Polaris

 

One name for a comprehensive Water For Injection solution

Standard packaged Water For Injection systems

POLARIS is the solution that fits biotechnology and pharmaceutical market expectations. POLARIS offers a major step forward in WFI generation systems by incorporating efficient design solutions and effective pyrogen removal.

The POLARIS range of WFI products is designed in accordance with GAMP, cGMP, ISPE and FDA guidelines to meet the product quality specifications of USP, Ph Eur and other international pharmacopoeia standards.

Water For Injection product range:

  • Multi Effect Distiller: POLARIS MED
  • Vapor Compression Distiller: POLARIS VCD
  • Clean Steam Generator: POLARIS CSG

The POLARIS range features double tube sheet heat exchangers and ASME BPE pipework with sanitary connections for product security, whilst an innovative phase separation system ensures complete water droplet removal - the key step in pyrogen removal since pyrogens are non-volatile and can only be carried by water droplets once the feed water has been converted to steam.

POLARIS shares a common control system architecture and software design with the other Veolia Water Solutions & Technologies' Critical Water Utilities system components, allowing easy integration into complete Purified Water and WFI systems. Access to the PLC based control system is via a password protected colour touch screen HMI using intuitive and easy to navigate display screens. Options include 21 CFR part 11 compliance and panel mounted PC SCADA.

Full validation documentation is provided to satisfy DQ, IQ and OQ protocols and, of course, all POLARIS water purification systems are fully supported by Veolia Water Solutions & Technologies' comprehensive after sales service to ensure long term, efficient operation for Critical Water Utilities applications.

Water For Injection standards

Comparison between European Pharmacopoeia and US Pharmacopoeia:

Properties Ph Eur USP
Conductivity

<1.1 µS/cm at 20ºC

<1.3 µS/cm at 25ºC*

TOC

<500 µg/l C**

<500 ppb

Bacteria (guideline)

<10 CFU/100ml

<10 CFU/100ml

Endotoxins

<0.25 IU/ml

<0.25 EU/ml

Nitrates

<0.2 ppm

-

Heavy metals

<0.1 ppm

 -

* Offline conductivity measurements possible. If in-line conductivity exceeds values then refer to USP tables in section 645 (Table 1). If value exceeds that in table 1, refer to Three Stage Philosophy.

** Or pass oxidisable substances test

*** If in-line conductivity exeeds values then refer to the European Pharmacopoeia (Ph Eur)