INNOVATIVE
MANUFACTURER

Single-use process components and assemblies with biopharma, life science,
and cell therapies in mind.

CLASS 7

Cleanroom Manufacturing

ISO 13485

Quality Management System

FDA REGISTERED

Facility Manufacturing

Single-Use Consumable Solutions

SUT Assemblies & Custom Tube Kits

Critical fluid management supporting bioreactor, cell culture, and cell therapy applications.

Platinum-Cured Silicone Gaskets

Sanitary fitting gaskets for the biopharma, biotech, and injectable markets where hygienic components are a must.

Transfer Bottle Assemblies

Complete bottle assembly for efficient aseptic transfer with 100% fluid path integrity.

W-TPE™ Tubing

Sealable and weldable TPE tubing suitable for the biopharmaceutical industry.

Intelligent Solutions Need Customizable Services

Injection Molding

Continually investing in injection molding capabilities ensures we evolve with your needs.

Design Services

Every aspect, from initial device design to full-scale production, can make or break a product’s success.

Device Assembly

Sourcing and production of custom tube kits and device assemblies help increase productivity, lessen costs.

Tubing Extrusion

Planning and preparing for your needs are what make us the supplier of choice for tubing extrusion.

Transforming Ideas Into Reality

Started in 2012, WHK BioSystems is a contract manufacturer of single-use assemblies and medical device components for cell therapies and the biopharmaceutical, life science, and medical industries. We have found that as demand for single-use systems increases rapidly, so do the lead times and costs for these products and services. Our company was founded in response to these trends.

We are proud to be an American-based company that offers fast, flexible, and efficient manufacturing from Clearwater, FL. We maintain an ISO 13485:2016 registered quality management system and operate Class 7 cleanrooms. We are also an FDA-registered facility. [Read more …]

WHK BioSystems, LLC, maintains an ISO 13485:2016 registered quality management system. It is an FDA-registered facility that operates Class 7 cleanroom manufacturing.