Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
6488581 | Food and Bioproducts Processing | 2015 | 17 Pages |
Abstract
As the biopharmaceutical industry matures, the trend towards increased flexibility and productivity, faster time to market and greater profitability are driving the replacement of traditional stainless steel equipment by single-use technology (SUT). The use of SUT in the biopharmaceutical industry can significantly impact the manufacturing process efficiency by reducing capital costs, improving plant flexibility, reducing start-up times and costs, and eliminating both non-value added process steps and the risk of cross-contamination. In addition it significantly reduces process liquid waste, labour costs and on-site quality and validation requirements. This paper reviews the current status of the technology and the impact of SUT in the biopharmaceutical industry, with the aim of identifying the challenges and limitations that still need to be addressed for further adoption of these technologies. Even tough SUT has a multitude of systems available, its components and assemblies have little standardisation as well as a lack of harmonised tests and procedures among suppliers, with an array of guidelines from a variety of sources and no critical limits have been established. In addition, the use of SUT has new validation requirements such as leachables and extractables, suppliers' qualification and SUT lot-to-lot variability. The lack of expertise in these areas and the new training requirements when using SUT also need to be addressed. To date the majority of the available literature regarding SUT is found in trade journals where typically suppliers are the main contributors. There is still a lack of engagement of the academic community, which contributes to very limited scientific proof from independent peer-reviewed research to support performance of SUT. This is particularly the case during operation and integrity testing of SUT, during for example on-site testing, transport and disposal. Another area where no work has been undertaken concerns conceptual approaches for facility clean-room requirement and appropriate layout design using SUT. Investment in novel technologies, research, standardisation and training is paramount for further development and implementation of SUTs across all sectors of the biopharmaceutical industry.
Keywords
USPDSPDFFSMBICPBSLCIPLDPECRFPDASIPEMEANVRASTMTOCSUTFDABPSAWFImAbheating ventilation air conditioningsingle-use bioreactorperformance qualificationPVACOGsTffwater for injectionMonoclonal antibodyEuropean Medicines agencyEuropean standardUltravioletUltrafiltrationdissolved oxygenUnited States pharmacopoeiaISOChoSimulated moving bedbiopharmaceuticalsFourier-transform infrared spectroscopyChinese Hamster Ovarycleaning-in-placeHVACAmerican society for testing and materialsSUBInternational Organisation for StandardisationFood and Drug Administrationbiosafety levelCMOSFTIRMass spectrometryEuropean PharmacopoeiaDownstream processingReviewRegulationCostsinductively coupled plasmaLow-density polyethylenePolyvinyl acetatePVCCode of Federal Regulationshigh-performance liquid chromatographyHPLCGas chromatographyTotal organic carbonPolyvinyl chloridedisposables
Related Topics
Physical Sciences and Engineering
Chemical Engineering
Bioengineering
Authors
Adriana G. Lopes,