Cleaning and operation of the mono block filling and sealing machine
1.0 OBJECTIVE
1.1 To describe the cleaning and operation of the mono block filling and sealing machine.
2.0 SCOPE
2.1 This procedure is applicable for mono block filling and sealing machine present in the production Liquid department.
3.0 RESPONSIBILITY
3.1 Operator – To perform the procedure.
3.2 Officer production- To ensure that the operation is being performed in compliance with the
SOP.
3.3 IPQA person – To ensure in-process checks, and counter check that the
Compliance is in line with SOP.
4.0 ACCOUNTABILITY
4.1 Department Head
5.0 PROCEDURE
5.1 Cleaning procedure Type A ( Batch To Batch Cleaning)
5.1.1 Ensure all the material is removed from the equipment.
5.1.2 Remove the product status label and affix ‘To be cleaned’ status label as per sop over the equipment.
5.1.3 After completion of the batch clean the machine with purified water.
5.1.4 Fill the Filling tank with fresh purified water and run the machine till the traces of previous batch is removed including connecting tubes & pumps
5.1.5 After ensuring the traces are removed completely by visual inspection, fill the filling tank with 90 liter of fresh purified water and run the machine for 20 rounds And drain it.
5.1.6 After 5 consecutive batches of same product follow type B cleaning procedure.
5.1.7 Affix “Cleaned “Label as per SOP to the machine.
5.1.8 Inform QA chemist for Line Clearance of the machine.
5.2 Cleaning procedure Type B ( product changeover)
5.2.1 Ensure all the material is removed from the equipment.
5.2.2 Remove the product status label and affix ‘To be cleaned’ status label as per over the equipment.
5.2.3 Fill the baffle tank with 100 liter potable water and start the machine at slow rpm, drain the water through filling nozzle completely.
5.2.4 Dismantle the nozzles, Teflon valves and SS line, side guard, star wheel, all clamps and rolling worm; wash with 20 liter potable water followed by 20 liter purified water.
5.2.5 Finally wash dismantle parts with 50 liter hot purified water (80 to 85oc) for sanitization except Teflon part.
5.2.6 Use 70% IPA to sanitize the Teflon part of filling and sealing machine. And ROPP cap assembly.
5.2.7 Dry all dismantle part by moping with lint free cloth.
5.2.8 Clean the surface of filling and sealing machine with spraying potable water followed by hot purified water (80 to 85oc).
5.2.9 Dry the surface by moping with lint free cloth.
5.2.10 Check and ensure cleaning of filling and sealing machine and its dismantle parts, then assemble and set the change parts as per BPR.
5.2.11 Inform IPQA to collect the rinse/swab sample for QC for analysis.
5.3 OPERATION
5.3.1 Ensure that the machine and area are cleaned before start operation.
5.3.2 Switch ON the electrical supply and release emergency button.
5.3.3 Set all change parts according to the required size.
5.3.4 Take trial for empty bottles by running the machine in inching mode by pushing yellow button.
5.3.5 Ensure that no nozzle is touches the bottleneck. If touches adjust the nozzle or guide or star wheel position.
5.3.6 Ensure that bottles moving smoothly through the guide, star wheel.
5.3.7 Fill the solution in to the buffer tank from storage tank
5.3.8 Loosen the stud nut of nozzle assembly
5.3.9 Adjust the volume of solution according to the measuring cylinder
5.3.10 Rotate the micro adjustment screw in clockwise direction to increase the volume.
5.3.11 Rotate the micro adjustment screw in anti-clockwise direction to decrease the volume.
5.3.12 Adjust the final volume of 12 syringes by fine adjustment screw and check the volume of 12 syringes individually with the help of calibrated measuring cylinder.
5.3.13 Tighten the stud nut after the adjustment is made
5.3.14 Adjust the bottle sealing as per requirement.
5.3.15 Push green button to Start the machine.
5.3.16 Switch ON the conveyer of filling machine
5.3.17 Adjust the speed of conveyer with the help of speed regulator knob.
5.3.18 Set the speed of filling machine with the help of speed regulator knob.
5.3.19 Push red button to stop the operation.
5.3.20 Piston ring changing frequency one year or when ever required.
5.3.21 All activity to be recorded as per sop
6.0 TRAINING
6.1 Trainer: Department Head.
6.2 Trainee: Production, Quality Assurance and Operator person.
6.3 Period: one hour or as per required.
7.0 DISTRIBUTION
7.1 One set of Master copy and one set of Controlled copy submit the QA department.
8.0 ENCLOSURES
8.1 NIL
9.0 ABBREVIATIONS
9.1 QA : Quality Assurance.
9.2 IPQA : In process Quality Assurance
9.3 % : Percentage
9.4 SOP : Standard operating Procedure.
9.5 QC : Quality Control
10.0 DOCUMENT CHANGE HISTORY
| Revision | Reason for revision | Effective Date
|
| 00 |
NEW SOP
|
Online Rejection in parenteral
Receipt of Batch from Production to Packing Department
sop for for Spillage Handling in parenteral area
sop for calibration of vessels with dipstick
sop for Cleaning of Bins and Containers
cip of mixing vessel and holding vessel
sop for Cleaning of Ampoule Filling and Sealing Machine
sop for Fogging in Sterile and Non Sterile Area
sop for for Filtration of Bulk Solution
sop for fumigation in production area
sop for post cleaning after media fill
sop for cip of mixing vessel mixing mobile vessel and holding vessel
sop for De-Bagging of Three Piece Vial Dropper Caps
sop for calibration and verification of check weigher
sop for Batch number and Manufacturing and Expiry Date Coding System
standard operating procedure machine history file
sop for operation and cleaning of Hand coder
sop for Cleaning and Handling and Silicone Tubes
sop on operation and cleaning of coating pan
sop for Operation of cleaning of pipe lines
sop for operation of capsule loading machine semi automatic
sop for Machine operation capsule inspection and polishing machine
Sop batch demarcation and batch coding
sop for monitoring of reprocessing of products
sop for in-process control on liquids orals
sop for in process controls on tablets capsules packaging line
sop for Issuance retrieval and destruction of BMR and analytical records
sop for in process controls during granulation compression coating inspection
sop for Cleaning of Blister packing machine
sop for for charge hand over between the shifts
Performance requalification report of visual inspectors
sop for Cleaning and operation of ROPP caps inspection table
sop for usage and destruction of filter pad and cartridge filter
sop for cleaning and storage of transfer pipe
sop for Cleaning and operation of labeling machine
Cleaning and operation of the mono block filling and sealing machine
sop for Cleaning and operation of empty bottle inspection table
sop for Cleaning and operation of filter press
sop for cleaning and operation of liquid transfer pump and line
sop for cleaning and operation of storage vessels
sop for cleaning and operation of sugar syrup manufacturing vessel
sop for cleaning issuance and retrieval of accessories and change parts
sop for Cleaning and operation of visual inspection conveyor belt
sop for Cleaning and operation of spray gun and assemble
sop for Fogging in Aseptic and Non Aseptic Area