Traceabilty, Compliance, Quality
& Engineering
By performing blow extrusion in-house, ATMI maintains full control and traceability of the contact film composition, from resin through to finished bag product.
ATMI's films comply with internal, industry and regulatory standards and are subject to strict change controls. Many are also totally free of any animal derived components (ADCF).
- Most ATMI LifeSciences films comply with USP Class VI (USP <87>, USP<88> and USP<661>) and EP 3.1.3.
- Shelf life 2009, 2012 ATMIments are supported by aging validation studies
- Sterility and bioburden evaluations available (ISO11137)
- Particle count data available (EP 2.9.19 or USP<788>)
- Manufactured in ISO Class 5 cleanroom conditions
- ISO certified: ISO9001/2008
- European current Good Manufacturing Practices (cGMP) certified facilities
ATMI's laboratory capabilities include:
- Physical properties of films and components
- Particle quantification and analysis
- Seal strength and integrity
- Bioburden & endotoxin (LAL)
- Resin characterization
- Extractables and leachables
- USP and EP testing
ATMI is an established leader in polyolefin extrusion technology. An extensive dossier of leachables/extractables and chemical compatibility data is available for liquid-contacting films. USP Class VI certification documents are available for all films. Our experienced polymer science group has an impressive track record of innovative thinking and finding single-use solutions that enhance customer process efficiency. Evidence for this is seen most clearly in our extensive portfolio of intellectual property in such fields as single-use mixing, liquid delivery and bioreactor technology.