UltraPure International
Manufacturer and integrator of custom single-use fluid-handling assemblies for the (bio)pharmaceutical and life sciences industries. Services include open-architecture design and engineering, controlled cleanroom assembly (ISO 14644‑1 Class 7/8/9), cGMP-aligned production, quality testing and documentation, supply-chain support, OEM manufacturing, and sustainability monitoring.
Industries
Nr. of Employees
small (1-50)
UltraPure International
Uithoorn, North Holland, Netherlands
Products
Filling assemblies for sterile final fill
Single-use filling sets designed to ensure precise and sterile transfer into vials or bottles; engineered to minimise pulsation and meet particulate, endotoxin and sterility assurance requirements.
Transfer sets
Tubing assemblies to reliably connect sequential process steps and maintain closed fluid paths across upstream and downstream operations.
T-transfer (manifold) assemblies
T-shaped or manifold-style single-use assemblies for controlled merging of multiple fluid streams used in formulation or buffer preparation.
Microfiltration assemblies
Single-use microfiltration filter assemblies for removal of viable and non-viable particles during harvesting, clarification and fluid preparation.
Sample sets for in-process control
Assemblies enabling aseptic sampling for in-process monitoring without interrupting closed systems.
PUPSIT-ready sterile filtration assemblies
Turnkey single-use filtration assemblies engineered to enable pre-use post-sterilisation integrity testing and associated documentation for regulatory compliance.
Filling assemblies for sterile final fill
Single-use filling sets designed to ensure precise and sterile transfer into vials or bottles; engineered to minimise pulsation and meet particulate, endotoxin and sterility assurance requirements.
Transfer sets
Tubing assemblies to reliably connect sequential process steps and maintain closed fluid paths across upstream and downstream operations.
T-transfer (manifold) assemblies
T-shaped or manifold-style single-use assemblies for controlled merging of multiple fluid streams used in formulation or buffer preparation.
Microfiltration assemblies
Single-use microfiltration filter assemblies for removal of viable and non-viable particles during harvesting, clarification and fluid preparation.
Sample sets for in-process control
Assemblies enabling aseptic sampling for in-process monitoring without interrupting closed systems.
PUPSIT-ready sterile filtration assemblies
Turnkey single-use filtration assemblies engineered to enable pre-use post-sterilisation integrity testing and associated documentation for regulatory compliance.
Services
End-to-end design, prototyping and production of bespoke single-use assemblies for upstream, downstream and fill & finish applications.
Production in ISO Class 7 (in operation) cleanrooms and ISO Class 8/9 spaces with trained operators and cGMP-aligned procedures.
Manufacture and packaging of assemblies for third-party branding, including custom labelling, barcoding and contract stockholding.
Vendor-managed inventory, exclusive stock management, scheduled deliveries (JIT/Kanban) and rapid-response inventory programs to mitigate component shortages.
Support for validation documentation, risk assessments, sterility assurance strategies and alignment with EU GMP Annex 1 and ISO requirements.
Development and deployment of tools to calculate CO2-equivalent per assembly and initiatives to monitor and reduce Scope 3 emissions.
End-to-end design, prototyping and production of bespoke single-use assemblies for upstream, downstream and fill & finish applications.
Production in ISO Class 7 (in operation) cleanrooms and ISO Class 8/9 spaces with trained operators and cGMP-aligned procedures.
Manufacture and packaging of assemblies for third-party branding, including custom labelling, barcoding and contract stockholding.
Vendor-managed inventory, exclusive stock management, scheduled deliveries (JIT/Kanban) and rapid-response inventory programs to mitigate component shortages.
Support for validation documentation, risk assessments, sterility assurance strategies and alignment with EU GMP Annex 1 and ISO requirements.
Development and deployment of tools to calculate CO2-equivalent per assembly and initiatives to monitor and reduce Scope 3 emissions.
Expertise Areas
- Single-use systems manufacturing
- Cleanroom assembly and controlled-environment production
- Sterile filtration and PUPSIT integration
- Quality assurance and analytical testing (particulates, endotoxin, bioburden)
Key Technologies
- Single-Use Technologies (SUTs)
- PUPSIT (pre-use post-sterilisation integrity testing)
- Gamma irradiation sterilisation (third-party processing)
- Microfiltration membrane processes
News & Updates
Whitepaper addressing eco-design, circularity, supply-chain collaboration and data-driven tools to reduce environmental impact of single-use assemblies.
Achieved Silver rating in the EcoVadis sustainability assessment, reflecting organisation-level sustainability actions across products, processes and partnerships.
Whitepaper addressing eco-design, circularity, supply-chain collaboration and data-driven tools to reduce environmental impact of single-use assemblies.
Achieved Silver rating in the EcoVadis sustainability assessment, reflecting organisation-level sustainability actions across products, processes and partnerships.