PHARMACARE - I Holland

1 MKT-47_ISSUE_07 PHARMACARE 7 STEP PROCESSPHARMACARE 01 CONTENTSINTRODUCTIONWHY USE PHARMACARE ?STEP 01: CLEANSTEP 02: ASSESSSTEP 03: REPAIRSTEP 04: MEASURESTEP 05: POLISHSTEP 06: LUBRICATESTEP 07: STOREAUDIT & TRAINING 030409131725313639457 STEP PROCESS02 INTRODUCTION7 SIMPLE STEPS TO PROTECT YOUR INVESTMENTIt s simply good business sense - manage, maintain and store your punches and dies correctly and you will produce a better product for longer, reduce costs and enhance profitability. I Holland 's PHARMACARE 7 Step Process is a planned, professional maintenance and storage programme which will provide a significant return on investment.

2 When the 7 Step process is combined with I Holland 's simple but comprehensive Tool Management System, the results speak for 7 STEP PROCESS01. CLEANT ooling should be cleaned and dried to remove any oil or product ASSESSV isually inspect tooling for signs of obvious damage and establish if maintenanceis REPAIRL ight surface corrosion and damage can be polished out and MEASUREM easuring is essential after repair to ensure that critical tooling dimensions have stayed within POLISHP olishing should result in a smooth mirror LUBRICATEL ubrication is important to protect, preserve and aid the smooth operation of STORES torage cabinets should be specially designed to maximise security.

3 Safety and minimise potential Holland TOOL MANAGEMENT SYSTEM7 STEP PROCESS04 WHY USE PHARMACARE ?OPTIMISE MAINTENANCE & MANAGEMENT OF TABLET TOOLINGT ablet compression tools are often viewed as consumable items that can be easily replaced at relatively low cost. Maintenance therefore, can be seen as an unnecessary evil and overlooked within the tablet manufacturing industry. However, by carrying out maintenance procedures and keeping the tooling in pristine condition, costly tablet press downtime and compression problems such as sticking, capping, tablet weight and thickness variation will be maintenance and management is critical in obtaining maximum life from tooling.

4 A high percentage of punch and die problems/damage can be conclusively traced back to poor handling and maintenance procedures. Serious issues with regulatory compliance can be pre-empted by having a planned professional procedure and carrying out audits of these on a regular Holland S RECOMMENDED 7 STEP PHARMACARE PROCESS:STEP 01: CLEANP unch and die cleaning is essential for the removal of residue to avoid product allows for accurate assessment of tooling condition during the inspection/assessment phase. Ultrasonic baths are recommended for cleaning as they allow for consistent cleaning results, reduced processing and operator time (cleaning times are normally 5 minutes) and reduced risk of tablet contamination.

5 Importantly, ultrasonic cleaning allows for the whole punch to be cleaned including in and around the embossing.| Ultrasonic cleaner| Ultrasonic punch holders05 STEP 02: INSPECT / ASSESSF ollowing cleaning, punches and dies should be assessed visually to determine their general condition allowing the user to identify the repair and polishing work required, if any. Inspection and assessment can be carried out visually using an eye glass or a high magnification camera / lens. Visual inspection importantly allows for tooling life to be monitored and potential failure predicted. It also ensures that tablet detail and definition are maintained and helps to validate the cleaning and maintenance 03: REPAIRThe repair stage allows the user to rectify minor damage to the tooling before polishing.

6 Minor damage and corrosion can be repaired using a motorised chuck. If damage is excessive, tools must be replaced. In all cases it is important to remember that repair to punches and dies should only be carried out when absolutely necessary as this can potentially change tooling dimensions resulting in other tabletting problems. Regular maintenance and repair work will help to extend tooling life, maintain tablet image and definition, optimise tooling productivity and prevent tooling breakages.| Lens| iNSPECT system7 STEP PROCESS06 STEP 04: MEASUREM easuring is essential after polishing and repair, as well as at regular intervals, to ensure that critical tooling dimensions have stayed within tolerance.

7 The critical dimensions to measure are working length and overall length. Other key dimensions that can be checked include: head form, barrel diameter, tip diameter, die outer diameter and die bore diameter. Measurement can be carried out manually using conventional equipment such as micrometers, height gauges, go/no-go gauges. However, using digital equipment interfaced with our simple but powerful Tool Management System, the data can be captured, analysed and used to control tooling life-cycles as well as satisfy audit and regulatory use of digital measurement systems allow for measurements to be taken consistently, reducing the risk of manual data entry errors.

8 Measurement is essential for validating the tooling specification and maintaining tablet weight and hardness thus avoiding non-conforming tablet production. It also allows for the proactive monitoring of the tooling inventory and the prediction of tooling replacements resulting in an improved return on investment.| IH-TMS with measuring equipment07 STEP 05: POLISHA utomated polishing is recommended to ensure punches are evenly polished to a consistent finish. Automated polishing ensures optimum and consistent tooling condition for maximum productivity, a reduced risk of damage compared to manual processes, reduced sticking, and saved labour costs.

9 Manual polishing using diamond paste or a dental motor can also be performed. However, this is an abrasive polishing method and care must be taken not to deform the tip profile and embossing causing a deviation from the tablet specification. Extensive polishing of die bores is not recommended as this can easily alter the size and geometry of the bore leading to ejection problems and incorrect tablet size, weight and dosage. Only light polishing or cleaning should be undertaken. Polishing should result in a mirror finish and smooth tooling Note: Re-cleaning after polishing is not required provided that a food grade polishing media and paste is used during this 06: LUBRICATEWhen storing tooling it is important to protect with a preservative or rust inhibitor to prevent corrosion.

10 Prior to this, it is important to ensure that the tools are perfectly dry as any remaining moisture may be sealed in by the coating of oil. Lubrication helps to optimise the interface between the tooling and the press, reducing machine down time. | MF40 automated polisher7 STEP PROCESS08 STEP 07: STORET here are many methods for storing punches and dies, from specially designed plastic storage boxes to custom designed and built storage cabinets. Correct storage facilitates good tooling management and ensures less press downtime as a result of poor handling and 7 step PHARMACARE process, coupled with IH-TMS, is essential for maximising tooling life and producing quality tablets.