UltraPure International


Manufacturer and integrator of custom single-use fluid handling systems for the (bio)pharmaceutical and life sciences industries. Offers open-architecture assembly and engineering from design to production in controlled cleanroom environments, with services for prototyping, supply chain management, quality testing and regulatory documentation.

Industries

manufacturing
pharmaceutical
product-design

Nr. of Employees

small (1-50)

UltraPure International


Products

Transfer set

Tubing assembly designed to connect two process steps and provide a controlled fluid path for transfer between unit operations.

Sample set

Assembly enabling aseptic in-process sampling to withdraw product samples without compromising closed systems.

Microfiltration set

Single-use membrane filtration assembly for removal of viable and non-viable particles (typical pore size 0.1–10 µm) used in clarification and sterile filtration.

T-Transfer set

T-shaped or manifold-style assembly used to combine two or more fluid streams for blending or formulation.

Filling set

Assembly for sterile, precise transfer into vials or bottles (fill-finish), often configured to minimize pump pulsation and meet particulate/endotoxin/sterility standards.

Buffer preparation set

Assembly for preparation and mixing of buffers to support upstream and downstream processes.

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Services

Custom single-use system solution design

Engineering of bespoke single-use assemblies using open-architecture design, including drawings, supplier qualification and prototype definition.

Prototyping and Rapid Response manufacturing

Fast-track prototyping and small-batch production for form-fit-function validation and emergency production using stocked standard components.

Cleanroom assembly and packaging for sterile supply

Assembly in ISO-classified cleanrooms, double-bagging and labeling, and preparation for sterilization with documented packaging processes.

Supply chain, inventory and VMI services

Storage, exclusive stock management, scheduled delivery programs and component availability planning to reduce lead-time risk.

Quality testing, QA support and regulatory documentation

Analytical testing (particulates, endotoxins, bioburden), provision of Certificates of Conformance/Analysis/Irradiation, and QA support for regulatory compliance and training.

OEM / contract manufacturing

Contract manufacture of customer-branded single-use products and assemblies under OEM agreements.

Expertise Areas

  • Single-use systems design and assembly
  • Cleanroom manufacturing and cGMP production
  • Supply chain and inventory management for biopharma components
  • Sterility assurance and validation programs
  • Show More (4)

Key Technologies

  • Single-use assemblies (tubing assemblies and manifolds)
  • Microfiltration (membrane-based filtration)
  • Aseptic disconnect/connectors for closed sampling
  • Peristaltic pumping for fill-finish
  • Show More (5)

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