Millipore Technical Publications |
 | Data Sheet - SDS1009E00 | |
Bacterial Retention Testing for Validation of Sterilizing-Grade Membrane or Quantification of Bioburden Reduction | ||
| Authors: | ; SDS1009E00 | |
| Citation: | SDS1009E00 | |
| Year: | 2006 | |
| Abstract: | Bacterial retention testing is required to validate retention of Millipore sterilizing-grade membrane filters with specific pharmaceutical preparations. Millipore’s Access Services Laboratories conduct testing on a lab-scale basis using scaled-down processing conditions. First, a standard test protocol is submitted to the client. Then, project specific parameters are determined by scaling down by filter area. Millipore and the client sign the project specific test protocol prior to the start of testing. A standard report summarizing testing data is submitted to the client at the completion of testing, and a copy of the test data is provided with the final report. | |
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Bacterial retention testing is required to validate retention of Millipore sterilizing-grade membrane filters with specific pharmaceutical preparations. Millipore’s Access Services Laboratories conduct testing on a lab-scale basis using scaled-down processing conditions. First, a standard test protocol is submitted to the client. Then, project specific parameters are determined by scaling down by filter area. Millipore and the client sign the project specific test protocol prior to the start of testing. A standard report summarizing testing data is submitted to the client at the completion of testing, and a copy of the test data is provided with the final report.
Millipore’s Access Services Specialists are committed to performing testing at validation labs in the U.S., Europe, India and Japan. Millipore welcomes and encourages cGMP audits at our worldwide laboratory facilities. Let the experts with years of filtration and process optimization experience save you time and resources.
Regulatory Compliance
Bacterial retention testing for pharmaceutical preparations is a critical step in filter validation required by all regulatory bodies worldwide. The United States Food and Drug Administration Guidance on Sterile Drug Products Produced by Aseptic Processing recommends that microbial retention testing be conducted using the candidate pharmaceutical preparation under simulated pharmaceutical processing conditions; this validates sterilizing-grade filter performance. PDA’s Technical Report 26 further outlines parameters to be considered and modeled during the testing process. Millipore’s testing is performed in compliance with these guidelines.
Test Procedure
Testing is conducted using worst-case client processing conditions to determine the ability of a sterilizing grade filter to retain a minimum challenge of 107 cells of Brevundimonas diminuta (B. diminuta) per cm2 of filter area. One lot of finished drug product or process fluid is evaluated using three lots of Millipore sterilizing-grade, 47 mm membrane discs. All test membranes will have pre-use, water-wet integrity test values at or near the stated minimum specification. Size controls are run with each test to prove that the test organism is the appropriate size. Although B. diminuta is the industry standard, a thorough evaluation of bulk or pre-filtration bioburden should be conducted by the client prior to requesting this test.
When to Perform Bacterial Retention Testing
- Filtration is the sole method of sterilization of a pharmaceutical drug or intermediate, there is no subsequent terminal sterilization, and sterilizing is required
- There is a sterilizing claim on a filter when sterility would not otherwise be required
- There has been a major change to a validated process
- There is a claim or requirement of bioburden reduction for a filter which would otherwise not require validation
What You Need to Know to Begin
- How much candidate test solution is available for testing, and when?
- Is there an MSDS for the candidate test solution?
- Is this a controlled drug? If so, what classification and code?
- Product incompatibilities
- May small batches of unpreserved candidate test solution be prepared?
- Pre-use flush information
- Exact filter catalogue number, number of filters, in parallel or in series
- Batch size
- Flow control parameter, flow rate or pressure. If pressure, how is that measured, upstream or differential across the filter?
- Filter/fluid contact time
- Fluid filtration time
- Filtration dynamic, intermittent or continuous
- Bioburden, identification and concentration
How to Request Microbial Retention Testing
To request microbial retention testing or to get information on other validation services, call your Millipore Applications Specialist or the Millipore office nearest you. In the U.S. and Canada, call toll-free 1-800-MILLIPORE (1-800-645-5476) or go to Access Services.