Frequency of sampling 2.
Clean room environmental monitoring sop.
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.
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.
Standard operating procedure title.
In aseptic processing one of the most important laboratory controls is the environmental monitoring program.
6 0 abbreviations cfu colony forming unit laf laminar air flow pda potato dextrose agar sop standard operating procedure ipa.
In this context the environmental monitoring data management course by eca academy 20 21 november in barcelona spain will present the basic methodology of evaluating the data using elementary statistical process control tools as well as the empirical approaches to set microbial control limits for cleanrooms.
This would access the environmental conditions in particular the microbiological and particulate quality of the pharmaceutical clean room.
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.
5 6 7 record the result.
Written sops should also address elements such as 1.
5 2 1 procedures 5 2 1 1 methods or standard operating procedures sops must be established.
As the fda guideline on aseptic processing gmp 2004 states.
5 6 6 sampling point for non viable air particle count.
When the samples are taken i e during or at the conclusion of operations.
5 6 5 the results are calculated and stated as per particle per ft3 fed std 209e.
Any deviation from this sop is to be recorded in the environmental monitoring comments book and a dr raised if necessary.
5 6 4 operate the instrument as per sop.
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.
