Packaging Materials

Packaging materials such as blister packs, infusion bags, plastic containers and plastic bags that are used as primary packaging for medicinal products must be checked for their quality.

The legislative authority has defined in the Pharmacopoeia which ingredients are allowed to be used and has also set limit values if they are necessary. The packaging material must also pass performance tests. These quality controls serve patient safety by protecting them from any potentially dangerous substances. In the European Pharmacopoeia, Chapter 3 (Material for the Production of Containers) regulates these quality controls. In the USP it is regulated by Chapter <661> “Containers Plastics“; or <671> “Containers performance testing”.

As a GMP-certified and FDA-approved contract laboratory in Switzerland with many years of experience, we can provide you with support in the development, validation and routing testing of your products. We will test for you whether your packaging materials conform with the Pharmacopoeia or to your own specifications.

Take advantage of our experience.

Packaging for pharmaceutical purposes 

The quality of the packaging has a direct influence on the quality of a drug. The task of the packaging is to protect the contents against external influences such as humidity, light, oxygen or temperature variations. Biological contamination must be prevented and the product must be protected against physical impacts. The packaging itself should neither interact with the contents of the packaging nor should it have a negative influence on the contents. Ideally, there will also be no transfer of ingredients from the packaging material to the drug.

Additives in plastics 

There always seem to be news stories hitting the headlines reporting that dangerous materials have been found in plastics, for example in children’s toys. To ensure that no such events events occur with the containers or primary packaging of medicines, the ingredients and additives are precisely regulated by the Pharmacopoeia. There are subchapters for the most frequently used polymers: Polyethylene, polypropylene, polyvinyl chloride, polyethylene terephthalate and polyethylene vinyl acetate.

Which additives are allowed? 

The Pharmacopoeia has a positive list with the plastic additives allowed. Other substances, even in low concentrations, are not permitted for pharmaceutical purposes and require special permission from the authorities. Further limitations arise in the number of different plastic additives and the overall level of their contents that are permitted to be contained in the product. A maximum of three different antioxidants or 0.3% content is permitted.

Containers are often manufactured from a mixture of a number of different plastic granules, it should be ensured that the processed mixture of materials, i.e. the finished packaging materials conform to the legal regulations.

What additives must be tested for?

Generally, not all substances that are reported to be on the positive list need to be tested for. Testing is generally limited to the additives contained according to the supplier certificate - they conform according to the composition and application of the substance.

Many manufacturers of plastic granules declare their products to be “compliant with the Pharmacopoeia” or “suitable for pharmaceutical applications”. For downstream quality testing however, a detailed, complete and quantitative declaration of the additives is required and if necessary, should be requested.

In special cases, it can be sensible to carry out further reaching tests for verification of the supplier certificate.

There is not an analysis method described in the Pharmacopoeia for all listed additives. If the analysis is to be in accordance with GMP standards, then method development and validation must be carried out.

What are the arguments for outsourcing your quality testing? 

• Access to the greatest level of specialist knowledge and a variety of analysis methods
• Being free from routine work and the opportunity to focus on core tasks
• Capacity peaks can be overcome
• Independent results from an accredited contract laboratory

Our services in detail:

• Advice on the testing of raw materials for the production of packaging and packaging products
• Testing in accordance with Ph. Eur., Chapter 3
• Testing in accordance with USP, <661> and <671>
• Testing for identity
• Testing for purity
• Testing for phenolic and non-phenolic antioxidants
• Testing for extractable substances, elements, heavy metals 
• (leachables and extractables)
• Additional services are according to the directory of services or upon request​​​​​​​