RFQ/OBP099/2026/27
VI Cell Concentration Control, Vi CELL Reagents Park & Z2 Coulter Counter Reagents and Calibration solution.
RFQ/OBP099/2026/27
2 VI Cell Concentration Control Supply of concentration control material for verification of cell concentration measurements on the Vi-CELL automated cell viability analyser. 1.Product Description A stabilized latex bead suspension with certified nominal concentration used to verify instrument concentration accuracy and performance. 1.1 Compatibility o Must be fully compatible with: o Vi-CELL XR analyzer 1.2 Nominal bead Concentration For Vi-CELL XR: o 1 × 10⁶ beads/mL 1.3 Physical Characteristics • Format: Latex bead suspension control standard. • Sterility: Non-biological control material • Homogeneous suspension • Suitable for automated aspiration systems 1.4 Packaging • 20 mL bottle. 1.5 Storage & Stability • typically 2–8°C • Minimum remaining shelf life upon delivery: ≥ 70% of total shelf life or ≥ 12months (whichever is longer) Quality Documentation Supplier shall provide: • Certificate of Analysis (CoA) • Certificate of Conformance (CoC) • Safety Data Sheets (SDS) • Instructions for Use (IFU) • Manufacturer ISO certification details (ISO 9001 / ISO 13485, if applicable) 2 2 Vi CELL Reagents Park This specification defines the requirements for the supply of Vi-CELL Reagent Pack for use with automated cell viability analyzers. Equipment Compatibility The reagent pack be fully compatible with: • Vi-CELL XR Kit Components • Trypan Blue solution 0.4% (w/v) • Cleaning solution • Buffer Solution • Rinse solution / system fluid (Disinfectant) Performance • Support accurate cell concentration and viability measurements. • Compatible with automated aspiration and mixing systems. • Formulations stable and free from precipitation or particulate contamination. • Lot-to-lot consistency maintained. Storage & Shelf Life • Minimum shelf life upon delivery: at least 12 months or ≥70% of total shelf life. Quality Documentation Supplier shall provide: • Certificate of Analysis (CoA) • Certificate of Conformance (CoC) • Safety Data Sheets (SDS) • Instructions for Use (IFU) • Manufacturer ISO certification details (ISO 9001 / ISO 13485, if applicable) (1X5L)eac Z2 Coulter Counter Reagents and Calibration solution This specifications defines Reagent packs for the Beckman Coulter Z2 Coulter Counter essential consumables. Iso flow II Diluent Formulation compatible with Beckman Coulter impedance technology Electrolyte solution compatible with Z Balanced electrolyte solution with stable conductivity suitable for cell sizing/counting Non-hemolytic, non-toxic, free of particulate contaminants Supplied in ready-to-use format Performance: Conductivity and osmolality suitable for animal cell suspensions Validated for use with Z2 Coulter Counter Aperture Diameter of (100μm ) Packaging/Volume: 5 L / bottle Performance: Demonstrated complete Cell lysis in standard dilutions Minimal cell debris post-lysis for reliable counts Coulter Cleaning Solution Chemically formulated for safe cleaning of apertures and fluid lines Compatible with plastic/metal components of the Z2 syste Non-abrasive, non-corrosive Removes debris, salts, and biological residue Packaging/Volume Options: Packaging/Volum 5 L / bottle Performance: Effective for routine flush and deep-clean cycles Does not affect future sample integrity Calibration Standards (Latex Beads) Bead Types: Monodisperse latex microspheres of known diameters Typical sizes required: 10 µm Concentration: Known bead count concentration (beads/mL) certified per lot High stability suspending medium (non-agglomerating) Performance Criteria: Tight size distribution (low CV % specified for each bead population) Stable over defined shelf life Compatible with Z2 impedance counting Format: Single bead size in via Volumes: 20ml Common Documentation Required (for All Items) Certificate of Analysis (CoA) Per lot, showing tested specifications Safety Data Sheets (SDS) Latest revision Lot traceability and manufacturing Date Storage conditions and self-liflife
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2026/07/13 16:00:00
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