Single Use Technologies and Processing Equipment
Smither supports the biopharmaceutical manufacturing sector in the compliant and effective use of single use technologies (SUT). Expertise ranges from polymer material selection and suitability to specialist support with control of extractables and leachables.
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. Smither uniquely qualifies to support clients in this challenge, with world-class polymer knowledge and specialist expertise in both standard and customised protocols to assess the impact of extractables and leachables on the use of these products.
How Smither can help
Our expertise extends beyond extractables and leachables. Smither 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 compliance with FDA, MHRA, EMA, USP and ISO as well as BPOG and PQRI guidelines.
Extractables and Leachables
Extensive expertise 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.
Shelf Life Studies
Accelerated aging and real-time aging test programs.
Packaging Performance
Range of tests including ISO 11607 package validation testing.
Transit Studies
Simulated distribution testing to recreate supply chain conditions faced by your device.
Technical Analysis and Failure Investigation
Problem troubleshooting and root cause failure analysis.
Product Simulation Studies
Combination of testing studies to simulate real life usage of your device and the impact this might have on patients through its lifetime.
Batch Release Testing
Based on functional requirements of the device or its packaging.
Supporting the industry
To support the continued growth of this industry Smither is 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 Parenteral Drug Association's Technical Report No.66 and BPOG.
Need SUT testing and compliance support?
Contact our team to discuss your single use technology testing, extractables and leachables, or regulatory compliance requirements.
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