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Flexible, scalable containment for bioprocessing workflows
Thermo Fisher single-use bioprocessing bags (BPCs) support sterile, ready-to-use performance—reducing direct contact with stainless steel to help minimize contamination risk and accelerate turnaround between production runs. Engineered with advanced films like Thermo Scientific Aegis5-14—a five-layer biofilm manufactured in a cGMP facility—these bags offer exceptionally low extractables and leachables to protect product quality. Every unit is produced under rigorous quality standards, aligned with cGMP (21 CFR Part 820) and ISO 9001, enabling consistent, reliable performance. Secure, leak-resistant connections are supported with the Thermo Scientific BioTitan Retention Device, creating a robust 360-degree seal you can trust throughout the various stages of your process.
Bag formats and configurations to support workflow stages
Bioprocessing workflows vary by volume, sterility, mixing, and transfer needs. Thermo Scientific single‑use bags align to each step of your workflow and scale:
Design your single-use fluid transfer assembly—faster and with confidence
Our Single-Use Assembly Configurator Tool makes it easy to create custom assemblies tailored to your process or select in-stock, ready-to-ship options to help reduce lead times.
Enhance productivity with specialty bioprocessing bags and containers
Integrity built into every step
From cleanroom manufacturing and component validation to shipment, installation, and use, every Thermo Scientific BioProcess Container is designed, tested, and supported to help protect your process when it matters most.
Integrity is more than the absence of leaks—it's the assurance that every aspect of the BPC performs as intended. Integrity is influenced by manufacturing controls, component design, sterilization, packaging, shipping, handling, installation, and operation. That's why Thermo Fisher approaches integrity as a complete system—not a single test. Explore the journey below to see how quality and integrity are built into every stage of a BioProcess Container's lifecycle.
- Stage 1
- Stage 2
- Stage 3
- Stage 4
- Stage 5
- Stage 6
- Stage 7
Stage 1: Manufacture
Built in a controlled environment
“How do I know contamination and variability are controlled before manufacturing even begins?”
Integrity begins long before a BioProcessing bag is filled. Every Thermo Scientific Single-Use Technology product is manufactured and assembled in ISO Class 7 cleanrooms with environmental monitoring programs designed to control air quality and surface conditions. Products are manufactured under controlled processes and documented quality systems before moving to inspection and testing.
Stage 2: Connect
Components designed for secure connections
“Leaks can occur at various points in a single-use assembly. How is that risk reduced?”
Bioprocess container chambers are built from high-performance multilayer films with validated heat-sealing processes to ensure reliable containment of your product. By providing both flexibility and strength, the chamber can withstand the physical demands of your process.
Connection points are among the most critical areas of any single-use system. Thermo Fisher developed the BioTitan Retention Device to create consistent 360-degree tubing retention and reduce risks associated with traditional cable ties and retention methods. The design has been tested across thousands of tubing and connector combinations and pressure-tested up to 80 psi without connection failures.
Stage 3: Test
Every container is inspected. Every lot is challenged.
“How do I know the container leaving the factory meets specification?”
Integrity is verified through multiple inspections and tests during manufacturing. Every bioprocess container undergoes visual inspection, with leak testing applied by product and use case. In addition, representative products are subjected to burst testing and tensile testing to verify seal strength, component attachment strength, and failure modes exceed design requirements. Inspection occurs throughout manufacturing and again during final release.
Stage 4: Sterilize
Sterility validation beyond individual components
“How do I know sterilization remains effective across complex assemblies?”
Sterility assurance requires validating more than individual components. Thermo Fisher utilizes worst-case validation assemblies containing extensive tubing, fittings, and film configurations to challenge sterilization processes under the most demanding conditions. Quarterly validation programs help verify sterility assurance, endotoxin, particulate, and irradiation performance across the product family.
Stage 5: Ship
Packaging designed for the real world
“What happens between the factory and my facility?”
Product integrity must survive transportation, handling, and storage—not just manufacturing. Packaging systems are qualified using internationally recognized ISTA shipping methodologies. Following transportation testing, products undergo inspection and leak testing to verify performance after shipment stresses.
Stage 6: Monitor
Visibility through field performance
“How often do integrity issues actually occur?”
Confidence is strengthened by transparency. Thermo Fisher continuously tracks and analyzes field performance data to monitor product quality and identify opportunities for continuous improvement.
STAT: 0.02% reported leak rate* based on real world data
*Overall complaint rate, leakage bag seam or connection, as of September 2025 based on complaint data ranging from January 2020 through August 2025. Impulse not included in mixing bags.
Stage 7: Install
Integrity doesn't end at delivery
“What if damage occurs during unpacking or installation?”
Even a perfectly manufactured container can be compromised by improper handling. To help customers protect integrity through deployment, Thermo Fisher provides detailed guidance covering receipt inspection, unpacking, handling, installation, and pre-use evaluation. The guidance includes defect identification criteria, handling best practices, and troubleshooting support.
Integrity is a system
Most discussions about integrity focus on a single test, but successful bioprocessing depends on a chain of controls working together:
✓ Experienced engineering support for custom design development
✓ Use of qualified raw materials and components, including the Global Standard Component Library (GSCL)
✓ Controlled cleanroom manufacturing
✓ Engineered connection security
✓ Inspection and leak testing
✓ Sterility validation
✓ Transportation qualification
✓ Field performance monitoring
✓ Installation and handling guidance
Because protecting your process requires confidence at every step—not just one.
Related fluid management solutions
Complementary solutions—validated connectors, tubing, aseptic transfer sets, and compatible rigid containers—work with single‑use bags to maintain sterility end‑to‑end.
Explore our fluid management page for details.
Frequently asked questions
Bioprocessing bags and containers enable single‑use operations by offering a sterile, closed barrier between process equipment and materials such as media, cells, and buffers. They lower contamination risk, speed changeovers by removing extensive cleaning, add flexibility across storage, mixing, and transfer, and help reduce cross‑batch risk in compliant single‑use workflows.
Start by confirming compatibility with your existing equipment and connectors. Then evaluate the film—the bag’s multilayer material—for mechanical integrity and barrier performance. Choose films with low leachables and extractables and widely used compatibility with your specific media, cells, and buffers to help minimize sample impact and leak risk.
Cable ties are used to secure tubing connections, but they can cause uneven compression, create sharp edges, and often require bubble wrap for shipping, leading to tedious unpacking. Thermo Scientific bioprocessing bags use the Thermo Scientific BioTitan Retention Device to create a smooth, 360-degree seal that helps prevent leaks and eliminates the need for bubble wrap during shipping.
Single‑use bags cut water, energy, and chemicals by reducing cleaning and sterilization, but create polymer waste that needs responsible disposal or energy recovery; stainless steel reduces solid waste but requires intensive clean‑in‑place/sterilize‑in‑place, increasing utilities, emissions, and wastewater. A process‑specific lifecycle assessment is recommended to quantify sustainability tradeoffs.
Additional bioprocessing resources
Bioprocessing resources
For research use or further manufacturing. Not for diagnostic use or direct administration into humans or animals.