Containment Performance Verification of the Potent Compound Suite Using Surrogate Monitoring

05/08/2015

As part of commissioning of the Regis’ Potent Compound Suite 1 (PCS1), an industrial hygiene monitoring was performed by Safebridge Consultants, Inc., on March 4 and 5 of 2015 with the purpose to evaluate the containment performance of the facility. Based on the occupational exposure limits (OELs) of the future Active Pharmaceutical Ingredients (APIs) to be handled, a containment performance target (CPT) was set to 50 ng/m3.  The objective of containment performance verification was to show that the CPT has been achieved.

The surrogate monitoring involved handling of surrogate material (naproxen sodium) in PCS1 by Regis’ employees, while performing the air and surface sampling by certified industrial hygienist in order to find out how much of material is escaping from the containment. The typical operations have been simulated three times, using a different operator for each assessment. The sampling strategy included collection of the following samples: background air, personal (breathing zone), general area, and surface wipe samples. The results of the study offer an estimate how efficiently the equipment will contain the potent APIs under similar circumstances.

The benefits of surrogate monitoring are:
•    Containment evaluation of new equipment without potential for employee exposure to potent API
•    Testing in instances when a validated method has not been developed for the compound of interest, which is typical for the early stages of drug development
•    Using an appropriate surrogate (less potent) material with very low limits of detection, to challenge installations. The limit of quantification (LOQ) for an air sample was 0.0500 ng. The LOQ for a surface sample was 0.500 ng.

The containment performance report was provided by SafeBridge Consultants, Inc. The report describes the testing methodology and provides an objective interpretation of the results indicating that the containment performance of the equipment is in full compliance with the Regis’ containment performance target (CPT) of 50 ng/m3. Personal and area measurements for surrogate powder handling showed that containment isolator system in the PCS1 can be used to handle a wide range of potent APIs. The surface sampling results were found to be well below the performance-based acceptable surface limit (ASL) for SafeBridge Category 3 (Regis HHC 4) compounds.  This evaluation gives further confidence that potent APIs are being handled safely at Regis Technologies, protecting employees, products, and environment.

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