Other resources

White papers, industry tools and further articles

• A study of the effect of post-curing on the reduction of cyclosiloxane contaminates in biopharmaceutical products
• Risky business: The importance of risk assessment in the single-use market
• The use of extractables data from single-use components for risk assessment

我们是生物处理系统联盟(英国石油公司的成员SA) and are active in a number of joint industry best practice initiatives in participation with BioPhorum Operations Group (BPOG). Please find recent industry initiatives listed below:

BPOG/ BPSA URS SUUR template

(Bio) Pharmaceutical companies utilising single-use systems (SUS) as part of their manufacturing process wanted a tool to be able to communicate their requirements for a single use system in a common way to SUS supply partners. This BPOG/BPSA single use user requirement template tool kit consists of industry recommendation documents and information request templates to aid the understanding and communication between end user and supplier of single use equipment.

BioPhorum Home - BioPhorum

Single-use systems - BioPhorum

Extractables and leachables - BioPhorum

Toolkit - BioPhorum

Video resources

• Extractables data from single-use components for risk assessments
• Single-use technologies: challenges and opportunities
• Single-use technology and USP 665 (Draft)
• Extractables studies on single-use components
• Using extractables studies to risk assess process equipment

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