PROCEDURE FOR MONITORING BACTERIOLOGICAL QUALITY OF DRAINS

1.0 Purpose :
The purpose of this procedure is to describe the method of bacteriological Quality of Drains by swab test method.
2.0 Scope :
This procedure covers all the activities related to the drain swab sampling, testing and interpretation of results.
3.0 Responsibility :
Microbiologist QC.
4.0 Procedure :
4.1.0 Material required:
4.1.1 150 mm length wooden stick consisting of a sterile cotton swab
wound round at one end and the other end is left free.
4.1.2 18mm x 150 mm rimless test tube.
4.1.3 Place the swab in 10ml of normal saline in test tube with non absorbent cotton cover the plug and sterilise in a validated autoclave.
4.20 Swab sampling
4.2.1 Carry the sterlized Swabs in a previously wiped with 70%v/v IPA stainless steel bin to the respective department.
4.2.2 Follow the gowning procedure of respective department.
4.2.3 An area of approximately 100 sq.cms shall be examined.
4.2.4 Press the swab with a rolling motion against the side of the glass tube to remove excess liquid with heavy pressure rub back and forth over the area to be examined so that all parts of the surface are covered by swab.

4.2.5 This swab shall be rotated so that all parts of it make contact with the surface to be examined and remove the swab.
4.2.6 The liquid is mixed by swirling the swab vigorously in the solution
4.2.7 Bring the swabs to microbiology department.
4.3.0 Testing
4.3.1 The test must begin within one hour of the above sampling.
4.3.2 After thorough mixing the swab is examined for absence of pathogens.
4.3.3 Transfer complete swab sample to 90ml of previously sterilised SCDB.
4.3.4 Incubate the SCD Broth at 30°C to 35°C for 48 hours.
4.3.5 At the end of incubation period observe the growth.
4.3.6 If any growth is observed continue the test for Pathogens.
4.3.7 For method of testing Refer SOP No. QC/MB/xx/xxx
4.4.0 Limits
E.coli/ swab Should be absent
Salmonella/ swab Should be absent
S. aureus/ swab Should be absent
Pseudomomas/ swab Should be absent
4.5.0 ACTION TO BE TAKEN WHEN PATHOGENS ARE PRESENT
4.5.1 During monitoring if the Pathogens are present actions to be taken.
4.5.2 Production department and QA department should be informed
4.5.3 Investigate the cause and take remedial action.
4.5.4 Immediately arrange for sanitisation drains using 2% Sodium Hypo-Chlorite solution.
4.5.5 Monitor the swab test of drains once again.
4.6.0 Frequency
Once in a month cover all the drains located in Manufacturing area, Washing area.
4.7.0 Sampling points of Drains:
Department: Tablets
Granulation I (equipment washing area)
Granulation II (equipment washing area)
Granulation III (equipment washing area)
Department : Liquid orals
Manufacturing Area
Equipment washing Area
Bottle washing Area
Department : Dry syrup
Equipment washing Area