Equipment Validation


OEL Testing
Given the trend of increasing potency in both pharmaceutical and bio pharmaceutical compounds, Operator Exposure Levels (OELs) are becoming more and more stringent.

95% of PSL equipment is designed for containment, to protect operators during the handling and processing of potent powders. PSL state OELs for each piece of equipment fabricated, some of these systems can achieve nanogram level containment. We can make these statements confidently as new designs are OEL tested and independently validated by a third party.

OEL testing involves performing a replication of the intended process with a non toxic product, such as lactose, and measuring the levels before, during and after the process has been carried out. Monitors are placed in various locations, including on the lapel of the testing operator.

This OEL testing can also be carried out as a client service as part of the FAT in order to validate their PSL containment equipment.

IQ OQ
Once completed, PSL equipment undergoes complete Factory Acceptance Testing to ensure that it leaves PSL in good working order.

PSL Commissioning Engineers have vast experience of installing equipment onsite and can provide IQ OQ services for new equipment.

Existing equipment can also be re-commissioned and re-validated.

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