sop on receipt storage inspection polishing & cleaning of punches & dies

 

sop on receipt storage inspection polishing and cleaning of punches and dies

 

1.0 Objective: To describe the procedure for receipt, storage, inspection, polishing & cleaning of
Punches & dies.
2.0 Scope: This procedure is applicable to all punch sets in tablet compression area

3.0 Responsibility: Operator / Production Officer / Executive.

4.0 Accountability: Department Head shall be accountable for the compliance of the system.
5.0 Procedure:

 

5.1 Issue & Usage of Punches and Dies:
5.1.1 Take out the die-punch set as mentioned in requisition slip or BMR.
5.1.2 Wipe the punches and dies with lint free cloth to remove food grade oil in the storage area.
5.1.3 Check the wear and tear or any defect of punches and dies using magnifying glass.
5.1.4 Issue the same to the operator of the respective compression machine cubicle.
5.1.5 Record the entry in die punch issuance register or BMR.
5.1.6 After completion of the compression, enter the data in dies and punches usage record for respective sets.
5.2 Cleaning of Die-punch: [Day End or During Product Change Over]
5.2.1 After completion of compression of the product take out the Die-Punches from the machine and clean the set using Isopropyl alcohol.
5.2.2 Apply a smear of food grade oil on each die-punch set and put them in tray and hand over to the die-punch store officer.
5.2.3 Record the activity in the register.
5.3 Cleaning of Die-Punch: [During Batch Change Over]
5.3.1 After completion of batch take out all powder on the machine turret including feed frame.
5.3.2 Clean the upper punches one by one with a dry lint free cloth.
5.4 Inspection of Die-Punch:
5.4.1 Inspect the punches and dies for their integrity using magnifying glass.
5.4.2 If any damage found segregate the damaged die / punch with “REJECTED” label on it, and put them in a container having label “Dies & Punches to Be Discarded”.
5.4.3 Disfigure and discard the rejected punches and dies after the authorization of the department head and send them to scrap yard.
5.4.4 Record the details in the register.
5.5 Storage of Die-Punch:
5.5.1 Arrange punches and dies in a tool tray and store in a designated cabinet in Die-punch storage room.
5.6 Polishing of Die-Punch:
5.6.1 Polish the punches and dies as & when required during usage.
5.6.2 Polish the punches and dies with the help of the punch polishing kit.
5.6.3 Use emery paste or diamond paste for the polishing the punch tip.
5.6.4 Clean the tip and stem of the punch using dry lint free cloth.

 

6.0 Abbreviations:

Abbreviation Expanded Form
BMR Batch Manufacturing Record
SOP Standard Operating Procedure
PR Production

7.0 Forms and Attachments:
Annexure – 1: Format for Die – Punch Issuance Record

8.0 Distribution List:

S. No. Department Name No. of Copy
1. Quality Assurance 01
2. Production 01

9.0 References:
In – House

 

Annexure – 1

Die – Punch Issuance Record

S. No. M/c No. Issue Date Punches Dimension

(mm)

Upper Punch (Nos.) Lower Punch (Nos.) Dies (Nos.) Issued By (Chemist) Received By (Operator) Returned By Returned Date Remarks
                       
                       
                       
                       

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