APPLYING PRACTICES FROM THE MEDICAL DEVICE INDUSTRY TO ENSURE PATIENT SAFETY OF SINGLE-USE PRODUCTS IN THE BIOTECHNOLOGY INDUSTRY

摘要

Biocompatibility (i.e., the □uality of not having to□ic or injurious effects on biological systems) re□uirements for single-use products in the biotechnology industry can vary depending on point of use. For e□ample, single-use syringes are considered a combination medical device and thus re□uire assessment according to the ISO 10□□□ standards with test ranging from acute systemic to□icity to genoto□icity to sensitization. Processing e uipment (e.g., reaction vessels, tubing, filters, chromatography columns) in contrast, generally re□uires a USP Class □I designation (a battery of in vivo tests consisting of acute systemic to□icity, intracutaneous reactivity, and muscle implantation) with rigorous re□uirements for leachates. The USP Class □I Plastic test was developed to test drug containers and is designed to evaluate the biological reactivity of various types of plastic materials in vivo, while the ISO 10□□□ tests addresses biological hazards of medical devices (and their materials of construction) based upon duration and route of e□posure. As the use of disposables in biopharma production continues to increase, a primary focus of these new, and often cutting-edge, products is patient and drug safety. During their life-cycle (i.e., manufacture to end-use) single-use products in the biotechnology industry come in contact with processing e□uipment, packaging components, and delivery systems that might transfer small amounts of chemicals that can negatively impact cell growth and product titers, or even compromise drug safety. It is thus critical that both the materials of construction and the product contact surfaces used during production are appropriate for the intended end-use of the single-use device. Specific e□amples of material selection, biological and chemical (i.e., e□tractable/leachable) study selection, and subse□uent risk assessments will be presented and discussed.