Our mission is to ensure the generation of accurate and precise findings.
Contact Us 80 Gravel Pike Building D Red Hill, PA 18076 (267)-313-4534 MONDAY - FRIDAY 09:00 AM - 05:00 PM info@bpssu.comOur single-use assemblies are manufactured in an ISO Class 7 cleanroom environment, providing controlled conditions for the production of bioprocess components used throughout upstream, downstream, filtration, fluid transfer, and final fill applications.
Environmental controls and established operating procedures help minimize contamination risk while supporting consistent production from lot to lot.
BPSSU cleanroom operations support a wide range of custom and standard single-use products, including:
Each assembly follows defined manufacturing procedures designed to support repeatability and traceability throughout the production process.
Depending on the project, our cleanroom workflow may include component preparation, assembly, in-process inspection, pressure or integrity testing, labeling, packaging, and preparation for sterilization. This gives customers a clear, documented manufacturing path from individual components to the finished assembly.
BPSSU also maintains documentation designed to support customer quality systems and audit requirements. This can include:
Our cleanroom facility is specifically oriented around single-use bioprocess assemblies, allowing our team to work with the tubing, connectors, bags, filters, bottles, and other components commonly used throughout biopharmaceutical manufacturing.
That specialization helps us support both established assembly designs and highly customized configurations.
Not every customer needs the same production volume. BPSSU can support:
Small quantities and rapid design iterations for teams developing or refining a process.
Documented, repeatable assemblies for clinical-stage programs where timelines and supply continuity are critical.
Repeat production with controlled specifications, documentation, and lot traceability.
Our cleanroom manufacturing operates alongside BPSSU's broader quality systems and inspection processes. Rather than treating quality as a final checkpoint, we build verification and documentation into the manufacturing process itself.
Whether you're replacing an existing single-use assembly, developing a new process, or looking for a more responsive manufacturing partner, our team can help you evaluate your application and build the right configuration.
