Thermo Scientific HyClone WFI Quality Water. Ultra pure to meet today s rapid manufacturing advances

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Blanche Merritt
5 years ago
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1 Thermo Scientific HyClone WFI Quality Water Ultra pure to meet today s rapid manufacturing advances

2 What sets Thermo Scientific HyClone WFI Quality Water apart? Our cgmp ISO 9001 manufacturing facility, located along the Northern Utah Wasatch Range of the Rocky Mountains, is far from the contaminating pollutants and chemicals common to more urbanized regions. This location provides access to pristine water from artesian wells and local municipality sources. With quality from the start, our water products are then further purified and tested to meet the demanding needs of today s biotechnology, biopharmaceutical and research customer. Water is a major commodity used by the pharmaceutical industry. Today s rapid advances in biotechnology and biopharmaceutical manufacturing create an ever-increasing need for dependable sources of WFI Quality Water, process liquids and buffers. Applications include: Cleaning or rinsing of primary packaging materials, production vessels, equipment and room surfaces Preparation of buffers for washing and elution Diafiltration or other purification processes Reconstitution during synthesis or manufacturing of finished product for both therapeutic and diagnostic applications

high-quality source water into ultra pure WFI

filtration Ion exchange for mineral and hardness

impurities Continuous Deionization (CDI)

3 Our Process Our validated system uses a sequential purification process turning high-quality source water into ultra pure WFI quality water, which follows current USP criteria for Water For Injection. These sequential steps include: Multimedia coarse filtration Ion exchange for mineral and hardness reduction Reverse Osmosis (RO) to remove impurities Continuous Deionization (CDI) Ultraviolet (UV) disinfecting light treatment Multi-effect Distillation for optimal purification Continuous hot loop circulation (maintained at > 80 C ) 0.1 µm final filtration for greater sterility assurance

WFI Quality Water Defined Bulk WFI refers to suitably purified system water produced and used on site. It is not packaged.

Accordingly, Sterile WFI can only be packaged by a licensed drug manufacturer.

Sterile WFI can be rendered suitable for parenteral use.

4 WFI Quality Water Defined Bulk WFI refers to suitably purified system water produced and used on site. It is not packaged. Sterile WFI is an injectable solution, packaged into single-dose containers of < 1 liter in size. It is intended for parenteral use or in the preparation of parental solutions and is therefore a drug. Accordingly, Sterile WFI can only be packaged by a licensed drug manufacturer. There are a number of different USP monographs for purified waters, including Bulk WFI, Sterile Water for Injection (Sterile WFI), Purified Water and Sterile Purified Water. Sterile WFI can be rendered suitable for parenteral use. The USP monograph for WFI recognizes water may be packaged in bulk volumes for outside uses and states that WFI packaged in bulk for commercial use elsewhere must meet the test requirements for Sterile Purified Water (SPW), except for labeling. Therefore, Thermo Scientific HyClone WFI Quality Water definition includes the following criteria: Must be produced from a validated water purification system that meets or exceeds current USP requirements for WFI Must have a QA monitoring system that ensures continuous compliance and incorporates system test and action limits Must meet all applicable chemical, purity and other acceptance criteria as outlined in the current USP for both system and packaged water Must include a lot-specific Certificate of Analysis (COA) listing both acceptance criteria and actual test results. Actual test results on COA must be from packaged samples of the given lot Not for parenteral use A summary overview of the current criteria for WFI, Sterile WFI and WFI Quality Water is provided below. Criteria Bulk WFI Sterile WFI WFI Quality Water Intended Use Parenteral Parenteral Not for Parenteral use Packaging N/A Single dose, plastic or glass container, less than 1 L Preserve in suitable, tight containers Purification method Distillation / RO Distillation / RO Distillation / RO Endotoxin < 0.25 EU/ml < 0.25 EU/mL < 0.25 EU/mL Conductivity Meets temperaturedependent specification TOC < 0.5 ppm N/A N/A N/A <5µS/cm at 25±1 C Particulate N/A Meets requirements USP <788> Meets requirements USP <788> Sterility N/A Meets requirements USP <71> Meets requirements USP <71> Oxidizable N/A Test for organic contaminants Test for organic contaminants All must be prepared from source water complying with US EPA National Primary Drinking Water Regulations, or comparable regulations of EP or JP.

Frequently asked questions about WFI Quality Water Is it cost effective? Installation of a WFI system represents a major capital expenditure for any biopharmaceutical company.

Furthermore, adding or upgrading WFI systems requires manufacturers to anticipate maximum capacity demand.

5 Frequently asked questions about WFI Quality Water Is it cost effective? Installation of a WFI system represents a major capital expenditure for any biopharmaceutical company. In addition to the initial investment and dedication of land, buildings, equipment and personnel are the even higher costs of validation and maintenance. 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. 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? That s another good reason why so many manufacturers trust our WFI Quality Water. It s never pooled into tanks, but filled directly from a recirculating hot loop, which maintains water temperature at > 80 C. In addition, as a leading manufacturer of disposable bioprocess containers, WFI Quality Water is available in Thermo Scientific HyClone BPC s ranging in sizes from less than 1 liter to 1000 liters in a single container. Our BPCs, made of CX5-14 film, are manufactured using no process aids or slip agents that typically contain animal-derived components. BPCs feature extremely clean product contact surfaces with minimal leachables and extractables. CX5-14 film meets current applicable USP, ISO and EP testing requirements. Whether your manufacturing group needs large volumes of WFI Quality Water for cell culture processes, for cleaning and rinsing, or large volumes of buffer solutions in customized bioprocess container packaging, we have the resources, expertise and capacity to be your partner of choice. Thermo Scientific HyClone WFI Quality Water is manufactured in a validated WFI purification system that meets current USP test requirements for WFI. As an ultra pure packaged water, it meets all applicable requirements for WFI packaged in bulk for commercial use elsewhere. Every lot comes with a lot specific COA that gives actual test results on the packaged water, not the system water. When we say WFI Quality, we mean it.

6 Ordering Information Containers are available in numerous volume and packaging configurations up to 1000 L. Stock sizes are listed below. To order or request additional information, please contact your account manager or call Unit Size Catalog Number 100 ml Bottle SH ml Bottle SH ml Bottle SH x 1000 ml Bottles SH30221.LS 10 L BioProcess Container SH L BioProcess Container SH L BioProcess Container SH L BioProcess Container SH L BioProcess Container SH Thermo Fisher Scientific Inc. All rights reserved. All trademarks are the property of Thermo Fisher Scientific Inc. and its subsidiaries. HyClone Laboratories Inc. 925 West 1800 South Logan, UT In Americas/Asia fax In Europe fax SM

Manual 042 Water Quality Standard

Manual 042 Water Quality Standard 1 Purpose Manual 042 Quality Standard To describe the quality standards required for the production, distribution, use and testing of water used in the manufacture of manufactured materials. 2 Scope and