When OELs are not available, OEL bands are estimated in accordance with Hovione’s internal procedures that define 6 bands (see table below) with each band setting minimum standards for engineering requirements and handling practices.
|OEL (µg/m3)||> 1000||1000 - 100||100 - 10||10 – 1||1 – 0.1||< 0.1|
|Hazard||Irritant||Moderately toxic||Very toxic||Potent||Highly Potent||Very Highly potent|
A range of equipment is available to ensure that employees are fully protected from hazardous substances, including glove bags, isolators, flow booths, split, continuous liners.
When handling hazardous substances operators should use PPE like full suits with PAPR or breathing air, as backup protection in case of abnormal occurrence.
Occupational Exposure Monitoring is part of containment equipment operational qualification. Periodic measurements are necessary with a frequency defined by the Occupational Exposure results and the OELs of products to be handled.
For potent compounds (category 3a and above) a protocol based on ISPE SMEPAC (Standardized Measurement of Equipment Particulate Airborne Concentration) guideline is used to demonstrate achievement of target design exposure level. Operations are simulated as closely as possible using a surrogate (lactose) and samples are taken from the operator’s breathing zone and near the potential leakage points in accordance with SMEPAC guidelines.