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  • 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.

  • Features
  • Tech Specs
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  • Download brochure
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Highly competitive total cost of ownership, robust traceability and great ergonomics combine to create a simply compliant, simply effective and simply transparent solution.

Features

  • 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

Tech Specs

PRODUCT SPECIFICATIONS
PURELAB Pharma Compliance 
Dispense Flowrateup 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 ***
pHEffectively 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 RateUp to 2.0 l/min
PRODUCT SPECIFICATIONS
PURELAB Pharma Compliance 
Dispense Flowrateup 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 ***
pHEffectively 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 RateUp 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

Consumables

Ultra filter
Ultra filter
Artikelnummer
LC151
Voraussichtliche Lebensdauer
24 months
Verunreinigungen entfernt
Microorganisms & Bacteria
Auswirkungen von übermäßiger Nutzung

Bacterial and endotoxin specification wil lnot be maintained. Reduced flow rate.

POU filter
Point-of-use Filter
Artikelnummer
LC145
Voraussichtliche Lebensdauer
3 months
Verunreinigungen entfernt
Microorganisms & Bacteria
Particulates
Auswirkungen von übermäßiger Nutzung

Potential recontamination of purified water and reduced flow rates

POU filter
Point-of-use Filter
Artikelnummer
LC134
Voraussichtliche Lebensdauer
6 months
Verunreinigungen entfernt
Microorganisms & Bacteria
Particulates
Auswirkungen von übermäßiger Nutzung

Potential recontamination of purified water and reduced flow rates

UV Light render image
UV Light
Artikelnummer
LC210
Voraussichtliche Lebensdauer
12-18 months
Verunreinigungen entfernt
Microorganisms & Bacteria
Auswirkungen von übermäßiger Nutzung

Uncontrolled bacterial contamination and TOC levels are not reduced

DI pack render image
DI Pack
Artikelnummer
LC232, LC244, LC245 or LC246
Voraussichtliche Lebensdauer
12 months
Auswirkungen von übermäßiger Nutzung

Weakly bound ions are released back into the water reducing resistivity

Biofilter - Point of Use Filter
Artikelnummer
LC197
Voraussichtliche Lebensdauer
3 months

Accessories

30 liter reservoir
PURELAB® Reservoir 30 l

Capacity: 30 liters

Dimensions: 660 (h) x 376 (w) x 340 (d) 

Flow Rate: 8 l/min

60 liter reservoir
PURELAB® Reservoir 60l

Capacity: 60 liters

Dimensions: 570 (h) x 532 (w) x 522 (d)

Flow Rate: 10 l/min

100 liter reservoir
PURELAB® Reservoir 100l

Capacity: 100 liters

Dimensions: 806 (h) x 532 (w) x 522 (d)

Flow Rate: 10 l/min

15 liter reservoir
PURELAB® Reservoir 15 l

Capacity: 15 liters

Dimensions: 470 (h) x 376 (w) x 340 (d)

Flow Rate: 6 l/min

30 liter reservoir
PURELAB® Reservoir 30 l

Capacity: 30 liters

Dimensions: 660 (h) x 376 (w) x 340 (d) 

Flow Rate: 8 l/min

60 liter reservoir
PURELAB® Reservoir 60l

Capacity: 60 liters

Dimensions: 570 (h) x 532 (w) x 522 (d)

Flow Rate: 10 l/min

100 liter reservoir
PURELAB® Reservoir 100l

Capacity: 100 liters

Dimensions: 806 (h) x 532 (w) x 522 (d)

Flow Rate: 10 l/min

15 liter reservoir
PURELAB® Reservoir 15 l

Capacity: 15 liters

Dimensions: 470 (h) x 376 (w) x 340 (d)

Flow Rate: 6 l/min

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.

FDA 483 whitepaper download icon

 

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

 

Download Whitepaper

Verwandte Inhalte

PURELAB RANGE 2021

Case Studies

Don’t take our word for it, check out some of our case studies and then get in touch with us.

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Ultrapure Water

Our ultrapure water does not contain any detectable endotoxins. This level of purity makes it a perfect reagent for laboratory work.

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F: +49 (0) 51 41 803 384

Referenzen

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