safe handling of potent and highly potent active...

1111 Newsletter - July 2011

NEWSLETTER NEWSLETTER NEWSLETTER NEWSLETTER

July 2011

Safe handling of potent and highly potent active Safe handling of potent and highly potent active Safe handling of potent and highly potent active Safe handling of potent and highly potent active pharmaceutical ingredients pharmaceutical ingredients pharmaceutical ingredients pharmaceutical ingredients

Potent and highly potent Active Pharmaceutical Ingredients (API) have the potential to cause serious health effects in workers at very low airborne concentrations. The use of containment equipment as part of a systematic approach to potent compound safety is advised to control worker exposure. Based on toxicological evaluations, APIs can be placed into control bands depending on their potency. In general, API’s are

classified using occupational exposure limit (OEL) as a classification scale.

Definition of OELDefinition of OELDefinition of OELDefinition of OEL

OEL is the airborne concentration of a compound to which nearly all workers can be repeatedly be exposed 8 hours a day, 40 hours a week, without adverse effects.

VF

GNOELOEL

*

*=

OEL — Occupational Exposure Limit mg /m3 OEB — Occupational Exposure Band mg/m3 DEL — Design Exposure Limit mg/m3 NOEL — No Observation Effect Level mg/kg*day G — Body mass 50 kg (female)/75kg (male) V — Breathing air volume in 8 hours m3/day ADI — Acceptable Daily Intake (=NOEL*G/F) mg/day

F — Assessment factor

© Lonza Ltd., Basel, 2007


OEB at LoOEB at LoOEB at LoOEB at Lonzanzanzanza

Classification followed by a containment strategy is the first step in a systematic approach to ensure worker safety when

handling potent and highly potent APIs

It is important to focus primarily on facility design, isolation and containment. As a second layer of protection personal protective equipment and personnel controls must be designed and implemented as well.

Containment StrategyContainment StrategyContainment StrategyContainment Strategy

Using a simplified selection criteria working through the following stages (see picture below)

Containment Strategy 1 Containment Strategy 2 Containment Strategy 3 Containment Strategy 4 Containment Strategy 5

Control General Ventilation

Airflow Booth Technology

Barrier Isolation Technology

Direct/Closed Connection within Barrier Isolation

Fully Automated system - No operator input

Containment Strategy 1 Containment Strategy 2 Containment Strategy 3 Containment Strategy 4 Containment Strategy 5


CONTAINMENT DEVICE SELECTIONCONTAINMENT DEVICE SELECTIONCONTAINMENT DEVICE SELECTIONCONTAINMENT DEVICE SELECTION

Selection of containment equipment generally has to include at least the following elements:

• Step by step analysis of the entire process to produce a detailed list of all tasks involved

• Setting of a containment performance target (CPTCPTCPTCPT).

• Specifying and selecting containment equipment based on the task list and CPTCPTCPTCPT.

• Verifying containment performance at the factory acceptance test (FATFATFATFAT) and the site acceptance test (SATSATSATSAT)

• Assessing occupational exposure to workers during actual operations involving the API The step by step analysis must be sufficiently detailed to identify all aspects of the process that may be encountered operationally. Examples of important issues that are often missed during this analysis are contained transfer of waste, decontamination of materials and equipment prior to transferring out of containment.

CONTAINMENTCONTAINMENTCONTAINMENTCONTAINMENT DEVICESDEVICESDEVICESDEVICES A wide range of devices are available which allow contained operations to be carried out during chemical production of potent

and highly potent APIs and during the formulation of pharmaceutical products containing these APIs.

Butterfly split valve


Charging Bags

Liner system with O ring canister


High containment system

Continuous liner system


Glove box isolator

Flexible isolator



Discharge Big Bag into the dryer View into the isolator working room with balance


Charge big bag


Charge big bag


Sampling of spherical dryer Discharging big bag into dryer




In this context, Lonza Engineering’s In this context, Lonza Engineering’s In this context, Lonza Engineering’s In this context, Lonza Engineering’s service could include:service could include:service could include:service could include:

Design service and consultancy

Risk analysis

Process simulation

Support procurement process

Project management

Pls. discuss your requirements with our experts, we would be very happy

to offer our support.

An extensive service list is available on our website:

http://www.lonza.com/engineering

Lonza Engineering Lonza Engineering Lonza Engineering Lonza Engineering LtdLtdLtdLtd

Lonza Engineering is a subsidiary of Lonza Group

Ltd and provides customer oriented services with a

professional, experienced and highly motivated

engineering team. We have more than 15 years of

successful project management experience in

China which makes us a perfect partner for the

chemical, pharmaceutical and biopharmaceutical

industry. A broad range of services with a project

reference list underlining our capabilities is

available upon request.

Lonza Engineering has successfully managed

multiple and complex projects such as continuous

operating plants for the production of food and

feed additives as well as active pharmaceutical

ingredient plants including waste gas and liquid

waste treatment facilities. The management team

of the new company consists of current Lonza

employees from Switzerland and China.

ContactsContactsContactsContacts

Lonza Engineering Ltd

Muenchensteinerstrasse 38, CH-4002 Basel,

Switzerland

Tel: +41 61 316 8606

Fax: +41 61 316 9606

Email: [email protected] [email protected] Website: http://www.lonza.com/engineering

Lonza Guangzhou Engineering & Consulting Co.

Ltd

68, Huanggedadao Bei, Nansha district,

Guangzhou, 511455, Guangdong Province, China

Tel: +86 20 3497 1118

+86 20 3497 3888 ext.2366

Fax: +86 20 3497 2288

Email: [email protected]

[email protected]

Website: http://www.lonza.com/engineering

Filtration

Operation in glove box



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