Handling of new punch set and polishing issuance retrieval and disposal of punch set
1.1 To describe the procedure for handling of new punches set & polishing, issuance, retrieval & disposal of punch sets.
2.1 This procedure is applicable to punches and dies set present in the production.
3.1 Operator – To perform the procedure.
3.2 Executive production- To ensure that the operation is being performed in compliance with the
SOP and BPR.
3.3 IPQA person – To ensure line clearance, in-process checks, and to counter check that the
Compliance is in line with SOP and BMR.
4.1 Department Head
5.1 HANDLING OF NEW PUNCHES SET
5.1.1 After inspection for physical parameter with URS, the punches shall be issued to production department.
5.1.2 Clean using lint free cloth dipped in 100% IPA.
5.1.3 Issue required number of punch sets for machine setting.
5.1.4 Excess punches sets smear with food grade oil SAE 90/140 and keep it in a punch sockets store them in a cabinet.
5.1.5 Compare each punch with the standard height block while checking it individually using the standard specification.
5.1.6 Record the observations after inspection as per the format no
5.2 CHECKS FOR PUNCHES
5.5.1 Tip Diameter (Limit ± 0.08mm): Check the tip diameter using digital micrometer.
5.5.2 Punch Concentricity (Limit ± 0.03mm): Check the concentricity of the tip and barrel using standard digital dial gauge and V-block.
5.5.3 Tip Surface: Check visually for scratches, damages, surface finish cracks, pits, spots and chrome plating (if applicable).
5.5.4 Chamfer: Check visually for angle, uniformity.
5.5.5 Embossing (where applicable): Check visually for letters flattening of letters, burr, roughness and cracks.
5.5.6 Central Break Line (where applicable): Check visually for position, flattening and roughness or deep score.
5.5.7 Punch Head and Tip Clearance: Check the punch head and tip clearance by inserting the head and tip inside the respective GO-NO GO die.
5.3 OVERALL LENGTH
5.3.1 Take out the punches from punch holding caps
5.3.2 Arrange them in sequence as per serial numbers engraved on the individual punches.
5.3.3 Place the digital dial gauge on the stand and tighten it.
5.3.4 Place the standard height block (supplied along with equipment) on platform and adjust it below the dial knob.
5.3.5 Set digital indicator to ‘zero’.
5.3.6 Keep the punch in ‘Head UP’ and ‘Tip Down’ position while checking the overall punch height. Record the reading observed on the digital indicator of the punches and record in the format no.PRD/020/F02/R-00 Dies and Punches Inspection record.
5.4 CHECKS FOR DIES
5.4.1 Outer diameter (Limit ± 0.08mm): Check the outer diameter with the help of vernier caliper.
5.4.2 Inner Surface: Check visually for scratches, damages, surface finish, cracks, pits, spots and chrome plating (if applicable).
5.4.3 Body Surface: Check visually for surface finish, level uniformity edges, die locking groove and plating (If applicable). (Both upper and lower surfaces).
5.4.4 Height (Limit ± 0.08mm): Check the height with the help of vernier caliper.
5.4.5 Chamfer: Check for uniformity of chamfer.
5.4.6 Table No. 1
Type of Punch Punch set life Height checking frequency
Circular/round 10 million tablets /sub set 5 million tablets / subset
Other than Circular 8 million tablets / subset 3 million tablets / subset
1 subset = 1 upper punch + 1 lower punch + 1 die
5.5 GUIDELINES FOR POLISHING OF PUNCHES AND DIES
5.5.1 Punch should be polished when,
188.8.131.52 There is burr or claw on punch tip.
184.108.40.206 Punch tip turns black.
220.127.116.11 Roughness on the tip is observed.
18.104.22.168 Sticking continues on embossing.
22.214.171.124 Appearance of tablet becomes dull.
5.5.2 Die should be polished when,
126.96.36.199 There is ring formation inside die-bore.
188.8.131.52 Die-bore turns black.
184.108.40.206 Corrosion is observed inside die-bore.
220.127.116.11 Table No. 2
Sr. No Tooling type Polishing tool Polishing material
1 Punches Nylon brushes Emery paste, Emery Flour and Diamond paste
2 Dies Felt Bob Emery Paste and diamond paste
5.5.3 Equipment to be used for polishing is motorized polishing machine, RPM of the machine can be controlled and used for cleaning and polishing of punch tip and die- bore.
5.5.4 Recommend tools and compounds are,
18.104.22.168 Magnifying glass, for identifying the damaged surface and finish of the tip.
22.214.171.124 Nylon brush, (cup type) with emery paste, for cleaning and polishing of punch tip.
126.96.36.199 Oilstone and lapping stick, for removing the burr or claw.
188.8.131.52 Felt bob, with emery paste, for polishing the die-bore.
184.108.40.206 Emery paper or luster bar or emery flour, for improving the surface finish.
220.127.116.11 Nylon brush (wheel type) for polishing embossed tips.
5.5.5 Procedure of polishing punches and dies
18.104.22.168 Use snood and eye goggle while operation of punch polishing machine. Select the correct polishing compound and tool.
22.214.171.124 Do not apply excessive pressure while rotating the nylon brush against the rotating punch tip.
126.96.36.199 Do not apply excessive quantity of emery paste and emery flour.
188.8.131.52 Set the nylon brush / felt bob needle with the equipment.
184.108.40.206 Switch ‘ON’ the mains and then the ‘Toggle’ switch.
220.127.116.11 Take out the punch from the cabinet, Apply small quantity of required polishing material as listed in Table No.2 compound to the punch tip.
18.104.22.168 Fix the punch carefully in the chuck and rotate it. Hold the rotating nylon brush against the rotating punch applying very little pressure. Ensure that nylon bristles of the brush are not getting flattened against the tip.
22.214.171.124 After a few seconds of polishing, dip the tip of punch into emery flour and repeat the step 126.96.36.199
188.8.131.52 Inspect the finish of the tip. If the polishing is not acceptable repeat the operation.
184.108.40.206 Keep the polished punch into the punch tray.
220.127.116.11 Take out the die from the cabinet, Apply small quantity of emery paste or diamond paste as required compound in die bore.
18.104.22.168 Polish the die bore by inserting rotating tip of the felt bob carefully, applying a very little pressure.
22.214.171.124 Inspect the finish of the die bore. If the polishing is not acceptable repeat the operation.
126.96.36.199 Keep the polished die into the respective tray.
188.8.131.52 After polishing switch OFF the mains Remove the plug top and dismantle the nylon brush / felt bob then clean the machine.
184.108.40.206 After polishing of punches and dies clean the punches and dies with 100% IPA.
220.127.116.11 After cleaning of dies set apply thin layer of food grade oil and store them in respective Dies and Punch storage cabinet.
5.6 Issuance, retrieval & disposal of punch sets.
5.6.1 Issuance of punch set
18.104.22.168 Issue the punches and dies for setting on the machine as per the serial number engraved on them. Store the spare remaining punches and dies in the drawer of the dies and punches storage cabinet.
22.214.171.124 Take the punch set from the storage cabinet and clean the punches and dies as per SOP.
126.96.36.199 Depending on the product and the compression machine, select a punch set for issuing it to the required machine.
188.8.131.52 Note: For uniform wear and tear of the punches and dies use the tooling in rotation of 1 sets during every issue for e.g. for 30 station compression machine during the first issue hand over the set from 1 to 30 and for next issue from 2 to 31 and so on. If the same punches and dies are being used for five consecutive batches then next set to be issued as per the rotation after completion of fifth batch.
5.6.2 Retrieval of punch set.
184.108.40.206 After completion of the compression of a batch or the production plan, dismantle the punches and dies from the machine.
220.127.116.11 Clean the punches and dies as per SOP.
18.104.22.168 Check all the punches and dies individually and store them in the dies and punches storage cabinet after applying food grade oil.
22.214.171.124 Make entry in dies and punches usage record (Format Number – 01).
5.6.3 Disposal of punch sets
126.96.36.199 Punch set shall be disposed when the set becomes incomplete due to reduction in the number of upper punches/lower punches or dies because of rejection during the usage of punch set.
188.8.131.52 If Individual punch or die becomes unusable due to damage to the tip / head / body of the punch or die during handling and usage of the punch set or due to corrosion of the surface then full set shall be disposed.
184.108.40.206 Punch set shall be disposed when one set completes the life period as per Table No. 1.
220.127.116.11 Collect all the defective sets and incomplete punch sets which are to be disposed. Deface the punch tip preferably using a grinder, before discarding.
18.104.22.168 Record the details of all these defective punches and dies in tooling destruction note format no. 01 and take the approval of the Head of the Department.
22.214.171.124 Transfer the punches and dies to the scrap yard along with the tooling destruction note. Get it checked by Engineering Stores and keep one photocopy of the note in the department.
6.1 Trainer: Department Head.
6.2 Trainee: Production, Quality Assurance and Operation person.
6.3 Period – One hour or as per required.
7.1 One set of master copy & controlled copy submitted the quality assurance department.
Die and punch uses record
New Die and punch observation
Die- Punch record
Die and punches cleaning record
9.1 IPQA : In-process Quality assurances
9.2 BMR : Batch Manufacturing record.
9.3 SOP : Standard operating Procedure.