Materials Are A Key Part of the Process
Not all films are applicable for use in contact with pharmaceutical compounds. Leachables, unacceptable levels of occlusions and gels, and foreign particulates are just some of the concerns that a recommendation to use any "big bag" can results in future issues.
Understanding this, we develop films specifically for current and emerging pharmaceutical and manufacturing needs.
ArmorFlex® - 114 Film
- Complies with FDA 21 CFR
- Fully compliant to 2002/72/EC and amendments
- Meets test parameters of EP 3.1.3
- Passes USP <661>
- Physicochemical Tests for Plastics
- Passes USP <88> Class VI (7 day implant)
- Passes <87> biological reactivity, in vitro
- No animal derived components
- 5-year shelf life
- Permanent antistat replaces migrating additives
- Passes Chilworth incendivity tests
- Tested for solvent resistance
- DMF filed with FDA
ArmorFlex® - 104
Our flagship film, we created the ArmorFlex™104 film in 1998 when working with Eli Lilly to develop the DoverPac System. Off the shelf films were not available to meet key process requirements like incendivity to 1x1011 at one half of the normal minimum ignition energy with a shelf life of 18 months.
Although we are creating new films, like ArmorFlex™110, to meet the emerging EU requirements, we will continue to carry ArmorFlex™104 to support applications where stability testing/materials of contact approvals have been completed on existing drug products.
- Passes Incendivity Testing Performed by Chilworth
- FDA, USP & EC Compliance Testing
- Applicable 21 CFR Sections
- USP 24(661), Physiochemical Tests for Plastics and USP 24(88), Class VI (7 day implant)
ArmorFlex® 110 Product Contact Film
In response to customer input and emerging regulations we've developed a robust new film to support our DoverPac® Containment Solutions line. This revolutionary product, ArmorFlex® 110, delivers permanent static dissipative properties while meeting FDA and 2002/72/EC requirements for food contact.
- Complies with applicable FDA 21 CFR Sections
- Meets 2002/72/EC requirements
- Passes USP (661) (Physiocochemical Tests for Plastics)
- Passes USP (87) biological reactivity, in vitro
- Passes USP (88) Class VI (7 day implant)
- Passes requirements set forth in the ArmorFlex®110 test protocol monograph
- No animal derived components
- No processing aids
- Compliant to the 94/62/EC and Coneg regulations for heavy metals.
- 5-year shelf life
- Permanent antistat replaces migrating additives
- No animal derived components
- Passes Chilworth incendivity tests
- DMF filed with FDA
ArmorFlex® - 113 Film
- Superior visual clarity ideal for Flexible Enclosures and Flexible Isolators
- No animal derived components
- No incineration off-gassing concerns
- Polyethylene base film provides excellent solvent resistance
- Permanent anti-stat provides better than 1 x 1011 Ohms per square surface resistivity
- 5 year shelf life
