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Microbiological purity

Quality control of raw materials and final products

Samples are analysed for the presence of microorganisms in general and specific pathogenic microorganisms according to the current edition of the European Pharmacopoeia (Ph. Eur.):

  • Ph. Eur. 5.1.4. Microbiological Quality of Non-sterile Pharmaceutical Preparations and Substances for Pharmaceutical Use
  • Ph. Eur. 2.6.12. Microbiological Examination of Non-sterile Products: Microbial Enumeration Tests
  • Ph. Eur. 2.6.13. Microbiological Examination of Non-sterile Products: Test for Specified Micro-organisms.

 

Examples of microbiological analyses:

  • Total aerobic microbial count (TAMC)
  • Total combined yeasts/molds count (TYMC)
  • Bile-tolerant gram-negative bacteria
  • Escherichia coli
  • Salmonella sp
  • Staphylococcus aureus
  • Psedomonas aeruginosa

 

Suitability testing

In order to follow the microbiological methodologies of the pharmacopoeia, it is important to verify the capabilities of the methods to detect relevant microorganisms in the sample material. This is called "Suitability of the counting method" and "Suitability of the test" in Ph. Eur. chapters 2.6.12 and 2.6.13, respectively.

The suitability test is conducted by recovery studies of up to 5 test microorganisms. If the test reveals antimicrobial activity of the sample, this activity has to be neutralized eg. by addition of neutralizing agents, dilution, membrane filtration or other methodologies. Thus, this approach can be used to document that the method applied is suitable for microbiological examination of the product in question and assure that any viable microorganisms represented by the test microorganisms will be found.

DB Lab conducts suitability testings or validation of the above-mentioned methods and develops methods for neutralization of antimicrobial activity