Application of Single-Use Bioprocessing Technology in the Pharmaceutical Industry
Single-use bioprocessing technology refers to the use of pre-sterilized disposable components, such as bioreactor bags, tubing assemblies, and filters, instead of traditional stainless steel systems in pharmaceutical manufacturing.
一.What Is Single-Use Bioprocessing Technology?
Single-use bioprocessing technology refers to the use of pre-sterilized disposable components, such as bioreactor bags, tubing assemblies, and filters, instead of traditional stainless steel systems in pharmaceutical manufacturing.
It is widely used in:
Monoclonal antibody (mAb) production
Vaccine manufacturing
Cell and gene therapy (CGT)
Biopharmaceutical development
Its main advantages include reduced contamination risk, increased flexibility, and faster production cycles.
二.Key Components of Single-Use Systems
1. Single-Use Bioreactors (SUB)
Volume: 50L – 2000L
Materials: multilayer films (PE/EVOH/PP)
2. Single-Use Tubing and Connections
Materials: C-Flex, Silicone, TPE
Sterile connectors for aseptic transfer
3. Single-Use Filtration Systems
Depth filters and sterilizing filters (0.2 μm)
4. Single-Use Bags
Capacity: 1L – 3000L
三.Key Technical Specifications
1. Sterility Assurance Level
SAL = 10⁻⁶
2. Extractables & Leachables
Controlled at ppm / ppb levels
Compliant with USP standards
3. Temperature Range
Typical: 2°C – 40°C
Optional: down to -80°C
4. Pressure Range
Typically <0.5 MPa
5. Biocompatibility
USP Class VI
ISO 10993 compliant
四.Single-Use vs Stainless Steel Systems
Parameter | Single-Use | Stainless Steel |
Cleaning | Not required | Required |
Contamination Risk | Low | Moderate |
CAPEX | Low | High |
Flexibility | High | Limited |
五.Applications in the Pharmaceutical Industry
Vaccine production
Monoclonal antibody manufacturing
Cell & gene therapy
六.Industry Solutions
Companies are focusing on aseptic connections and high purity fluid handling systems.
For example, Shanghai Cunjian Fluid Technology Co., Ltd. provides customized single-use fluid connection solutions for biopharmaceutical applications.
七.Conclusion
Single-usebioprocessingtechnology is transforming pharmaceutical manufacturing by offering:
Lower contamination risk
Faster deployment
Greater flexibility
八.FAQ
1. What is single-use bioprocessing?
It is a manufacturing approach using disposable components instead of reusable systems.
2. Is single-use technology safe?
Yes, it meets SAL 10⁻⁶ sterility standards.
3. Why is it widely used in pharma?
Because it reduces contamination and improves efficiency.
