Follow
Objective: To define the manufacturing and filling to be carried out in the Mixing and Filling Room.
Scope: This SOP is applicable for the different products manufactured in MDI Unit.
Responsibility:
1. Production Officers
2. IPQA Officers
Accountability:
1. Manager Production
2. Manager Quality Assurance
Precaution:
1. Perform reconciliation at every stage of manufacturing and filling operation.
2. Maintain and monitor the environment to control.
Procedure:
=>> Manufacturing (Annexure – I)
=>> Dispense the materials with proper labeling to all containers/ bags as per latest version of dispensing SOP.
=>> Add all the components sequentially and slowly into the slurry preparation vessel.
=>> Mix for five (5) minutes with High Shear Mixer to prepare slurry at desired rpm as mentioned in Batch Manufacturing Record (BMR) of the batch to be manufactured.
=>> Affix the status label on the Mixing Vessel. Be sure that the bottom valve of the Mixing Vessel is closed.
=>> Place the SS Funnel into the product inlet (D/M 65mm) of the Mixing vessel and add slurry through the Funnel into the Mixing Vessel.
=>> Take care to avoid the spillage of slurry to be added within fifteen (15) minutes after preparation.
=>> Adjust the total weight and mix for desired time and at desired rpm as mentioned in Batch Manufacturing Record (BMR) of the batch to be manufactured.
=>> Send sample to QC department through QA and wait for QA approval for filling.
=>> Can Cleaning (Annexure – I)
=>> Fix status Label to Can Cleaning Machine. Clean all the empty cans with can cleaning machine.
=>> Place all the cleaned cans upside down position (inverted) in the SS tray with proper label.
=>> Place the SS tray with Cleaned empty Cans in the SS Trolley and fix the status label on the SS trolley.
=>> Send the trays with cleaned can to the filling area through the Pass Box.
=>> Perform and record in process check to ensure the cleanliness of the cleaned cans.
=>> Filling (Annexure – I)
=>> Determine the average weight of empty cans and Metering valves taking 10 Cans and Valves each to be used for filling to make a Tare can.
=>> Adjust the Product Filler and fill ten cans then take printout of these ten cans and affix with BMR.
=>> Adjust the Crimper to set crimp height and diameter. Measure the crimp height and diameter and record in the BMR
=>> Perform crimper strength test before start, middle and at the end of filling operation.
=>> Adjust the Propellant Filler and fill ten cans then take printout of these tens cans and affix with BMR
=>> Send two filled cans to QA for crimper strength test.
=>> Start filling operation after having QA approval for filling.
=>> Perform in process check for fill weight at every thirty (30) minutes taking consecutive five (5) cans and record in the BMR with their printout of checked weight.
=>> Perform in process check for crimp height and dia at every two hours taking two (2) cans and record in the BMR.
=>> Place the filled cans on the SS Tray with status label on it.
=>> Complete filling operation within 24 hours of manufacturing operation.
=>> Pass the SS Tray with filled Cans from Mixing and Filling room to the weight Check room through the Pass Box.
=>> Weight Checking (Annexure – I)
=>> Fix the status label to the Checkweigher. Perform the function (challenge) test of the Checkweigher.
=>> Pass all the filled cans through the Checkweigher.
=>> Place all the qualified (good) filled cans on the SS tray upside down position and then place the SS tray in the SS quarantine cabinet.
=>> Place and hold the Quarantine Cabinet with filled cans in the Quarantine area for the 14+3 days (HFA Products) 28+3 days (CFC products).
=>> Perform 2nd weight after quarantine period as mentioned in the above step 6.4.4.
=>> Send final sample to QC through QA for batch analysis.
