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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
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.
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.
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
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