Case study: Contract manufacturing & Automated tablet testing

15. September 2010

Contract manufacturing is very competitive, and the ability to offer unsurpassed quality, reduce direct manufacturing costs and provide clients with concise, easy-to-understand test reports can be paramount in maintaining a competitive edge.

A contract manufacturer with 17 press bays outputting as many as 15 different products a day – ranging from dietary supplements to OTC products – used five manual tablet testers shared by all the press operators. The qualitycontrol lab used the same model tester as production. Because of the extremely widerange of formulas in manufactureat any given time, plausibility andT limits were not programmed orrecorded on the compressionfloor. To do so resulted inspecification input errors, testing errors, confusion, avoidable production stoppages and unnecessary waste of labour. Plausibility and T limits were manually calculated in the quality control (QC) lab using production tester printouts. Batches were then authorised for release. The entireprocess was incredibly inefficient, laced with opportunities for error and very time-consuming.

After reviewing internal IPC and QC processes, the contract manufacturer decided to replace the manual testers with four fully automated testers (in this case, AutoTest 4 Tablet Testing Systems from Dr. Schleuniger Pharmatron) – three in production and one in the QC lab. The automatic tester in the QC lab and one of the production units had a so-called ‘12-magazine feeder’ to allow the set-up of as many as 12 tests at the same time – making it possible to quickly and easily test multiple samples from a wide variety of products and batches.

Whereas one tester could be shared among agroup of press bays in production, it proved to be equally useful to use a 12-magazine feeder in QC to streamline processes and minimise investment costs. The two remaining automated testers were installed directly in the compression room in combination with portable tablet diverters and an air transport system. One of the main advantages of realising the press integration with a stand-alone testing system was that no modification of the existing presses was required. Stacklights were programmed to signal whether a T limit had been exceeded, alerting the press operator.

The benefits and increased efficiencies were immediately apparent. Test reports by batch including plausibility, T1 and T2 limits were generated with each tablet sampling in real-time. Confusing data became a thing of the past and batch release authorisations took place in synergy with production schedules. Customers were pleased to receive test data by email within hours of their products being completed. Delivery times were reduced, as were direct labour costs.

WHAT’S NEXT?

Automating tablet testing is one of the key determinants of achieving reliable quality and productivity in tablet production – making it an important factor for optimised, cost-efficient operations. Given the ongoing market consolidation and increasing cost pressures within the industry, manufacturers are under pressure to look not only at automation but also at other possibilities along the value creation chain to increase production throughput without compromising quality. Holistic product development strives to design new products not only from a formulation and marketing point of view, but also taking production and quality control aspects into account. The use of alternative technologies such as automated near-infrared (NIR) spectroscopy is being actively pursued by almost all international pharmaceutical companies and will continue to change the way that the industry operates. The first successfulprocess analytical technology (PAT) projects where a realtimerelease (RTR) using automated NIR technology hasbeen realised open up new possibilities in automated tablet testing and show how significant cost-savings can be realised. Related topic: Content uniformity