STANDARD OPERATING PROCEDURE Procedure for Microbial Testing of Compressed Air

	STANDARD OPERATING PROCEDUR
	Department: Quality Control	SOP No.: QC/MB/xxxx
Procedure for Microbial Testing of Compressed Air		Effective Date:
		Review Date:
		Page No.:

1.0            OBJECTIVE:

1.1                   To lay down a procedure for microbial testing of compressed air, used in various manufacturing process of drug product.

2.0            SCOPE:

2.1                   This SOP is applicable to user points of compressed air used in Pharma Pvt Ltd.

3.0            RESPONSIBILITY:

3.1                 Microbiologist- Execution of activity

3.2                 Section In-charge – To review the procedure

3.3                 QC Head- To implement the Procedure

3.4                 Head QA-Overall Compliance

4.0            PROCEDURE:

4.1         Media Plates Preparation:

4.1.1             Prepare SCDA and SDA plates as per current version of QC/MB/xxx and pre-incubate the prepared SCDA plates at 30°C to 35°C for 24 to 48 hours and SDA plates at 20°C to 25°C for 24 to 48 hours.

4.1.2             After completion of incubation period observe the plates, if any contamination observed discard the contaminated plates.

4.2                   Compressed Air Sampling and Testing Procedure:

4.2.1             Use pre incubated plates of Soya bean Casein Digest Agar (SCDA) for TAMC and Sabouraud Dextrose Agar (SDA) for TYMC in compressed air testing.

4.2.2             Label each pre incubated SCDA & SDA plates with name of the media, sampling ID, and date of testing.

4.2.3             Carry the labelled plates in stainless steel petri plate carrier which is   previously wiped with 70% IPA along with compressed air sampling kit to the respective locations.

4.2.4             Follow the gowning procedure as required by the respective department to avoid the additional contamination.

4.2.5             Perform a blind test (negative control) before and after completion of sampling from all locations, the actual measurement by carrying out for all samples without starting the slit-sampler. The dishes which are used for blind test shall not show any growth.

4.2.6             Perform the compressed air sampling by using compressed air sampler as per the current version of QC/MB/056 (Operation and Calibration procedure for Compressed Air Sampler).

4.2.7             Sample 1000 liters of air in 10 minutes (with the air flow of 100liters/minute) per location mentioned in Annexure - III and it should be perform as per as current lay out given by QA.

4.2.8             After completion of sampling from all locations collect all exposed plates in stainless steel petriplate carrier which is previously wiped with 70% IPA and bring to microbiology lab for incubation.

4.2.9             Enter the details in Annexure- II ‘Inward of compressed air samples’.

4.2.10         Allot A.R No for compressed air samples.

4.2.11         The A.R. Number contains CA/YYXXX, where CA denotes compressed air, YY denotes last two digits of current calendar year and XXX denotes sequential number starts with 001.

4.2.12         After entering of samples in inward register, incubate the SCDA plates in inverted position at 30°C to 35°C for 3 - 5 days for Bacterial growth and incubate the SDA plates in inverted position at 20°C to 25°C for 5 to 7 days for fungal growth.

4.2.13         Count the colony forming units in the plate at the end of incubation time and use conversion table given in annexure-I of QC/MB/056 to report the results as cfu/1000 litres of compressed air (cfu/m³).

4.2.14         Record the results in Annexure-I

4.3                 Precautions:

4.3.1             Follow the gowning procedure as required by the respective department to avoid the additional contamination.

4.3.2             Wear hand gloves and nose mask during sampling.

4.3.3             Spray 70% IPA before sampling at the site of user point.

4.4                 Limits:

4.4.1             Total Viable Aerobic Count: Limit – NMT 10 cfu/ m³

                                                                Alert Limit: 5 cfu/ m³

                                                                         Action Limit: 7 cfu/ m³

4.5                 If the results are above the alert limit, microbiologist will inform to QC manager, QA Head and engineering head to take further action.

4.6                 If the microbial limits of compressed air will cross the alert limit clean filters at the point use to reduce the microbial limit below alert limit.

4.7                 If the microbial limits of compressed air will cross the action limits, the source of the contamination shall be investigated through the deviation control.

4.8               Compressed air user points are listed in Annexure-III whenever new user points are included the list will be updated.

4.9                 Frequency:  Quarterly, ±7 days.

5.0            ABBREVIATIONS:

QC: Quality Control	QA: Quality Assurance
SOP: Standard Operating Procedure	IPA: Iso Propyl Alcohol
CFU: Colony Forming Unit	LAF-Laminar Air Flow
SCDA-Soya bean Casein Digest Agar	SDA – Sabouraud Dextrose agar
IPA-Iso Propyl Alcohol	NMT-Not More Than
A.R.No. -Analytical Reference Number	TAMC: Total Aerobic Microbial Count
TYMC: Total Yeast and Mold Count	CAUP: Compressed Air User Point

6.0           ANNEXURES :

6.1                 Annexure I - Microbial Test report of Compressed air: Current Version of QC/MB/.

6.2                 Annexure II - Inward of compressed air Samples: Current Version of QC/MB/.

6.3                 Annexure III - List of Compressed air sampling points: Current Version of QC/MB/

7.0            REFERENCES:

7.1                 ISO 8573-7 (Test method for viable microbiological contaminant content of compressed air).