sop for De-Bagging of Three Piece Vial Dropper Caps


sop for De-Bagging of Three Piece Vial Dropper Caps


To lay down a procedure for De-Bagging of Three Piece Vials/Dropper/Caps.

2.0 SCOPE:
This SOP is applicable for De-Bagging of Three Piece Vials/Dropper/Caps in Production area of Three Piece Line

Officer/Executive – Production

Head –Production

Ensure that Three Piece Vials / Dropper / Caps boxes are clean and free from dust.
Verify the quantity and size of Three Piece Vials / Dropper / Caps as per Batch Manufacturing Record (BMR).
Remove shrink wrap or strapping from the box & transfer through Dynamic Pass Box to De- Cartoning area by the SS Trolley.
Open the intact box of Three Piece Vials / Dropper / Caps by opening the sealing.
The shrink wrap mop with 70% filtered IPA & remove.
Remove the Three Piece Vials/Dropper/Caps from the box and transfer outer poly bag to Buffer Zone area through Dynamic Pass Box.
Verify the dispensed quantity of Three Piece Vials/Dropper/Caps.
Mop outer poly bag of Three Piece Vials/Dropper/Caps with 70% filtered IPA.
Remove outer shrink wrap & kept into Dynamic Pass Box for 20 minutes.
Transfer De-Bagging Three Piece Vials/Dropper/Caps into the LAF.
As per filling plan, the De-Bagging Three Piece Vials/Dropper/Caps transfer into filling room through the mobile LAF.
Remove inner shrink wrap & feed into hopper under LAF.
Before feeding of Three Piece Vials / Dropper / Caps, inspect any breakage or other defect and Observation record in Annexure-I, Titled “Log of De-Bagging Three Piece Vials/Dropper/Caps”.

Ltd.                  Limited
SOP                Standard Operating Procedure No. Number
QA                  Quality Assurance

Annexure- I      :    Log of De-Bagging Three Piece Vials/Dropper/Caps

A  Master Copy                             Quality Assurance
Controlled Copy                      Production

in House


Revision No. Change Control No. Details of Changes Reason of Changes Effective Date Done By
00 Not Applicable Not Applicable 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 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 !!