MICLAB 100 Microbiological Testing of Compressed Gasses Pharmaceuticals quality assurance & validation procedures GMPSOP

Department	Micro Laboratory		Document no	MICLAB 100
Title	Microbiological Testing of Compressed Gasses
Prepared by:		Date:		Supersedes:
Checked by:		Date:		Date Issued:
Approved by:		Date:		Review Date:

Document Owner

Micro Laboratory Manager

Affected Parties

All Microbiology Laboratory colleagues

Purpose

The purpose of this procedure is the outline the steps necessary to carry out compressed gas testing to verify that clean compressed gas meets specified demands for micro organisms in all areas where compressed gas may affect product or clean room conditions.

Scope

Step	Description	Responsibility
1.	Safety	Micro. Lab. Staff
2.	Testing of compressed gas outlets	Micro. Lab. Staff
3.	Recording of results	Micro. Lab. Staff

Definition

N/A

EHS Statement

Safety glasses must be worn when testing compressed air.

Procedure

1. General – This test should be performed at point of use.

2. Microbiological Monitoring

For Microbiological monitoring of compressed gas, the following equipment is used:

Sterile 0.45mm hydrophobic membrane filter (Millipore Cat. No. HVLP04700 or equivalent)
Filter holder
Gas flow meter.

3. Method

3.1. The filter holder is dismantled using the Allen key from the Micro. Lab and a filter placed into the filter holder. Sterilize the filter holder and filter by placing in a Dacron (brand) autoclave bag and autoclaving for 30 minutes at 121°C.

3.2. Once in location, the holder is aseptically connected to the gas flow meter and the compressed gas system to be tested.

3.3. Turn the regulator knob on the gas flow meter anti-clockwise so that the gas flow through the filter is regulated at 50L/min (22.5 on the flow meter scale) and is tested for 20 minutes.

NOTE A total of 1000L must pass through the filter.

3.4. The regulator knob is then turned clockwise until airflow reads ZERO on the flow meter.

3.5. Disconnect the hose from the sample port being aware that here may be some pressure in the line. Label the outlet sampled on the filter holder and return it to the Micro. Lab. inside the Dacron autoclave bag.

3.6. For compressed air, the filter is then aseptically transferred to a Tryptone Soy Agar petri dish and incubated at 32°C for 5 days before reading the result. When testing compressed nitrogen the filter is transferred to a Reinforced Clostridial Agar petri dish and incubated anaerobically at 32°C for 5 days.

3.7. The results are then graphed in the “Compressed Air/Nitrogen Testing File”.

3.8. The capability to be switched to compressed air but will be using Nitrogen on a regular basis.

4. Limits

Normal value = 0 colonies/1000L of compressed gas.

Any results over the normal value must be retested immediately and the Microbiology Manager must be informed of the result.

5. Testing Frequency

All available sample ports are to be tested annually or when requested by Production staff.

6. Summary of Changes

Version #	Revision History
MICLAB 100	New

MICLAB 100 Microbiological Testing of Compressed Gasses