ArmorFlex® 116 Film – Flexible Containment Solution
Source: ILC Dover
At ILC Dover we are going “beyond boundaries” by listening carefully to our customers. In response to customer input and emerging regulations, we’ve developed a robust new film to support our DoverPac® Containment Systems. This revolutionary film, ArmorFlex® 116, employs high quality ingredients with known performance while eliminating antistatic additives. ArmorFlex® 116 meets FDA and EU Regulations 10/2011 requirements for food contact and EP 3.1.5.
- Complies with applicable sections of FDA 21 CFR and applicable Food Contact Notifications
- Passes overall migration testing IAW EU Regulation 10/2011
- Compliant to European Pharmacopeia EP 3.1.5
- Passes USP <661> Physicochemical Tests for Plastics
- Passes USP <88> Class VI (7 day implant)
- Passes <87> biological reactivity, in vitro
- 5-year shelf life
- Tested for solvent resistance
- European Directive 94/62/EC & CONEG compliant for heavy metals
- DMF filed with FDA
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