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Objective:
To lay down a procedure for cleaning of vial sealing machine.
Scope
This SOP is applicable on procedure for cleaning of vial sealing machine for Production dry powder Injection facility.
Responsibility Production Officers /Executive
Accountability Production Head shall be accountable for the compliance of SOP.
Abbreviations
SOP : Standard Operating Procedure.
No. : Number
S.S: Stainless Steel
Procedure Cleaning of vial sealing machine is done after day’s work is over or whenever necessary.
Remove the Aluminum seals (if any) from the hopper and chute.
Remove the rejected aluminum seals, glass vials and rubber stoppers (if any) from the machine and conveyor belts and collect them in a poly bag.
Remove the spilled powder on the machine (if any) with the help of a nylon brush and collect in a poly bag.
Clean the outer body of the machine by wet mopping soaked in purified water using a lint free duster.
Clean the conveyor, hopper, s. s. star wheel, delrin guides, delrin feed worm, and aluminum chute with wet lint free duster soaked in Purified Water.
Clean the rejection collector s. s. box with wet lint free duster soaked in purified water.
Clean the dies and crimping rollers of the sealing machine by wet mopping, using lint free duster.
Open the front panel of the machine. Clean the inside portion with the help of a lint free duster soaked in Purified Water.
Clean the glass and acrylic sheets and frame of the cabinet from both inner and outer surface by using a lint free duster soaked in Purified Water.
Write the ‘Cleaning Status’ of the machine on the Equipment Status Tag fixed on the machine and get the cleaning checked by the Production Officer.
Record the details of cleaning operation in the operation and cleaning record as per SOPand get it checked by concerned Supervisor / Officer.
Note: If the cleaning is required in between Production, stop the further incoming of vials from Powder Filling Room. Complete the sealing of all filled vials present on the machine and conveyor.Carry out the cleaning as per step: Remove the rejected aluminum seals, glass vials and rubber stoppers (if any) from the machine and conveyor belts and collect them in a poly bag. Remove the spilled powder on the machine (if any) with the help of a nylon brush and collect in a poly bag.
Forms and Records (Annexures)
Not Applicable
Distribution Master copy – Quality Assurance
Controlled copies- Quality Assurance, Production, Quality Control
History
Date Revision Number
Reason for Revision
–
00
New SOP
END OF SOP
Post Views: 95
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