Containment-Verification Testing For Pharmaceutical Equipment Performance - Pharmaceutical Technology

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Containment-Verification Testing For Pharmaceutical Equipment Performance
A Good Practice Guide from the International Society of Pharmaceutical Engineering provides a framework to assess how well pharmaceutical equipment contains hazardous APIs.

Pharmaceutical Technology
Volume 37, Issue 5, pp. s24-s27

Ensuring successful testing

Purchasing a containment system or equipment from a reputable supplier should ensure the achievement of containment objectives. Proper planning and testing, however, is needed to obtain accurate reliable data during a containment-verification test. The following steps can help ensure a successful containment-verification test:

1. Set a CPT as an airborne concentration (g/m3) based on the OEL of the API to be handled.

2. Select a surrogate material to use during containment performance verification. Some of the chemical/physical properties to be considered in the selection of the surrogate include:

  • Powder-flow characteristics
  • Detection sensitivity
  • Pharmacological activity
  • Cost
  • Availability
  • Cost of analysis
  • Available particle-size range
  • Consistency of particle size
  • Ease of disposal
  • Solubility in water
  • Stability

3. Develop a sampling strategy that includes:

  • Type of sampling (air and/or surface sampling)
  • Where to sample
  • The number of samples to be taken
  • The types of samples (area and/or personal) to be taken
  • The duration of each sample
  • At least three iterations (runs)
  • Utilization of different operators (if possible)
  • Limit of detection for the surrogate

4. Use an accredited laboratory for the analysis. Verify there is a validated method for the airborne and surface surrogate samples with sufficient sensitivity to evaluate the containment performance. >

5. Review the containment equipment and/or system with the users prior to testing. >

6. Perform a dry run without the surrogate material prior to testing. >

7. Keep the surrogate material in an area or room outside the test room or process room. >

8. The containment-verification report should describe the testing methodology and provide an objective interpretation of the results. The data collected should be analyzed consistently and according to accepted statistical methodologies. An appropriate number of samples as noted previously (minimum of three runs) should be taken to reduce the variability and maintain consistency when evaluating the containment equipment. Finally, the use of traditional statistical measures such as the 95th percentile (if a sufficient number of samples are taken) or using European Standard EN 689:1986 or Bayesian analysis to confirm that airborne release concentrations will not normally exceed the CPT. >


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