Opening And Closing Of The Capsule Department

 

Opening And Closing Of The Capsule Department

 

1.0 Objective
To lay down a procedure for opening and closing of the capsule department.
2.0 Scope
This Standard Operating Procedure is applicable for opening and closing of the department at formulation plant of abc Company.
3.0 Responsibility
3.1 Officer Production
3.2 Head Production
4.0 Abbreviations and Definitions
SOP : Standard Operating Procedure
PC : Production Capsule
F : Format
P&A : Personnel and Administration
5.0 Procedure
5.1 Opening procedure
5.1.1 Collect the keys from the security gate.
5.1.2 Switch on the lights located at the entry of the department.
5.1.3 Check that the seal on the main door of the department is intact & only then open the department.
5.1.4 Keep the main key on the department keyboard & collect other keys of different area.
5.1.5 Open each section of the department. Switch on the lights.
5.1.6 After opening of each area, keep all the keys respectively on a department keyboard.
5.1.7 Intimate to maintenance department for air handling unit starting.
5.1.8 Check the following points for cleanliness:
5.1.8.1 Main floor. (Floor of all area.)
5.1.8.2 All machines in the department.
5.1.8.3 All the drum containers are close & clean.
5.1.8.4 Walls of the shifting area.
5.1.8.5 Dust bins.
5.1.9 Early in the morning before the day’s work starts, the officer has to maintain the daily record for

department opening & cleanliness checks. Any abnormal observations or deviations must be given in

writing to the department head.
5.2 Closing procedure
5.2.1 Switch OFF the exhaust system of the department.
5.2.2 Switch OFF the switches of all the equipment.
5.2.3 Check that the water taps are closed properly.
5.2.4 Check that the vacuum valves are closed properly & indicator shows 0 reading.
5.2.5 Check that the compressed air valves are closed properly & indicator shows 0 reading.
5.2.6 Check that all balances are switched OFF.
5.2.7 Switch OFF all the lights of cubicles.
5.2.8 Switch OFF the computer.
5.2.9 Check the following points for cleanliness.
5.2.9.1 All drums & containers are closed & cleaned from outside.
5.2.9.2 All the machines in the department are cleaned & mains of machines are switch OFF.
5.2.9.3 Floor of all the area is cleaned.
5.2.9.4 Floor of corridor is cleaned.
5.2.9.5 Wall of the manufacturing cubicles is cleaned.
5.2.9.6 Dustbins are emptied & clean.
5.2.9.7 Switch OFF all the main switches except officer’s cabins & the main corridor.

(Section to be locked if instructed by the department head).
5.2.9.8 Put the key in the internal keyboard of the department.
5.2.9.9 Switch OFF all the lights, compressed air valves & purified water.
5.2.9.10 If any section to be locked collect the keys from the department keyboard, lock it and

put it back on its appropriate no. on the keyboard.
5.2.9.11 Take a sticker & collect the main key of the department.
5.2.9.12 Lock the department.
5.2.9.13 Switch OFF the lights located at the entry of the department.
5.2.9.14 Hand over the keys & safety checklist at the security gate.
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

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 cleaning of dust exhausts

Entry Exit and Gowning Procedure in Dispensing Area

sop for Receipt and Storage of Raw Materials

sop for Verification of Weighing Balances

Cleaning of Washing Area

Opening And Closing Of The Capsule Department

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