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1.9 Requirement for an IE Licence

AbbVie is applying to the Environmental Protection Agency (EPA) for an

Industrial Emissions Licence (IEL) for the operation of a biopharmaceutical

manufacturing and scale-up development facility at the IDA Industrial Estate in

Carrigtwohill, Co. Cork.

Based on market demand, AbbVie plans to introduce a new manufacturing

suite to the site to supply Creon DR (Creon) to the market. The production of

Creon will require the use of solvent in the manufacturing process. The

expected annual quantity of solvent usage is such that AbbVie will require an

Industrial Emissions (IE) licence to carry out this process. The relevant class

of activity in the First Schedule of the EPA Act 1992, as amended, are as

follows:

- 12.2.1 The surface treatment of substances, objects or products using organic solvents, in particular for dressing, printing, coating, degreasing, waterproofing, sizing, painting, cleaning or impregnating, with a consumption capacity of more than 150 kg per hour or more than 200 tonnes per year.

Notification of the application was posted at the site location; submitted in

writing to Cork County Council, and advertised in the Evening Echo, issue of

29th October 2016.

Planning Permission has been applied for to Cork County Council for the

proposed development (Ref. No. 166170). An Environmental Impact

Statement was included in the planning package. These documents have

been included in this IEL application as attachments.

The activity does not come under the Chemicals Act (Control of Major

Accident Hazards Involving Dangerous Substances) Regulations 2015 (S.I.

No. 209 of 2015). It has been concluded that the proposed increase in solvent

storage and usage will not result in any change in COMAH/Seveso status of

the site.

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2 New Developments

AbbVie is among the leading producers of pharmaceutical products in the

world. A significant portion of the company’s product portfolio is in the

biopharmaceutical category and many of these products are currently under

development in the company’s research facilities. In late 2015, the

Carrigtwohill facility was selected by AbbVie Global as the optimum site for

the development of a new Creon DR tablet finishing facility. The need for such

a facility was due to a current shortfall in the supply of Creon DR to meet the

global demand for this product.

Creon DR (Delayed Release) is a prescription medicine used to treat people

who cannot digest food normally because their pancreas does not make

enough enzymes due to cystic fibrosis, swelling of the pancreas that lasts a

long time (chronic pancreatitis), removal of some or all of the pancreas

(pancreatectomy), or other conditions. AbbVie proposes to develop a new

tablet manufacturing line at the existing facility within the existing site

boundary to accommodate this new product. The development will include

modification and expansion to the existing facility. The new development will

also expand the production capacity for biopharmaceutical products at the

Carrigtwohill plant.

The new development will involve:

A building accommodating the new Creon DR production line;

Redevelopment of former warehousing area to accommodate

new Creon DR production related activities;

Installation of a solvent bulk storage tank;

Installation of a bulk liquid waste storage tank;

Installation of a Thermal Oxidiser (TO);

Commissioning of new plant and equipment.

The new development will consist of a dedicated Creon production building

with a total gross floor area of 1,808 m2 over four stories. The new

development will house the majority of the production equipment over these

four stories, which will be further sub-divided by access platforms,

mezzanines and interstitial spaces.

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3 Best Available Techniques

Processes are similar to existing site operations, which are well proven and

utilise Best Available Techniques (BAT), and will be operated using best

available practices. In particular, the technologies and systems to be

employed to minimise and control environmental emissions are considered to

comply with the standards of BAT. An assessment of BAT for the AbbVie

facility was undertaken and is included in this IEL application as an

attachment. The following BAT guidance documents, BREF or BAT

Conclusions decisions were relevant to the facility:

1. ‘BAT Guidance Note on Best Available Techniques for Solvent Use in

Coating, Cleaning and Degreasing’, EPA, 2008.

2. ‘Reference Document on Best Available Techniques on Surface

Treatment Using Organic Solvents’, EU IPPC Bureau, 2007.

3. ‘Reference Document on Best Available Techniques in Common Waste

Water and Waste Gas Treatment / Management Systems in the

Chemical Sector’ EU IPPC Bureau, 2003.

4. ‘Reference Document on Best Available Techniques for Energy

Efficiency’ EU IPPC Bureau, 2009.

5. ‘Reference Document on the General Principles of Monitoring’ EU

IPPC Bureau, 2003.

6. ‘Reference Document on Best Available Techniques on Emissions from

Storage’ EU IPPC Bureau, 2006.

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4 Facility Operations

Operations are based on formulation activities, consisting of blending of raw

materials, granulation, drying and coating processes, with subsequent filling

and packaging operations and product distribution from the site. The facility

specialises in Active Pharmaceutical Ingredient (API) particle size reduction

resulting in lower dosage formulations.

There are associated warehouse facilities both on-site and off-site which

provide storage facilities for raw materials and final product. AbbVie are

currently constructing a new warehouse on-site which will remove the

requirement for off-site storage. This new warehouse is due for completion in

early 2017.

In addition to production facilities, there is a 1/10th scale-up facility and a

range of production support facilities including chemical storage, laboratories,

warehousing, utility generation, effluent treatment facilities, maintenance,

offices, staff facilities and a cafeteria on-site.

A detailed description of existing and proposed operations at the facility is

given in Attachment D – Site Operational Description.

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5 Environmental Impacts

Environmental

Factor

Likely effects

identified

Brief description of

effect

Mitigation measures proposed to

control effect

Human Beings Health Effects

Use of lands for

industrial purposes

could result in

impact on public health

from water, air and

traffic effects.

The facility is located in an

established industrial site on suitably

zoned lands in an industrial area.

Emissions will be controlled and

abated where appropriate (in

accordance with the EPA IED

licence) to ensure compliance with

required environmental quality

standards.

Operations at the facility are carried

out in strict accordance with all Irish

and European regulations governing

safety in the work place with specific

regard to the regulations

implemented under the Safety,

Health & Welfare at Work Act, 2005

(as amended). AbbVie provides and

maintains appropriate fire protection

& prevention equipment, and

methods to protect the safety of its

employees and facility operations.

Increased

Employment

The project will

generate new jobs on-

site, in the locality and

region. This will have a

positive long term

impact by ensuring

that the economic and

social benefits

associated with the

site will continue into

the future.

Positive effect so no mitigation

required.

Flora and

Fauna

There would be no

significant impacts as

a result of the

proposed

development on the

Cork Harbour Natura

2000 sites considered

in the Report for

Appropriate

Assessment

Screening.

There are no predicted impacts on

ecology and therefore no proposed

mitigation measures.

Soil Removal of subsoil

during construction

phase (increased

Construction Stage

During construction of

the development, there

will be a risk of

Construction Stage

Construction Environmental

Management Plan includes

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Environmental

Factor

Likely effects

identified


effect


control effect

vulnerability to

contamination)

Accidental spills and

other leaks to ground

during operations

accidental pollution

incidences.

Excavations could

potentially result in

additional siltation in

adjacent surface water

bodies.

Operational Stage

Risk of accidental

contamination from

spillage and other

losses to soil.

measures to ensure silt laden waters

are controlled and managed on-site.

Operational Stage

All storage tanks will be bunded and

subject to regular integrity testing to

ensure spills and leaks are

contained and impacts minimised in

unlikely event of occurrence.

Provision of spill kits

Regular maintenance and monitoring

Training in Spill Response and

provision of relevant Standard

Operating Procedures (SOP’s).

Water Effects as above for

soil in relation to spills

and leakages.

Potential for impact on

receiving waters and

local drainage network

(including downstream

WWTP).

Firewater generation

in the event of major

fire event.

Construction Stage

During construction of

the development, there

will be a risk of

accidental pollution

incidences.

Excavations could

potentially result in

additional siltation in

adjacent surface water

bodies.

Operational Stage

Risk of accidental

contamination from

spillage and other

losses to groundwater.

Construction Stage

Construction Environmental

Management Plan includes

measures to ensure silt laden waters

are controlled and managed on-site.

Provision of surface water isolation

valves in the event of a fire or spill.

Operational Stage

All proposed storage tanks and

storage areas are bunded and will

be subject to regular integrity testing

to ensure spills and leaks are

contained and impacts minimised in

unlikely event of occurrence.

Provision of spill kits

Training in Spill Response and

provision of relevant SOP’s

Provision of surface water isolation

valves in the event of a fire or spill.

Separation of process, foul and

surface water drainage systems

Emissions will be controlled and

abated where appropriate (in

accordance with the EPA IED

licence) to ensure compliance with

required environmental quality

standards.

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Environmental

Factor

Likely effects

identified


effect


control effect

Air Dust and other

nuisances

from construction.

Emissions to

atmosphere

from boilers and

Thermal Oxidiser.

During emergencies,

backup power will be

provided by diesel

backup generators

which will also

generate emissions

with potential to

impact local air

quality.

Nuisance to

neighbouring site and

residences.

A variety of pollutants

will be released from

boilers (NOx, CO2,

etc.) and the

emergency generators

A dust minimisation plan will be

employed for construction stage.

Boilers will typically run on natural

gas thereby maximising efficiency

and minimising emissions. The

biomass boiler provides a carbon

neutral alternative to the gas boilers.

A suitable level of redundancy will be

incorporated into abatement systems

to ensure their maximum availability.

A comprehensive preventative

maintenance regime will also be

employed.

Operation of facility in accordance

with IED licence conditions will

ensure compliance with required air

quality standards and relevant

legislation.

Emergency generators will not run

during normal operations

Climate Emission of

greenhouse

gases from boilers

and the Thermal

Oxidiser.

A variety of pollutants

will be released (NOx,

CO2) which have the

potential to impact on

climate (and Irelands

national climate

change targets)

Due to the relative nature and

volume of emissions from the

proposed development, it is

anticipated the emissions will

have a negligible impact on

climate.

THE LPHW biomass boiler provides

a carbon-neutral alternative to the

gas boiler.

Landscape Landscape and Visual

Impacts

Negative impact as the

proposed development

will introduce a

different building

height to the site and

the surrounding

business and

technology park.

Visual impact from the

Thermal Oxidiser stack

No mitigation proposed as the site is

located in an industrial

area with low residential

population in the immediate

environs.

A high standard of external

finish to site buildings and

infrastructure is proposed.

Material Assets Use of natural

resources

including raw

materials,

water, power etc.

Depletion of resources

available from

suppliers, water supply

network, national grid,

etc.

The operation of the facility will

incorporate a variety of energy

efficiency measures to minimise the

use of natural resources and waste

generation.

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Environmental

Factor

Likely effects

identified


effect


control effect

Cultural

Heritage

Damage to previously

unidentified

archaeological

monuments during

construction

While the proposed

development includes

ground disturbance

associated with the

construction of new

buildings and for

ancillary works

including landscaping,

these works will occur

within previously

developed areas of the

site.

As development associated with this

proposal will occur within the existing

site and no impacts on

archaeological heritage are

expected, no further archaeological

mitigation measures are required.

Table: 1 EIS Summary the Likely Significant Effects of the Activity

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6 Raw Materials and Product

6.1 Materials

Bulk raw materials are currently stored in a warehouse located off-site. The

amount of raw materials required for production is delivered to the site daily.

On the 4th July 2016, AbbVie received planning permission (Planning Ref no.

164551) for the construction of a warehouse, with a gross floor area of

2,480m2, to the rear of the existing production building. Upon completion, this

warehouse will enable AbbVie to store all the sites raw materials,

intermediates and finished products on-site, and hence remove the

requirement for off-site storage.

Due to the nature of the activity, there are a number of individual raw

materials used on-site. These raw materials include chemical raw materials,

biological raw materials and media. In addition to production raw materials,

there is a range of materials used in laboratories and in the maintenance and

servicing of utilities on-site.

All materials and products are listed in Tables G.1 (i) and G.1 (ii) of this

application.

The raw materials utilised at the AbbVie facility for production operations may

be categorised as follows:

Physiologically active substances (Active Pharmaceutical Ingredients -

APIs);

Physiologically inactive substances (Excipients);

Purified Water;

Solvents (Creon DR only).

APIs form the physiologically active material in a tablet, which provide the

therapeutic effect in the tablet.

Excipients are typically biologically inactive substances, which are utilised in

tablet production for any of the following reasons:

(i) Coating: May be incorporated into tablet manufacture to apply a

different colour to tablets, to make tablets easier to swallow, improve

appearance or taste or for other reasons.

(ii) Binder: May be utilised as substances to bind the other ingredients

together prior to pressing.

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(iii) Disintegrators: May be incorporated into tablet manufacture to facilitate

rapid adsorption of the active ingredient after the tablet is ingested into

the system. This is achieved by the disintegrator causing the tablet to

swell resulting in the break-up of the tablet form and the release of the

active ingredients.

(iv) Diluents: May be utilised to varying degrees depending on tablet

specification. Diluents provide the inert material, which is mixed with

the active material to form the tablet.

(v) Lubricants: The addition of this substance is to improve movement of

the tablet mix in the processing stage, thus minimising blockages in

process pipelines.

Purified Water

All water is sourced from mains water and is treated and purified to the

required standard on-site. Purified water is used in the manufacturing process,

and for automated and manual cleaning of equipment.

Purified water is generated by the Reverse Osmosis (RO) Plant.

Solvents

The use of organic solvent (Acetone) is used in the Creon DR tabletting

process as a carrier for the coating dispersion. In addition, small quantities of

solvent are utilised in cleaning procedures for specific equipment systems.

Small quantities of organic solvents are also used in the laboratory.

6.2 Products

Currently, the facility is used for the commercial manufacture of six products –

TriLipix product is manufactured as a 135mg and 45mg capsule.

Fenofibrate product (TriCor) is a film tablet manufactured in two

dosage strengths (145mg and 48mg).

Kaletra is a Yellow film coated tablet, manufactured in one strength,

200mg/ 50mg.

Aluvia is a Red film coated tablet, manufactured in one strength,

200mg/50mg.

Cholib is a film coated tablet manufactured in two dosage strengths,

145/20 and 145/40 mg.

Viekirax is a film coated tablet manufactured in one strength,

12.5/75/50 mg

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7 Emissions to Atmosphere

7.1 Boiler Emissions

There are currently 3 boilers in operation at the AbbVie facility, 2 gas boilers,1

Low Pressure Hot Water (LPHW) woodchip boiler and 1 gas fired Low

Pressure Hot Water Boiler. The natural gas fuelled boilers at the Carrigtwohill

facility are below 5MW and hence are classified as minor emissions. The

woodchip boiler has a duty of 200kW which is below the 250 kW threshold

and hence has also been classified as a minor emission.

7.2 Main Emissions

Main emissions include all emissions of environmental significance. To

determine environmental significance, reference is made to the emission limit

value (ELV)/mass emission threshold used in the applicable BAT Guidance

Notes for this facility.

A summary list of main emission points to atmosphere is provided in Table 1

below, this includes both the existing and proposed main emission points.

Emission Reference

Point

Description

A2-1 Thermal Oxidiser Stack

A2-2 R370 Dust Collector Exhaust air

A2-3 Process Dust Collector Air Exhaust (M-13-1-DC-001)

A2-4 Fluid Bed Dryer Exhaust

A2-5 Dust collector exhaust (250mm diam)

A2-6 Scale Up Fluid Bed Dryer Exhaust

A2-7 Fluid Bed Dryer Exhaust (500mm diam)

A2-8 Glatt Vessel Vent

A2-9 Glatt Fluid Bed Dryer Exhaust (400mm diam)

A2-10 Glatt Fluid Bed Dryer Exhaust (250mm diam)

A2-11 Tablet Coater 1 Process Air Exhaust (M-14-1)

A2-12 Tablet Coater 2 Process Air Exhaust (M-14-2)

A2-13 Coater Exhaust (M-14-3)

A2-14 Future Emission Point 1 (Process Equipment)

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Emission Reference

Point

Description

A2-15 Dust Collector Vent to atm. (4 presses)




A2-19 Future Emission Dust Collector Vent to atm.


Table: 2 Summary of Main Emission Points to Atmosphere

7.3 Minor Emissions

Emissions not regarded as environmentally significant and having a discharge

associated with them during normal operation are regarded as minor emission

points.

A summary list of minor emission points to atmosphere is provided in Table

E.1 (iv): Minor Atmospheric Emissions.

7.4 Fugitive & Potential Emissions

Potential emission points are those that under Normal Operation do not emit

any discharge but may do so in Abnormal Operation, e.g.; pressure release

valves.

Fugitive emissions are emissions of gases or vapours from pressurised

equipment due to leaks and other unintended or irregular releases of gases.

Fugitive emissions are also associated with the use of highly volatile

substances which are inclined to vaporise in ambient atmospheric conditions,

such as the use of volatile organic compounds (VOCs).

A summary list of potential and fugitive emission points to atmosphere is

provided in Table E.1 (v): Fugitive and Potential Atmospheric Emissions.

The facility has been designed to minimise potential sources of fugitive

emissions arising from process areas and buildings. Fugitive emission

sources may be limited to minor leakages from connections, isolation and

control valves, relief valves, equipment seals and analysers. Fugitive solvent

emissions are expected to be minimal due to; the closed loop systems and

dedicated abatement systems on-site.

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Good housekeeping practices, preventative maintenance and routine

monitoring of equipment on-site minimise the potential for any equipment

leaks.

Conservation vents will be fitted to the bulk tank containing volatile materials

to minimise any fugitive emissions during storage of materials. Standard

operating procedures will be implemented to minimise any fugitive emissions

during road tanker loading/unloading.

Additionally, the use of >50 tonnes of organic solvent per annum will require

AbbVie to comply with the fugitive emission limit values specified for the

activity in European Union (Installations and Activities using Organic Solvents)

Regulations 2012, (S.I. No. 565 of 2012).

7.5 Control & Abatement Technology

As site operations comprises mainly tablet manufacture, process emissions

are generally particulate in nature. Control and abatement technology

employed on-site for particulate emissions include built-in extraction systems

for process equipment and local vacuum systems for areas associated with

tablet manufacture and packaging. Dust collection systems include a

combination of cartridge and high efficiency particulate air (HEPA) filters,

which are subject to routine monitoring and inspections. The HEPA filters

provide 99.95% efficiency for dust collection. As part of the Creon DR

development a number of HEPA filters will also be installed to abate the

potential emission of particulates.

Solvent vapour emissions may also arise on-site, primarily due to solvent use

in tablet manufacture. In particular, it is proposed that Acetone will be used as

a carrier of the coating dispersion in the production of Creon DR. It is

proposed that solvent vapours from the coating process will be directed to a

dedicated Thermal Oxidiser (TO). The TO will remove organic solvents from

the air stream through thermal oxidation.

All main emissions to atmosphere will be continuously monitored as per the

requirements of the IE Licence.

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7.6 Assessment of Impact of Atmospheric Emissions

Based on the information provided in the accompanying EIS and Air

Dispersion Modelling Report provided in Attachment I.1, it is concluded from

these assessments that the new development will have no significant impact

on local air quality. With regard to the regulations outlined in the Schedule of

Principal Polluting Substances in the Environmental Protection Agency

(Industrial Emissions) (Licensing) Regulations 2013, (S.I. No. 137 of 2013) the

assessment confirms that the operation of the new development will not result

in any breach of air quality standards.

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8 Emissions to Sewer

8.1 Process Emissions

There is one process effluent emission point to sewer (SE-1) at the AbbVie

site which is summarised in Table 3. The new processes will connect to the

existing process drainage system and therefore not result in an additional

emission point to sewer. Process emission drawings are included in

Attachment E to this application.

Ref No. Location Source

SE-1 Existing 305 mm diameter pipe

discharging to existing foul water sewer

line outside site boundary to the south.

Process Wastewater

Table: 3 Emissions to Sewer

Process effluent arises primarily from:

Automatic washings of process vessels (referred to as CIP washes) –

mostly blending and granulation vessels, and coating and drying

equipment;

Manual washings of equipment, such as IBCs and small equipment

parts between production runs;

Hand washes and showers taken by staff working in production;

Cooling tower make up water;

Boiler blowdown;

Laboratory sinks;

Surplus purified water;

Scale-up facility effluent.

8.1.1 Process Effluent Treatment

The site’s effluent management system consists of an automated pH

neutralisation system including a balancing tank.

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

site’s current Discharge License.

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8.1.2 Assessment of Impact of Emissions to Sewer/Waters

Respirometry testing previously conducted on process effluent from the

AbbVie facility indicated that the process effluent is not adversely affecting the

operation of the Carrigtwohill Waste Water Treatment Plant (WWTP). The

results indicated that the AbbVie sample tested exhibited no acute

toxicity/inhibition to a mixed microbial population, including nitrifying

organisms in the activated sludge, from the lower aeration basin of

Carrigtwohill WWTP. The impact of effluent emissions is discussed further in

Attachment I.3 to this application.

8.2 Sanitary Emissions

Sanitary wastewater from the AbbVie site is discharged into the IDA Park foul

network at two separate locations. Foul effluent consists of the canteen and

sanitary effluent from the toilets which is routed into the Irish Water foul sewer

and treated at the Carrigtwohill WWTP.

9 Emissions to Surface Water

Stormwater drainage at the site is collected separately from the process

drains and foul drains. The stormwater drainage is a conventional gravity

system. The stormwater drainage network serves the carpark, the roofs of the

buildings and other outdoor areas of the site. The quantities of surface water

arising on-site depend on rainfall. The existing drainage system operates as

follow:

1) Roof areas are drained via appropriate falls provided to roof surfaces

that allow the surface water run-off discharge to downpipes and into

the dedicated existing surface water network.

2) Hardstanding areas such as roads, paths and other hard standing

areas are drained by means of a series of gullies & drains that

discharge the surface water run-off into a dedicated existing surface

water network.

There are four petrol interceptors on the stormwater network through which

stormwater drains prior to discharge into the Cork County Council storm

sewer.

The Cork County Council stormwater sewer also serves other facilities in the

IDA Business Park within which the AbbVie facility is located. The combined

surface water is discharged from the Council stormwater sewer to the

receiving waters in the Great Island Channel. Surface water bodies are

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considered the sensitive receptor in the event of unconfined or uncontrolled

loss of contaminated water mixtures from AbbVie.

The new development will be connected to the existing system and will not

result in any additional emission points for storm waters. Surface water

emission drawings are included in Attachment E to this application.

Ref No. Location Source

SW-1 South-eastern Corner of Site (Adjacent

to main site entrance)

Storm Water Runoff

SW-2 Southern boundary of the site Storm Water Runoff

Table: 4 Emissions to Surface Water

10 Emissions to Ground

There are no emissions to ground from the AbbVie site. Results of

groundwater monitoring indicate groundwater of good quality.

AbbVie has completed a Baseline Report on soil and groundwater conditions

at the facility in compliance with the requirements of the Industrial Emissions

Directive. This report can be found in Attachment I.4 of the application.

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11 Noise Emissions

Noise sources on-site consists of internal equipment such as production plant

and ancillary plant i.e. boilers, compressors and refrigeration equipment. All

this equipment is contained within the production and plant buildings and

therefore has a minimal contribution to site noise emissions.

External noise sources consist of plant located on roofs and adjacent to

production buildings such as air handling units, abatement equipment and site

traffic.

Annual noise surveys conducted at the AbbVie site have demonstrated

compliance with typical noise emission conditions which would be applied by

the EPA for daytime and night-time measurements.

The minimisation of noise emissions has been an integral part of the design of

the new processes. Noise level criteria have been specified for particular

items of equipment to ensure that operation of the facility has minimal impact

on any noise sensitive receptors.

Noise attenuation measures will be used where possible. These will minimise

any noise emissions arising on-site. These measures include:

Selection of plant with low inherent potential for generation of noise

and/ or vibration;

Erection of barriers as necessary around items such as generators or

high duty compressors;

Location of any noisy plant as far away from sensitive properties as

permitted by site constraints; and

The use of vibration isolated support structures where necessary.

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12 Waste

Wastes arising at the AbbVie facility from process, laboratory, packaging, and

other typical sources are both hazardous and non-hazardous, and are

classified accordingly. Waste management programmes are controlled by

standard operating procedures.

As part of the new development, two bunded bulk storage tanks will be

installed. These tanks will contain virgin solvent and aqueous waste streams.

Under the ISO14001 Management System, waste management programmes

are on-going at the facility, incorporating the waste management principles of

prevention, minimisation, re-use, recycling, recovery and disposal. Waste

prevention is an integral part of the site’s Environmental Management System.

12.1 Waste Segregation

Waste management procedures are established on-site for waste

segregation, handling, labelling, documenting, storage and treatment/disposal

of waste off-site. Appropriate skips and containers appropriately identified and

labelled for particular waste streams are located at several points around the

site to allow the separation of material for recycling/recovery or disposal.

Examples of materials that are recycled include paper, cardboard, plastics,

food waste, timber pallets, scrap metal, batteries, waste oils and waste

electrical and electronic equipment. These wastes are segregated, classified,

packaged and labelled for transport by the licenced site waste contractor to

EPA or Local Authority licenced facilities for recycling/recovery. This process

is actively reviewed by EHS personnel.

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13 Sampling and Monitoring

Monitoring of emissions to the environment will be conducted in accordance

with BAT for the sector. AbbVie will ensure that all current and proposed

control and treatment systems will operate to specification and in compliance

with emission limit values to be prescribed by the IE Licence. Provisions for

monitoring, sampling and analyses of environmental emissions have been

incorporated into the design of the new development.

14 Energy Efficiency

The main energy using aspects at the site are:

Heating, ventilation and air conditioning systems;

Steam production;

Hot Water;

Chilled Water;

Plant & Equipment;

Compressed air systems.

Small quantities of diesel are available for use in the site firewater pumps, the

site emergency electrical generators and in a limited range of site transport

vehicles. Renewable energy is generated at the site through a 200 kW

Biomass boiler.

AbbVie has an Energy Management System certified to ISO 50001. Energy

conservation plays an integral part in plant operations at the Carrigtwohill site

and this is demonstrated by adhering to annual Environmental Management

System energy reduction targets.

As with existing operations, operation of the utilities of the new development

will be automated and controlled by a central building management system

(BMS) allowing for accurate control and monitoring of the systems to improve

energy efficiency. In addition, the new Thermal Oxidiser will be regenerative to

maximise energy efficiency.

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15 Containment of Accidental Spillages & Emissions

The surface water system collects surface water runoff from the site and

discharges to the municipal surface water sewer. The storage and

containment of all materials at the AbbVie facility will conform to IE Licence

requirements and best practice. Rainwater collected in bunded areas will be

inspected and if uncontaminated will be released to the municipal surface

water sewer under controlled conditions. If the bund water is contaminated,

then it will be appropriately stored on-site, prior to disposal off-site by an

appropriately licensed waste management contractor.

AbbVie has comprehensive spill response procedures in place to address the

emergency action and remedial measures required in the event of a spillage

on-site.

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 at Carrigtwohill, Co Cork are not required.

AbbVie has established emergency response procedures to minimise the

impact of accidental emissions on the environment.

16 Emergency Response

AbbVie ensures that appropriately high standards of safety and environmental

protection measures are implemented and appropriate equipment used to

prevent and minimise accidental/uncontrolled emissions to the environment.

In addition, AbbVie has established emergency response procedures for all

potential emergencies.

AbbVie has developed and implemented accident and emergency response

procedures for unexpected events that may occur during operations at the

facility. These include for accidental spills or leaks, emergency situations

outside of normal working hours and arrangements for abnormal operating

conditions including start-up, leaks or malfunctions. Standard operating

procedures are in place as part of the site OHSAS 18001 and ISO 14001

management systems. These procedures will be amended as required to

include the new development.

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17 Decommissioning

AbbVie has prepared a Decommissioning Management Plan (DMP) for the

Carrigtwohill site, providing details and costs for the decommissioning of the

site in the event of full or permanent partial closure. This DMP identifies all

known risks on-site and sets out the steps required to render safe, any soils,

materials, wastes, plant, buildings and equipment on-site that may result in

environmental pollution. This DMP will be reviewed and updated as required

on an annual basis.

The DMP for the Carrigtwohill site is included in Attachment K of this

application.

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Drawing A1 – Site Layout Map

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TEL 021-4396960 E-MAIL [email protected] WEB www.fgcl.ie2a RIVER HOUSE, BLACKPOOL PARK, BLACKPOOL, CORK.

CONSULTING ENGINEERS

NOTES:

1. ALL LEVELS RELATE TO ORDNANCE SURVEY

DATUM, MALIN HEAD

2. CO-ORDINATES TO IRISH GRID PROJECTION

LEGEND:

SITE BOUNDARY

FOURNIER LABORATORIESIRELAND LTD.,

IDA Industrial Estate, Carrigtohill,County Cork, Ireland.

A

CREON OPTIMISED

1000 SITE LAYOUT PLAN

16415-L-03

SITE LAYOUT PLAN

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Attachment B.1 Certificate of Incorporation

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( Number 345437

Certificate of Incorporation

I hereby certify that

FOURNIER LABORATORIES IRELAND LIMITED

is this day incorporated under the Companies Acts 1963 to 1999 and that the company is limited.

Given under my hand at Dublin, this

Thursday, the 12th day of July, 2001

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Attachment B.2 Site Location Map

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EPA Export 14-11-2016:15:20:06



REPRODUCED BY PERMISSION OF ORDNANCE SURVEY IRELAND LICENCE NO. EN0054716É Ordnance Survey Ireland / Government of Ireland.

Reproduced by Permission ofOrdnance Survey Ireland,Licence No. EN 0054716É Ordnance Survey Ireland / Government of Ireland.

SCALE 1:10560 (6" = 1 mile)Cork O.S. Sheet CK075

LEGEND:

BOUNDARY TO WHICH

THE APPLICATION

RELATES

PROPOSED

SITE

FOURNIER LABORATORIES

IRELAND LTD.

16415-L-01 A

CREON OPTIMISED

1-10,560 SITE LOCATION MAP

IE LICENCE



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Reproduced by Permission ofOrdnance Survey Ireland,Licence No. EN 0054716É Ordnance Survey Ireland / Government of Ireland.

SCALE 1:2500Cork O.S. Sheets 6341-C & 6386-A

SITE NOTICE

LOCATION

SITE NOTICE

LOCATION

LEGEND:

BOUNDARY TO WHICH

THE APPLICATION

RELATES

X

X

A N N G R O V E T d .




FOURNIER LABORATORIES

IRELAND LTD.

16415-L-02 A

CREON OPTIMISED

SITE LOCATION MAP

IE LICENCE



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consent of copyright owner required for any other use. non ... · copy of the annual environmental...

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