As stated in the Technical guidelines for registration of proprietary Chinese medicines under Chinese Medicine Ordinance (Chapter 549 of the Laws of Hong Kong),non-sterile products, including the staring materials, excipients and the finished products, should be tested for the presence of viable microorganisms, due to the following reasons:
Toxins building up by these microorganisms may be harmful to consumers or influence the properties of the medicine. Some of these microorganisms, if being ingested in a certain amount, may be harmful to the consumers. These microorganisms may interact with the medicine causing deterioration and changing of properties of the medicine.
The criteria of microbial limit for proprietary Chinese medicines cover three aspects, namely total aerobic count, moulds and yeast count and the presence of specified bacteria such as E.coli, Staphylococcus aureus, and Pseudomonas aeruginosa. For details of the criteria, please refer to the Application handbook of Registration of proprietary Chinese medicines.
Enviro Labs Ltd. (ELL) provides microbial testing services for proprietary Chinese medicine using analytical method stated in the Pharmacopoeia of the People’s Republic of China (volume 1, 2005 edition), as recommended by the Technical Guidelines for Registration of proprietary Chinese medicine.