How to keep tablet tooling in check to meet standards
I Holland offers a guide for tablet manufacturers on how to keep their equipment in good condition to avoid downtime on mass production lines.
The cost of tablet tool replacement is often predictable, however, hidden costs such as those created by badly maintained tooling or the unavailability of tools due to avoidable damage is not as obvious. The implementation of an established tool maintenance process, together with an in-depth management system, will not only benefit production efficiency and the bottom-line but also meet exacting regulatory requirements.
Producing quality tablets quickly is essential in modern tablet production. One area that is hugely influential on the success of mass-production is the condition of the tooling used during the process. Through the application of a planned and professional maintenance and management process, tablet tooling can be used to enhance production, stop rejected tablets, wasted formulation, costly press damage and press downtime.
The first step to enhance tooling and extract the maximum life from punches and dies is through a consistent and accurate approach to maintenance. This includes employing a seven-step process which should be carried out as a standard operating procedure. It must be performed regularly to achieve efficiency, quality output and improve speed to market. The seven steps include: clean, assess, repair, measure, polish, lubricate and store.
1. CLEAN- This is vital to prevent cross-contamination during tablet compression and minimise potential production issues such as sticking and picking. Use cleaning equipment specifically designed for tooling, for example, an ultrasonic cleaner equipped with a specially designed fixture that holds the segment safely and securely within the tank.
2. ASSESS - Visually inspect tooling for signs of obvious damage and establish if maintenance is required. Identifying damage of the tablet press is by far a more efficient method when it comes to time and capital than running tablet production with faulty tooling.
3. REPAIR- Light surface corrosion and damage can be polished out and repaired. This should be carried out when absolutely necessary and only by well-trained and experienced maintenance technicians.
4. MEASURE - Measuring is essential after repair to ensure that critical tooling dimensions have stayed within tolerance and also ensures that tablet weight variation is controlled.
5. POLISH - Polishing should result in a smooth even mirror finish. This should be achieved in a controlled and repeatable way through an automated regime.
6. LUBRICATE - Lubrication is important to protect, preserve and aid the smooth operation of tooling.
7. STORE - Storage cabinets should be specially designed to maximise security, safety and minimise the damage of tooling during transportation.
Applying specific maintenance procedures will ensure tooling is clean, serviceable and within specification when required for production, resulting in a better product for longer, reducing costs and increasing profitability. Importantly, it also helps to meet the Food and Drug Administration (FDA) regulatory standard - Current Good Manufacturing Practice (CGMPs). This provides for systems that assure the proper design, monitoring, and control of manufacturing processes and facilities. Tablet tooling should come under this quality management.
To establish compliant, efficient and accurate maintenance of punches and dies, it is important to also implement an in-depth computer-based monitoring system. This will ensure quality specifications are met and regulatory standards are adhered to. Crucially, manufacturers should have a complete audit trail covering tooling usage and maintenance which a tool management system can fulfil. This is not only good practice but an important regulatory requirement in the majority of pharmaceutical environments.
A tool management system is not just important for maintenance history as it keeps track of tooling inventory, but it also supports regulatory procedures and complies with legal requirements in tablet production, for example, the 21 CFR (Code of Federal Regulations) regulation, part of the CGMPs.
It consistently records a 21 CFR part 11 compliant audit trail of all production and maintenance. The data can also provide information to effectively measure areas of performance by way of showing what and how many products have been produced and a summary of any production issues experienced. Overall it ensures that tooling is never a cause for delay in the production schedule.
Keeping tooling in check is essential to efficient, cost-effective tablet production. Through a logical planned seven-step maintenance process, and the incorporation of an advanced tooling management system, tablet production will be optimised and regulatory and quality standards will be met.