OBJECTIVE:
To lay down the procedure for polishing of punches and dies.
SCOPE:
This SOP is applicable to the procedure for polishing of punches and dies.
RESPONSIBILITY:
Initiator Executive/Designee: Production shall ensure the compliance of the SOP.
Initiator Officer/Designee: Production shall perform the operation activity as per SOP.
ACCOUNTABILITY:
QA Head shall be Accountable for implementation of SOP.
PROCEDURE:
Polishing punches and dies is a crucial step in maintaining tablet press tooling. Over time, normal use can cause wear and tear, leading to issues like sticking, picking, and capping. Polishing helps restore the smooth surface finish of these tools, ensuring proper tablet formation and ejection. It involves using specialized polishing compounds and tools to remove imperfections and create a mirror-like finish. This process not only improves the quality of the tablets but also extends the lifespan of the punches and dies, saving costs and downtime in the long run.
Polishing of Punches and Dies:
Polishing of the punches and dies will be carried out to reduce the tabletting problems like sticking, picking, etc which may also occur due to repeated usage punches and dies.
Ensure the following tools and compounds available before starting the polishing activity.
Magnifying glass – for identifying the damaged surfaces and finishing of the Punch tip.
Nylon / Brass brush – Wheel type.
Nylon / Brass brush – Cup type.
Diamond paste – for smoothening for removing the burrs.
Clean the punch / die surface with lint free cloth.
Loosen the locking nut of the holding chuck, insert the suitable Polishing brush (as per the shape of the surface into the chuck and tight the locking nut properly.
Switch on the power supply of the polishing machine.
Press the ON / OFF press button located on the polishing machine.
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Apply diamond paste on the surface of the punch for which polishing has to be done (emery Powder can also be used along with the Emery paste for improving the surface finish).
Hold the punch properly and feed the face of the punch for which polishing has to be done against the rotating polishing brush.
Adjust the RPM of the polishing machine with the help of Speed adjusting knob to get the required surface finishing.
Clean the surface of the punch thoroughly with I.P.A Solution and followed by wiping with Dry lint free cloth.
Repeat above steps unless the required surface finishing is achieved.
After completion of polishing activity
Each and every punch and die surfaces should be individually smeared with food grade oil and shall be stored in its designated racks.
Punch polishing details shall be recorded.
REFERENCES:
Not Applicable
ANNEXURES:
Not Applicable
ENCLOSURES: SOP Training Record.
DISTRIBUTION:
Controlled Copy No. 01 : Head Quality Assurance
Controlled Copy No. 02 : Head Production
Master Copy : Quality Assurance Department
ABBREVIATIONS:
| PD | : | Production |
| No. | : | Number |
| SOP | : | Standard Operating Procedure |
| IPQA | : | In process Quality Assurance |
REVISION HISTORY:
CHANGE HISTORY LOG
| Revision No. | Details of Changes | Reason for Change | Effective Date |
| 00 | New SOP | Not Applicable | To Be Written Manual |
Click the link to download word file copy of this document:
https://pharmaguidehub.com/product/polishing-of-punches-and-dies/