Pharmaceutical plastic packaging solutions need to fulfill EU and US regulatory demands. Authorities will regulate solutions to be safe, pure, non-leaching, functional, cost-efficient, and sustainable. Design for recycling will come more and more into focus. In 2030, all plastic packaging in the EU shall be reusable or recyclable. Norner has taken the challenge to be a full service provider of services in all relevant aspects of the plastics pharmaceutical packaging industry.

Materials

Norner’s polymer material and additivation competence have developed over several decades and is continuously being enhanced. We collaborate with the majority of the global polymer material and additive manufacturers being in an excellent position to serve our clients with the most cost-efficient, clean and sustainable medical grade materials available on the market. This also includes technology for adding booster materials for enhancing properties to enable the reuse of recycled materials.

Sustainability

The sustainability aspect is also becoming increasingly important in the healthcare industry. Downgauging, mono-material solutions, design for reuse and circularity shift from less sustainable materials to polyolefins are all areas where Norner can be of value. At Norner’s recycling pilot centre, we have unique facilities for upgrading pharma packaging waste for reuse.

Challenge: You would like your rigid packaging to become lighter and keep the same mechanical strength and barrier properties solution. This can be achieved with Norner Booster Material Technology (figure 1).

Testing

All relevant analytical, mechanical and lifetime requirements can be tested in our laboratories. This also includes testing directly on product prototypes. We also provide regular test services as part of your QC to confirm compliance with the Pharmacopeia monographs for PE, PP and PET raw materials. We offer testing according to the methods given in Ph. EU Monograph 3.13-3.1.6, 3.1.15 and USP <661.1>, <661.2> and <671>.

Pharmacopeia testing at Norner

• European Pharmacopeia Monographs
• EP 3.1.3 Polyolefins
• EP 3.1.4 Polyethylene for containers without additives
• EP 3.1.5 Polyethylene for containers with additives
• EP 3.1.6 Polypropylene for containers and closures
• EP 3.1.15 Polyethylene Terepht­halate for containers for preparations, not for parenteral use
• US Pharmacopeia General Chapters
• 661.1 Plastic materials of construction
• 661.2 Plastic packaging systems for pharmaceutical use
• 671 Containers performance testing

Barrier testing and simulations

Norner is experienced in the barrier performance and requirements of packaging. Our laboratory can test OTR and WVTR on films as well as packages and we can make pilot trials with multilayer barrier films and sheet. We have also developed a novel simulation tool, the Norner SIM on-line calculator, which allows our customers to estimate how different changes to their packaging may impact the barrier performance.

Challenge: You seek optimal barrier properties for your packaging. With the combination of Norner material, processing, and testing capabilities, we can develop solutions meeting your requirements. We also take advantage of the vast amount of barrier data we have generated over many years for various packaging design- and material solutions with our proprietary barrier simulation software.

Oxygen Transmission Rate Instrument (OTR)

Processing

Norner Application Centre and its competence in the processing of thermoplastic materials is unique. The Application Centre can facilitate full-scale tests with a variety of mono and multilayer processing machines for blow and injection molding, blown and cast film, thermoforming as well as compounding extruders. Based on your design and functional requirements, we can test and optimize polymer recipes and process parameters to fit the target performance.

Contact us and receive more information