sop for post cleaning after media fill

1.0 OBJECTIVE:
To lay down a procedure for Post Cleaning after Media Fill of Production Line.

2.0 SCOPE:
This SOP is applicable for Post Cleaning after Media Fill in Production Area

3.0 RESPONSIBILITY:
Officer / Executive – Production Officer / Executive – QA
Officer / Executive – QC (microbiology)

4.0 ACCOUNTABILITY:
Head – Production

5.0 PROCEDURE:

5.1 After Completion of Media Fill activity, Collect the used gown, hand gloves, mops, used Product filter and vent filters from

Holding tank in a poly bag and send for destruction along with status label.

5.2 Used garments, Hand gloves & mop shall be cut into pieces vertically to make it unfit for reuse.

5.3 Product filter shall be sent to Microbiology Lab for sterilization and further destruction.

5.4 Remaining media solution shall be sent to Microbiology for decontamination in suitable SS Bin.

5.5 CLEANING & STERILIZATION OF MIXING VESSEL / HOLDING VESSEL:

5.5.1 Cleaning of vessel shall be carried out immediately after transfer of complete media for further process without any hold.
5.5.2 Mixing /Holding Vessel shall be filled with Water for Injection (Approx. 40% of Vessel Capacity or 100 Litre whichever is less).

5.5.3 Run the stirrer for 15 minutes (If vessel having stirrer) or and collect the drain in separate vessel.

Note: In case vessel doesn’t have the stirrer facility, drain the WFI immediately and collect the rinse in separate vessel.

5.5.4 Add the NaOH into the collected rinse necessary get the pH between 8.0 – 10.0.

5.5.5 Check the pH of rinse and drain the solution in drain.

5.5.6 Sanitize the drain point as per respective SOP.

5.5.7 Perform the CIP & SIP of vessels as per SOP.

5.5.8 Printout of CIP & SIP cycle to be verified for proper cleaning and Sterilization parameters.

5.5.9 After successful completion of CIP of vessel, rinse shall be taken from vessel and shall be sent to Microbiology for bio burden analysis and Quality Control lab for pH, Conductivity and Analysis.

5.5.10 For another 2 consecutive days CIP & SIP of vessels shall be performed and printouts shall be verified for accuracy of cleaning and sterilization process and rinse sample shall be sent to Microbiology for bio burden analysis and Quality Control lab for pH, Conductivity and Analysis.

5.5.11 In case of Dry powder injection line, Media vessel shall be sent to Microbiology lab along with remaining media after decontamination of outer surface by 2.5% of NaOCl solution for further decontamination and discarding.

5.6 CLEANING & STERILIZATION OF FILLING / SEALING MACHINE PARTS, UNUSED PRIMARY PACKAGING MATERIAL:

5.6.1 Immediately after Completion of Filling operation, dismantle the silicone tubes and dip into disinfectant solution for 10 minutes and transfer to washing & sterilization area.
5.6.2 Allow the Silicone tubing in disinfectant solution for 10 minutes.

5.6.3 Remove the silicone tubing from disinfectant solution and dip in to another bucket having NaOH solution (pH 8.0 – 10.0) for 15 minutes and drain the disinfectant solution in drain.

5.6.4 After 15 minutes, drain the NaOH solution in drain trap followed by sanitization of drain as per respective SOP.

5.6.5 Cut the silicone tubes to make it unfit for further use and collect in poly bag and Send for further discarding with status label.

5.6.6 Machine Parts shall be dismantled and Media contact parts of machine shall be dipped immediately into disinfectant solution for 10 minutes and transfer to washing & sterilization area.

5.6.7 Non-contact parts of machine shall be transferred to washing & sterilization area and shall be dipped in disinfectant solution for 10 minutes.

5.6.8 Keep the Machine Parts in disinfectant solution for 10 minutes.

5.6.9 Remove the Machine parts from disinfectant solution and sanitize with 70% IPA.

5.6.10 Drain the remaining disinfectant solution through drain point followed by sanitization of drain point as per respective SOP.

5.6.11 Clean the Machine parts as per respective SOP for Cleaning. Collect the rinse and send to QC for pH, Conductivity, and Bioburden analysis.

5.6.12 Sterilization of machine parts shall be performed as per respective SOP.

5.6.13 Sterilization printout of autoclave shall be checked for accuracy of sterilization process.

5.6.14 Microbiologist shall be informed to collect the swab samples of sterilized machine parts.

5.6.15 For another 2 consecutive days cleaning and sterilization of machine parts shall be performed and autoclave printouts shall be verified for accuracy of sterilization process.

5.6.16 Remaining rubber bungs, Vials / Ampoules & flip off seals, three piece vials, plastic , plastic caps & shall be sent to washing & sterilization area and dip in disinfectant solution for 10 minutes and drain the disinfectant solution in drain point.

5.6.17 All primary packaging material shall be collected in a poly bag and sent to scrap yard for destruction.

5.7 CLEANING & SANITIZATION OF AREA:

5.7.1 Cleaning and Sanitization of Aseptic area, manufacturing area and washing & sterilization area shall be performed as per respective SOP.

5.7.2 Mounted parts of Equipment i.e. Platform of Filling and Sealing machine / Dynamic Pass Box / Autoclave surface inside and outside of aseptic area, Laminar Air Flow etc shall be cleaned with 70% IPA solution as per SOP twice.

5.7.3 After complete cleaning of area, Fogging shall be performed as per respective SOP.

5.7.4 After fogging, Microbiologist shall performed Microbiological environmental monitoring of area as per respective SOP.

5.7.5 Cleaning, fogging and Microbiological Monitoring of area shall be continued for consecutive three days in static condition.

5.8 Microbiological monitoring of drain point shall be performed for 3 days.

5.9 On the basis of 3 consecutive days CIP / SIP cycle of vessels & machine parts, cleaning and sanitization of area etc. and based on the 72 Hrs. (Third Day) microbiological observations of first day Settle Plate Exposure, production line shall be allowed for routine production activity.

5.10 ACCEPTANCE CRITERIA:

5.10.1 Rinse sample should comply the specification of Water for Injection for Bioburden, pH, Conductivity.

5.10.2 Swab samples of sterilized machine parts should comply the sterility test.

5.10.3 Area Environmental monitoring should comply as per respective SOP.

5.11 In case any non-compliance of any test result, Product manufactured after media fill shall be put on hold and further decision shall be taken based on the investigation findings.

6.0 ABBREVIATIONS:

CIP :Clean in Place
IPA :Isopropyl Alcohol
LDPE :Low Density Polyethylene
QA :Quality Assurance
QC : Quality Control
SIP :Sterilization in Place
SOP :Standard Operating Procedure
SS :Stainless Steel
WFI :Water for Injection

7.0 DISTRIBUTION:
• Controlled Copy No. 01 Head Production
• Master Copy Quality Assurance Department

8.0 REFERENCES:
In House

9.0 REVISION HISTORY: