Purity that exceeds expectations

Thermo Scientific HyClone WFI Quality and Deionized Water

Water is a major component for the pharmaceutical industry. Today’s rapid advances in biotechnology and biopharmaceutical manufacturing create an ever-increasing need for dependable sources of WFI Quality Water.

Applications include:

• Preparation of culture media and process buffers

• Cleaning or rinsing of primary packaging materials, production vessels, equipment and room surfaces

• Diafiltration and other purification processes

• Reconstitution of products during synthesis

• Manufacturing of finished product for both therapeutic and diagnostic applications

Our cGMP ISO 9001 manufacturing and logistics facilities are strategically located to meet the needs of biopharmaceutical and research customers throughout the world.

for WFI Quality WaterApplications

2 Visit our web site at www.thermoscientific.com/hyclone

Manufacturing & Logistics

3To order or request additional information, call 1.800.492.5663

Logan, UtahMedia, Process Liquids,

BPCs, Serum, Logistics

Cramlington, UKMedia, Process Liquids, BPCs, Logistics

Aalst, Belgium

Logistics

Tauranga, New ZealandSerum,

Logistics

Mordialloc, AustraliaSerum,

Logistics

Beijing, ChinaMedia, Logistics

Global

Our ProcessOur validated system uses a sequential purification process that converts high-quality source water into ultra pure WFI Quality Water.

These sequential steps include:

Process Steps WFI Quality Water

Deionized Water

Pretreatment

Reverse Osmosis

Continuous Deionization

Ultraviolet Light Treatment

Multi-Effect Distillation  > 80° C Hot Loop Circulation  0.1 µm Final Filtration

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Pretreatment

ContinuousDeionization

>80°C Hot LoopRecirculation

ReverseOsmosis

Multi-EffectDistillation

Ultraviolet LightTreatment

0.1 µm Final Filtration

• Particulate removal• Water softening

• Removal of organics, colloids and microbes

• Removal of dissolved impurities

• Inactivation of microbes

• Optimized purification

• Maintenance of sterility during storage

• Microbial barrier when dispensing into BPCs

Standards

Process Steps WFI Quality Water

Deionized Water

Pretreatment

Reverse Osmosis

Continuous Deionization

Ultraviolet Light Treatment

Multi-Effect Distillation  > 80° C Hot Loop Circulation  0.1 µm Final Filtration

5To order or request additional information, call 1.800.492.5663

and Specifications

US Specifications*Intended Use Not for parenteral use

Purification Method Reverse osmosis/distillation

Appearance Clear liquid

Sterility Meets requirements of USP <71>

Endotoxin < 0.25 EU/mL

Conductivity** < 5µS/cm at 25 ± 1°C

Oxidizable Substances Not detected

Particulate Matter Meets requirements of USP <788>

EU SpecificationsIntended Use Not for parenteral use

Purification Method Reverse osmosis/distillation

Appearance Clear colorless liquid

Sterility Meets requirements of EP (2.6.1) and USP <71>

Endotoxin < 0.25 EU/mL

Conductivity** < 1.1µS/cm at 25 ± 1°C

Oxidizable Substances Not detected

Particulate Contamination 0.1 µ final filtration

Acidity or Alkalinity Passes EP test for Sterilized Water for Injections

Chlorides Passes EP test for Sterilized Water for Injections

Nitrates ≤ 0.2 ppm

Sulfates Passes EP test for Sterilized Water for Injections

Ammonium ≤ 0.2 ppm

Calcium and Magnesium Passes EP test for Sterilized Water for Injections

Residue on Evaporation ≤ 0.003%

Total Organic Carbon** < 500 ppb

Deionized Water Specifications - US & EUAppearance Clear Liquid

Sterility No Growth

Endotoxin ≤ 0.05 EU/mL

Deionized water specifications are identical for each manufacturing location:

Thermo Scientific HyClone WFI Quality Water is produced in Logan, Utah, USA, and Cramlington, UK. WFI Quality Water produced in the USA follows the USP monograph for Sterile Purified Water, and WFI Quality Water produced in the UK is based upon the EP monograph for Sterilised Water for Injections. In both manufacturing locations, WFI Quality Water is produced to the following standards:

• Produced using a validated water purification system that meets or exceeds current USP or EP requirements for WFI

• The Quality Assurance monitoring system ensures continuous compliance and incorporates system test and action limits

• Includes a lot-specific Certificate of Analysis (COA) listing both acceptance criteria and actual test results

Specifications for WFI Quality Water produced in each manufacturing location are as follows:

*US manufactured WFI Quality Water can be tested to EU specifications upon request.**Tested on water system on day of fill.

Should we set up our own facility?Installation of a WFI system represents a major capital expenditure for any biopharmaceutical company. In addition to the initial capital investment and dedication of land, even higher costs come from validation and maintenance of buildings and equipment, and training of personnel. Furthermore, adding or upgrading WFI systems requires manufacturers to anticipate maximum capacity demand. Once in place, these capital investment and maintenance costs are ever present regardless of the system usage. Even when depreciating these costs over many years of service, the per liter cost for finished product can be staggering. Establishing a supply of ready-to-use WFI Quality Water in packaging suitable for your application can save time and money.

What if we already have a WFI system?For companies with validated systems in place, qualification of the Thermo Scientific HyClone WFI Quality Water provides a reliable secondary source for added security and resource flexibility. Have you ever experienced manufacturing or scheduling irregularities? Demand exceeding capacity? Downtimes or equipment failure? Since you only order what you need, the inherent scalability balances the unpredictability in production scheduling. As a result, many leading biopharmaceutical manufacturers have audited and qualified our WFI Quality Water as their preferred outsource supplier for large volume demands.

What about contact with materials of animal origin?WFI Quality Water is packaged in BioProcess Containers (BPCs) made from our proprietary CX5-14 film. CX5-14 film is manufactured using no process aids or slip agents that typically contain animal-derived components. Our BPCs have been extensively tested and are held to the highest industry standards. CX5-14 film meets current USP, EP and ISO testing requirements.

Whether your manufacturing group needs large volumes of WFI Quality Water for cell culture processes, for cleaning and rinsing, or for buffer preparation, we have the resources, expertise and capacity to be your partner of choice.

Our WFI Quality Water is manufactured in validated WFI purification systems that meet current USP or EP test requirements for WFI. As ultra-pure packaged water, it meets all applicable requirements for WFI packaged in bulk for commercial use. Every lot comes with a lot-specific COA that provides actual test results for the packaged water, not the system water. When we say WFI Quality, we mean it.

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Frequently Asked Questions About WFI Quality Water

WFI Quality Water is available in numerous volume and packaging configurations up to 1000 L. Made to stock (MTS) items are listed below. Custom volume, packaging or testing options are provided on a made to order (MTO) basis.

WFI Quality WaterUnit Size MTS US Part No. EU Part No.500 mL Bottle US SH30221.17  

1000 mL Bottle US SH30221.10

10 L Labtainer US SH30221.24 CH30154.01

20 L Labtainer US & EU SH30221.25 CH30154.02

50 L Top Drain Drum US SH30221.26 CH30154.03

100 L Top Drain Drum US SH30221.27 CH30154.04

200 L Top Drain Drum US & EU SH30221.28 CH30154.05

200 L Top Drain UN Drum US SH30221.36  

Deionized water is available in two popular volumes, with custom options available upon request.

Deionized WaterUnit Size US Part No. EU Part No.20 L Labtainer SH30922.02 (MTO) SH30925.04 (MTO)

200 L Top Drain Drum SH30922.01 (MTO) SH30925.07 (MTO)

To order or receive additional information, please contact your account manager or visit us at www.thermoscientific.com/hyclone.

7To order or request additional information, call 1.800.492.5663

InformationOrdering

©2011 Thermo Fisher Scientific Inc. All rights reserved.All trademarks are the property of Thermo Fisher Scientific Inc. and its subsidiaries.

SM0446.02

Cell Culture and BioProcessing

In the Americas and Asia 925 West 1800 SouthLogan, Utah 84321Tel: +1 (435) 792-8000Toll-Free: +1 (800) 492-5663Fax: +1 (435) 792-8001www.thermoscientific.com/hyclone

In EuropeIndustriezone III, Industrielaan 279320 ErembodegemBelgium+32 53 85 71 80+32 53 85 74 31 faxwww.thermo.com/perbio