sop for De-Bagging of Three Piece Vial Dropper Caps
1.0 OBJECTIVE:
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
3.0 RESPONSIBILITY:
Officer/Executive – Production
4.0 ACCOUNTABILITY:
Head –Production
5.0 PROCEDURE:
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”.
6.0 ABBREVIATIONS:
Ltd. Limited
SOP Standard Operating Procedure No. Number
QA Quality Assurance
7.0 ANNEXURES:
Annexure- I : Log of De-Bagging Three Piece Vials/Dropper/Caps
8.0 DISTRIBUTION:
A Master Copy Quality Assurance
Controlled Copy Production
9.0.0 REFERENCES:
in House
10.0 REVISION HISTORY:
| Revision No. | Change Control No. | Details of Changes | Reason of Changes | Effective Date | Done By |
| 00 | Not Applicable | Not Applicable | New SOP |
ANNEXURE – I
LOG OF DE-BAGGING THREE PIECE VIALS/DROPPER/CAPS
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