The trend towards biopharmcaeuticals poses several challenges for packaging specialists. It will be up to them to ensure the safe commercialisation of sensitive substances.
Growth in the pharmaceutical and biotechnology industry continues at a dynamic pace. A large number of new diagnostic and therapeutic formulations are exiting from the development pipeline. 49 drugs which were placed on the German market in 2014 are based on new active ingredients. Besides innovative R&D and production techniques, advances in packaging technology are also needed for these products. In particular, the primary packaging material which comes into direct contact with the product ingredients has a crucial influence on product safety. Some producers are attempting to put advanced quality assurance systems in place to support development of primary packaging and to monitor the filling process. “Intelligent” packaging is another significant trend. Pre-filled disposable syringes and packaging with built-in quality detectors and dose administration aids provide additional functionality. At ACHEMA 2015, exhibitors in Hall3, in the Forum and in the Pavillon Agora will present their innovations in the field of pharma packaging.
Packaging Errors are the Number One Quality Issue
Protection of high-value ingredients and formulations, quality assurance and unrestricted functionality are top priorities during selection of drug packaging. The same applies to the ever expanding range of biopharmaceuticals produced with elaborate process technologies and used in applications such as the fight against cancer. Producers of packaging for pharmaceutical products must also comply with a number of anti-counterfeiting and traceability regulations. Then there are external factors to consider during shipment and storage such as temperature, exposure to light, vibration and contamination hazards.
8832 spontaneous reports of quality deficiencies and undesirable side effects were submitted to the German Pharmacists Association’s Drug Commission (AKM) in 2014. According to information released by the Association, 41.6% of the incidents were the result of packaging faults, 12.5% involved mechanical defects and poor quality was the suspected cause of reduced effectiveness in 3.1% of the incidents. New EU directives mandate additional safety features such as serial numbers, seals and enhanced anti-tamper protection. The intention is to enable users and patients to immediately recognize whether or not the packaging has already been opened.
A Demanding Product: Sensitive Protein
The risk of quality degradation is a particular concern with medication that contains proteins. Proteins tend to unfold on surfaces and may interact with glass as well as with plastic, rubber or silicone components. Small amounts of the proteins in the formulation can be absorbed by the packaging material, impairing or altering the effectiveness of the medication. This is a particular concern with low-dose active ingredients. Thermal and mechanical stress during transport, storage and preparation can also significantly degrade the stability of proteins.
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