Quality

High quality standards

Airnov seeks to make life better by protecting their partners’ products and users. Excellence, quality, and safety in our manufacturing processes are a cornerstone of this engagement.

Airnov has 65-plus years of experience in meeting the highest standards in manufacturing quality, delivering tailored solutions that are safe and meet the highest standards of compliance in highly-regulated industries.

To ensure product quality, maintain a superior service level, and comply with all relevant regulations, Airnov Healthcare Packaging follows several operations excellence methodologies and strict product stewardship oversight across five production sites.

  • 6 Sigma / Lean culture
  • 6 S (Safety, Sort, Straighten, Shine, Standardize, Sustain)
  • ISO 15378 – ISO 9001 certified plants, certifying management system in accordance with Good Manufacturing Practices (GMP) and a quality management system (QMS) for the manufacture of primary packaging materials for pharmaceuticals.
  • Safety and environment management system

 

All of Airnov’s manufacturing facilities are ISO 15738:2017 Certified for Good Manufacturing Practices. That means that each facility not only follows strict quality and compliance requirements, but also incorporates risk management protocols, including batch/lot traceability and validation of critical processes and environmental control. 

We are proud of our commitment to quality, and our legacy as an experienced, trusted, reliable partner in helping our customers deliver a safe product that exceeds regulatory and compliance standards.

Airnov offers desiccants, sorbents and container-closure systems that are compliant with governmental health authority regulations for use in pharmaceutical applications. As applicable, Airnov offers products that comply with relevant sections of the following:

  • FDA Compliance (21 CFR) certificates available
  • EU Compliance (N°10/2011) certificates available
  • USP <670> compliant materials
  • Drug Master Files (DMFs)
  • Change Control Procedures in place

 

Airnov can provide as applicable other statements for the absence of Bisphenol A, Dimethyl Fumurate, Melamine, and Latex/Natural Rubber.

Our commitment to quality, safety, and compliance is the reason why Airnov is trusted by leading pharmaceutical companies worldwide.