SOP on operation, cleaning and maintenance of the Stericheck systemObjective:
To lay down a procedure for operation, cleaning and maintenance of the Stericheck system.
This SOP is applicable to Stericheck system present in the microbiology lab of (Pharmaceutical Company Name).
- Officer or above of Microbiology Laboratory:
- Head – Microbiology section / Nominee.
- Head – Quality Control / Nominee.
- Abbreviations and Definitions
SOP : Standard Operating Procedure
QC : Quality control
- Switch ON the power key to turn on the Stericheck apparatus.
- Dissolution of the Product
- Remove the Dilutor from the packing aseptically.
- For Dissolution of Raw Material (250 ml vial) – Insert the double tubing into the Stericheck pump- head and close the head, while in case of finished product (vials) For Dissolution of Finished product (10 ml vial) -separate the double tubing from the middle and insert only one tubing into the pump head .
- Carefully decontaminate the surfaces of the Peptone water container and the vial containing raw material paying close attention to the top septum area of the container.
- Hold the Peptone water container (250 ml) upright and aseptically insert one of dilutor’s needles (1 piece) into the container up to its base. Insert the 2 piece needle at other end into the product vial .Insert the second needle into the peptone water container.
- Set the pump at the appropriate speed and press the START/STOP key to turn on the pump. (While using the foot control accessory. Press the pedal down with your foot and keep it on it to keep the pump running).
- Invert the Peptone water container and place it on the bottle support.
- After all the product in the vial (in case of finished product) has dissolved remove the peptone water container from the support assembly and place it upright and then invert the product vial and hold it above to allow the peptone water to pass back into the bottle.
- Repeat the process for dissolving the other product vial (no. of vials as recommended by the pharmacopoeia)
- After all the vials have been dissolved discard the needles and the tubing.
- In case of raw material, transfer 200 ml peptone water into the 250 ml vial containing the raw material and then dissolve the product in the peptone water by shaking.
- Pre wetting of the membranes.
- Aseptically open the sterilized plastic tray that contains the Stericheck canisters and tubing-needle set, by peeling back the lid. Place the canisters into the drain tray and label them.
- Load the canister tubing into the pump head.
- Carefully decontaminate the surfaces of the rinse container paying close attention to the top septum area of the container.
- Remove the protective cap of the testing needle and immediately flame it and allow it to cool.
- Hold the rinse fluid container upright and aseptically insert the Stericheck needle into the rinse container up to its base.
- Insert plastic plugs at the bottom of the canisters.
- Press the START/STOP key to turn on the pump. Invert the rinse fluid container and place it on the bottle support.
- Transfer approximately 50 ml of the sterile rinse solution into each of two canisters.
- Plug the air vents with rubber plug to allow the solution to filter through the membranes completely.
- Remove the rinse fluid container from the support assembly and place it upright.
- Testing the Product
- Carefully decontaminate the surfaces of the peptone water container containing product paying close attention to the top septum area of the container.
- Remove the Stericheck needle from the rinse fluid container and quickly flame it and then allow it to cool.
- Hold the product container upright and insert the needle aseptically into the container up to its base.
- Set the pump at the appropriate speed and then switch on the pump.
- Invert the product container and place it on the bottle support. Place the stabilizing bar on the bottom of the inverted container.
- Aseptically place a red cap onto the top of each canister’s air vent.
- Allow the entire contents (or the volume recommended by the pharmacopoeia) of the container to transfer to the canisters.
- Turn the Steripump off.
- Remove the container from the support assembly and place it upright and then turn on the pump until all the residual product clears the tubing and filters through the canisters.
- Rinsing of the Tubings, Canisters and Membranes with Buffer solution
- Remove the red caps from the top of the air vents of the canisters.
- Remove the Stericheck needle from the product container and flame it and allow it to cool.
- Insert it up to the base of the bottle containing 200 ml rinsing solution.
- Set the pump speed at 55 or lower and press the START/STOP key to turn on the pump.
- Invert the bottle and place it on the bottle support.
- Pump 100 ml of the buffer solution into each canister and then turn off the pump.
- Remove the buffer bottle from the bottle support and place it upright.
- Aseptically replace the red caps onto the top air vents of the canisters.
- Turn on the pump and allow the 100 ml of the buffer solution to filter slowly through the membranes until the canisters are empty. Then turn off the pump.
- Repeat steps 220.127.116.11–18.104.22.168 four more times.
- Adding the Media to the Canisters
- Remove the red caps from the air vents of the canisters.
- Lift one of the canisters from the drain tray and aseptically place a red plug into the bottom outlet port of the canister.
- Return the canister to the drain tray and repeat the process for the other canister.
- Clamp off one of the canisters close to the ‘Y’ connector.
- Decontaminate the bottle septum containing 100 ml of Fluid Thioglycollate Medium with 70% I.P.A.
- Remove the Stericheck needle from the last rinse bottle and flame it and allow it to cool.
- Insert the Stericheck needle into the FTM bottle up to the base.
- Set the speed of the pump at 28-30 and then turn on the pump and then invert the media bottle and place it on the bottle support. Transfer the media into one canister.
- Turn off the pump when the tubing is clear of the media.
- Remove the clamp from the tubing and clamp the other tubing line as before.
- Decontaminate the bottle septum containing 100 ml of Soyabean Casein Digest Medium with 70% I.P.A.
- Remove the Stericheck needle from the FTM bottle and flame it and then allow it to cool and then insert it into the bottle containing 100 ml of Soyabean Casein Digest Medium up to its base.
- Set the pump speed at 35 or lower and then turn pump on, and invert the media bottle and place it in the bottle support.
- Transfer the media from the bottle into the second canister. Then turn off the pump when the line is clear of the media.
- Remove the bottle from the bottle support and place it upright.
- Clamp shut both tubing lines approximately 6 cm from the canister inlets.
- Remove the tubing from the pump.
- Using sterile scissors, cut the tubing approximately 2 cm above the clamp.
- Fold over and insert the tubing into the top air vents of the canisters.
- Remove the canisters from the drain tray and then incubate the canisters for appropriate time and temperature.
- Clean the Steri pump casing first with sterile water and then disinfect it with 70% I.P.A.
- Dry the Steri pump after each cleaning.
- To clean the drain tray remove it from the main pump and immerse it in a mild detergent solution. Rinse and dry.
- Do not cover or block the air vents provided on the unit to prevent overheating of the pump drive motor.
- Always remove the media from the tubing after each test by keeping the pump on for few minutes more.
- Cleaning of the pump should be done before and after each analysis.
Forms and Records (Annexures)
- Not applicable
- Master copy – Quality Assurance
- Controlled copies – Quality Assurance, Production, Quality Control, Stores, Engineering and Human Resource
Reason for Revision
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Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field.
During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube