Clean Room Environmental Monitoring Sop

As the fda guideline on aseptic processing gmp 2004 states.

Clean room environmental monitoring sop.

5 6 4 operate the instrument as per sop. 5 6 5 the results are calculated and stated as per particle per ft3 fed std 209e. Standard operating procedure title. All environmental monitoring locations should be described insops with sufficient detail to allow for reproducible sampling of a given location surveyed.

Personnel see miclab 095 and miclab 060 3 1. 5 6 6 sampling point for non viable air particle count. Operator s gloved hands the number of viable micro organisms on the gloved hands of sterile area operators is to. The program includes sampling sites frequency of sampling and.

Written sops should also address elements such as 1. In aseptic processing one of the most important laboratory controls is the environmental monitoring program. Environmental monitoring em of cleanrooms is the microbiologist s responsibility and it requires making many decisions such as how often to monitor where to monitor what samples to take which culture media to use how long to incubate how to interpret data and which identifications to perform. This would access the environmental conditions in particular the microbiological and particulate quality of the pharmaceutical clean room.

Frequency of sampling 2. 5 2 1 procedures 5 2 1 1 methods or standard operating procedures sops must be established. Environmental monitoring program documented program implemented through standard operating procedures that describes in detail the procedures and methods used for monitoring particulates as well as microorganisms in controlled environments air surface personnel gear. Any deviation from this sop is to be recorded in the environmental monitoring comments book and a dr raised if necessary.

Sop for environmental monitoring of manufacturing area by settling plate count standard operating procedure to ensure the control over viable count of different areas of manufacturing department of solid dosage forms. Environmental monitoring of clean rooms take three one minute one cfm 28 3 liters samples per location for better statistical reliability test laminar flow work stations and barrier isolators the same way testing should be done every six months or after any repairs or renovations. 6 0 abbreviations cfu colony forming unit laf laminar air flow pda potato dextrose agar sop standard operating procedure ipa. 5 6 7 record the result.