Harmonization of Microbial Limit Test
Monitoring microbial contamination is a critical procedure to ensure safety of various products, such as pharmaceutical, healthcare or cosmetic products. Several methods have been employed for many years in different regions of the world according to the local regulations. However, the lack of their alignment often creates extra burden for manufacturer intended to market their product worldwide.
Currently, the United States Pharmacopeia (USP) Chapter <61>: “Microbial Limit Tests” is divided into two chapters: USP<61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests, and USP<62> Microbiological Examination of Nonsterile Products: Tests for Specified Organisms. These chapters will officially become effective on May 1, 2009.
Below is the harmonized microbial with the corresponding chapters in the USP and European Pharmacopeia (EuP) for your ref.:
USPEuPUSP <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests
Microbial:Total aerobic microbial countTotal yeast and mold countChapter 2.6.12 Microbiological Examination Of Nonsterile Products:
Microbial Enumeration Tests
Microbial:Total bacterial count FungiUSP <62> Microbiological Examination of Nonsterile Products:
Tests for Specified Organisms
Microbial:Bile tolerant Gram negative bacteria (NEW!)Escherichia coli Salmonella speciesPseudomonas aeruginosaStaphylococcus aureusClostridia species (NEW!)Candida albicans (NEW!)Chapter 2.6.13 Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms
Microbial:Enterobacteria and Certain other Gram negative bacteriaEscherichia coli Salmonella speciesPseudomonas aeruginosaStaphylococcus aureusClostridia species The most obvious change in the harmonized USP<61> is the need of verification of enumeration. Also, sample preparation on different matrix is added. Furthermore, more information is included on the neutralization and removal of antimicrobial activity of the product, and a better definition of growth promotion requirements for media is stated in this chapter. In order to verify testing conditions, negative control is included and there should be no growth of microorganisms in the media. In USP<62>, it describes the specific requirements for the growth and recovery of specified test organisms. More species are added, including Clostridia and Candida albicans. Another significant change in these new chapters is that the confirmation of doubtful result by retested using 25 grams specimen of product is abolished.
As the leader in one-stop total quality services, SGS Hong Kong is equipped with state-of-the-art facilities and expert team. Our testing service ensures compliance with the harmonized method. With the strong technological background, we offer high-level expertise in testing, verification, technical consultancy and inspection of products from cosmetic industry.
t: + 852 2609 9611 (ext 3354)
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t: + 852 2609 9611 (ext 3356)
f: + 852 2603 7577
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