PURELAB® Pharma Compliance
A reliable, intuitive and simple to use system that meets GxP requirements.
Features- 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.
- 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.
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.
"Highly competitive total cost of ownership, robust traceability and great ergonomics combine to create a simply compliant, simply effective and simply transparent solution. "
Tech Specs
| 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 |
| 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
Consumables
Accessories
Bacterial and endotoxin specification wil lnot be maintained. Reduced flow rate.
Potential recontamination of purified water and reduced flow rates
Potential recontamination of purified water and reduced flow rates
Uncontrolled bacterial contamination and TOC levels are not reduced
Weakly bound ions are released back into the water reducing resistivity
Bacterial and endotoxin specification wil lnot be maintained. Reduced flow rate.
Potential recontamination of purified water and reduced flow rates
Potential recontamination of purified water and reduced flow rates
Uncontrolled bacterial contamination and TOC levels are not reduced
Weakly bound ions are released back into the water reducing resistivity
FAQs
- I don’t have a network connection in the lab?
The Pharma Compliance doesn't need internet or network access. USB connection only.
Can you prove that there are no threats for our network associated with the activation of PURELAB Pharma Proposition?
The PURELAB Pharma Compliance Compliance is not directly connected to your IT network and will therefore not pose a threat to its integrity. Exporting data from AuditSure to your LIMS, Server, ELN (Electronic Laboratory Notebook) and SDMS/ECN is in an open file format. You will need to follow your own data protection and security protocols after data is extracted.
Will we be able to provide on-site TOC Validation (customer site)?
Yes, the Suitability test is required to be performed on site.
Can ELGA LabWater or its distributors connect to PURELAB Pharma Proposition remotely?
No. You can send an export diagnostic package by email for remote diagnostic support.
WHITEPAPER
Whitepaper: FDA 483s and Non-compliance in Pharma
A single form 483 tells a company exactly which areas to improve, or to correct, to remain compliant (and therefore operational). Downplaying the 483 content and, more importantly, not responding seriously and completely to the observations can have costly consequences.
Download this whitepaper to learn more about:
- What a 483 is, and how they are an essential tool for keeping up the high standards of compliance and quality management
- The consequences of non-compliance in drug production and QC, and how a company must respond to a 483 or product recall
- The contribution of compliant water purification systems to the success of drug production and QC
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