Disposable Assemblies Quality Testing
| Product Qualification/Validation Testing | |
| Manufacturing facility | Environmental testing for viable and non-viable particulate in clean room |
| Film product contact surfaces | Conformance to USP Biological Tests for Plastics, Class VI as follows: Acute Systemic Toxicity Intracutaneaous Toxicity Implantation Test Cytotoxicity Endotoxin levels by LAL Heavy Metals Concentration; conforms to USP<661> Buffering Capacity Non-volatile Residue Residue on Ignition |
 | European Pharmacopoeia Testing as follows; conforms to EP 3.2.2.1: Appearance, Acidity, and Alkalinity Absorbance, Reducing Substances |
| Physical Properties testing as follows: Film Water Vapor and Gas Transmission Rates (O2 and CO2) |
| Lot Release Testing | |
| Raw Materials | Testing of Raw Materials (Components Parts) as follows: Visual Inspection Film Thickness Film Tensile Strength & Elongation Film Chemical Composition verified by FT-IR Spectrometry Seal of Integrity of Film and Tubing/Fittings |
| Assemblies - Gold Certification | Class VI USP <88>: Post-gamma irradiated component family Integrity testing consists of leak testing 100% of lot on full assembly & process container* LAL & Particulate: Lot Release *Complete assembly testing is performed unless prohibited by the design. |
| Assemblies - Silver Certification | Class VI USP <88>: Post-gamma irradiated component family Integrity testing consists of in-process leak testing LAL & Particulate: Quarterly review of results |
| Assemblies - Bronze Certification | Gamma-irradiated >25 kGy, not validated sterile Class VI USP <88>: Pre-gamma; resin only |
| Assemblies - Basic Certification | Class VI USP <88>: Pre-gamma; resin only |
