White Paper
Surrogate Powder And ASHRAE-110 Testing Of A Multi-Purpose Enclosure For Weighing/Sieving/Fluid Bed Dryer Applications
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•White Paper: Surrogate Powder And ASHRAE-110 Testing Of A Multi-Purpose Enclosure For Weighing/Sieving/Fluid Bed Dryer Applications
By Chris Mento, Geoff Williams, Bryan Prince, Ray Ryan, Flow Sciences, Inc.
Advances in the pharmaceutical industry have led to increased potency and increased receptor selectivity of Active Pharmaceutical Ingredients (APIs). While this leads to more effective drug treatments for patients, the increased potency puts the pharmaceutical laboratory worker at a greater risk of exposure to harmful compounds at lower exposure levels. This drives the need for increased safety measures for better worker protection in the laboratory.
There are numerous categorization systems to quantify the hazards that certain APIs pose to the worker. One system used to rate the potency of a substance is outlined by the International Society of Pharmaceutical Engineering (ISPE), in which compounds are placed into four categories with defined Occupational Exposure Limits (OELs). Compounds placed in Category I are generally low in potency and have an OEL of 100 µg/m3 or greater. Category II includes APIs that have a higher toxicity and have an OEL range between 20 µg/m3 and 100 µg/m3. Category III compounds are considered potent and/or toxic, and their OEL range is between 5 µg/m3 and 20 µg/m3, and highly potent compounds in Category IV have an OEL of below 5 µg/m3.
To properly protect the laboratory workforce, engineering controls must be put in place to provide appropriate containment of APIs. These controls should be designed to contain the API source as close to the source and as far away from the worker as possible. For Categories II, III, and IV of the ISPE hazard categorization system, containment equipment is recommended to reduce potential exposures of APIs. Containment equipment include completely enclosed units such as isolators and soft-walled units as well as ventilated enclosures with open ventilated work zones. With good standard operating procedures (SOPs) and skilled, trained workers, low-flow ventilated enclosures are an effective engineering control to provide containment of equipment and processes involving potent APIs.
Click Here To Download:•White Paper: Surrogate Powder And ASHRAE-110 Testing Of A Multi-Purpose Enclosure For Weighing/Sieving/Fluid Bed Dryer Applications
