Punches and Dies (Compression m/c) – Handling SOP

Standard Operating Procedure (SOP) and Guideline for Handling of Punches and Dies used in the compression machine for tablet compression. This SOP covers the procedure for procurement, Issuance, Handling, Cleaning,
Inspection and Rejection of punches and dies.

SOP for Punches & Dies

1.0   Purpose:

    • To define the procedure for procurement, Issuance, Handling, Cleaning, Inspection, and Rejection of punches and dies.

2.0   Scope:

    • This procedure is applicable for :

    • Procurement of Punches and Dies.
    • Inspection of Punches and Dies upon receipt.
    • Handling and storage of tools.
    • Issuance and cleaning of punches and dies before assembling.
    • Retrieval and Cleaning of punches and dies after usage.
    • Periodic inspection of punches and dies.
    • Procedure for rejection.

3.0   References:

    • Pharmaceutical dosage forms: Tablets, Volume 2, 2nd edition, Edited by Herbert

4.0   Responsibility:

    • Concern Person from the Production Department :

    • Raise purchase requisition for new punch and die set as per the defined procedure.
    • Inspect punches & Dies and update the inspection record.
    • Ensure safe handling and storage of punches and dies.
    • Check for cleaning of punch and dies as per the defined procedure.
    • Send the request for issuance of the toolset of required punch & die.
    • Clean the Punch Storage Cabinet with the defined procedure and maintain a record of it.
    • Ensure the proper lubrication of the punches before storage.
    • Initiate destruction of punch & dies.
    • Send rejected punches & dies to engineering department for destruction.
    • Concerned Supervisor – Production Department.

    • Ensure the implementation of guidelines.
    • Provide training to the new operators before involving in operation.
    • Update and maintain all necessary records.
    • Department Head – Production Department.

    • Provide the training to all concerned involved in the activity before the implementation of the guidelines.
    • Procure new punch & die set.
    • Approve & reject the consignment of the new toolset.
    • Ensure the implementation of guidelines.
    • Quality Assurance:

    • Review & approve punch and die inspection records.
    • Review & approve punch and die destruction scrap notes.
    • Ensure proper maintenance of records.
    • Ensure the cleanliness of the punch Storage cabinet as per the defined procedure.
    • Engineering Department.

    • To perform Punch & Die destruction.

5.0   Abbreviations – Punches and Dies

    • OHNS: Oil hardened non – shrinkage steel.
    • Million: Ten lacs.

6.0   Procedure for Handling of Punches and Dies

    • Procurement of Punches and Dies :

    • As per the requirement, raise Purchase requisition for the new Punches and Dies set.
    • The purchase requisition raised by the Production head/designee.
    • Purchase requisition shall specify the following details:
      • The total number of punch and die set required which shall decide on the basis of Tablet press to use for the particular product.
      • Details like but not limited to Shape/type of punch set required (caplet, circular, square or standard concave, deep concave, beveled edge, double-radius shapes) and type of embossing on the punches.
      • Type of tooling required (B/D/BB tooling)
      • Punch size (dimensions)
      • Name of the manufacture and make.
    • Inspection of Punches and Dies upon receipt :

    • On receipt of the consignment, Review the party report & diagram & verify for meeting the punch & die acceptance criteria.
    • The reviewer shall sign the Party report & diagram.
    • In case of receipt of the part quantity of a particular punch set, Inspect the punches against the diagram supplied initially if the diagram not supplied again by the supplier for the part quantity of a particular punch set.
    • Upon receipt of the consignment, excessive oil/ grease on the Punches and Dies shall be wiped by using a clean dry cloth followed by cleaning with Isopropyl alcohol and then with a clean, dry, lint-free cloth.
    • Use the Punch inspection kit for the inspection of punches and die.

Note: Ensure the calibration status of instruments before measurement. Calibrate all measuring instruments ( Vernier Calliper, Micrometer & dial indicator) at a frequency of 6 months ± 15 days.

    • Check the punch set by using the Punch measurement kit against the purchase requisition and delivery Chalan. Record the details Attachment No. 01
    • The standard values for the various parameters are as given in the table :

 

Type of Tooling

 

Punch Length (mm)

Barrel Diameter (mm) Dies
Height (mm) Outer diameter (mm)
D 133.60 Upper Punch: 25.40

Lower Punch: 25.35 

23.80 38.10
B 133.60 Upper Punch: 19.00

Lower Punch: 18.95

    22.20      30.15 
BB 133.60 Upper Punch: 19.00

Lower Punch: 18.95

22.20  24.00
    • Check the total length and punch tip of upper & lower punches by using a punch inspection kit.
    • Check the depth of the upper and lower punch by using a punch inspection kit.
    • The tolerance limit for punch length and punch tip parameters is ± 0.05 mm.
    • The limit of acceptance (tolerance) is not applicable for depth measurement.

    • Measure the Barrel diameter of upper and lower punches by using a punch inspection kit.
    • The tolerance limit for barrel diameter is as per the above-mentioned table.
    • In case of punch not passing, a particular punch set shall be rejected or can be released for use after approval from QA head by taking machine suitability.
    • Punch concentricity shall be measured by using a punch measurement kit. It shall be between 0 to 0.03 mm

Note: Supplier’s certificate data for concentricity of die bore shall be acceptable.

    • The visual inspection of the upper and lower punch head shall be checked by a go-no-go gauge.

Note: In case of punch failing in go-no-go gauge, a particular punch set shall be rejected, or can be released for use after approval from QA head by taking machine suitability.

    • Supplier’s certificate data for go-no-go gauze tests of die shall be acceptable instead of checking it at the location.
    • Upper & Lower punch description as observed in the mirror will be checked against punch description for the correctness of punch embossing.
    • The height and outer diameter of the die shall be checked by using a digital Vernier Calliper/punch inspection kit.
    • Punches and dies shall be checked visually for-

    • Cleanliness of tools
    • Rough surfaces on the tip of punches and die surface
    • Damage to the tip of the punches.
    • Lustre of punches and dies.
    • Dies having rings.
    • Any pinholes, minor cracks, or crevices.
    • Drawing number and serial number.
    • Engravings on Punch tip ( using a mirror )
    • Note: Magnifying glass shall be used for the visual inspection.

    • In case any deficiency is observed as given above, the particular punches and dies shall be rejected and document the same.
    • If the Toolset of one location is transferred to another location, the new location shall continue to use the parent location number.
    • In such case, xerox copies of punch & die inspection record, the record of polishing & usage of the toolset, toolset cleaning record shall be transferred to recipient location.
    • On receipt of toolset from other locations, toolset no shall be continued as assigned originally, and documents such as punches & dies inspection record,
    • A record of polishing & usage of the toolset, tool set cleaning record, punches, and die destruction record shall be transferred to the recipient location as scan copies.
    • Toolset shall be inspected as provisions applicable to the new toolset on receipt.No. of tablets compressed on tooling shall be continued onwards as per records received from other locations.
    • Punch cabinet shall be labeled and numbered as per Attachment No. 02
    • The toolset number shall be updated with the product name in the toolset index as per Attachment No. 03.
    • The toolset number allotted at the location shall be mentioned on the certificate/inspection report supplied by the supplier for traceability.
    • Handling and storage of tools (Punches and Dies):

    • While inserting or removing punches, check that the edges of the tip are not touching with the edges of other punches or with the tablet press turret.
    • While inserting or removing the punches avoid collision of punch tip with guide hole.
    • Remove the punches from the tablet press one at a time, wipe and place in a set trolley.
    • While cleaning of punch and die ensure that it is being cleaned one by one and not together.
    • Transfer all punch set in a duly labeled punch and die set trolley covered with poly bag.
    • Always apply a thin film of light liquid paraffin or food-grade oil on the toolset before storing them in the tool cabinet.

Note: Light Liquid Paraffin, food-grade oil are rustproof.

    • For the storage of Punches and dies, storage cabinets shall be used.
    • Once in a six months Plastic holder of the cabinet, all Punches and dies shall be cleaned.

Related: SOP for Operation and Cleaning of Compression Machine

    • Store the punches and dies in the specially designed tool cabinet.
    • Store the tools, which require polishing separately preventing mix-ups.
    • Unused punches & dies shall be cleaned after every six months as punches in use are cleaned before and after use.
    • Issuance and Cleaning of Punches and Dies before assembling :

    • The punch set shall be used in the rotation method. (Between two campaigns of manufacturing & in case of one batch.
    • For Example
    • If available punch set is 55 nos. and the requirement is 45 for 45 – station compression machine, 1st time punch set no. 1 to 45 shall be issued then 2nd-time punch set no. 2 to 46 shall be issued, 3rd-time punch set no. 3 to 47 shall be issued and so on.
    • Each Subcabinet number corresponding to the total number of plastic sleeve/punch holder present in each sub – cabinet.
    • Issue each Punch (Upper/Lower) with respect to the number of punch in rotation with the corresponding number of dies embossed on the upper punch, lower punch, and a die.
    • Issue the toolset by the supervisor or designee to the Operator. (Attachment no. 04)
    • Transfer the Toolset from the Punch cabinet to the respective cubicle by covering the punch set trolley using a Polyethylene bag.
    • Label the trolley with the specification and quantity of the punch set.
    • Punches and dies shall be cleaned in the respective cubicles.

    • Clean the tool set using Isopropyl alcohol by taking into Stainless Steel bowl and wipe with the clean and dry cloth.
    • Check the tool set for appearance and record in the Attachment no. 04 (Record of Polishing and usage of Tool set ).
    • In case of defective punch or dies found then,the entire punch set (one Upper punch, Lower punch and Die) is rejected by sending to engineering department as per Attachment no. 05 for destruction.
    • Smear the punch head and punch barrel with food grade oil lightly before assembling into Tablet Press.
    • Retrieval and Cleaning procedure of Punches and dies  after usage :

    • Tool set shall be retrieved by the supervisor or designee from the Operator . (Attachment no. 04)
    • Punches and dies shall be cleaned in the respective cubicles.
    • After removal from the tablet press, the toolset shall be wiped by using clean and dry cloth to remove the adhering powder.
    • During campaign production, upper punches & upper surface of the turret where dies are in place can be cleaned with a dry clean lint-free cloth to remove adhering powder between two successive batches.
    • After 3rd batch lower & upper punches, as well as dies, shall be cleaned to remove adhering powder.
    • The toolset shall be cleaned by using Isopropyl alcohol in a Stainless Steel bowl and then wipe with clean and dry Cloth.
    • The tool set shall be checked for appearance and record in Attachment No. 04, in case of defective punch set, it shall be discarded and record in Attachment no. 04 and send to the engineering department after approval of punch and die in scrape note (Attachment no. 05).
    • Cleaned punches and dies shall be transferred to the clean tool set trolley covered with Polyethylene bag and shall be taken to the tool room.
    • Smear the punches and dies with food grade oil lightly and arrange it in the respective punch cabinet and record in the Attachment no. 04.
    • Toolset numbering shall be as per the following procedure:-

T/001,T/002,T/003,…………………Where T  is = Toolset 

    • Periodic inspection of Punches and Dies :

    • The first inspection shall be carried out after compression of 1.5 million tablets per punch set (Set of one upper punch, one lower punch and a die) and record in the Punch and Die inspection record. (Refer attachment no. 01.)
    • The second inspection shall be carried out after compression of 2.5 million tablets per punch set and record in the punch and die inspection record (Refer attachment no. 01.)
    • Procedure for rejection Punches and Dies:

    • If any defect observed in the new toolset received, reject that particular punch and die sets, record the same in the punch and die inspection record (Attachment no. 01) specifying the type of defect observed and send it to Manufacturer/Supplier for the replacement.
    • During the punch and die inspection after 1.5 million per punch set and 2.5 million per punch set if the damage is observed then the entire punch set shall be rejected.
    • Discard the punch and die set after compression of 3.5 million tablets per punch set and record in the Punch and Die inspection record (Refer attachment no. 01)
    • Tool set No. of punches & dies destroyed shall be recorded in the remarks column of tool set index (Attachment – 03).
    • After usage toolset shall be observed visually for the appearance and in case of a defect, it shall be discarded.

    • In case of rejection of punches, utilization record (Attachment 4) to be updated &  cumulative quantity  per punch shall be calculated by dividing the cumulative quantity with the remaining quantity of the punches available e.g, If a punch is broken of a tool set with 55 no. of punches and number of available punches reduced to 54, then cumulative per punch set shall be calculated by dividing cumulative quantity with 54.
    • Punch and die set shall be discarded by sending it to the engineering department through the punch and die Destruction Scrap Note. (Refer Attachment – 05).
    • The Engineering Department shall destroy the Punches ( especially tips) and Dies by de-shaping them after making the entry in Punch and die Destruction Scrap Note and then shall return the scrap note to the Production department.
    • In case of rejected punches of whatsoever reason, Record the rejected punch no. in Attachment – 04 & Attachment – 05.e.g If in a toolset with 55 no. of punches, punch No 07 is rejected and toolset is reduced to 54, the last punch of the toolset with punch No. 55 renumbered as punch No 07 by engraving no. 07 on neck of the Punch along with the die and defacing the existing no. 55 on the punch with the mark of Cross (X).

7.0   Attachments:

Attachment -1: Punch and Die inspection record.

Tool Set No. Supplier’s Initial Inspection /Re – inspection
Specification Type of Tooling No. of tablets  Compressed at   Re-inspection
Upper Punch Date of Receipt
Lower Punch Tolerance limit ± 0.05  mm Spot Observation
Dies

 

Punch No.

Total Length Working length Tip Dia Depth* Barrel diameter Head (Go & No go) Punch concentricity Dies

Height

Die no Dies

Outer diameter

Visual inspection

* Tolerance limit is not applicable for depth

Traceability:

Traceability Digital  Vernier  Calliper Digimatic Micrometer Number Dial Indicator
Number
Calibration Due On

Attachment -2: Punches and Dies cabinet label.

 CABINET NO. :…………………………….        TOOL SET NO. ::……………………………. 

 TYPE OF TOOLING:…………………………….

DESCRIPTION:…………………………….

                             SIZE  -:…………………………….

                              SHAPE -:…………………………….

                              UPPER PUNCH  -:…………………………….

                              LOWER PUNCH -:…………………………….

UPPER PUNCHES (Qty) LOWER PUNCHES (Qty)  DIES (Qty)
     

Attachment -3: Toolset index.

Tool Set No.: ____________                          Type of Tooling:__________

Description:___________________________________________________

Sr. No. Product Remarks

Attachment -4: Record of Polishing and usage of Toolset.

Tool Set No.: ____________                                           Date of Initial inspection:__________

Date of Approval: _________           Specification:_____________ Qty. of Tool Set:______________

Date Issued to Issued by Before Use Toolset appearance checked by (Before use) Toolset polished Tablet Press Product Batch No. Punch-Die set used From -To Quantity of tablet compressed (Lac)
                         
Quantity of tablets compressed per punch set (Lac) Tool set appearance checked by (after use) Retrieved from Retrieved by After Use Observation (Defective Punch Die Set No. Re-Inspection Required /Not Required Checked by
                 

Attachment -5: Punches and Dies destruction scrap note.

To,                                                                                                       Date :__________________

Engg. Dept.

Scrap Note No.:                                                                    From: Tablet  Dept

Please receive the following punch/Die for destruction.

Specification:

Punch No.                              Upper   :

Lower   :

Die No. :

Too Set No.:

Reason :

Cumulative Quantity  Compressed:

                Initiated by:                                                                                  Approved by :                                   

For the Use of Engineering department

Punches and dies Destroyed by:_____________________

Attachment -6: Punch and Die Cabinet Cleaning Record

Sr. No. Date Cabinet No. Cleaning Time Checked By Production Checked

 by QA

From To

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pharmabeginers

Janki Singh is experienced in Pharmaceuticals, author and founder of Pharma Beginners, an ultimate pharmaceutical blogging platform. Email: [email protected]

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