New Microbial Examination of Non-Sterile Products
On 1 May 2009, a new microbial examination method in United States Pharmacopeia (USP) - USP<61> Microbiological Examination of Non-sterile Products: Microbial Enumeration Tests, and USP<62> Microbiological Examination of Non-sterile Products: Tests for Specified Organisms, will officially become effective.
This new method will be harmonized with the corresponding test in European Pharmacopeia (EuP), and it is applicable to wide range of products, including pharmaceutical, healthcare (e.g. disposable wipes, sanitary napkins, diapers) and cosmetic products. It is useful for monitoring the degree of cleanness during the manufacturing process, and to study the quality of the finished products.
Several changes are made in the new test method:
Verification of organism recovery with <100 cfu of test species New media and incubation conditions for test species Altered sample quantities Screening for additional pathogens has been added for certain products For products required to comply with Good Manufacturing Practices (GMP), microbiological control is one of the key aspect. SGS offers the latest microbial examination test for various products for fulfilling your needs and concerns.
If you are interested in our new microbial test, contact us now.
Man Mak (Life Science)
t: + 852 2609 9611 (ext 3356)
f: + 852 2603 7577
Man Chan (Hardlines)
t: + 852 2774 7168
f: + 852 2646 0026
Systems and Services Certification
t: + 852 2765 3620
f: + 852 2333 2257
SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 75,000 employees, SGS operates a network of over 1,500 offices and laboratories around the world.