General Purpose Pro Centrifuges Cell Therapy Systems (CTS™) Series consist of equipment, documentation, and certifications, as well as compliance services that support Good Manufacturing Practice (GMP) requirements. The CTS Series helps you get up and running faster, stay compliant and current with all necessary regulatory certifications, navigate regulatory audits, and stay on schedule, taking cell therapy from discovery to clinical research and commercial manufacturing. The refrigerated 4 L (4×1000 ml) floor standing and bench models are designed to meet the needs of today’s rapid-fire discoveries, with updates to help get research done quickly, consistently, and reliably.
- Intuitive touchscreen interface enables easy access and programming
- Auto-Lock™ Rotor Exchange helps save time for faster results
- TX-1000 swinging bucket rotor provides an unprecedented 4 L capacity (in a 3 L footprint) with the ability to hold up to 40×50 ml conical tubes, 96×15 ml conical tubes, or 4×500 ml conical bottles in one run
- Scheduling features and preventative maintenance queues help reduce downtime to avoid delay of cell processing, to lower the impact on cell viability
- Floor model option is ideal for space-challenged laboratories and is supplied with locking casters as standard to be easily moved for cleaning or relocation
- ClickSeal™ Biocontainment Lids help prevent contamination
- Compatible with common cGMP and cleanroom disinfecting procedures such as STERIS™ VHP dry heat sterilisation
- Front USB port for easier plug in and data transfer in non-altered (PDF) format
Product documentation package includes the following certifications and protocols to help with validation:
Product support documents
Design qualification (technical data sheet, drawings)* - Basic spec descriptions of the product and may include some summary drawings
Recommended customer maintenance schedule - Vendor-supplied customer-based maintenance and schedule
Regulatory and compliance certifications :
Declaration of conformity with EU laws (CE) - CE certificate proof
Certificate of environmental status - Regulatory certificates for various sustainability items
Quality Management System (QMS) certificate - Factory/site-based quality system description
Traceability/validation documents
Certificate of conformance - Production certificate
FAT report* - End-of-line test summary with checklist of performance
Key material of construction specifications - Technical specifications
Steris VHP compatibility certificate - Test certificate for vaporised hydrogen peroxide cleaning
Particle emission certificate - Test certificate defining particle emissions of product
Porton Down certificate - Test certificate for centrifuge rotor biocontainment
Lieferumfang: Factory acceptance compliance packages includes centrifuge, TX-1000 rotor (521-2616), set of 4×1000 ml buckets (521-2615), set of 4 ClickSeal™ biocontainment certified lids (521-2618), adapters for 10×50 ml conical tubes, 30×120 mm (521-1414), adapters for 24×15 ml conical tubes, 17,5×121 mm (521-2154) and adapters for 500 ml Corning™ conical bottle (98×133 mm), 4×500 ml (requires centrifuge tube cushions) (521-3414) plus Factory Acceptance Certification Package.
Bitte beachten *Serialised documents.
