Masterstudiengang "Drug Regulatory Affairs"


Chemical and Toxicological Qualification of Plastic Packaging Materials for Sterile Solutions ***

Dr. Susanne Gluding (Abschlußjahr: 2005)

Language: English

A wide variety of plastic materials for medical use are available on the market. Plastic materials, which are used for the packaging of drug products or medical devices, play an important role for the quality, in particular for the stability, of products like sterile solutions.
This paper gives an overview on important plastics used as packaging materials for medicinal products and substances which are used for the production of plastics, e.g. additives, processing aids, catalysts.
Additionally, a survey of the most important regulations concerning the composition and the chemical and toxicological testing of plastic packaging materials for sterile solutions in Europe and the U.S. is given.

Substances that are likely to migrate out of plastic materials into the medicinal product are known to have the highest potential to cause toxic reactions, therefore packaging materials should be made of materials that will not leach harmful or undesirable amounts of substances to which a patient will be exposed during treatment with the drug product. This consideration is especially important for plastic packaging materials for sterile solutions since they are in direct contact with the dosage form. It is not a simple process to determine that a plastic material is safe for its intended use. A standardised approach has not been established for evaluation of plastic packaging materials. However, the container closure system, the route of administration, the drug product formulation, the dosage form, the indication and the dose regimes (short-term or chronic dosing) should be taken into consideration.

By using examples, different approaches for chemical and toxicological qualification of plastic materials are explained in this paper.
First, the qualification of a material the composition of which complies with the requirements of the European Pharmacopoeia is demonstrated by investigating worst-case materials. Results are given for the chemical and toxicological qualification of different worst-case materials and the possibilities and limits of using these materials for evaluation is discussed.
Second, a decision tree for the chemical and toxicological qualification of a plastic material is proposed, which is not described in the European Pharmacopoeia. From this example, the difficulties, which can occur in the course of toxicological qualification of plastics and their leachables for the use as plastic packaging materials for sterile solutions are discussed.

Finally, a proposal is made to close the loophole in the “Guideline on Plastic Immediate Packaging Materials” for leachables in the same way as for impurities of drug substances.

Pages: 48