Single-use assemblies

Single-use assemblies (SUAs) have fundamentally transformed biomanufacturing by replacing rigid stainless-steel piping and vessels with pre-sterilized, disposable polymer fluid paths. Comprising biocontainment bags, platinum-cured silicone tubing, sterile connectors, and integrated sensors, these assemblies arrive ready-to-use after gamma or X-ray irradiation. By eliminating the need for energy-intensive Clean-in-Place (CIP) and Steam-in-Place (SIP) operations, SUAs reduce facility water consumption by up to 80% and drastically shrink capital expenditure. Crucially, single-use technology allows contract manufacturers to switch between entirely different cell lines or biologic products in hours rather than weeks, virtually eliminating the risk of batch-to-batch cross-contamination.

The key directions of single-use assemblies are:

1. Bioprocess Containers (2D/3D Bags): Multilayer polymer bags ranging from 50 mL to 3,000 L, utilizing advanced contact layers (e.g., ULDPE or EVA) engineered to minimize the shedding of extractables and leachables (E&L) into the drug product.
2. Sterile Connectors and Disconnectors (Connectors): Patented mechanical valves (e.g., AseptiQuik) that allow operators to securely join two separate sterile fluid paths in an unclassified (non-sterile) environment without breaching the sterility of the internal flow.
3. Pre-assembled Manifolds (Custom fluid paths): Highly customized networks of tubing, filters, and aseptic sampling ports designed to seamlessly connect bioreactors directly to downstream chromatography and filtration skids.
4. Integrated Single-use Sensors (Smart assemblies): The embedding of pre-calibrated optical dissolved oxygen, pH, and pressure sensors directly into the polymer matrix, eliminating the need to insert reusable probes.

Sectoral value chain#

[Polymer Extrusion & Film Casting] ──> [Component Assembly & Welding] ──> [Gamma/X-Ray Sterilization] ──> [E&L Validation]
                                  │
                          (Sterile Connectors)
                                  │
                                  ▼
[Biopharma Manufacturing] <─── [Logistics & Inventory] <─────┘

Value chain levels#

Cross-cutting technologies of the sector:

• X-Ray sterilization: A rapid pivot away from cobalt-60 gamma irradiation towards machine-generated X-ray sterilization to overcome global radioactive isotope supply chain bottlenecks.
• Advanced film architecture: The development of ultra-low density polyethylene (ULDPE) contact layers that exhibit near-zero interactions with sensitive mammalian cells (e.g., CHO).
• Automated tube welding: Devices that thermally melt and fuse thermoplastic elastomer (TPE) tubing to create a sterile connection without mechanical connectors.

The reliability of single-use assemblies hinges entirely on the integrity of the polymer film, the robustness of the sterile connection, and comprehensive material science validation.

1. Multi-layer Bioprocess Film:
   • Comprises up to 7 layers, including a structural outer layer (PET or nylon), an oxygen/gas barrier core (EVOH), and a highly inert inner contact layer (ULDPE or EVA).
   • Prevents gas exchange that could ruin cell cultures while ensuring no toxic plasticizers leach into the drug substance.
2. Mechanical Sterile Connectors:
   • Features overlapping, peel-away sterilization membranes.
   • Operators physically connect the two halves, click them into place, and simultaneously pull away the protective membranes, instantly creating a sterile fluid path in a non-sterile room.
3. Thermoplastic Elastomer (TPE) Welding:
   • TPE tubing is placed into an automated heated jaw device. The device cuts the tubing, aligns it with another tube, and melts them together at over 200°C.
   • Provides a permanent, sterile, and leak-proof fusion capable of withstanding high internal pressures during downstream filtration.