Culture Media for Compendial Methods

Compendial pharmacopeial tests are standardized methods for many pharmaceutical raw materials and finished products. Testing and compliance with these standards detailed within compendial methods is a basic requirement for the global product development, release, and distribution of pharmaceutical ingredients and drug products. Compendial tests are performed to determine drug compatibility, and safety or for routine quality control.

MICROBIOLOGICAL QUALITY CONTROL OF NON-STERILE PRODUCTS

The three internationally most important Pharmacopoeias (Ph Eur/JP/USP) published harmonized versions of their chapters on microbial examination of non-sterile products in 2009. In addition, the 2016 edition of the Chinese Pharmacopoeia is, for the most part, harmonized in terms of media composition and performance criteria, although growth promotion testing needs to be performed with strains from the Chinese strain collection. These methods address the total aerobic count (TAMC and TYMC) and the test for specified microorganisms.

Our culture media portfolio for microbial examination of non-sterile products complies with the harmonized Pharmacopoeia. As compendial methods change, be assured that we monitor this thoroughly, and any changes to composition or performance testing will be implemented quickly so that you won’t need to worry about the regulatory compliance of our media.

Browse from our range of products to support your compendial pharmacopeial tests:

• Dilution media
• Dehydrated culture media (DCM)
• Culture media - Ready-to-use plate
• Culture media - Ready-to-use liquid
• Neutralizing agents

MICROBIOLOGICAL QUALITY CONTROL OF NON-STERILE PRODUCTS

The three internationally most important Pharmacopoeias (Ph Eur/JP/USP) published harmonized versions of their chapters on microbial examination of non-sterile products in 2009. In addition, the 2016 edition of the Chinese Pharmacopoeia is, for the most part, harmonized in terms of media composition and performance criteria, although growth promotion testing needs to be performed with strains from the Chinese strain collection. These methods address the total aerobic count (TAMC and TYMC) and the test for specified microorganisms.

Our culture media portfolio for microbial examination of non-sterile products complies with the harmonized Pharmacopoeia. As compendial methods change, be assured that we monitor this thoroughly, and any changes to composition or performance testing will be implemented quickly so that you won’t need to worry about the regulatory compliance of our media.

PHARMACOPEIA COMPENDIAL TESTING

Regulatory agencies must implement pharmaceutical drug testing and follow the respective pharmacopeia methods or validated methods.

SAMPLE PREPARATION FOR COMPENDIAL TESTING

The choice of the dilution media and additives used depends on the properties of the test sample. The products with antimicrobial properties can be countered by using neutralizing agents.

COMPENDIAL METHODS FOR MICROBIAL ENUMERATION

Microbial Enumeration Tests are quantitative methods to determine the contamination level of mesophilic bacteria and fungi that grow under aerobic conditions in a pharmaceutical product. The tests include detecting the total aerobic microbial count (TAMC) and total yeast and mold count (TYMC). Membrane Filtration, Plate-Count, or the Most-Probable-Number (MPN) is the most common enumeration method, and the choice of method depends on the test product.

Before a method is chosen, the suitability should be proven in the presence of the product. This involves the preparation of suitable test strains, growth promotion tests of the culture media, and suitability tests for the counting method in the presence of the product.

Tests for Specified Microorganisms

Depending on the microbiological quality specification of each non-sterile pharmaceutical product, the manufacturer is required to determine the absence or limited occurrence of the following seven organisms:

These organisms serve as general indicator organisms, but depending on the nature of the product, its designated use, the recipient group, and the method of application, other pathogenic microorganisms may be relevant. The following overview of required media is limited to explicit Pharmacopoeia requirements.