PURELAB® Pharma Compliance

PURELAB® Pharma Compliance

Secure software offers a range of admin, security and data features providing evidence to meet FDA (FDA 21 CFR Part 11) and EU (EUDRALEX Annex 11) standards for digital record keeping.

Purification processes fulfil United States Pharmacopeia standards 643 and 645.

Supported by a global network of service teams with significant experience of supporting laboratory equipment subject to validation under GMP.

Space saving to enhance QC output, designed to be modular and stackable to save space.

The Pharma Compliance delivers a lab water solution focused on building the perfect relationship between discovery, production and traceability, resulting in an intuitive, efficient and compliant purification system.

PURELAB Pharma Compliance is packed with innovative features optimised for QC laboratories. It offers all the necessary purification, software capabilities, qualification documentation and online support services necessary for the validation required to meet Good Manufacturing Practice (GMP). It includes secure software providing the evidence to meet FDA and EU standards for digital record keeping. Purification processes fulfil United States Pharmacopeia standards 643 and 645. Qualification documents provided enable the unit to support labs subject to validation under GxP.

规格

• PRODUCT SPECIFICATIONS: PURELAB Pharma Compliance
• Dispense Flowrate: up to 2 L/min
• Inorganics (resistivity at 25°C): 18.2 MΩ.cm
• Organics (TOC): 1–3 ppb *
• Bacteria: <0.001 CFU/ml **
• Bacterial Endotoxin: <0.001 EU/ml
• pH: Effectively Neutral
• Particles: <0.01 μm
• DNase: <5 pg/ml
• RNase: <1 pg/ml
• Daily Usage (max): 120 l/day
• Daily Usage (min): 1 l/day