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.
- 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
Instruments, service and support in Australia exclusively by Metrohm Australia. Contact us for more information.
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| 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