SAFELY AND SECURELY PACKAGED
Anyone who produces or uses packaging wants to be certain that it is sufficiently sturdy. The pharmaceutical industry places particularly high demands on this aspect. The contents of any packaging must be protected against environmental factors such as humidity or oxygen, etc. Foil and other packaging materials must be capable of being easily formed and sealed as part of a reliable process.
The first commandment for manufacturers of packaging materials is quality assurance. A high degree of materials expertise, experience gained over many years, the very latest equipment, an extensive range of analytical methods, flexibility and reliability – all these form the basis for developing packaging solutions which meet the pharmaceutical industry’s discerning needs.
Quick reaction keeps production outages to a minimum
Every problem is unique. Materials, requirements, manufacturing processes and, not least, the causes of failures are very customer-specific. Materials experts will systematically analyze the failure using different investigative methods. The first step is to determine the actual failure. For example, computer tomography, light microscopy and scanning electron microscopy (SEM) will be used to examine in detail the surfaces and cross-sections of the affected components.
The results of comprehensive analyses will provide information about possible residues and adverse effects. Specialists will then work out appropriate solutions. Rapid processes and flexible implementation can hugely shorten the length of a costly production outage.
FORMING PROCESSES DURING BLISTER MANUFACTURE (SIMULATION AND MEASUREMENT)
Maintaining stable processes: materials on the test rig
Characterizing packaging materials mechanically and simulating the forming processes makes it possible to predict the extent to which certain materials are formable and the degree to which the process reduces the thickness of the foil.
Processes are subject to fluctuations. If they fall outside a permitted range, there is an increased risk that an unstable version will be produced. Process reliability can be achieved by a professional formability analysis. So that pharmaceutical products are safely and securely packaged and rejects avoided, any materials which are intended for use in the production process should be analyzed beforehand. Customers do not need to introduce any in-house testing procedures. They will be provided with accurate information specifying which forming processes are possible and whether the procedures they wish to carry out can be implemented.
BARRIER AND SHELF-LIFE PREDICTION
Packaging in commercial circulation
Whether it's tablets or foodstuffs: for the contents to remain permanently intact, they must be protected against moisture and oxygen as soon as they have been produced. The fundamental question is: from what point in time and to what extent will any thinning of the packaging or the sealing layer affect barrier capacity and, consequently, a product's shelf life? With pharmaceutical products in particular, the water-vapor barrier must meet very high standards. Water-vapor diffusion through the plastic of a blister pack can have a significant adverse effect on the contents and, in the worst case, can make them unusable.
Efficient calculation tools can provide detailed information about the barrier properties of various packaging materials and can also predict how long the product can be kept in good condition; the tools take all the relevant characteristics into account (shelf-life calculation, LOD prediction). Our experience, gained over many years, can achieve this without customers incurring any in-house expenditure. In this way, costly stability tests can be completed in a shorter time or replaced completely.
Matthias Schellenberg studied mechanical engineering at the Swiss Federal Institute of Technology in Zurich. He is responsible for the packaging business unit and is the contact person for matters concerned with packaging development and, specifically, for foil packaging for the pharmaceutical industry.