What is a Single-Use System (SUS) in biopharmaceuticals?
A single-use system (SUS) is a disposable fluid handling device system used in biopharmaceutical production, typically consisting of disposable bags, tubing, filters, and connection components. These systems can be discarded after a single use, without the need for cleaning or sterilization, thereby reducing the risk of cross-contamination and improving production efficiency.
What is a single-use system (SUS) in biopharmaceuticals?
A single-use system (SUS) is a disposable fluid handling device system used in biopharmaceutical production, typically consisting of disposable bags, tubing, filters, and connection components.
These systems can be discarded after a single use, without the need for cleaning or sterilization, thereby reducing the risk of cross-contamination and improving production efficiency.
Disposable systems are widely used in:
Biopharmaceutical production
Vaccine manufacturing
cell culture
Protein purification
Thanks to its flexibility and high cleanliness, SUS has become one of the key technologies in modern biopharmaceutical manufacturing.
What is a single-use system?
A single-use system (SUS) is a biopharmaceutical production equipment system that employs disposable materials, replacing traditional stainless steel equipment with one-time-use components.
Traditional biopharmaceutical equipment typically requires:
wash （CIP）
sterilization （SIP）
Strict Verification
Disposable systems avoid these complex steps by using pre-sterilized disposable components.
The SUS system is usually composed of the following components:
Disposable bioreactor bag
Disposable hose assembly
sterilizing filter
One-time connectors and joints
Application of disposable system in biopharmaceutical
Single-use systems play an important role in the multiple stages of biopharmaceutical production.
cell culture
In biopharmaceutical production, cell culture is a critical step.
SUS can be used for:
single-use bioreactor
Culture medium storage bag
culture medium delivery system
These systems can reduce pollution risks and increase production flexibility.
Downstream purification
In the production of proteins or antibodies, downstream purification steps also require high-cleanliness equipment.
Disposable systems are commonly used for:
Buffer storage
fluid delivery
Filtration and concentration
Filling and Solution Preparation
In the drug manufacturing process, single-use systems can also be used for:
Sterile solution preparation
Medicine delivery
Filling system
Primary advantages of disposable systems
The rapid development of SUS in the biopharmaceutical industry is mainly attributed to the following factors.
Reduce pollution risk
Disposable systems are typically pre-sterilized to reduce:
microbial contamination
cross contamination
Residual cleaning
Reduce production costs
The elimination of the need for cleaning and sterilization equipment allows the disposable system to reduce:
Cost of cleaning equipment
Water and steam consumption
equipment maintenance cost
increase production flexibility
The one-time system features a highly modular design, enabling rapid adaptation to diverse production requirements.
for instance ：
short run production
multi-variety production
clinical trial production
Common materials for disposable systems
Disposable systems are typically manufactured using high-purity polymer materials, such as:
Medical-grade silicone
polytene （PE）
sulan （PP）
TPE thermoplastic elastomer
These materials have the following characteristics:
Good biocompatibility
low precipitate
Irradiation sterilization is feasible
Development trend of disposable system
With the rapid development of the biopharmaceutical industry, the application of disposable systems is becoming increasingly widespread.
Future trends include:
A larger-scale one-time bioreactor
higher cleanliness material
automated fluid processing system
modular production system
Disposable technology is gradually becoming an important part of modern biopharmaceutical factory.
frequently asked questions FAQ
What is a biopharmaceutical single-use system?
The single-use system (SUS) in biopharmaceutical production is a disposable fluid handling device system used for cell culture, filtration, transportation, and solution preparation in biopharmaceutical manufacturing processes.
What are the advantages of disposable systems?
Key advantages include:
Reduce pollution risk
Reduce cleaning and sterilization steps
Reduce production costs
increase production flexibility
In which fields are disposable systems primarily applied?
SUS is primarily used for:
Pharmaceuticals
Vaccine production
cell therapy
Antibody drug production
sum up
The single-use system (SUS) for biopharmaceuticals is a technical solution that accomplishes fluid processing and production operations through disposable components.
Compared to traditional stainless steel systems, disposable systems provide higher cleanliness, lower contamination risks, and greater production flexibility.
With the development of the biopharmaceutical industry, disposable systems will play an increasingly important role in future drug production.
About Us
This article is compiled and released by Shanghai Cunjian Fluid Technology Co., Ltd. The company specializes in fluid transportation solutions, with products including biopharmaceutical hoses, sanitary-grade connectors, and various high-purity fluid components, which are widely used in the biopharmaceutical, food, and semiconductor industries.
