AboutMichael Anisfeld Expertise Disclaimer:
SORRY BUT I DO NOT ANSWER QUESTIONS RELATED TO: DRUG ACTIONS/INTERACTIONS, INTERNET DRUG PURCHASES, RESULTS OF DRUG TESTS, IDENTIFYING DRUGS (FOR WHICH YOUR LOCAL PHARMACIST IS THE BEST PERSON TO CONSULT).
My expertise is answering questions relating to pharmaceutical manufacturing and quality technologies, drug regulations and specifically GMP requirements
Experience
Past/Present clients UN agencies (UNFPA, UNICEF, UNIDO)
Governments (Australia, Canada, India, United Kingdon, United States
Companies - over 200 companies in 37 countries
Expert: Michael Anisfeld Date: 7/10/2008 Subject: Sampling conditions for non sterile raw materials
Question I wanted to know if there are any environmental conditions that should be adhered to for non sterile raw materials that have been properly sampled and properly sealed. Aseptic technique is used during the sampling process; but there were concerns that the area that is used to sample the raw product would introduce the sample to contamination and therefore we couldn't get a good sample for microbial analysis.
Answer Sampling for chemical testing is routinely performed in a Class 100,000 (ISO Class 8) environment. Sampling for microbial testing is routinely performed using sterile sampling tools under a Class 100 (ISO class 5) laminar flow situated in a ISO Class 8 area.
