Key Product Detail – GemPureTM Select Water for Injection (WFI) Quality Water

GemPure™ Select Water for Injection (WFI) Quality Water (USP Grade)

GemPure™ Select Water for Injection (WFI) Quality Water (USP Grade)

GemPure™ Select Water for Injection (WFI) Quality Water (USP Grade) enables our customers to optimize their workflow and productivity – from development to commercial production – by providing WFI quality water that meets the USP monograph for Water for Injection packaged in bulk for commercial use.  

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WFI quality water that meets the needs of upstream and downstream bioprocessing and manufacturing. 

Overview

For cell culture and other applications across the biopharma and advanced therapies workflows, GeminiBio offers GemPureTM Select Water for Injection (WFI) Quality Water.  GemPureTM Select meets the USP monograph for Water for Injection packaged in bulk for commercial use. Available in 1-liter, 10-liter, 20-liter, 100-liter, and 200-liter package sizes.  Custom manufacturing options are available.

Our GemPureTM Select Water Portfolio 

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Key Product Features

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Meets USP Requirements

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GeminiBio GemPureTM Select WFI Quality Water* significantly exceeds WFI water requirements and meets USP requirements for Water for Injection packaged in bulk for commercial use.

Off the Shelf and Custom Sizes 

 

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For cell culture and other applications across the bioproduction workflow, GemPureTM Select Water for Injection (WFI) Quality Water is available in 1-liter, 10-liter, 20-liter, 100-liter, and 200-liter package sizes.  Custom manufacturing and packaging options are available.

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Our Integrated Quality Approach 

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Certifications, Registrations and Compliance01

To meet the stringent quality requirements of our customers, GeminiBio is certified to ISO 13485:2016, maintains an FDA registration under Class I Medical Devices, and is aligned with 21 CFR Part 820: Quality System Regulation. 

 

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Certifications Registrations and Compliance
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Manufacturing Design02

GeminiBio’s facilities are designed with current Good Manufacturing Practices (cGMP) and our customer’s quality requirements in mind. Our animal origin free (AOF) manufacturing facility is 1/4 mile away from our animal origin (AO) manufacturing facility. In addition, our cGMP warehouse is designed with flows for both personnel and materials, including segregation of AO and AOF materials.

 

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Manufacturing Design
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Risk Management03

GeminiBio has developed a robust and rigorous risk management mitigation program.   Our four-step approach includes Supplier Management, Change Management, Internal Audits governed by ISO 13485:2016, and Customer Audits.

 

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Risk Management

Let’s Keep In Touch

We are committed to helping you optimize your cell culture and process liquid workflows – how can we help you?

 

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