Get detailed information on performance, stability, extractable compounds, and analytical methods for chromatography resins.
The RSFs contain product information such as:
- Product description providing information on product characteristics, a reference spectrum, and links to support materials such as Safety Data Sheets (SDS)
- Product quality including a statement on animal origin, analytical specifications and test methods as well as a certificate of analysis example
- Manufacturing description covering a description of the facilities, a brief overview of the manufacturing process, and information on raw materials and container materials used
- Product stability containing, for example, results from chemical stability testing, compatibility with expected process conditions, stability at recommended CIP protocol, and information on shelf life
- Extractable compounds providing information on residual solvents and clearance of shipping solution as well as an assessment of possible degradation products
- Toxicological information including results from toxicological studies. This is sometimes replaced with a theoretical risk assessment based on data from leakage studies.
- Product description, for example drawings of components, list of construction materials, and descriptions of regulatory conformance of wetted parts
- Product quality, for example description of Cytiva’s processes and approach to assure product quality
- Manufacturing description describing the manufacturing facilities and an overview of the manufacturing processes
- Verification of product specifications, for example results of various tests performed to verify the product specifications, such as integrity tests and chemical compatibility
- Extractable compounds including results from extractables tests for the various components or assemblies, for example metal ion content, volatile organic compounds, and non-volatile compounds
- Toxicological information, included when toxicological studies have been carried out
VSFs describe the software development life cycle management according to Cytiva Quality Management System, and provide important information for manufacturing processes that use software such as UNICORN, DeltaV, FlexFactory Automation or XDUO Automation.
The software VSFs include documentation such as:
- Overview of software development and documentation describing the quality system and development model used
- Supplier self-assessment questionnaire describing the development of the software
- 21 CFR part 11, EU Annex 11, and GAMP 5 category assessments
- Audit certificate and audit report from the audit performed by an external and independent expert. The audit covers compliance to the development model and technical compatibility to 21 CFR part 11 and EU Annex 11.
For some BioProcess hardware and single-use products you can subscribe to Extractables Information, showing chemical compounds migrating from materials in contact with the product, when exposed to solvents under exaggerated conditions.
Hardware Product Documentation is delivered with BioProcess hardware. The documentation follows the global industrial standard, ASME-BPE 2016 vendor documentation requirements guidelines. The package includes documentation demonstrating that BioProcess hardware and software are in compliance with and/or enable compliance with legal and regulatory requirements.