The healthcare market has stringent requirements for product safety, quality and consistency

• The authorities require extensive documentation regarding regulatory compliance for materials used in pharmaceutical applications.
• Norner has long experience in polymers used in healthcare packaging and medical devices. Being an independent plastics institute Norner operates as a cooperation partner to clients.
• Norner has leading expertise in plastics and packaging including additives, catalysts, monomers, polymer structure and characterization. 
• Our expert group has broad knowledge in international regulations for polymers used in food contact and medical applications as well as REACH regulation.

Norner services

Testing of European Pharmacopoeia standards

The European Pharmacopoeia is a collection of quality standard for medical substances aimed for testing.

We can offer: 

• Testing of materials for medical segments.

Polyolefines:

• Polyethylene without additives for Containers for preparations for Parenteral and for Ophthalmic Preparations.
• Polyethylene with additives for Containers for preparations for Parenteral and for Ophthalmic Preparations.
• Polypropylene for Containers and Closures for Parenteral and Ophthalmic Preparations. Plastic additives.

Polymer long term stability studies

• Advanced polymer analytic methods are used to follow if any changes in polymer structure, composition and properties is taking place during exposure in defined media and conditions.
• Polymer degradation studies (ref. ISO10993-13).
• Chromatography testing.

Polymer additive and composition analysis

• Detailed polymer composition and additive analysis  in order to confirm compliance to Eur. Pharmacopoeia regulation regarding additives
• Chromatography testing

Investigation and detection of potential contaminants/foreign matters in products

• Microscopy center
• Chromatography testing

Quality control and product consistency

• Raw material  batch- to- batch quality and consistency
• Final product control
• Chromatography testing
• Rheology testing

Wide range of analytical and chemical services

• Analysis of additives and monomers in packaging
• (EC) 1935/2004, (EU) 10/2011, REACH and FDA expertise
• Overall migration testing according to EN 1186
• Identification of possible SML components
• Specific migration testing according to EN 13130
• Notification services for US and EU food contact regulations
• Heavy metals in toys
• Analysis of volatiles

We give advice regarding selection and testing of different  polymer grades available in the market for medical applications.