Applying tool management

Alex Bunting reveals how to improve tablet production

In today’s culture of high-volume, tightly controlled and audited tablet production, the availability and condition of tooling are of primary importance for uninterrupted manufacture. This is especially important in the pharmaceutical solid dose manufacturing environment, where productivity and efficiency are key.

Tablet tooling that is not in optimum condition can seriously affect production. If you are not in control of your tooling you can’t be in full control of what is being produced.

The hidden cost of poor tooling

Tablet tooling was once considered an expendable part of the manufacturing process and factored in as a part of the production outlay. However, there are hidden costs to consider, for example, lost time due to unforeseen tooling replacements, or punches used when they should have been in maintenance. Using tools in non-optimal conditions creates tableting problems like sticking and picking. This leads to issues with the end product when it is found that the tooling being used does not meet the highly demanding process of tablet manufacture. Rejected tablets, wasted formulation and press downtime are the usual results.  In addition to this, not having a clear picture of tooling availability may lead to the loss of opportunities in a fast-moving competitive environment.

Why tooling fails

There are many reasons why tooling fails and leads to poor tablet production. Inadequate tablet press maintenance and poor tool condition are only the tip of the iceberg. Inappropriate tablet design and difficult granule, and even using an incorrect tool coating can all affect production. Issues created by these common problems result in time-consuming and costly mistakes for the tablet manufacturer.

Tool damage through handling is another significant production failure commonly encountered. There are several stages of the tablet manufacturing process where damage can take place, including unpacking the tooling, loading/unloading the tools in or out of the tablet press, during tool cleaning/maintenance procedures and storage/transportation. If damage occurs it can lead to the production of poor-quality tablets, and even further damage to both the tooling and the tablet press.

It is important to understand the delicate nature of tablet tooling and operate good tool care, maintenance, storage and handling procedures to optimise tooling life. To achieve the maximum life from punches and dies, the correct maintenance of tooling is critical as many punch and die problems can be conclusively traced back to poor handling and maintenance procedures. Follow a simple tool maintenance process that includes clean, assess, repair, measure, polish, lubricate and store. Applying specific procedures will ensure tooling is clean, serviceable and within specification when required for production. This will result in a better quality product, reduce costs and increase profitability.

Manage your tooling

The answer to efficient and effective tool maintenance is the use of a tool management system (TMS). Through the development of computer-based monitoring systems, considering tablet compression tooling as consumable items is changing and manufacturers are now maximising productivity per punch.

A TMS is a register of all tooling that largely automates the visibility of what is happening with the tools. Its main objective is to establish compliant, efficient and accurate maintenance of punches and dies and to ensure that tooling is never a cause for delay in the production schedule.

Crucially, an in-depth monitoring system is not only 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 Current Good Manufacturing Practice regulations enforced by the FDA.

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. By implementing an advanced TMS, problems such as wear to punch heads and tips can be detected before they impact production. It can also highlight when specific punch and die cleaning actions are required. These can be essential to avoid common manufacturing problems such as sticking and picking, cross-contamination and corrosion.

Managing tools increases productivity

Ensuring tablet punches and dies are kept in peak condition to produce high-quality tablets is critical for productivity and overall equipment efficiency. This can be understandably difficult if several production lines and tablet presses are running simultaneously.

Through the adoption of a simple structured tooling maintenance process, and the implementation of a TMS, tablet manufacturers can fulfil the core requirement of managing tooling in an ordered and traceable way. A TMS recognises where every tool is, what condition it is in, how long it has been in service and can identify maintenance issues or poor handling problems by auditing all tooling and its respective processes.

The efficient and accurate management of punches and dies is vital to optimising tablet output and profitability. A TMS will help tablet manufacturers achieve this goal.

Alex Bunting is with iHolland

Recent Issues