To check viable count in to clean equipment from Solid dosage area.
This SOP is applicable for checking of viable count on surface of clean equipment by SWAB method.
3.1 Doing : Technical Assistant ( Q.C) / Executive.
3.2 Checking : Executive / Manager.
Head of the department.
5.1 Frequency :Once in a month to cover all equipment in solid dosage area.
5.2 Requirement :Sterile SWAB Sticks, 10 ml Sterile Normal Saline tube/ 10 ml sterile water, Melted SCD Agar Medium, 70% filtered IPA. Micropipette, Sterile tips (1ml).
5.3 Take SWAB sample as per point No 5.5 in presence of Q.A & Production Representative. As per approved list of clean equipment.
5.4 Media Preparation :Melted SCD Agar Medium
5.4.1 As per the instruction, weigh specified quantity of media powder in a beaker whose capacity is double the final volume of the media to be prepared.
5.4.2 Add appropriate quantity of Purified water and mix it properly.
5.4.3 Check the pH of the medium and adjust the pH using 0.1
HCl / 0.1N NaoH, if
5.4.4 Heat and dissolve the medium constituents with constant stirring to avoid charring.
5.4.5 While in the molten state, distribute the specific volume of the media into the appropriate glass container.
5.4.6 Seal the mouth of the glass container using cotton plug.
5.4.7 Cover the cotton plugs with wrapping paper.
5.4.8 Sterilize the media at 121°C for 20 min as per S.O.P.
5.4.9 After sterilization, media should be kept in to oven / water bath whose temperature should be between 50°C – 60°C until use so that it should remain in molten state.
5.5 Sampling Procedure :
5.5.1 On request through requisition slip from Production / Q.A department for viable count of clean equipment. Take the SWAB sample with the help of sterile SWAB sticks.
5.5.2 Wear gloves and wash the hand with 70% IPA before sampling.
5.5.3 Take the sterile SWAB stick and moistened in 10 ml sterile
Normal saline or 10 ml sterile water
5.5.4 Apply the SWAB in a controlled fashion as indicated in the figure below and with uniform pressure, to the pre – determined clean equipment. Cover 100-sq. cm. area for sampling
5.5.5 Put this SWAB in to 10 ml Sterile Normal Saline /10 ml sterile water for injection.
5.5.6 Label it with equipment ID.No, Location, Cleaning Date, sampling date & time
5.5.7 Send the sample via material entry through microbiology laboratory and swabs should analyze within 24 hours while stored at 2-8 °C.
5.5.8 Put the sample in to LAF of microbiology laboratory.
5.5.9 Testing should be done in duplicate under LAF.
5.5.10 Properly marked two sterile Petridishes with equipment ID.No, Location, sampling date & time and testing Date & Time.
5.5.11 Take two different aliquot of 1 ml sample aseptically with sterile pipette and transferred in to two different sterile petridishes, because testing should be done in duplicate.
5.5.12 Pour Melted SCD Agar medium, whose medium temperature is 50°C – 60°C into sample containing petridishes, swirl well and close the petridishes.
5.5.13 Wait for some times to solidify the medium and put it into incubator for incubation at 30°C – 35°C for 5 days.
5.5.14 After incubation, Count the Colony and multiply with 10 ( dilution Factor) and note down the results in the requisition Slip as colony/100 sq.cm.
5.5.15 Submit the Requisition Slip to requester ( production dept/ QA Dept.for further action.
SCD : Soybean Casein Digest.
LAF : Laminar Air Flow.
Q.C : Quality Control
Q.A : Quality Assurance
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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