This new standard describes a filter challenge test for standardizing test parameters across laboratories using 47 mm discs and using A. laidlawii as the test organism.

While this standard is primarily to educate users and filter manufacturers about best practices for mycoplasma reduction filtration, this test is also to be used by the filter manufacturers to validate a mycoplasma-retentive filter within a manufacturing process and to qualify a filter for a mycoplasma retentive claim.

This method may also be used to evaluate mycoplasma retention of any filter intended for that use to determine the degree of removal that filter provides. The test gives mycoplasma retention a standard unit of measure so that different filters can be compared under the same conditions.

It is important to note that validation of a drug manufacturing process employing such a filter must be done under applicable process-specific conditions.

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Table of Contents:

Introduction

• Scope
• Normative References
• Terms and Definitions
• Acronyms and Abbreviations
• Mycoplasma Filtration
• Summary of mycoplasma challenge testing
• Test validity criteria
• Summary of test parameters
• Method
• Material and equipment
• Preparation of media and buffer
• Preparation of challenge microorganism
• Preparation of the challenge suspension
• Challenge test apparatus
• Reporting results
• Test acceptance criteria
• Bibliography