As is the case with most manufacturing operations, companies manufacturing pharmaceutical tablets are under ever-increasing pressure to make their production more effective, cost-efficient, and speedy. Outsourcing-Pharma spoke with I Holland marketing manager Alex Bunting about factors impacting tablet manufacturing, and how to effect improvements along the process.
OSP: Could you please share an overview of how the aging global population is impacting drug development and pharmaceutical manufacturing?
AB: Life expectancy is increasing globally thanks to growing prosperity, and the increase in effective pharmaceuticals. This means there are now many more older people within the population.
This can present a problem when it comes to tablets. Elderly people often have difficulties with dexterity and loss of hand strength making simple tasks like breaking a tablet difficult. This means they can break in uneven parts which can affect the dosage. Manufacturers are having to adapt their design and produce tablets that can be easily used by all age groups, including those with dexterity issues.
Innovative tablet tooling has been designed to help in the manufacture of tablets that can be broken easily and evenly. Patients who have issues with fine motor function through either chronic illness or age-related degenerative disorders such as arthritis can find it painful or impossible to break tablets.
One solution to this is the use of specially defined and adapted break lines on the tablet. One specific answer is the snap tab or deep quadrisect designs. With the snap tab design, the dose can even be split on a flat surface with relatively light pressure from the heel of the hand, for example.
As you may expect, a tablet with a quadrisect design breaks into four sections. A snap tab has bigger break lines included in the design often on both the upper and lower tablet punches to influence a very accurate break.
Thanks to the expertise of tablet tooling manufacturers these tablet design and tooling advancements are possible and ensure breakability is possible. This has helped to ensure patient safety through accurate dosing.
OSP: Then, could you please focus a little bit more on how this “graying” has impacted demand and other considerations for oral solid-dose manufacturing?
AB: An aging population and an increased interest from developing countries is seeing the requirement for solid-dose forms to increase. There is great pressure on tablet manufacturers to mass-produce quality tablets quickly, more efficiently, and at a lower production cost. It is therefore extremely important to enhance the production of pharmaceutical tablets to ensure demand is met in a cost-effective way. Important areas to consider during manufacture, and can make a substantial impact on productivity includes:
- Ensuring the correct tablet tooling is used
- Ensuring punches and dies are optimized to give the best performance and durability.
It is extremely important to speak to a tooling manufacturer who has the experience and know-how to advise on production optimization.
OSP: What words of advice do you have for companies looking to make production cost-effective?
AB: Making production cost-effective is extremely important. Multi-tip tooling can be very efficient and help to meet the challenge. A multi-tipped tool is a punch that can make more than one tablet per station with each rotation of the press. This can range from a two-tip punch to one with over 40 tips per punch body.
It has several benefits, including greater productivity due to the increased number of tablets per turret rotation. The number of tool set-ups required per production batch is also reduced with product batches completed quicker, therefore decreasing the overall time required to produce the product.
A multi-tip solution also prevents the need to purchase a new tablet press to increase production. Therefore, capital outlay on a new tablet press is removed and fewer presses are required to satisfy production levels.
Another cost-effective method for enhanced tablet production is the use of specific tool coatings. Specialized punch and die coatings can have a huge impact on the efficiency of tablet manufacture. With the correct coating or treatment in place, some of the biggest challenges that can delay production like sticking, corrosion, and wear issues can be prevented.
Coating technology has advanced significantly over the years, and when used in conjunction with high-quality tooling steel, tool coatings are increasingly seen as an acceptable means of solving production problems. They allow for better tableting efficiency and output by reducing the requirement for tools to be taken out of production for additional cleaning and maintenance work to remove problematic residue which, if left untreated, can cause potential production issues.
OSP: Can you share advice on how to boost speed to market?
AB: The tooling used can be hugely influential in speeding the time to market. Again multi tipped tooling can help here, as well as choosing the correct tool steel and coatings. Perhaps another area that is often not considered is effective training.
For optimized manufacturing processes, the importance of skilled and well-trained operators, technicians, supervisors, and managers is essential. Investing in learning and development provides several tangible benefits including reduced downtime, greater productivity, higher profits, and boosting the speed to market.
Effective training will not only save on time and labor by recognizing problems that could stop production before they happen, but it results in a well-trained workforce.
OSP: Then, how can a company maintain acceptable product quality?
AB: Tablet quality has to be top of the agenda when manufacturing tablets. One area that helps to improve this is the effective maintenance and management of tablet tooling.
Keeping tooling in good working condition reduces tablet press downtime and compression problems. When combined with a management system to monitor all aspects of the punches and dies, high-quality tablets are produced quickly and efficiently.
It is important to understand the delicate nature of the tooling and operate good tool care, maintenance, storage, and handling procedures, to optimize tooling life. This should be done by adopting a planned process for tooling maintenance and storage, and the incorporation of a tool management system.
To obtain the maximum life from punches and dies, the correct maintenance of tooling is critical. Many punch and die problems can be conclusively traced back to poor handling and maintenance procedures. With the use of a monitoring system that can record data in real-time and offer instant solutions, together with the application of a structured maintenance process, the direct impact on the reduction of many common tablet and tooling problems results in a quality end product.
OSP: You suggested tablet manufacturers consider production process improvements. Where do you suggest they begin?
AB: As mentioned above, a good start is the adoption of a logical, planned, and professional approach to tooling maintenance, measuring, and storage, this will benefit tablet production enormously.
Follow a simple process like the I Holland 7 step tool maintenance process which includes cleaning, assessing, repairing, measuring, polishing, lubricating, and storing. Applying specific 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.
OSP: What are some common challenge areas in process design and execution that personnel should look out for?
AB: The most common challenge for tablet manufacturers is sticking. Sticking occurs due to build-up of granules on the punch tip face. There are a number of reasons this happens, including physicochemical properties of the formulation components, surface characteristics of the punch face, machinery issues, and environmental factors including humidity, temperature, and speed.
Sticking has a negative effect on the tablet weight and appearance resulting in the need to remove tablet tooling from production for regular cleaning and maintenance, which leads to tablet press downtime. Each sticking problem is usually characteristic to the product being made and a specific solution must be found for each formulation.
It is therefore important to contact an experienced tooling manufacturer who has the knowledge and expertise to offer educated solutions to a sticking problem. This can include everything from design changes to the use of specialized tool coatings and punch material.
OSP: How can improved maintenance plans/schedules lead to better outcomes?
AB: Improved maintenance of tooling will always lead to better outcomes. Knowing where tools are, and what condition they are in, should be a priority. Without this information either unnecessary tooling replacements are made, reducing productivity, or punches are deployed when they should be in maintenance or replaced.
Poor punch maintenance will also lead to problems with the end tablet. Rejected tablets, wasted formulation, costly press damage, and press downtime is the usual result. The unavailability of tooling can also have a huge impact on production.
Any problems within tool inventory management can have serious implications on the bottom line and manufacturers should have a complete audit trail covering tooling usage and maintenance. Through the use of a robust, and preferably computerized, management system that controls the procedure efficiently the outcome will improve immeasurably.