Lifemeta® FCS Single-use Filling Needles

Quality Assurance

• ISO® 9001: 2015 Quality Management System
• ISO Class 7 clean zones
• 316L passivated Stainless Steel Needle + Animal Derived Component Free (ADCF) Polysulfone
• Meet the requirement of USP<87> In Vitro Biological Reactivity Test
• Meet the criteria of the USP<88>Biological Reactivity Test for Class VI plastics
• Aqueous extraction contains<0.25 EU/mL as determined by Limulus Amebocyte Lysate (LAL), USP<85>
• Particulate matter in the product eluent meets the requirements in USP<788> for small volume parenterals
• Can be gamma irradiated at 25-45 kGy in sterile package or can be autoclaved for 90 minutes at 135°C
• Provide Extractables and Leachables Testing Repor