Indent, Inspection and Maintenance of Punches and Dies

In this post Standard Operating Procedure Indent, Inspection and Maintenance of Punches and Dies in Pharmaceuticals is describe.

1.0 OBJECTIVE:

To lay down a procedure for indent, inspection and maintenance of punches and dies.

2.0 SCOPE:

This procedure is applicable to indent, inspection and maintenance of punches and dies used in production department.

3.0 RESPONSIBILITY:

Technical Associate : Cleaning as per defined procedure Officer and Executive : Supervision

Head Production : SOP compliance

4.0 DEFINITION(S):

5.0 PROCEDURE:

5.1 Indent of dies and punches

5.1.1 For ordering a new set, raise a requisition to Purchase Department with the required specifications in ERP system.

5.1.2 Get the indent approved by the head of the unit and forward it to purchase department at head office.

5.1.3 On receipt of the proper drawing from supplier, the same is to be approved by Head Production and Head QA.

5.1.4 Send the approved drawing to the supplier for manufacturing.

5.2 Inspection and maintenance of punches & dies

5.2.1 On receipt of intimation from stores, collect the punch set.

5.2.2 Verify the quantity received against the Purchase Order.

5.2.3 Each punch and die shall be cleaned using a dry duster to remove any adhered grease, followed by duster dipped in 70 %v/v IPA and record as per the Annexure-II of SOP.

5.2.4 Assign the set identification number and enter the same in the punch and die inventory record as per the Annexure-I.

5.2.5 Each lower punch, upper punch and die shall be checked for various parameters with standard gauge as per reference SOP.

5.2.6 If various parameter of lower punch, upper punch and die not comply with standard parameter specified in SOP then inform to deparment head and return the punch set to stores department.

5.2.7 Each set will be having separate identification code abbreviated product name followed by year of manufacturing and serial no.

For Example:-

i) PAR 500/2401

Where Par 100 is abbreviation of Paracetamol 500 product name, ‘24’ is the year of Manufacturing and 01 is serial no.

ii) AML 5/2401

Where AML 5 is abbreviation of Amlodipine 5, ‘24’ is the year of manufacturing and 01 is serial no.

5.28 Apply a thin layer of food grade lubricant on the surface of punches and dies. Place individual punch in the plastic cover.

5.2.9 Engrave number of punch set with the identification number and the quantity.

5.2.10 Transfer the punch sets from the original container into a suitable Stainless steel cabinets or plastic container and label with the product name, Identification No., punch dimension, shape and quantity.

5.2.11 In case of rejection of dies or punches, inform the purchase department and return the punches to stores for further action.

5.2.12 Incase of product change over (type-B cleaning), clean the punches with 70 %.

5.2.13 Ensure that the punch sets are cleaned.

5.2.14 Apply a thin layer of food grade lubricant on the surface of punches & dies.

5.2.15 NOTE: Verify the quantity of each individual punch set and record the same in Annexure-I when the punches are received.

6.0 ABBREVIATION(S):

QA : Quality Assurance

SOP : Standard Operation Procedure ml : Milliliter

IPA : Iso Propyl Alcohol v/v : Volume by volume

7.0 RERERENCE(S):

SOP: Inspection of punches and dies.

SOP: Issuance, use and retrieval of punches and dies.