SOP for Ordering, Receiving, Storage, Issue, & Destruction of Dies, Punches

1.0 OBJECTIVE

To lay down the procedure for Ordering, Receiving, Storage, Issue, & Destruction of Dies & Punches.

2.0 SCOPE

This SOP shall be applicable for all the dies & punches used in Manufacturing area at Production department.

3.0 RESPONSIBILITY

3.1 Execution: Operator
3.2 Checking: Production Pharmacist & Above

4.0 ACCOUNTABILITY

HOD-Production / Assigned Designee

5.0 PROCEDURE

5.1 ORDERING NEW PUNCHES & DIES

5.1.1 Whenever a new punch set is to be ordered, the required size, shape & embossing is communicated to the punch set manufacturer through intimation along with the type of punch & type of machine on which the punch set is to be used and quantity required.
5.1.2 A sample set is obtained from the manufacturer and trial is conducted, on the machine using dummy granules. The tablets obtained are observed, for size, shape and embossing etc. Also, the punch set is checked for dimensions, height, etc. If the sample set is not satisfactory, then improvements are suggested accordingly and revised sample set is obtained.
5.1.3 After the approval of the sample set, the purchase order is raised for the required quantity.

5.2 RECEIVING NEW PUNCH SET

5.2.1 After receiving the punch set from the manufacturer, the quantity is checked as per the delivery challans.
5.2.2 The punch set is then taken to the storage area in the manufacturing department.
5.2.3 Each punch set is cleaned & checked for the following.
5.2.3.1 General condition of the punch set.
5.2.3.2 Height & Diameter of the punches.
5.2.3.3 I.D., O.D., & Height of Dies.
5.2.3.4 Concavity of the tip in case of concave punches.
5.2.3.5 Punch tip as per the tablet specifications.
5.2.3.6 Embossing as per specifications.
5.2.3.7 Mfg Date and other markings on the punch necks and dies.
5.2.3.8 The relevant information should be recorded in the format.

5.3 STORAGE OF PUNCH SET

5.3.1 Punches & dies are to be stored in the M.S. Storage cabinet. All the Dies & Punches should be smeared with a thin layer of Food Grade Oil during storage. Punches should be stored in such a way that, punch tips of the adjacent punches are facing in opposite direction so as to avoid collision of the tips.
5.3.2 Punches & Dies should be stored product wise in separate drawers appropriately labeled. Punch cabinets should be locked & should be under control of the shop floor Pharmacist.

5.4 ISSUE & RECEIPT OF THE PUNCH SET

5.4.1 Punches & Dies should be issued by the Pharmacist to the concerned machine operator & during the issue, the Punches & Dies should be checked by both for quantity and condition. Also while returning the punch set, the Pharmacist should confirm the quantity, condition & cleanliness of the punch set.
5.4.2 The details of date of issue, quantity, B.No. for which it is issued, B.No. after which it is returned, are to be recorded in the format.

5.5 MAINTENANCE OF DIES & PUNCHES CLEANING OF PUNCHES/DIES

5.5.1 After the use, the powder on Punches & Dies should be cleaned with the help of dry lint-free cloth & then with the help of 70% I.P.A.
5.5.2 Before taking for the compression, the oil layer should be cleaned with the help of dry lint-free cloth & then with the help of 70% I.P.A.
Frequency of cleaning: - Before & after each use.

5.5.2.1 POLISHING OF PUNCHES (TIPS)

5.5.2.1.1 Apply a small quantity of polishing compound to the punch tip.
5.5.2.1.2 Holding the punch in hand carefully, rotate the tip against the rotating brush, applying very little pressure (Do not flatten the nylon bristle against the tip). Excess pressure may lead to rounding of tips or edges, distortion of tip face or embossing.
5.5.2.1.3 After few seconds of polishing, dip the tip into the emery flour and repeat the step 2 till required finish is achieved.
5.5.2.1.4 Frequency of Polishing: - As & when required. (Whenever the tablets compressed starts showing sticking pitted appearance, excessive flash or collaring etc.).
5.5.2.1.5 Details of Polishing should be recorded in format.

5.5.3 POLISHING COMPOUNDS / TOOL SELECTION CHART

Table No.:1 FOR PLAIN TIPS

CONDITION	TOOL	COMPOUND
Surface finish is in good condition	Nylon Brush Felt Bob	Luster Bar Emery Flour
Surface finish is deteriorating	Nylon brush          Felt Bob	Emery Paste Luster Bar, Emery Flour

Table No.: 2 FOR EMBOSSED TIPS                                                           

CONDITION	TOOL	COMPOUND
Surface finish is in good Condition.	Nylon Brush	Luster Bar Emery Flour
Surface finish is deteriorating	Nylon brush	Luster Bar ,Emery Flour

IMPORTANT: Emery Paste should be sparingly used or excessive metal removal will occur with subsequent reduction of punch life.

5.5.4 INSPECTION OF DIES & PUNCHES

5.5.4.1 Punches should be inspected at a specified frequency for their height & diameter (dimensions) by using the inspection kit provided (dial gauge).
5.5.4.2 Adjust the `zero’ on the dial by using the standard punch length provided with the kit.
5.5.4.3 Place the punch below the dial with the tip facing in downward direction & head touching the dial probe.
5.5.4.4 The deflection of the needle on the dial should not be more than 10 thou than the standard.
5.5.4.5 Pass the punch through GO – NO GO provided & check the clearance.
5.5.4.6 With the help of magnetic holder provided in the kit, check the uniformity of the Surface & radius of the punch or die.
5.5.4.7 Punches are also to be inspected for the condition of tips, inner & outer head angle etc. from time to time. Dies to be checked for the condition of the die bore for any formation of rings in the presence of Q.A. Person.
5.5.4.8 The details of inspection, etc. should be recorded in the format.

5.6 DESTRUCTION OF PUNCHES & DIES

5.6.1 Defective punches & dies found during a regular issue or periodical inspection should be destroyed or defaced so as to avoid its further use.
5.6.2 Deface the punches, their tips by using of hammer & head is defaced by grinding on the grinder wheel.
5.6.3 To deface the dies, the die bore should be damaged by hitting it with a tapering pin with the help of the hammer, till original die bore shape is changed or till the die gets divided into two parts. All the process should be done in the presence of Q.A. person.
5.6.4 Count the No. of rejected punches and dies and record the rejection in the format.

6.0 ABBREVIATIONS

6.1 SOP: Standard Operating Procedure
6.2 Q.A.: Quality Assurance
6.3 HOD: Head of The Department

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