1.0 Objective: To lay down a procedure for Cleaning and operation of vials washing machine to make vials free from particulate matter.
2.0 Scope: This SOP is applicable to the Injection Section of the production department.
3.0 Responsibility:
Officer- Production to implement this procedure
Head – Production to overall compliance to this SOP
4.0 Distribution:
Master Copy: Quality Assurance Department
Control Copy: Production Department
Display Copy: Production Department
5.0 Procedure:
5.1 Precaution:
5.2 Operation
5.3 Cleaning
5.1 Precautions:
5.1.1 Ensure that the area and the machine are clean and free from the previous batch or product traces.
5.1.2 Put ON the LAF unit half an hour before the start of the operation.
5.1.3 Unauthorized persons shall not be allowed in the area. The movement of persons should be restricted to a minimum.
5.1.4 Men’s must Wear clean overalls, surgical gloves, and nose masks by the persons operating the washing machine and arranging the washed ampoules in S.S. Boxes.
5.1.5 Check and ensure that the filters of water and compressed air lines are in good condition.
5.2 Operation of vials washing machine :
5.2.1 Switch on the mains
5.2.2 Before starting of operation, check the following:
- Compressed air pressure NLT -1.5 to 2.0 kg/cm2
- D.M. water supply line. Water flow pressure NLT -2.0 kg/cm2
- Washing cycle:
- Air
- D.M. water
5.2.3 WFI Collect the D.M. water in the tank for the first washing cycle.
5.2.4 Open the valve of the WFI line for the final washing cycle.
5.2.5 Open the valve of the compressed air.
5.2.6 Switch on the machine.
5.2.7 Empty and run the machine and check the water jets from the needles. Ensure that the pressure of the jets is sufficient. Stop the machine and clean the needles if any choke.
5.2.8 Check and ensure that the clarity of the water is satisfactory. In the case of either the clarity of the water being not good or the jet pressure of the needle, the bed does not adequately replace the concerned filter.
5.2.9 Keep the washed empty S.S. boxes under the LAF unit.
5.2.10 De-carton the vial boxes and place the vials on the vial holder. Place the holder on the washing machine.
5.2.11 Bring the handle down so that all the needles rightly go inside the vials. In case any of the needles do not go inside the vials, fix such vials by hand.
5.2.12 Close the lid of the machine and switch it on to start the washing cycle.
5.2.13 After completing the cycle, open the main lid, lift the handle and take out the vial holder.
5.2.14 Place an S.S. plate above the vial holder and hold it with Both hands. Invert the vial holder to unload the vials in the S.S. plate.
5.2.15 Transfer the washed vials from the S.S. Plate to the washed S.S. vial boxes under the LAF.
5.2.16 Load all the Washed vial boxes to the dry heat sterilizer at the end of the shift.
5.2.17 Check the clarity every two hours and before the start of the operation after breaks.
5.2.18 Record the necessary details in the batch manufacturing record and the makes entry in the Equipment log sheet.
5.2.19 at the end of the day’s operation, drain the water from the tank and clean the machine.
5.3 Cleaning of vials washing machine:
5.3.1 Switch of the mains.
5.3.2 Close the water supply line.
5.3.3 Open the per Perspex guard of vial washing needles.
5.3.4 Clean the washing needle assembly with compressed air to remove the broken glass pieces and foreign matter.
5.3.5 Clean the inverter with a sponge
5.3.6 Clean the pusher wheel.
5.3.7 Clean the PVC tube with D.M. water.
5.3.8 Clean the platform side plate and side cover by scrubbing with D.M. water.
5.3.9 Record the cleaning observation in the Equipment log sheet.
6.0 Acceptance Criteria
Compliance with the above guidelines
7.0 Abbreviations:
SOP: Standard Operating Procedure
QA: Quality Assurance
