Root cause analysis and solution of a quality problem

(Troubleshooting, Packaging optimization)

An increasing problem, ranging from tears of a few millimeters to complete rupture, was observed with print-mark-controlled aluminum foils for tablet blister packs on several different, but structurally identical packaging machines. The machines and the aluminum foils had been used unchanged over a period of many years without any problems. The possible cause of the tearing was eventually found after extensive and complex troubleshooting involving microscopic tests undertaken at Munich University of Applied Sciences. As a result, the client was able to prepare a facts-based complaint and solve the quality problem.

Cost-effective packaging of small batches

(Process design and simulation, Packaging optimization, Material selection, Sustainability)

On behalf of an internationally active pharmaceutical company, a new, fully automated secondary packaging system (platform system) was developed which would consider the foreseeable expansion of the portfolio. The cost of implementing the new system was coordinated with various packaging material manufacturers (folding cartons, package leaflets, adhesive labels). A number of different packaging machine manufacturers were asked to put forward their designs for machines. In collaboration with the client a rating matrix was generated for the packaging system and the proposed packaging machines. This enabled us to identify a future-proof and cost-effective packaging material/machine combination.

Root cause determination for a pharmaceutical product recall

Problems with the quality of a new type of primary packaging material for a new medicinal product arose after just a few months. Once the cause had been identified, additional GMP tests were carried out and changes were made to the machinery. The packaging process was re-qualified and subsequently re-validated. All the processes were measured and monitored. The primary packaging materials were checked and changes to the specifications were suggested.

Solving tightness problems of a primary packaging material

Problems arose with the tightness of a primary packaging material that had been used for many years and the cause could not be clearly identified. Following a comprehensive fault analysis supported by instrumentation, the cause was identified and eliminated.

Solving bonding problems in secondary packaging

A manufacturer of medical devices complained about top-loading folding boxes that opened automatically during shipping and storage. The packaging process and the packaging materials used were analyzed and suggestions for improving process and product safety were developed. After extensive material tests at the Munich University of Applied Sciences, a variant was found in cooperation with adhesive manufacturers that helped to solve the bonding problems.

angerhoefer consulting

+49 170 7927457

angerhoefer consulting
Prof. Dr.-Ing. Martin Angerhöfer
Eichenweg 17, 88289 Waldburg