ArmorFlex® 116 Film – Flexible Containment Solution

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