Single use technologies for bioprocessing and manufacturing of biologics

Single use technologies (SUT) are increasingly being used at all stages of the biopharmaceutical manufacturing process and their adoption has greatly accelerated in recent years. These disposable polymer-based components may include:
  • Filters
  • Process containers (bags)
  • Tubing
  • Connectors
  • Gaskets
  • Valves

Controlling extractables and leachables for SUT

Unfortunately all product contact surfaces have the potential to release extractable material into a process - so extractables and leachables must be considered to ensure components are unadulterated. Smithers uniquely qualifies to support clients in this challenge, with world-class polymer knowledge and specialst expertise in both standard and customised protocols to assess the impact of extractables and leachables on the use of these products.

How Smithers can help

Our expertise extends beyond extractables and leachables, Smithers can support you throughout the development process for your SUT.
  • Materials: Expert support with selection, characterization and compatibility
  • Compliance: Testing to help you demonstrate regulatory with FDA, MHRA, EMA, USP and ISO as well as BPOG and PQRI guidelines.
  • Extractables and Leachables: extensive expertize in controlled extraction studies, identification of extractables and leachable profile assessments.
  • Device Testing: From testing container closure to connection compatibility, we test devices to ensure they perform as designed and meet relevant regulations.
  • Transit studies: Simulated distribution testing to recreate supply chain condition faced by your device.
  • Product simulation studies: Combination of testing studies to simuate real life usage of your device and the impact this might have on patient safety through its lifetime.
 

Supporting the industry

To support the continued growth of this industry Smithers is an active member of the ASTM E55 committee on the Manufacture of Pharmaceutical and Biopharmaceutical Products and the work item WK43975 “New Standard Determining and Characterizing BioProcess Extractables from Components, Subassemblies, and Assemblies Used in Single-Use Applications: Part 1-Preparation of Extractables Test Solutions”. 

Smithers is also a member of the Bioprocess Systems Alliance (BPSA), an industry-led corporate member trade association dedicated to encouraging and accelerating the adoption of single use manufacturing technologies used in the production of biopharmaceuticals and vaccines. We support users and SUT manufacturers with industry protocols such as the Parential Drug Association’s Technical Report No.66 and BPOG.

 

Single Use Technologies and Processing Equipment