Certification

Working to the highest standards

Facilities where Nelipak^® products are made are certified to ISO 13485: 2003 or ISO 9001:2008.

At all levels of the organization, we continuously improve our procedures and processes. All our staff are responsible for monitoring and improving the quality of their work. The production operations for medical and pharmaceutical products are based on the GMP guidelines.

Additionally, we have a thorough product traceability system. The raw materials, auxiliary materials, inspection results, production conditions and employees involved can be traced for all our products.

Key Features

• EN ISO 13485: 2003 and EN ISO 9001:2008 certified
• Work according to EU and FDA GMP directives
• Automated statistical process control (SPC) system .
• Bacteriological testing of Class 7 cleanrooms