SOP Title: Inspection, Utilization and Cleaning of Punches and Dies
- Objective:
To define procedure for Inspection, Utilization and Cleaning of Punches and Dies.
- Scope:
This SOP is applicable for Inspection, Utilization and Cleaning of Punches and Dies used for compression of tablets in compression area.
- Responsibility:
- Production Department: To prepare and review the SOP. To follow the procedures laid down for the Inspection, Utilization and Cleaning of Punches and Dies.
- Quality Assurance Department: To provide line clearances prior to operation.To review and approve the SOP and Annexure. To monitor the activities performed in the area as per SOP.
- Accountability:
Head, Production Department.
Head, Quality Assurance.
- Procedure:
- Definition:
- Production Associate: Executive or Operator of Production Department or any personnel trained to perform duties as per this SOP.
- Quality Assurance Associate: Executive of Quality Assurance Department or any personnel trained to perform duties as per this SOP.
- Type A Cleaning: Dry Cleaning with clean dry soft cloth in the following cases,
- To remove the previous batch residue.
- Before starting the next batch of the same product.
- After End of the shift or before the start of the shift, if the same product to be continued.
- Type B Cleaning: Cleaning with IPA 100 % (v/v) of in the following cases,
- Removal of traces of the previous product.
- Change in product if any.
- After polishing of Punch set.
- Procedure:
- Definition:
| Precautions | ||
| 5.2.1 | To avoid the damage of punches and dies care should be taken while handling the punches. | |
| 5.2.2 | Store the punches after proper cleaning and lubrication in plastic tubes provided in punch cabinet. so that, the tip of the punches does not get damaged. | |
| 5.2.3 | During dismantling or setting, punches /dies should not be kept on the any part of the machine unless it is fixed on the machine turret. | |
| 5.3 | Inspection of Punches and Dies: | |
| 5.3.1 | After receiving new punch set, punch dimension (tip diameter, punch height, body diameter, embossing) of all punches must be inspected by calibrated Vernier Caliper and record the all punch dimension detail in Annexure. | |
| 5.3.2 | Check the Dies dimension (outer diameter, inner diameter and height) by calibrated Vernier Caliper and record the all dies dimension detail in Annexure. | |
| 5.3.3 | Embossing, crack, damage of Punches tip must be inspected by magnifying lens. | |
| 5.3.4 | Cross verify the received punches and dies specification with approved drawing. | |
| 5.3.5 | Put the respective code no. for each set as per following example.
For example:12.5 mm D tooling punch set received first time, then the punch set number will be D/12.5mm/01. Where, D – stands for D tooling, 12.5 is the punch diameter, 01- is the first set. |
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| 5.3.6 | All these should be recorded in identification for punch set record format in Annexure. | |
| 5.3.7 | Lubricate the punch tips by applying food grade lubricant before keeping into their respective storage cabinet. | |
| 5.4 | Utilization of Punches and Dies: | |
| 5.4.1 | Issue the die and punches as per the respective product BMR. Check the cleanliness and integrity of Punches and Dies and record the number of punches and dies issued in the format “Utilization and Cleaning record for Punches and Dies”. | |
| 5.4.2 | Transfer the punches and dies on SS trolley to the respective compression area. | |
| 5.4.3 | Once the compression is completed, clean all the punches and dies with IPA (100% v/v). | |
| 5.4.4 | Lubricate all cleaned Punches and Dies with food grade oil. Then transfer it to the respective storage cabinet. | |
| 5.4.5 | Record the cleaning and utilization of Punches and Dies in the Annexure. | |
| 5.4.6 | Cleaned Dies and Punches to be checked by the responsible production supervisor/officer before placing into the punch pockets. | |
| 5.5 | Rotation of Punches and Dies: | |
| 5.5.1 | Rotation of punches should be done by one punch. The rotation details of upper punches, lower punches and dies with their specified nos. to be recorded in Annexure to ensure that all the punches and dies are used in a rotational manner. | |
| 5.5.2 | If any damaged Punch/Dies found must be reported immediately to the Officer/Department Head. | |
| 5.5.3 | The damaged punch number should be entered and mention remarks in “Utilization and Cleaning of Punches and Dies” in Annexure. | |
| 5.5.4 | The damaged punch should be destructed by defacing the punch tip in presence of QA. | |
| Frequency: Rotation of Punches should be done for every product change over. | ||
| 5.5.5 | Perform either “TYPE A” cleaning or “TYPE B” cleaning as applicable. | |
| 5.6 | Cleaning of Punches and Dies at the end of shift: | |
| 5.6.1 | Remove all the upper punches, dry clean it with dry duster smear it with food grade lubricating oil and put back in the respective upper punch guide hole. | |
| 5.7 | Cleaning of Punches and Dies during Type A (Batch change over): | |
| 5.7.1 | Remove the upper punches one by one and dry clean with soft clean duster then place them in to the respective punch guide hole. | |
| 5.7.2 | Record the cleaning of Punches and dies in the attached Annexure. | |
| 5.8 | Cleaning of Punches and Dies during Type B (Product change over): | |
| 5.8.1 | Remove any spilled material from the area with clean lint free cloth / Vacuum Cleaner. | |
| 5.8.2 | Clean the punches and dies with lint free cloth to remove the adhered powder. | |
| 5.8.3 | Clean the inner surface of the dies with nylon brush. | |
| 5.8.4 | Finally clean the punches and dies with clean lint free cloth moistened with IPA 100% w/w. | |
| 5.8.5 | Lubricate the cleaned Punches and Dies with food grade oil. Record the cleaning activity in attached Annexure. | |
| 5.8.6 | Note:
1. If the product compressed is causing rusting/ blackening to the punches, then dry clean the punches and smear food grade lubricating oil with clean duster/brush. 2. Keep the punches in the punch tray and next day before continuing the compression, wipe the punches with soft clean duster and put all punches in to the respective punch guide hole. |
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| 5.9 | Polishing of Punches and Dies: | |
| 5.9.1 | Take the punches to be polished and open the polishing kit and fit the required type of polishing brush in to the slot provided in the front side of the polishing kit. | |
| 5.9.2 | Switch “ON’ the polishing kit and check the proper fitting of brush. | |
| 5.9.3 | Apply little amount of polishing (Embry) paste on the surface of the punch tip. Start the machine then slowly touch and hold the polishing surface on the brush. | |
| 5.9.4 | For polishing of Dies, use felt bob type brush to polish the inside the die bore. | |
| 5.9.5 | Note: During polishing of punches, tip should not touch the metallic body of the brush to avoid the damage of the punch tip. | |
| 5.9.6 | In-between check the polished surface for smoothness, do not over polish the punches, over polishing may cause damage to the chrome plating. | |
| 5.9.7 | After polishing clean the punches with lint free duster moistened with IPA. | |
| 5.9.8 | Before storage of Punches and Dies, lubricate with food grade oil. | |
| Frequency: Polishing of punch and dies to be performed, after compression of 50 million tablets (per punch set), OR roughness/sticking/blackness observed on the surface of the punch set whichever is earlier. | ||
| 5.9.9 | Record the polishing details in “Punches and Dies Polishing Record”. | |
| 5.9.10 | Note: The punch head never to be polished to allow the diameter of the dwell flat. | |
| 5.10 | SHELF LIFE: | |
| 5.10.1 | The punches and dies shall be used for a maximum of 180 million tablets for round shaped each punch set, and 75 million tablets for other than round shaped punch set. | |
| 5.10.2 | Further the punch set can be used after re-inspection and physical status of the punch set, after approval by QA Head. The further approval will not be granted for more than 2 million tablets. |
- Abbreviation:
| Abbreviation | Expansion |
| SOP | Standard Operating Procedure |
| No. | Number |
| IPA | Iso-Propyl Alcohol |
| mm | Millimeter |
| QA | Quality Assurance |
| % | Percentage |
| v/v | Volume by Volume |
*Note – Ready to use SOP available in “DOWNLOAD” Section.