1.0 Purpose :
This SOP provide written guidelines for monitoring the bioload in compressed air.
2.0 Scope :
This SOP extends to all the user points of compressed air used in the departments like Tablets, Liquid orals and Dry syrup
3.0 Responsibility :
4.0 Procedure :
Test for bioload (by membrane filteration method)
4.1.0 Media used :
4.1.1 Soyabean casein digest agar.
4.1.2 Soyabean casein digest broth. ( Transfer 100ml of SCDB in a 250ml gas washing bottle. Cover the capillary ends with aluminum foil and sterilize ( for Media composition & preparation refer SOP No. QC/MB/XX/XXX)
4.2.0 Preparation of SCDA Plates
4.2.1 Refer SOP No. QC/MB/10/1.0 from steps 4.2.1 to 4.2.10
4.3.1 Gas washing bottle 250ml capacity.
4.3.2 Flow meter.
4.3.3 Membrane filteration unit with sterile 0.22um membrane filter.
4.4.0 Sampling procedure
4.4.1 Only trained and evaluated personnel should collect the samples.
4.4.2 Precaution to be taken by the microbiologist while connecting inlet of
Compressed air to the sterile flask. Nosemask and gloves to be worn.
4.4.3 Carry the flasks in a closed Stainless steel bin previously wiped with 70% v/v IPA to the respective areas.
4.4.4 External surfaces of all sampling points are to be sprayed with 70% v/v IPA.
4.4.5 Connect the sterile flow meter tubing’s to compressed air sampling pre-determined points.
4.4.6 Carefully insert the outlet of flowmeter into the flask containing broth.
Set the flow rate 30 liters/minute and bubble the air for 34 minutes so as to sample 1,000 liters of air.
4.4.8 On completion of sampling remove the tubing from the flask and cover the ends with aluminum foil.
4.4.9 Identify each flask with proper status label indicating sampling point, sampling date and bring to the microbiology department.
4.4.10 Method of testing
4.4.11 Test to be carried out in clean room under laminar flow only.
4.4.12 Use filter cone with membrane filter and transfer the sample from the gas washing bottle to the filter holder.
4.4.13 Follow the membrane filteration technique.
4.4.14 After completion of filteration remove the membrane filter using sterile Forceps and place it on a pre-incubated SCDA plate.
4.4.15 Incubate the inverted plate at 30°C to 35°C for 72 hours.
4.4.16 At the end of incubation count the number of colonies.
Calculate the TAMC/1,000Lts of compressed air.
4.4.17 If any microbial growth is there after incubation identify the colonies morphologically. Continue the tests for Indicative organisms as per
SOP No. QC/MB/XX/XXX
Using autoclaved media prepare negative controls for each days testing.
Growth promotion test to be performed for positive control.
TAMC/1000LTS OF COMPRESSED AIR NMT 5CFU.
PATHOGENS/1000LTS OF COMPRESSED AIR : SHOULD BE ABSENT.
1. SOLVENT DISPENSING AREA.
2. TABLET PRINTING AREA.
3. NEOCOTA AREA.
4. F.B.P. AREA.
Once in six months.