SOP For Non-Viable Particle Counting is described in this post which you can follow in the section of the microbiological lab.
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Objective:
This procedure has been established to evaluate the non-viable Particulate matter in the controlled environment of sterile manufacturing area and sterile testing area i.e. (Microbiology Lab) by using Particle Counter.
Scope:
This procedure is applicable to the sterile area (Manufacturing & Microbiological Testing Lab).
Responsibility:
Microbiologist.
Sterile Area Pharmacist.
Microbiology Lab Attendant.
Accountability:
Quality Control Manager.
Procedure:
Personal entering in sterile area should wear first sterilized uniform, safety goggles, surgical gloves.
Disinfect the equipment before sampling either with 70% IPA (Isopropyl Alcohol) if allowed otherwise disinfect under UV Mopping atleast 24-48hrs before the sampling needs to be done.
Remote sampling shall be performed for all locations.
First of all switch “ON” the equipment.
Main menu shows either particle size of 0.5µ and 5µ.
To begin counting, press the START/STOP button.
The equipment shall start taking air samples automatically for 1 minute as per recommended sampling time and sampling rate.
At the end of air sampling equipment will give a beep and LCD will display the number of particles either /Ft3 or /m3 for each specific location.
Take air samples at least 3 times from a single location and average reading shall be noted.
Record the results for each specific location.
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