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Overview

Features

  • Fully customizable, brand-agnostic assemblies
  • Double bagged and labeled
  • Gamma irradiation available (25-40 kGy)
  • Sterility, Endotoxin and Particulate claims available up request
  • (COC) Certificate of Conformance with each lot
  • Manufactured in an ISO Class 7 Cleanroom
  • Meets ISO 13485 requirements
  • USP<88> – USP Class VI for all components
  • USP<87> – ADCF Animal-Derived Component Free for all components

Description

Purity One Single Use Tubing Assemblies are custom-designed solutions for fluid transfer in single-use and aseptic processes in biopharmaceutical applications. These systems are designed by high-purity process and bioengineering professionals, who offer personalized attention to address the specific needs of an application. Purity One tubing assemblies are available with TPE or silicone tubing and with a variety of sterile or non-sterile connectors. For applications requiring safe and sterile disconnection, devices may be included from trusted brands such as Colder Products, Millipore, Pall, and Sartorius.

Purity One offers sterilized and non-sterilized assemblies, allowing versatile and cost-effective solutions for complex systems. Pre-sterilized single-use hose and tube assemblies reduce cross-contamination risks and eliminate the need for expensive CIP and SIP processes. All pieces are manufactured in an ISO Class 7 Cleanroom environment and meet GMP and ISO 13485 requirements for the manufacture of medical devices.

Tubing Options: 

  • Thermoplastic Elastomer (TPE)
  • Platinum-Cured Silicone
  • Other available upon request

Connector Options:

  • Colder Products Aseptiquik G/S/L sterile aseptic connectors
  • Colder Products MPC, MPX, and MPU connectors
  • Millipore, Pall, or Sartorius sterile connectors
  • Hose barb, tri-clamp, or other connector types
  • Others available upon request

Disconnector Options: 

  • Colder Products HFC Disconnector
  • Millipore Novaseal
  • Pall Kleenpack Disconnector
  • Sartorius Quickseal
  • Others available upon request

Applications

  • Sampling assemblies
  • Jumper assemblies
  • Filtration assemblies
  • Media Transfer assemblies
  • Storage and fluid transfer
  • Custom mixing assemblies
  • Single-use tubing manifold and pump solutions