Artinus Ultra Pinch Clamp (UPC) is manufactured in clean-room for critical pharmaceutical, biomedical, cosmetic, and food applications. The raw material, Ultra-Pure PP 20, is compliant to USP Class VI, US HAZCOM 2012 (29 CFR 1910.1200), ISO 10993, and European Pharmacopoeia 3.2.2 Plastic containers and closures for pharmaceutical use.
Key Features
• Manufactured according to ISO 13485 2016 Quality Standards.
• The material, Ultra-Pure PP 20, is compliant to USP class VI
• Sterilizable by autoclave (steam sterilization), radiation (gamma and beta radiation), and EO.
• UPC is not classified as hazardous to human health.
Specifications
• Melting Point/Range: 130 – 170 °C
• Density: 0.9 – 1.0 g/cm³
• Ignition Temperature: > 320 °C
• Solubility(ies): Insoluble in water
Documents
• Certificate of Conformance is provided on a lot basis.
• Regulatory summary and BPOG test report are available upon request.
Sterilization Stability
• Gamma Radiation : Very good to commonly used sterilization doses (6 Mrads).
• Ethylene Oxide (EtO) : Highly compatible
• Autoclave : Limited to 121°C for 20 minutes due to low heat deflection temperatures.
Package
• 10 ea/pk
• Double-bagged
• Non-sterile
• Gamma-irradiated package is available upon request.
