SOP on Sampling and testing procedure of swab sample

0
2265

1.0 Objective:

1.1 To lay down the procedure for Sampling and testing procedure of swab sample.

2.0 Scope:

2.1 This SOP is applicable for Sampling and testing procedure of swab sample in the Microbiology lab of pharmaceutical formulation plant.

3.0 Responsibility:

3.1 Officer or above of Microbiology laboratory: Preparation of the SOP.

3.2 Head – Microbiology section/ Nominee: Checking of the SOP.

4.0 Accountability:

4.1 Head – Quality Control/ Nominee: Compliance of SOPs.

5.0 Procedure:

5.1 Prepare the sterile swab in 0.9% saline (10 ml) solution in the test tube having cotton plug or use readymade sterile moisten swab (Hi media).

5.2 Sterile the swab media in the autoclave by operating the autoclave as per respective SOP.

5.3 The swabbing shall be done on the area of 100 cm2 by following horizontal strokes first followed by vertical strokes.

5.4 Place the swab back in the test tube and vortex. Incase of readymade sterile moisten swab pour about 10 ml of 0.9% saline in tube and vortex.

5.5 Filter the content through 0.45µ membrane filter and place the filter on the Petri plate having sterile SCDA medium.

5.6 Incubate the plate at 30 – 35 º C for 48 hrs and further at 20 – 25 º C for 72 hrs.

5.7 Count the colonies and report the total microbial count as CFU/100 cm2 in Annexure-I.

6.0 List of Annexure / Formats 

Sr. No. Format Title Format Number Annexure Number No. of Pages
1 Report for Total Microbial Count of swab sample      

 

7.0 References (if any).

7.1 Not applicable.

8.0 Reason for Revision

8.1 Periodic Review.

9.0 Abbreviations:

9.1 SOP          : Standard operating procedure.

9.2 No.           : Number

9.3 QC           : Quality Control

9.4 QA            : Quality Assurance

9.5 CFU         : Colony Forming Unit

9.6 SCDA       : Soyabean Casein Digest Medium

Annexure-I

Report for Total Microbial Count of swab sample

Name of Sample  : __________________________________

Date of Sampling : __________________________________

Date of Testing    : __________________________________

Date of Report     : __________________________________

 

Area/Location: ____________

 

 

 

TOTAL MICROBIAL COUNT :  (Membrane Filtration Method)

Medium Used : ___________________   Autoclave Lot No.: __________________________

For Bacteria:

Incubation Condition : Temp _______, Time : From _____________to____________

Incubator ID No.:_____________________

For Fungus:

Incubation Condition : Temp _______, Time : From _____________to____________

Incubator ID No.:_____________________

Date of testing Location ID Observation cfu/100 cm2
Bacteria Fungus
 

Interpretation: Sample Complies/Does not comply as per respective SOP.

 

Sr. No. Grade Acceptable level of Total Microbial Count (cfu/100 cm2)
01 A <1 cfu/100 cm2
02 B NMT 5 cfu/100 cm2
03 C NMT 50 cfu/100 cm2
04 D NMT 100 cfu/100 cm2
05 Fungus NMT 10 cfu/100 cm2

LEAVE A REPLY

Please enter your comment!
Please enter your name here