is an FDA-approved Class II medical device manufacturer who transforms water into sterile pharmaceutical and medical-grade solutions that promote the highest levels of safety and purity. As a leading provider of high purity compendial waters, we specialize in large-scale USP/EP-grade sterile water for injection (SWFI) quality water and saline production. Our manufacturing capabilities extend to custom cGMP process solutions produced to exact customer specifications.
We offer a diverse selection of standard packaging configurations in sizes ranging from 3mL to 1100L for a variety of applications in the pharmaceutical, medical device, and healthcare industries. Our commercial-use products, including bulk sterile water for injection quality water and aqueous process solutions are offered in customizable bulk bioprocess containers (BPCs) as well as smaller format options such as bottles and pour bag cubitainers, while our medical products are comprised of pre-filled flush syringes with additional offerings in the works.
As a fully vertically integrated facility, we manufacture our own custom single-use systems (SUSs) for the sterile transfer, delivery, and packaging of product, allowing full control of the product life cycle. We also develop tailored SUS solutions for seamless integration into customer workflows. In industries where lead times are critical,
’s in-house SUS manufacturing makes the difference.
’s fully customized systems improve efficiency, reduce costs, and minimize risk in producing cutting-edge, life-sustaining applications for:
excels in SUS manufacturing, producing all bioprocess containers (BPCs) and tube sets in-house, unlike competitors who rely on global suppliers with long lead times. This end-to-end control ensures unmatched product purity, rapid customization, and superior quality, delivered with industry-best lead times and pricing. Our unwavering commitment to quality and service ensures that all products meet the highest industry expectations.
’s leadership team pioneered single-use systems for the biopharmaceutical industry and brings more than 30 years of experience to the design and integration of SUSs. This expertise enables us to provide expert consultation for customizing our products, such as WFI packaging and delivery systems, to optimize your process.
Need help integrating our products into your process? Contact us for a complimentary consultation and discover our one-stop shop for the SUS you need to make it work!
As a preferred water for injection quality water supplier of USP/EP grade sterile WFI,
is committed to providing the highest purity sterile waters that exceed the standards for quality and performance. Our innovative tankless, on-demand water generation system, paired with a fully closed-loop continuous filling process, ensures uncompromised purity. Distributed via SUS tubing with an inline sterilizing filter and delivered into custom
-manufactured, gamma-irradiated Bioprocess Containers (BPCs), our sterile waters maintain end-to-end purity, eliminating any risk of contamination.
Looking for a reliable bulk sterile saline provider? With lot sizes up to 25,000L,
can provide you with the same high-quality saline used in the downstream manufacturing of our sterile flush syringes.
Need another solution? We can manufacture custom cGMP process solutions tailored to your exact specifications and lot size needs. Let us know how we can support your workflow.
is a trusted manufacturer of FDA-approved Class II medical devices, including pre-filled saline flush syringes, essential for maintaining and ensuring the patency of intravenous (IV) catheters. Our innovative low-temperature sterilization methodology ensures negligible break force, offering smooth operation and greater control for our customers. Available in sterile field ready and sterile fluid and path formats, our syringes are trusted by healthcare providers nationwide.
Since 2005, our US-based manufacturing facilities have delivered high-quality, essential products — from water for injection quality water to advanced bioprocess solutions and medical devices — to clients across various industries.
delivers the highest levels of safety, purity, and reliability in water for injection quality water, water-based medical devices, and aqueous process solutions.
We realize this mission through operational excellence, innovative product development, and superior service.
Upholding the highest standards in all operations, including R&D, raw materials, design, development, manufacturing, storage, and distribution, our team is dedicated to delivering world-class products and customization. We serve our clients through attentive listening, thoughtful learning, and creative problem-solving.
We are proud to be 100% made in America. Our commitment to quality and craftsmanship is evident in every product we make, and you can be sure that when you purchase from
, it was created with utmost care and attention right here in the USA.
We are committed to helping you enhance and hyper-accelerate your workflows.
Let us know how we can help.
