Pharmaceutical packaging needs to fulfill very strict requirements and their use is regulated by the continental medical authorities.
EU and USA have a long tradition of such regulations but during recent years the procedures have been significantly updated.
These regulations are published in European and US Pharmacopoeia which companies have to comply with to ensure that pharmaceuticals sold in Europe and US will not be harmful or pose any health risk. These regulations provide restrictions to the use of any physiological hazardous materials in pharmaceutical packaging.
The regulations give guidance on both the chemical compositional requirements of components for the pharmaceutical packaging as well as chemical toxicity levels for potential extracts of either inorganic or organic contaminants.
Norner is an ISO 9001 certified laboratory and we have experience in performing these tests. Recently, we have increased our capability for analysis of plastics for pharmaceutical packaging. In this way we will help our medical customers ensure that their plastic packaging systems for pharmaceutical use are safe for the consumers.
Norner is prepared to perform testing according to this list of European (Ph. Eur.) and United States (USP) Pharmacopoeias.
PH.EUR. GENERAL CHAPTERS:
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
USP GENERAL CHAPTERS:
661.1 Plastic Materials of Construction
661.2 Plastic Packaging Systems for pharmaceutical use
Testing includes FTIR Identification, differential scanning calorimetry (DSC), heavy metals, nonvolatile residue, and buffering capacity (Acidity or Alkalinity), UV Absorbance, Total Organic Carbon, HPLC/UV, Sulfated ash, Reducing substances and TLC for Plastic Additives Testing.
Norner will provide our customers with all necessary documentation for the European (Ph. Eur.) and United States (USP) Pharmacopoeias.
Norner will continue to expand our services for the healthcare industry. Testing of pharmaceutical packaging made of other polymers such as e.g. PET is expected to be part of our validated service offering during the coming months.