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.comBPSSU is grounded in ISO 9001 and ISO 13485 certifications. But certifications are only the starting point. What matters is how we apply them to every assembly and shipment that goes out our door.
The single-use assemblies we ship don't end their lives in our cleanroom. They go out into bioreactors, drug substance fills, and downstream operations that touch medicines, vaccines, and therapies people rely on. Some of those people are friends, family, or neighbors. We treat that as a real responsibility, not a marketing line.
That's why our quality program isn't built around the minimum required to maintain certification. It's built around what would we want for someone we love. The people on our team take pride in the assemblies they build, and that pride shows up in the consistency of the products we ship.
Quality is only useful if it's traceable. Every BPSSU assembly ships with the documentation your incoming QC and audit trail need.
CoC issued with every shipment confirms the assembly meets your specification and quality requirements.
Lot numbers tied to every assembly, with full traceability back to component sources and assembly records.
All components used in your assembly are traceable to source by supporting your supplier qualification and regulatory submissions.
Gamma sterilization certificates from our partner sterilization vendors supplied with every sterile assembly shipment.
Our customers operate in regulated environments like biopharma manufacturing, GMP facilities, 503B compounding pharmacies, and beyond. We design our quality program to support your regulatory submissions and audit preparations, not just check our own boxes.
Components used in our assemblies are USP Class VI compliant where required. Materials selection is guided by ISO standards and our processes are documented in a way that lets you verify every claim we make.
