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Engineering Conferences International
Single-Use Technologies: Bridging Polymer Science to Biotechnology Applications
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Applying Practices From The Medical Device Industry To Ensure Patient Safety Of Single-Use Products In The Biotechnology Industry, Jan Oberdoerster
Applying Practices From The Medical Device Industry To Ensure Patient Safety Of Single-Use Products In The Biotechnology Industry, Jan Oberdoerster
Single-Use Technologies: Bridging Polymer Science to Biotechnology Applications
Biocompatibility (i.e., the quality of not having toxic or injurious effects on biological systems) requirements for single-use products in the biotechnology industry can vary depending on point of use. For example, single-use syringes are considered a combination medical device and thus require assessment according to the ISO 10993 standards with test ranging from acute systemic toxicity to genotoxicity to sensitization. Processing equipment (e.g., reaction vessels, tubing, filters, chromatography columns) in contrast, generally requires a USP Class VI designation (a battery of in vivo tests consisting of acute systemic toxicity, intracutaneous reactivity, and muscle implantation) with rigorous requirements for leachates. The …
Hazard And Risk Assessments For Impurities, Residual Solvents, Extractables, And Leachables., Jan Oberdoerster
Hazard And Risk Assessments For Impurities, Residual Solvents, Extractables, And Leachables., Jan Oberdoerster
Single-Use Technologies: Bridging Polymer Science to Biotechnology Applications
During their life-cycle (i.e., manufacture to end-use), single-use products in the biotechnology industry come in contact with processing equipment, packaging components, and delivery systems. Small amounts of chemicals that may transfer to the single-use product at any step in the life-cycle may subsequently leach into the pharmaceutical drug product and be delivered to the patient along with the dose. It is important that this chemical transfer does not occur in quantities that alter the safety, identity, strength or quality of the drug product. The assessment of potential leachable chemicals begins with a detailed analysis of compounds released from the single-use …
Thermodynamics Of Migration In Polymers: Can Contamination From Materials In Contact Be Predicted, Controlled And Possibly Avoided?, Olivier Vitrac, Phuong Nguyen
Thermodynamics Of Migration In Polymers: Can Contamination From Materials In Contact Be Predicted, Controlled And Possibly Avoided?, Olivier Vitrac, Phuong Nguyen
Single-Use Technologies: Bridging Polymer Science to Biotechnology Applications
The contamination from materials is coined as “migration” and refers to a combination of various mass transfer mechanisms under thermodynamic control: molecular or mutual diffusion, sorption and desorption phenomena linear with concentration or not. The contamination pathways are particularly complicated when they involve several components or steps and strong interactions between materials and the medium in contact. They have been studied and mathematically described with two possible purposes: i) simplified approaches with a goal of overestimating the real contamination and ii) more sophisticated approaches to optimize the design of polymer materials, packaging materials or to redesign plastic additives with lower …