With the continuous development of life sciences and biotechnology, cold chain biological products are increasingly used in the fields of medical treatment, vaccines, biopharmaceuticals, regenerative medicine, etc. The common feature of these products is that they are extremely sensitive to temperature. During the entire production, transportation and storage process, they must always be maintained at a certain low temperature to ensure their biological activity and product stability. In the cold chain system, the separation and purification process of the stock solution also faces higher technical challenges, especially in achieving efficient separation while maintaining low temperature. Traditional centrifugal equipment does not work efficiently under low temperature conditions, and the “tubular centrifuge” has gradually become an indispensable and important equipment in the processing of cold chain biological products due to its excellent separation performance, high speed design and excellent adaptability to low temperature environments.
Separation requirements and challenges of cold chain biological products
Introduction to cold chain biological products
Cold chain biological products mainly include vaccines, monoclonal antibodies, blood products, gene therapy drugs, recombinant proteins, enzymes, bioactive peptides, etc. These products generally have the following characteristics:
High heat sensitivity: Once exposed to room temperature or even higher temperature environment, proteins are prone to denaturation and active substances will quickly lose their effectiveness;
Complex ingredients: Contains a large amount of protein, peptide, cell fragments, viral vectors or impurity particles;
High purity requirements: Medical use determines that there are extremely strict restrictions on the content of impurities and pollutants;
Difficult process: Separation and purification are completed under low temperature and sterile environment, and the equipment stability and hygiene level are extremely high.
Main technical challenges faced by cold chain separation
High temperature control accuracy requirements: The process usually needs to be maintained at 2℃~8℃ or lower, and conventional equipment is difficult to operate stably for a long time.
Traditional centrifugal equipment is inefficient or not suitable for low temperature: insufficient separation accuracy, low speed, and cumbersome cleaning.
Various batch sizes and high flexibility requirements: There are both experimental-level needs and large-scale commercial production.
Increasing demand for sterile and closed systems: prevent cross contamination and comply with GMP regulations.
In this context, tubular centrifuges that can operate stably in low-temperature environments are gradually showing their unique value in cold chain separation.
Technical features and core advantages of tubular centrifuges
Tubular centrifuges are high-speed, high-field strength liquid-solid separation equipment. The strong centrifugal force field generated by the vertical cylindrical high-speed rotating drum can effectively separate fine suspended particles or cells from liquids. Its applicability in cold chain biological product processing is reflected in the following aspects:
High separation accuracy
The speed of tubular centrifuges can usually reach 15,000 rpm or even 20,000 rpm, and the centrifugal force generated is as high as 20,000 g~25,000 g. It can effectively separate nano- to micro-sized particles, especially suitable for the separation of protein precipitation, virus particles, cell fragments, impurities and residues.
Excellent low temperature adaptability
After matching cooling jackets, cooling coils or low-temperature control systems, tubular centrifuges can operate stably for a long time at 2℃~8℃ or even lower temperatures. The body material is made of stainless steel 316L, which has good thermal conductivity and corrosion resistance, ensuring uniform temperature distribution and no risk of thermal damage.
Closed aseptic design
Fully enclosed structure, can be used with CIP/SIP cleaning and disinfection system, reduce manual intervention, meet aseptic production and pharmaceutical GMP certification requirements, suitable for high-grade biological preparation production.
Easy to operate, low maintenance cost
Simple structure, easy maintenance, can be operated continuously or intermittently; very cost-effective for pilot workshops and small batch production.
Adaptable to a variety of processing volume requirements
From small laboratory models (5L/hour) to industrial large-capacity models (more than 100L/hour), corresponding configurations can be provided to help enterprises integrate from R&D to industrialization.
Typical applications of tubular centrifuges in cold chain biological products
Vaccine stock solution separation
In the process of vaccine preparation, whether it is inactivated vaccine, attenuated vaccine or genetically engineered vaccine, it is necessary to efficiently separate the supernatant, virus particles and cell residues at low temperature. Traditional filtration methods are inefficient and frequently blocked, while tubular centrifuges can stably output pure vaccine stock solution and improve the efficiency of subsequent fine filtration.
Low temperature separation of plasma products
Human plasma contains a variety of biologically active substances (albumin, immunoglobulin, etc.), and the precipitated substances must be separated at 2~6℃. Under the premise of maintaining low temperature, the tubular centrifuge can quickly strip off cell fragments and protein precipitation to improve the extraction efficiency.
Separation of recombinant protein and biological enzyme
When obtaining recombinant protein in expression systems such as Escherichia coli and yeast, the fermentation broth must be treated at low temperature to separate cells and supernatant. Tubular centrifuges can accurately separate insoluble inclusion bodies or soluble proteins, keeping enzyme activity and conformation intact.
Sample purification during cold chain transportation
For biological samples (such as cell culture fluid, RNA virus extracts, etc.) in the cold chain logistics process, they need to be purified or concentrated at the terminal. As a portable auxiliary equipment, the tubular centrifuge can quickly complete the separation task and reduce the cold chain interruption time.
In the highly sensitive and expanding industry chain of cold chain biological products, separation and purification are crucial. With its excellent low-temperature adaptability, high-speed and high-precision separation performance and good aseptic design, tubular centrifuges are becoming an indispensable key equipment in this field. For pharmaceutical companies, biotechnology companies and even scientific research institutions, choosing a tubular centrifuge with excellent performance and scientific configuration will greatly improve product quality, reduce process risks and enhance market competitiveness.
