PURELAB Pharma Compliance
Bringing ELGA's ultrapure water purification to GXP Quality Control Laboratories
PURELAB Pharma Compliance
en
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.
- Innovative features optimised for QC laboratories
- Purification, software capabilities, qualification documentation and online support services necessary for the validation required to meet Good Manufacturing Practice (GMP)
- 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.
Brochure: ELGA PURELAB Pharma Compliance
Select the right PURELAB QUEST for your research
| 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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