Pharmaceutical production is subject to strict quality and safety requirements. Also, packaging and process materials have to be tested to ensure the drugs therapeutic efficacy and fulfills the quality requirements.
This testing consist usually of two studies:
All our laboratories are certified according to DIN EN ISO/IEC 17025. We test materials, filters and other materials that have contact with drugs in terms of critical substances. We offer this testing raw material suppliers as well as pharmaceutical manufacturers.
We offer you packaging tests of glasses according to Pharm. Eur. and USP NF.
For this purpose, we have qualified a ball mill which enables a blank-free analysis due to different inserts made of zirconium oxide and agate.
The use of plastic single-use systems in the pharmaceutical production is growing very fast. These systems reduce the expensive cleaning processes and validations and reduce the risk of cross-contamination. However, the use of plastic has disadvantages as they consist of polymers and contain a lot of different additives. These substances, the reaction and decompositions products from the polymer can migrate from the materials into the product during the production process or final packaging stage and decrease the quality of the final product.
We offer extractable studies to identify substances that could potentially migrate. We extract these extractables with extracting agents, e.g. ethanol, from the contact material. Throughout this process, the plastics have to “prove” themselves under harsh conditions, such as long contact times or high temperatures.
We are also happy to conduct studies using process-/active ingredient-like simulants to depict realistic worst-case scenarios.
Extractables/leachables can come in many different forms, such as adhesives, elastomers, coatings, accelerators, antioxidants, printing inks, vulcanization agents, secondary packaging or even the base polymer itself. However, they can also be produced by processing, using or sterilizing the contact materials.
Testing for possible extractables is done using a range of different methods to cover as large a range as possible:
With the help of our comprehensive technical equipment and experienced staff, we can offer the perfect package for your needs.
Extractable database To aid extractable studies, we have compiled a database of typical plastic additives, which we are gradually expanding. This database can be used to easily and quickly identify critical substances. Unknown contaminants can be identified through high-resolution HPLC-MS using a sum formula and fragment studies.
We have a long history with plastics, having spearheaded many new developments. For instance, polycarbonates, polyurethanes and synthetic rubber were all invented at the CHEMPARK sites. Our experts know exactly which substances are to be used for polymerisation and how they are to be applied. This enables them to make well-founded statements about whether and under what conditions substances can leak out and enter the product.