PURELAB® Pharma Compliance
Ultrapure lab water designed for pharmaceutical compliance and QC efficiency
Features for Pharmaceutical 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.
- 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.
The PURELAB® Pharma Compliance system delivers a complete pharmaceutical lab water solution - combining advanced purification, intuitive software, and secure data handling to meet the strict demands of GxP, FDA 21 CFR Part 11, and EU Annex 11 regulations. This system is ideal for QC laboratories, pharmaceutical manufacturing, and any environment requiring ultrapure water for pharmaceutical laboratories.
Get a quote from our experts to explore how the PURELAB® Pharma Compliance can support your lab’s regulatory needs.
Who this suits
QC labs operating under GMP needing Type I water with audit-ready software and qualification packs. System provides secure electronic records aligned to FDA 21 CFR Part 11 and EU Annex 11, and purification aligned to USP <643>/<645>.
Bringing ELGA's ultrapure water purification to GXP Quality Control Laboratories
PURELAB® Pharma Compliance is a purpose-built lab water purification system designed to meet the rigorous demands of GxP-regulated pharmaceutical environments. Whether you're validating drug purity or conducting routine QC analysis, this system delivers:
Consistent Type I ultrapure water
Robust digital documentation
Full qualification support
These capabilities are essential for any pharmaceutical laboratory water system operating under Good Manufacturing Practice (GMP).
Why choose PURELAB Pharma Compliance for your QC Lab?
PURELAB Pharma Compliance offers a comprehensive solution tailored to the needs of pharmaceutical quality control environments:
Packed with innovative features optimised for QC laboratories
Delivers all the required purification processes and software for GMP compliance
Includes qualification documentation and access to expert online support services
Features secure software that meets FDA 21 CFR Part 11 and EU Annex 11 standards for digital record keeping
Fulfils USP 643 and 645 standards for ultrapure water in pharmaceutical labs
Supplied with the full documentation needed to support validation under GxP protocols
"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 |
* dependent 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
- Is PURELAB Pharma Compliance connected to my lab’s network?
No, the system operates offline with secure USB-based data export. There are no risks to your lab network, and data can be transferred safely to your LIMS, ELN, or SDMS.
- Can we validate TOC on-site?
Yes, on-site TOC validation is supported and recommended as part of your standard suitability testing.
- Can ELGA or its partners access the system remotely?
No, the system is not remotely accessible. However, you can export diagnostics and share them via email for remote technical support.
- Is this system suitable for QC labs in pharmaceutical manufacturing?
Yes, the PURELAB Pharma Compliance is purpose-built for lab water in QC laboratories and meets all the validation requirements for GMP and GxP-compliant environments.
Download the brochure or read the whitepaper on FDA 483 compliance to learn more about the role of water systems in pharmaceutical validation.
- 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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