| Intended Applications: | Monitoring of mammalian cell cultures in CHO or HEK293 media |
| Analytical Performance | |
|---|
| Measurement / reporting period: | 1 per minute |
| Glucose | |
|---|
| Units of measurement: | Grams per liter (g/L) |
| Measurement range: | 0 to 10 g/L |
| Measurement precision: | Approximately 0.1 g/L |
| Lactate | |
|---|
| Units of measurement: | Grams per liter (g/L) |
| Measurement range: | 0 to 5 g/L |
| Measurement precision: | Approximately 0.1 g/L |
| Total Biomass | |
|---|
| Units of measurement: | Biomass units (BMUs) |
| Measurement range: | Equivalent of 0 to 25 x 106 cells/mL |
| Measurement module connections: | 6 with power and data over ethernet |
| User interface: | 25.4 cm touch screen |
| Data export: | XLSX or CSV format via USB-C or USB-A port or over LAN |
| Digital communication protocol: | OPC UA |
| Networking: | Ethernet |
| Dimensions (H x W x D): | 17 cm x 21 cm x 26 cm |
| Weight: | 2 kg |
| Power requirements: | 120/240 VAC, 50/60 Hz |
| Ingress protection rating: | IP 5X |
| Operating temperature range: | 15°C to 25°C |
| Operating humidity range: | 20-80% RH (non-condensing) |
| Software: | In accordance with GAMP 5 Category 3 guidelines and CFR 21 part 11 compliance ready |
| Excitation wavelength: | 785 nm |
| Laser output power: | Approximately 450 mW (strictly less than 500 mW) |
| Spectral range: | 200 cm^(–1) to 3,200 cm^(–1) |
| Spectral resolution: | Approximately 6 cm^(–1) |
| Fiber-optical cable length: | 200 cm |
| Power requirements: | 40 W power-over-ethernet (POE) supplied by Hub |
| Integrated controllers: | Hysteresis controller with configurable analog output |
| Ingress protection rating: | IP 5X |
| Laser classification: | Class IIIB laser; NOHD 10 cm from probe tip (equivalent to Class I beyond 10 cm) |
| Analog outputs: | Two channel analog: 4 -20 mA or 0 -10 V |
| Dimensions (H x W x D): | 8 cm x 20 cm x 26 cm |
| Weight: | 2 kg |
| Operating temperature range: | 15°C to 25°C |
| Operating humidity range: | 20-80% RH (non-condensing) |
| Probe length and outside diameter: | 220 mm length, 12 mm diameter |
| Minimum reactor wall clearance: | 40 mm |
| Bioreactor connection: | Compression fitting; 12 mm I.D. ; PG-13.5 thread |
| Compatible sterilization methods: | Autoclave or steam sterilization |
| Maximum recommended sterilization temperature and pressure: | 121°C, 15 psi |
| Wetted materials: | 316L stainless steel with Ra 15 Electro-polish surface finish, sapphire, EPDM, and Bio-compatible ISO: 10993 certified lubricant |
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