Operating of Capsules Polishing and Inspection Machine
1.0 Objective
To lay down a procedure for operation of capsule polishing and inspection machine.
2.0 Scope
This Standard Operating Procedure is applicable for capsule polishing & inspection machine at abc Company.
3.0 Responsibility
3.1 Officer Production
3.2 Operator
3.3 Head Production
4.0 Abbreviations and Definitions
SOP : Standard Operating Procedure
PC : Production Capsule
F : Format
No. : Number
5.0 Procedure
5.1 Operation of Capsule Inspection and Polishing Machine:
5.1.1 Remove status label “cleaned “affixed on the machine. Take line clearance from QA.
Affix the status label with all relevant details of Product name, Batch no, Mfg date,
Exp date, Size, Stage duly signed by Production executive.
5.1.2 Switch ON main power supply.
5.1.3 Connect the compressed air pipe tube with polishing unit for filtered compressed
air supply and open the valve.
5.1.4 Control the speed of vibrator using speed regulator.
5.1.5 Connect dust extraction pipe.
5.1.6 Switch ON polishing unit.
5.1.7 Turn the regulator of vibrator as required controlling the flow of filled capsules on to the conveyor.
5.1.8 Sort out defective capsules coming on the conveyor under tube light for visual defects.
Ensure that all capsules are sorted out thoroughly so that only good capsules will be polished
and polished capsules are ready for packing.
5.1.9 Check filled capsules for the following visual defects.
(i) Capsules with pinholes (ii) telescopic rejection (iii) damaged
(iv) Chipped (v) Dented (vi) Cracks etc.
5.1.10 Start the polishing, of the capsules, Collect the polished, capsules in the HDPE Drums
containing double poly bag. Label the container with all relevant details like Product name,
Batch No., Batch Size, Mfg Date, Exp. Date, Stage and weight of filled, inspected capsules.
Collect the rejected capsules in poly bag and destroy.
5.1.11 After completion of operation Affix a “To be cleaned” label duly filled in.
5.1.12 For cleaning and operation of capsule filling machine follow the equipment
cleaning and operation logbook
6.0 Forms and Records
6.1 None
7.0 Distribution
7.1 Master Copy – Documentation Cell (Quality Assurance)
7.2 Controlled Copy – Production Department
8.0 History
| Revision Number | Details For Change |
Reason for Revision |
| 00 | New SOP | NA |
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
Cleaning And Assembly Of Tube Filling Machine
Proper Handling of Non Recoverable Residues
sop for Handling Of Off Line Packing
Air Washing Of Collapsible Tube
sop for Pest and Rodent Control
Cleaning of Uniforms (Factory cloths)
sop for General Instruction For Employees
Key Deposition and Issuing Procedure
sop for Cleaning and Sanitization of Drains Point
SOP for Cleaning of Change Rooms
SOP for Entry and Exit Procedure in Manufacturing Area
Entry and Exit of Employee, Staff and Visitors to Manufacturing Area