Microbial Limits
Although the production techniques of Chinese medicine and strict quality management have greatly reduced the presence of microorganisms nowadays, microorganisms are still difficult to be completely eliminated. Some microorganisms may also help for the efficacy of Chinese medicine. To ensure the safety and efficacy of Chinese medicine, the government has established microbial limit standards to control the types and quantities of microorganisms.
Furthermore, Hong Kong legislation also requires all Chinese medicine product manufacturers to comply with the "Good Manufacturing Practice in respect of proprietary Chinese medicines" (i.e. GMP Certificate in pCm). This includes strict requirements for the production environment, equipment, personnel, and processes, to ensure the quality and safety of the products.
The microbial limit test is a method used to inspect the degree of microbial contamination in non-sterile preparations and their raw/auxiliary materials, including the examination of bioburden and control of microorganisms.
Enviro Labs Ltd. (ELL) is registered as a HOKLAS accredited laboratory (HOKLAS 128), serves providers with microbial limits detection in Chinese medicine that are included in the guidelines provided by the the Hong Kong Chinese Medicine Council. To ensure the security of Chinese medicine, please contact us for testing arrangement.
Microbial limit for various dose form of pCms (Unit: per g or per ml)
(For those dose forms not listed in the table below, they will be considered by the Chinese Medicines Board on individual basis. )