Application Guide for Single-Use Liquid Storage Bags in Biopharmaceuticals: Core Advantages and Selection Key Points

 

In the field of biopharmaceuticals and bioprocesses, single-use liquid storage bags, as key consumables, have become the preferred solution for liquid storage and transportation due to their sterility, flexibility, and safety. With the iterative upgrading of technology, the application scope of such consumables continues to expand, providing strong support for pharmaceutical companies to improve process efficiency and compliance.

 

I. Analysis of Core Application Scenarios

1. Culture Medium and Buffer Solution Treatment

Single-use liquid storage bags are widely used for storing the culture medium and buffer solutions required for cell culture. Their sealing performance can prevent microbial contamination. Coupled with the chemical stability of the multi-layer film material, they ensure that the components of the liquid do not degrade during transportation and temporary storage.

2. Management of Bulk Drugs and Intermediate Products

In the production process of biological products such as monoclonal antibodies and vaccines, liquid storage bags can safely store high-value bulk drugs and intermediate products temporarily. Some models are designed with an EVOH barrier layer to effectively reduce the oxygen permeability, meeting the storage requirements of oxygen-sensitive products.

3. Harvested Liquid and Downstream Processing

From the harvesting of cell culture fluid to the chromatography purification stage, liquid storage bags can achieve closed liquid transfer. When used in conjunction with automated equipment, their elastic structure can adapt to different pressure environments, reducing the risk of human operation errors.

4. Sample Collection and Quality Control

For small-batch samples on the R & D end, customized liquid storage bags provide a variety of sampling port designs, supporting aseptic sampling and sample retention traceability, which comply with the regulatory requirements of the FDA and NMPA for data integrity.

 

II. Technical Performance and Core Advantages

Through material innovation and process optimization, modern single-use liquid storage bags have formed the following differential competitiveness:

- Sterility Assurance System: Gamma-ray irradiation sterilization is adopted, and the inner layer film material has passed the USP Class VI biocompatibility test, ensuring that there are no extractables when in direct contact with the liquid medicine.

- Breakthrough in Materials Science: The five-layer co-extruded film technology has become the industry benchmark, combining mechanical strength and low-temperature tolerance. Some products support storage in a wide temperature range from -80°C to 121°C, meeting the requirements of freeze-thaw processes.

- Customized Adaptability: 3D three-dimensional bag body designs of different specifications are provided, which can integrate intelligent modules such as temperature sensors and mixing devices to meet the flexible production needs of pharmaceutical companies.

- Compliance Traceability System: Electronic records are established from the raw material batch to the production process, complying with the full life cycle management requirements of key consumables in the "Good Manufacturing Practice for Pharmaceuticals".

 

III. Scientific Selection Strategy

Biopharmaceutical companies need to systematically evaluate three dimensions when selecting liquid storage bags:

1. Process Compatibility

Choose the 2D (flat) or 3D (three-dimensional) structure according to the volume of the reaction system. For large-scale production, three-dimensional bags with a capacity of more than 2000L are preferred, and the filling efficiency can be improved by using an automatic bagging system.

2. Liquid Compatibility

The compatibility of the liquid storage bag material with the pH value and ionic strength needs to be verified. For example, special film materials with a fluoropolymer inner layer should be selected for strongly acidic solutions.

3. Supply Chain Stability

It is recommended to choose suppliers with dual production bases to reduce the risk of supply interruption through regionalized production capacity layout. At the same time, pay attention to the supplier's verification document system to ensure that a complete extractables/leachables research report can be provided.

 

IV. Industry Technology Development Trends

Currently, there are three major innovation directions in the field of biopharmaceutical consumables:

- Iteration of Multi-Layer Film Materials: The new five-layer co-extruded film reduces the oxygen transmission rate to the level of 0.01 cc/100 in²/day by optimizing the thickness of the EVOH barrier layer, extending the preservation period of products such as stem cell preparations.

- Intelligent Upgrade: Integrated sensors can monitor the temperature and pressure parameters inside the bag in real time. The data is directly connected to the MES system through the Internet of Things platform, contributing to the construction of a digital pharmaceutical factory.

- Acceleration of Localized Production: Domestic enterprises are accelerating the realization of full localization of consumables by breaking through the core material technologies such as PVDF filter membranes. International leading enterprises are shortening the supply cycle to 4 - 6 weeks by building regional production bases, significantly enhancing the resilience of the supply chain.