PURELAB Pharma Compliance

PURELAB Pharma Compliance

Bringing ELGA’s ultrapure water purification to GXP Quality Control Laboratories

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.

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Description

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.

Elga Laboratory Equipment

  • Secure software offers a range of admin, security and data features providing evidence to meet FDA and EU 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, whether wall-mounted or under the bench.
  • Cost effective design delivering water to support QC tests necessary to validate drug purity in pharma manufacturing. Consumables are designed to minimise cost and environmental waste. ELGA delivers lower total cost of ownership that can be easily integrated into any laboratory.

Pharma Compliance with Model

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
Delivery Flow Rate Up to 2.0 l/min
* dependant on feed water ** with a LC134 or LC145 or LC197 Point-of-use 0.2μm *** with a LC197 Point-of Use Biofilter fitted

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