cip of mixing vessel and holding vessel
To lay down the procedure for Cleaning of Mixing Vessel/Holding Vessel, Cartridge Housing and Filter Housings and Pipe lines using CIP.
This SOP is applicable to Cleaning of Mixing Vessel, Holding Vessel, Cartridge Housing and Filter Housings and Pipe Lines using CIP of Production Area
Officer/Executive – Production
Head – Production
SOP : Standard Operation Procedure
WFI : Water for Injection
QA :Quality Assurance
CIP :Clean in Place
IPC :Industrials Programmable Control
MMV :Mobile mixing vessel
MV : Mixing vessel
BV : Buffer vessel
HV :Holding vessel
6.1.1 Ensure the CIP in working condition.
6.1.2 Ensure all the utility supply for CIP operation.
6.1.3 Ensure the mixing tank is empty.
6.2 The Cleaning of Mixing Vessel, Mobile Mixing Vessel, Holding Vessel, Filling Vessel, Filter Housing and
Filtration Pipe lines with Purified water followed by rinsed with WFI. The Procedure to be
adopted after and before the production processing.
6.3 CIP OF MANUFACTURING AND FILTRATION LINE:
6.3.1 MIXING VESSEL, HOLDING VESSEL, FILTRATION LINE, FILTER CARTRIDGES AND BUFFER VESSEL:
18.104.22.168 Connect the CIP outlet supply to inlet of mixing vessel.
22.214.171.124 Connect the filtration line inlet to the mixing vessel outlet and followed by connect filter cartridge.
126.96.36.199 Now connect the filter cartridge outlet to CIP inlet.
188.8.131.52 Clean the outside body of mixing vessel, holding vessel, filtration line, filter cartridge housing
and Buffer vessel with Hot WFI using lint free sponge as a mopping pad
184.108.40.206 Clean the mixing vessel vent filter separately with hot WFI and refit it.
220.127.116.11 Clean the sampling valve of mixing vessel.
18.104.22.168 Close the manhole of the mixing vessel with air tight.
22.214.171.124 Now set the IPC of CIP as per following parameter and batch details:
126.96.36.199 1st press of IPC as show Display.
188.8.131.52 2nd Step click .User name and password entry
184.108.40.206 3rd Step Login successes fully for next processing
220.127.116.11 4th Step Welcome MV and MMV tank select for next processing
18.104.22.168 5th Step HV with BV tank select for next processing
22.214.171.124 6th Step go to mode selection for processing.
126.96.36.199 7th Step semi auto mode selection for MV, MMV, HV tank and press the start CIP Pre wash.
Cycle complete than after press CIP Intermediate wash mode and final wash mode.
188.8.131.52 8th step Comments fill up for propose
184.108.40.206 Run the CIP cycle as per the SOP for Operation of CIP.
220.127.116.11 Remove air packets in the cartridge filter assembly by air vent valve during the operation for every 5minutes.
18.104.22.168 Intimate QA to collect the sample of rinse water for its analysis in QC.
22.214.171.124 Collect the CIP sample at the end of cycle by opening the sampling valve and send immediately to rinse water test like:
1. Conductivity 2. pH 3. Absorbance
126.96.36.199 Once the process is completed the CIP IPC will display “Final wash mode Completed successfully”.
188.8.131.52 Now switch off the IPC.
184.108.40.206 If QC result is not OK once again repeat the CIP cycle up to get OK result form QC.
220.127.116.11 Now the Mixing Vessel, Holding vessel Filtration Line and Filter Housing are all ready for SIP operation.
18.104.22.168 Write the Status Board Manufacturing Line is ready for further processing.
22.214.171.124 Verify the CIP cycle print outs. Record the details as per “Equipment Log SOP”.
6.4 CIP OF FILTRATION LINE:
6.4.1 Ensure the CIP in working condition.
6.4.2 Ensure all the utility supply for CIP operation.
6.4.3 Ensure the Holding tank is empty.
6.4.4 Connect the CIP supply to inlet of Holding vessel.
6.4.5 Connect the Holding vessel outlet to the CIP outlet valve.
6.4.6 Clean the outside body of Holding Vessel with Hot WFI using lint free sponge or mopping pad
6.4.7 Clean the Holding vessel vent filter separately with hot WFI and refit it.
6.4.8 Ensure the purified water and WFI flushing spray ball in working condition.
6.4.9 Close the manhole of the Holding vessel with air tight.
6.4.10 Open the Holding vessel CIP inlet valve and bottom CIP outlet valve.
6.4.11 Now set the IPC of CIP as per following parameter and batch details:
6.4.12 Run the CIP cycle as per SOP for Operation of CIP.
6.4.13 Remove air packets in the air vent valve during the operation.
6.4.14 Intimate QA to collect the sample of rinse water for its analysis in QC.
6.4.15 Collect the CIP sample at the end of cycle by opening the sampling valve and send immediately to rinse water test like
1. Conductivity 2. pH 3. Clarity
6.4.16 Once the process is completed the CIP. IPC will display “Final wash mode Completed successfully”.
6.4.17 Now switch off the CIP.
6.4.18 If QC results are not OK once again repeat the CIP cycle up to get OK result form QC.
6.4.19 Now the Holding vessel is ready for SIP operation.
6.4.20 Write the status board Holding Vessel is ready for processing.
126.96.36.199 Verify the CIP cycle Print Outs. Record the details as per “CIP Log Book”.
6.5 FREQUENCY OF CIP:
After each batch changeover or product changeover.
• Controlled Copy : Production
• Controlled Copy : Quality Assurance
• Master Copy :Quality Assurance Department
Clean in Place of manufacturing and filtration line