Thermo Scientific HyClone WFI Quality and Deionized Water Purity that exceeds expectations
Applications for WFI Quality 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. 2 Visit our web site at www.thermoscientific.com/hyclone
Global Manufacturing & Cramlington, UK Media, Process Liquids, BPCs, Beijing, China Media, Logan, Utah Media, Process Liquids, BPCs, Serum, Aalst, Belgium Mordialloc, Australia Serum, Tauranga, New Zealand Serum, To order or request additional information, call 1.800.492.5663 3
Our Process Our validated system uses a sequential purification process that converts high-quality source water into ultra pure WFI Quality Water. These sequential steps include: Pretreatment Particulate removal Water softening Reverse Osmosis Removal of organics, colloids and microbes Continuous Deionization Ultraviolet Light Treatment Multi-Effect Distillation >80 C Hot Loop Recirculation Removal of dissolved impurities Inactivation of microbes Optimized purification Maintenance of sterility during storage 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 0.1 µm Final Filtration Microbial barrier when dispensing into BPCs 4 Visit our web site at www.thermoscientific.com/hyclone
Standards and Specifications 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: Intended Use Purification Method Appearance US Specifications* Not for parenteral use Reverse osmosis/distillation 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> Deionized water specifications are identical for each manufacturing location: Deionized Water Specifications - US & EU Appearance Sterility Endotoxin Clear Liquid No Growth 0.05 EU/mL EU Specifications Intended 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 *US manufactured WFI Quality Water can be tested to EU specifications upon request. **Tested on water system on day of fill. To order or request additional information, call 1.800.492.5663 5
Frequently Asked Questions About WFI Quality Water 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. 6 Visit our web site at www.thermoscientific.com/hyclone
Ordering Information 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 Water Unit 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 Water Unit 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. To order or request additional information, call 1.800.492.5663 7
Cell Culture and BioProcessing In the Americas and Asia 925 West 1800 South Logan, Utah 84321 Tel: +1 (435) 792-8000 Toll-Free: +1 (800) 492-5663 Fax: +1 (435) 792-8001 www.thermoscientific.com/hyclone In Europe Industriezone III, Industrielaan 27 9320 Erembodegem Belgium +32 53 85 71 80 +32 53 85 74 31 fax www.thermo.com/perbio SM0446.02 2011 Thermo Fisher Scientific Inc. All rights reserved. All trademarks are the property of Thermo Fisher Scientific Inc. and its subsidiaries.