Pharmaceutical packaging and medical devices. Norner has broad knowledge in international regulations.

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

• Norner has broad knowledge in international regulations.
• 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.

We offer:

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.