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how to carry out the overall consideration of bacterial retention validation?

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start this week with one of the most important topics in the validation module:Bacterial Retention Validation.


Bacterial Retention Validation is used to confirmfilter membraneand use representative challenge microorganisms to prove that they are from a product or product family.completely.removal of microorganisms. The validation of sterilizing grade filters requires consideration of two main factors:


Filter membrane level, it is carried out in the manner of a bacterial challenge using applicable standardized tests or similar methods.


Process Validation, a challenge is performed by the user of the filter or a laboratory commissioned by the filter (e. g., the manufacturer of the filter or a contract laboratory) using representative microorganisms to demonstrate that the filter can completely remove microorganisms from each product or product family under production conditions. A scientific explanation for each product family should be established.

these two filter testing concepts are not interchangeable and should be independently validated. The purpose of these tests was to demonstrate that the sterile filtration production process resulted in a sterile filtrate.


bacterial retention validation study was to obtainDocumentary evidence, proof insimulation process conditions, the filtration process can continue to remove high levels of standard bacterial or related microbial contaminant isolates suspended in the product or substitute fluid.

study determines whether to use a diaphragm or full-size process filter. If the purpose of the study is to verify the bacterial retention efficiency of a particular membrane material, then the use of a small test membrane is generally considered to be satisfactory. The detection method used to determine the physical integrity of the process filter should be correlated with the bacterial retention test results.


process timeanddifferential pressurecan affect the results of bacterial retention tests. The bacterial challenge test at the full process time can evaluate those time-related factors, including filters.Compatibility,integrityandoccurrence time-dependent penetrationand so on.

when verifying the bacterial retention of the product on the membrane filterneed to consider the following:


responseFiltration Processoncea thorough assessment, including solvent properties (e. g., water-based, acid, base, organic), filtration time, process differential pressure, process flow rate, process temperature, and filter design parameter specifications.


product bacterial retention validation studies should includemultiple filtration membrane batches(usually 3 batches). In some cases, the product properties are considered to be damaging to the filter membrane, and the exact number of filters and experimental design depends on the process.


At least one of the 3 batches used in the bacterial retention validation study should be pre-study or pre-use physicalintegrity testingpassed but close to the conformity standard provided by the filter manufacturer. If the low bubble point filter membrane (low production specification filter membrane) is not used in the verification, the bubble point value of the standard solution filter membrane/core used in the actual production must be higher than the minimum bubble point value of the filter membrane actually used in the verification test.


bacterial retention validation studies using filtration membranesPhysical integrity test valueshall be included in the test report. The physical integrity test shall be carried out using the corresponding wetting fluid of the existing test standard: for example, water, product or other wetting fluid, and shall be completed before the microbiological challenge.


If the bacterial challenge test is followed by either filter, this should be investigated. If the investigation identifies a filter that meets the requirements of the microbial penetration integrity test for the test, the suitability of the filter model for these operating conditions should be reconsidered.


hassame componentsand only the concentration is differentthe same family of productscan be used.Challenge Limit Concentrationmethod was validated, instead accepting intermediate concentrations. If a product is determined to be representative of the worst case, an explanation and data description are required.


liquid filterreusefor the pharmaceutical process is usuallyis not recommended.. However, if the sterilization grade filter is reused, it needs to be explained and fully verified or confirmed according to the corresponding regulations and guidelines.












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