Monitoring in Sterile Filling Area : Pharmaceutical Guidelines

Monitoring in Sterile Filling Area

Sampling of air is carried out during manufacturing in sterile area to monitor the cleanliness of the area. it is a mandatory requirement of regulatory agencies.
Sterile bottle filling is a critical process that has to be monitored for contaminants. Following two test must be carried out during the filling process to ensure the sterility of the products being manufactured in the area.

Air Sampling

1. Prepare SCDA medium as per SOP for preparation of culture media.
2. Aseptically pour approximately 15 – 20 ml of sterile molten (cooled to about 40°C) SCDA agar into each sterile 90 mm Petri plates under LAF.
3. Allow the media to solidify in the plates under LAF, after solidification label all the plates with the name of media, preparation batch no. and date of preparation.

4. Invert and incubate the plates at 30 to 35°C for 24 hrs. After incubation check the plates for any contamination, if there is contamination discard the plates as per SOP for Destruction of Microbial waste by Autoclaving.
5. After pre-incubation, label all the plates with the date of use and plate no. with the help of a marker pen and wrap with aluminum foil. Keep the wrapped plates in a clean and sanitized SS container.
6. Transfer the container and air sampler which is sanitized and wrapped in aluminum foil, to the sterile area through material entry and personnel must be entered through airlocks as per SOP for Entry/ Exit procedure in cleanroom area.
7. Remove the lid of the plate and place the pre-incubated SCDA plate in air sampler holder. Perform the sampling activity by operating the air sampler as per SOP for operating instruction for Air Sampler.
8. After air sampling, remove the plates from air sampler, close the lid immediately wrapped with aluminum foil and place aside.
9. Immediately clean the air sampler with 70% v/v sterile IPA solution and carry out the air sampling for other specified locations.
10. After air sampling collect the plates in clean SS container and send to microbiology laboratory through pass box. Follow the exit procedure to come out from sterile area..
11. Prepare positive control by streaking Bacillus subtilis (MTCC 441) and negative control plate without opening.
12. Invert all the plates and incubate at 20 to 25°C for 72 hrs and then 30 to 35°C for 48 hrs.
13. After incubation, count the number of colony forming units with the help of colony counter. Operate the colony counter as per SOP and express the result cfu/ m3.
14. Record the result as per the following formula –
        X = Pr X 1000/V
Where
X = cfu/m3
r = colony forming units counted on 90 mm plates
P = Probable count obtained by positive hole correction against r value
V = Volume of the air sample

Air Borne Particle Counts

1. Transfer the Air Borne Particle Counter to the sterile area through material entry and personnel must be entered through Air locks as per SOP for Entry/Exit procedure.
2. Place the Air Borne Particle Counter in filling area, verify the zero count by using zero filter and operate the Air Borne Particle Counter as per SOP for operating instruction for Air Borne Particle Counter and take the print out of the result.
3. Count the No. of Particles per cubic foot of size ≥ 0.5 µ and ≥ 5.0 µ. The entire filling zone shall be scanned for determination of particle count.
4. Particles of ≥ 0.5 µ must not exceed 100 particles per cubic feet. There shall not be any particle of ≥ 5.0 µ

Precautions

1. Before commencing the monitoring of the filling zone, ensure that all the measuring and testing equipment and instruments are calibrated.
2. Start the blower of the filling zone for at least 10 minutes before commencing any monitoring.
3. All accessories taken in the clean room must be sterilized.
4. Always follow all the instructions needs to maintain the clean room.

Frequencies

Air Sampling – Daily
Air Borne Particle Counts - Daily





Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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