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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
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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
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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
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Butterfly split valve
Butterfly split valve
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Charging Bags
Liner system with O ring canister
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High containment system
Continuous liner system
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Glove box isolator
Flexible isolator
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© Lonza Ltd., Basel, 2010
Discharge Big Bag into the dryer View into the isolator working room with balance
© Lonza Ltd., Basel, 2007
Charge big bag
© Lonza Ltd., Basel, 2007
Charge big bag
© Lonza Ltd., Basel, 2007
Sampling of spherical dryer Discharging big bag into dryer
© Lonza Ltd., Basel, 2007
© Lonza Ltd., Basel, 2007
9999 Newsletter - July 2011
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: info.engineering@lonza.com sales.engineering@lonza.com 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: info.engineering@lonza.com
sales.engineering@lonza.com
Website: http://www.lonza.com/engineering
Filtration
Operation in glove box
© Lonza Ltd., Basel, 2007
© Lonza Ltd., Basel, 2007