Kraemer Elektronik and Charles Ischi have complemented the pharmaceutical development and manufacturing process with a method of ensuring quality control for tablets and capsules.
Requirements that need to be met by a tablet testing system to guarantee a successful product release is dependable upon a combination the system’s quality, speed, technology, flexibility, and safety.
Today, there are more challenges than ever before as the pharmaceutical industry endeavours to make products safer by guaranteeing that they are of the highest quality, protect operators by ensuring safety in the production environment, and save time and money through the use of flexible systems that speed up release times.
The current industry buzzword is continuous production, but what does the industry need to make it happen?
Modularity and flexibility
There is an approach to design that divides a particular system into smaller parts. These modules can be used in various systems but also made independently. This approach is called modular design or modularity in design.
A standard modular system can be identified by functional sub-division into separate, scalable, and reusable parts; well-defined modular interfaces; and usage of industry standards for interfaces.
Modular design offers exclusion and augmentation, meaning a new solution is added by simply plugging in a new module. This is combined with flexibility in design and tangible cost reduction, owing to shorter learning times and less customisation. Numerous examples of modular systems surround us in our everyday life. This modularity is an attempt to combine the benefit of customisation with those of standardisation.
The laboratory testing devices in the P-Series are designed to offer the latest technology, space-saving design and maximum flexibility. The basic devices, models P2-P5, can be tailored to the operators needs at any time thanks to the plug and play extension module. This also allows for the upgrading of the semi-automatic basic devices to a fully automatic testing system at any time. The P5 version tests all five parameters: hardness, weight, thickness, length, and width.
Process analytical technology (PAT) and uniformity checking
Batches can easily reach sizes of more than 1,000,000 tablets. However, only 30 tablets are used for content uniformity (CU) release testing. This same assay of samples is typically checked for other parameters such as weight, hardness, thickness, and diameter.
These huge batch sizes, and the trend for the change to continuous production, require rapid and accurate analysis methods such as the well-known parameter tester Universal Test System (UTS) from Kraemer Elektronik and the rapid near-infrared (NIR) measurement device VisioNIR LS for CU from visiotec. The UTS-Extended, with integrated VisioNIR LS technology, can check for these physical-chemical characteristics.
In some cases, the thickness or bizarre shape of tablets does not allow for the transmission measurement. A solution is the possibility to switch via a multiplexer from transmission to reflection mode to enable the user to measure each available tablet on the market.
For detailed homogeneity inspection requirements, the tablet can be area-scanned in reflection mode. The resulting plot is an image of the tablet showing a tablet’s active pharmaceutical ingredient (API) content distribution. On the other hand, the mean content of this multi-spot measurement can be used for an overall statement of the API content of the tablet. From a quality point of view, the RAS measurement provides more solid results.
As opposed to the required 30 samples, the UTS-Extended can increase the sampling size up to 240 samples per hour. The system can be run at-line configuration for automated tablet feeding from a connected tablet press or as a standalone system in production, or the laboratory. The reliable trend monitoring visualises the CU prediction value of each sampled tablet. Outliers can be safely identified.
The UTS-Extended is dedicated to real time release (RTR).
Operator and environment protection
In a comparatively short time, containment systems that protect operators from extremely active or toxic ingredients have taken a significant step forward and containment strategies and technologies in the pharmaceutical industry have altered a great deal during the past decade.
The pharmaceutical industry is still the driver of new and improved containment solutions, which provide better protection of operators and more thorough cleaning to avoid cross contamination of different products. Because of these requirements, Charles Ischi had various requests from customers to find a more cost-efficient solution.
Containment manufacturing operating costs can approach hundreds of thousands to millions of euros and a major contributing factor is the time taken to change between products and cleaning. The most up-to-date containment strategies merge the production process equipment with containment to keep the contaminated space as small as possible.
The UTS IP65i system is an addition to washable tablet presses for wash-in-place (WIP) or wash-off-line (WOL) applications for processing medium and highly potent products up to occupational exposure band (OEB) level 5. As an addition to the existing dust-proof and easy-to-clean testing systems UTS4.1-S10 and UTS IP LR, the UTS IP65i is claimed to be the first fully washable, universal testing system. The UTS IP65i tests the physical parameters of tablets, including their weight, thickness, hardness, and diameter.
Ten year forecast
According to chair of the ISPE Containment Group Richard Denk, containment in 2025 will see a lot of changes in the design and implementation, as well as better integration of current process technologies. Three focal areas for containment over the next ten years will be process integrated containment, disposables, and cleaning.
Process integrated containment calls for a better understanding between the process expert and containment expert. Containment implemented in the process instead of adapted to the process will be one of the biggest changes the pharmaceutical industry has had to accommodate. The aforementioned UTS IP65i is a good example of a step in this direction.
A number of other containment integration solutions can already be found in the packaging industry. Cleaning is an equally important consideration. It is currently a huge challenge in multi-purpose facilities and the situation is predicted to worsen with the European Medicines Agency (EMA) having published new regulations.
Containment is a very complex interaction between process, room, containment technologies, validation, cleaning, waste, and operators. This is so much so that it called for the ISPE Containment Expert Group’s formation in 2010. The group has just announced the impending launch of its containment manual, which is scheduled for November this year and offers comprehensive guidance on the containment lifecycle, from start to finish.
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