Certifications : We work to the highest standards

Nelipak is committed to Quality Management. All of our facilities are ISO 13485 certified for the design and manufacture of custom thermoformed plastic packaging and products to customer specifications

Key Features

  • EN ISO 13485 certified
  • Work according to EU and FDA GMP directives
  • Automated statistical process control (SPC) system
  • Bacteriological testing of class 7 and 8 cleanrooms
  • Certified member of the Sterile Barrier Association

ISO certifications

Cranston This quality certificate covers the following Americas sites: Cranston, RI; Whitehall, PA; Phoenix, AZ; Humacao, Puerto Rico and Heredia, Costa Rica.

ISO 13485:2016 

Venray EN ISO 13485:2016 & ISO 13485:2016 UK
EN ISO 13485:2016 & ISO 13485:2016 NL
EN ISO 13485:2016 & ISO 13485:2016 DE
EN ISO 13485:2016 & ISO 13485:2016 FR
ISTA Membership Certification
Galway EN ISO 13485:2016

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