Whitepaper: Single-use technologies in biosimilar development
Posted: 20 December 2022 | Ami Polymer | No comments yet
ImaLINK™ manifold, which is designed to minimise the need for fittings, connections or assembly of all leak points, entrapment areas are eliminated.
Single-use systems are ideal for multi-product manufacturing facilities, especially where process steps may differ. They eliminate contamination crossover, change out time and downtime for cleaning and sterilisation between batches and products. Options include over moulded and barbed connectors, filters, clamps and tubing.
CERTIFICATION
- FDA 21 CFR 177.2600
- USP Class VI
- USP Class 87
- ISO 10993
- USP 381 Elastomeric closure for injection
- EP 3.1.9 BPOG standardised extractable test.
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Related topics
Analytical techniques, Biologics, Biopharmaceuticals, Bioprocessing, Biosimilars, Chromatography, Drug Delivery Systems, Endotoxin, Environmental Monitoring, Formulation, Freeze Drying, Gene therapy, Good Manufacturing Practice (GMP), Lab Automation, Manufacturing, Medical Devices, Microbiology, Microscopy, Outsourcing, Packaging, Proteomics, QA/QC, Research & Development (R&D), Spectroscopy, Stem Cells, Supply Chain, Vaccines
