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Understanding current CFR 21.11 and data integrity requirements

8 August 2018 | By SUEZ

Data integrity and 21 CFR Part 11/EU Annex 11 requirements are hot topics when ageing analytical equipment is to be replaced. Common questions from pharma and biopharmaceutical manufacturers include: is the new technology compliant with auditor expectations? Can we get the right data saved the right way in the right…

Strategy for the adoption of single-use technology

22 March 2018 | By

Recent technological advances are enabling manufacturers to move away from equipment that must be sterilised or consumables that are recycled or pose a risk with their transfer into cleanrooms, towards the adoption of disposable and single-use sterile items. This article considers the advantages of implementing single-use technology and outlines a…

Single-use systems for biotechnology products

12 February 2018 | By Scott Rudge, COO, RMC Pharmaceutical Solutions Inc

Single-use systems have become an important tool in the development and scale up of biotechnology processes. Single-use systems save space, increase flexibility in scale and space planning and, to a large extent, eliminate cleaning costs in development and change over. However, single-use systems come with their own challenges, including complete…

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