Centrifuges that Support 21 CFR Part 11 Compliance
As technology and software advance, security and protection of data is becoming increasingly important to ensure a properly functioning lab environment. Floor-standing centrifuges are vital to many bioproduction processes and must support regulations when used in Good Manufacturing Practice (GMP) environments. Innovative features built into Optima XPN ultracentrifuge and Avanti JXN high performance centrifuge support compliance while eliminating much of the administrative work of other systems.
User Management
- Multi-level, unique, user logins and passwords, links individuals to the instrument and procedures entered
- Instrument requires username and PIN authentication to operate
- Generates record of operation and captures electronic signatures
- User specific pre-defined programs limit potential for errors
Data Logging Parameters for Traceability
- Records data usage by user, providing an audit trail of centrifuge activities
- Provides read-only records of centrifuge activities within the instrument
- Reports available as a PDF, XML, or CSV file and exports to a USB device if needed
Download the Centrifuge Support 21 CFR Part 11 Compliance Brochure to discover additional ways these instruments support GMP requirements.
Helpful Links
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Industry Standards
- USP<643>
- IVDR 2022 is a marathon, not a sprint. We’ll help you go the distance.
- 21 CFR Part 11 - Data Integrity
- Maintaining Data Integrity: Understanding FDA ALCOA Guidance
- European Pharmacopoeia EP 2.2.44
- EU GMP Annex 1
- EU GMP Annex 11
- ICH Q2
- ISO 21501
- ISO Regulations
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IVD-Regulation (IVDR)
- IVDR compliant software*
- Building IVDR compliant panels for haematological disorders
- Laboratory Developed Test (LDT) vs IVD Validation Workflow
- Potential Impacts of EU IVD-Regulation on the Clinical Flow Cytometry Lab
- IVD-R: Key Considerations to Validate a Flow Cytometry Assay According to ISO 15189 Requirements
- Regulatory Entities: Separation with Cooperation
- USP 1046
- USP 1047
- USP <645>
- USP <788>, <787> and EP2.9.19
- USP <790>
- ISO 11171 Standard
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ISO 14644: Airborne Particulate Cleanliness in Cleanrooms and Clean Zones
- Particle Counters Designed to Support ISO 14644-1 and ISO 21501-4 Requirements
- 2015 Published Standards for ISO 14644
- ISO 14644-1 Classification of Air Cleanliness by Particle Concentration
- ISO 21501-4: Light Scattering Airborne Particle Counter for Clean Spaces
- Particle Counting: Terms and Formulas
- USP <787>