Food & Pharma

Food & Pharma testing

Pharmaceutical packaging & 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

Quality control and product consistency

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

 
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