Your trusted partner for High Purity Water and GMP Bioprocess Liquids
High Purity Water Products
Intermountain Life Sciences’ manufactures a complete portfolio of water for pharmaceutical purposes as outlined in USP <1231>. All products are manufactured under cGMP and ISO 13485 guidelines in an FDA registered and fully validated facility. Our portfolio consists of:
Water for Injection EP/USP — Water for Injection USP — Water for Irrigation USP — Sterile Purified Water USP — Purified Water USP — Cell & Molecular UltraPure — Molecular Certified
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Phosphate Buffered Saline (PBS) 1X w/o Ca & Mg, pH 7.2
Phosphate buffered saline (PBS) 1X, pH 7.2 is a physiological salt solution commonly found in many cell culture applications and is manufactured utilizing USP raw materials formulated in USP Water for Injection. It is sterile, low endotoxin, isotonic and nontoxic to cells. Manufactured under cGMP and ISO 13485 guidelines in a FDA registered facility.
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Sodium Chloride 0.9% (Normal Saline), USP, Sterile Grade
Sodium Chloride 0.9% is a sterile solution of sodium chloride in water for injection. It contains no antimicrobial agents. It contains NLT 95.0% and NMT 105.0% of the labeled amount of sodium chloride (NaCl). It meets the current USP monographs for Sodium Chloride Injection and Sodium Chloride Irrigation. Manufactured under cGMP and ISO 13485 guidelines in a FDA registered facility.
View and order SalineDiscover the Intermountain Difference.
Addressing the need for cGMP media and buffer preparation, Intermountain Life Sciences (ILS) has emerged as an innovative, responsive and quality driven outsourcing partner. Driven by our complex customer applications, ILS utilizes our state-of-the-art Salt Lake City production site to provide large volume process liquids, to exacting standards, allowing ease of integration in today’s diverse manufacturing platforms.
Solution outsourcing allows customers to focus on the science and complex manufacturing strategies needed for today’s cutting edge therapeutics. Eliminating the extensive CapEx, infrastructure and validation required to prepare process fluids allows companies to efficiently progress through clinical trials and achieve market approval quicker.
GMP Process solutions for your entire bioprocessing workflow
With the largest lot size liquid capabilities in the industry and over 60,000L/Day of WFI production, Intermountain Life Sciences is removing the hurdles of large volume liquid outsourcing. Strategically focused on Bioprocessing, ILS can meet your most demanding Upstream and Downstream requirements allowing an efficient path to commercialization.
Sterile Water for Injection
At Intermountain Life Sciences, we are fortunate that our Water for Injection systems are fed with water sourced from the Rocky Mountains; home to some of the highest quality natural water on the planet.
At the heart of the operation are cutting edge, 9 step Water for Injection (WFI) purification systems, capable of producing in excess of 60,000 Liters per day. The manufacturing process is fully validated to multi-compendial requirements with defined quality water standards including sampling and system controls. We utilize this Water for injection for all of our custom manufacturing applications.
In addition, ILS offers a highly competitive core portfolio of Water For Pharmaceutical Purposes including USP and EP compendial Water for Injection in sizes of 500mL bottles to 200L drums for manufacturing applications.
Uncompromised Quality
A comprehensive Quality System is the foundation of Intermountain Life Sciences. In order to serve today’s stringent outsourcing requirements, ILS’ quality and validation programs ensure a highly defined manufacturing process to consistently deliver a quality product lot after lot.
ISO 13485:2016
The International Standard for a Quality Management System for Medical Devices.
ISO 5 Aseptic Filling
Industry Leading Clean Room Filling for Aseptic manufacturing.
21 CFR 820
FDA current Good Manufacturing Practice (cGMP) quality system regulation for medical devices.
MasterControl
Industry Leading digital Quality Management System (QMS).
FDA Registered
Registration Number: 3005038345 / Owner Operator Number:10050879.
FormWeigh.Net
Industry Leading digital control over component weighing and formulation.
Animal Component Free (ACF)
Completely Animal Component Free Facility.
21 CFR Part 11
Compliant with (FDA) regulations on electronic records and electronic signatures.
Closed System Filling
Closed system manifold filling for Bioprocess Containers.
Supplier Qualification
An integrated supplier qualification process to mitigate the associated risks of raw materials.