sop for Cleaning and operation of ROPP caps inspection table

sop for Cleaning and operation of ROPP caps inspection table

 

1.0 OBJECTIVE
1.1 To describe the procedure for cleaning and operation of ROPP (roll on pilfer proof) caps inspection table.
2.0 SCOPE
2.1 This procedure is applicable for ROPP caps inspection table 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
5.1.1 Switch “OFF” mains power supply
5.1.2 Ensure remove all ROPP caps from inspection table.
5.1.3 Clean the inspection table with dry clean lint frees cloth to remove adhering material.
5.1.4 Wipe with dry lint free cloth. & allow it for air dry.
5.1.5 Finally clean with moping of lint free cloth dipped in70% IPA solution and allow it for air dry.
5.1.6 Affix status label “CLEANED” as per sop
5.1.7 In case the inspection table is not used for 72 hours, clean it again before use.
5.2 Operation



5.2.1 Take 50 ROPP caps selected randomly from bag for inspection.
5.2.2 Hold each cap against diffused light & rotate slowly to observe light is passing through each of perforations, between bridges.
5.2.3 If all perforations of all 50 ROPP caps are OK, then only after recording the observations, allow the bag to be processed further for checking.
5.2.4 If any rejection is observed in any of PP Caps (Out of 50 No’s), Re sample more caps (50 no’s) and repertory the test. If it is OK, the bag can be PASSED, but if still rejects observed then REJECT that particular bag.
5.2.5 If 3 such bags are rejected in consignment, then reject entire consignment.
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 SOP : Standard operating procedure
9.2 ROPP : Roll on pilfer proof
9.3 % : Percentage
9.4 QA : Quality assurance
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 BATCH MANUFACTURING

sop for placebo batch

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

sop for Sanitization of Seals

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 equipment assembly

sop for operation of capsule loading machine semi automatic

sop for Machine operation capsule inspection and polishing machine

Sop for issue of material

Sop batch demarcation and batch coding

sop for material receipts

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

 

 

Leave a Comment

error: Content is protected !!