Disposable Open Liquid Preparation Bags: An Efficient Solution for Solution Handling in the Biopharmaceutical Industry

 

In the field of biopharmaceuticals, disposable open liquid preparation bags have become core consumables for processes such as culture medium preparation and buffer solution preparation, thanks to their safety, flexibility, and high efficiency. Through the combination of innovative design and advanced material technology, these products offer pharmaceutical companies liquid handling solutions that better meet GMP standards.

 

Core Features and Technological Innovations

1. Multi - layer Protective Materials

Food - grade multi - layer co - extruded film materials are used, integrating wear - resistant polypropylene woven fabric and antioxidant functional layers. This not only improves the anti - penetration ability but also allows the bags to withstand environmental temperatures ranging from - 40°C to 80°C. Some products are equipped with a patented protective layer, which enhances tear resistance by improving the fiber structure, reducing the risk of side - wall impact caused by liquid sloshing during transportation or stirring.

 

2. Intelligent Safety System

High - end models are integrated with an automatic pressure regulation device that automatically releases pressure when the internal air pressure exceeds 0.0065 MPa, preventing the bag from bursting. The integrated valve system, with its protective sleeve design, can prevent liquid from contaminating the container and reduce the residual discharge volume. The residual rate is reduced by more than 30% compared with traditional containers.

 

3. Customized Configuration System

Twelve standard specifications ranging from 19 liters to 568 liters are supported, and customization services for pipeline interfaces, stirring ports, etc. are also provided. Some systems can be matched with overhead stirring devices to meet the large - scale solid - liquid mixing requirements of over 2000 liters, and are compatible with all scenarios from laboratory research and development to industrial production.

 

Analysis of Industry Application Value

- Process Adaptability: These bags are suitable for processes that require a strict aseptic environment, such as protein purification and vaccine preparation. After irradiation sterilization, the microbial control level of the products can reach ≤10⁻⁶ CFU/cm², meeting the USP<71> pharmacopoeia standard.

- Cost Optimization Model: Compared with stainless - steel containers, they can save 40% of cleaning verification costs and 70% of storage space. The single - use feature avoids the risk of cross - contamination, making them especially suitable for multi - product co - production workshops.

- Improvement of Operational Efficiency: Models equipped with gravity or screw - type filling ports, combined with a PLC - controlled quantitative packaging system, can achieve a filling accuracy of ±0.5%, with a maximum processing speed of 5 bags per hour.

 

Key Dimensions for Selection Decision - making

1. Verification of Process Matching Degree

- For buffer solution preparation, attention should be paid to the pH tolerance range (it is recommended to be 2 - 12).

- For high - temperature sterilization processes, the material should pass the heat - resistance test at 121°C for 30 minutes.

 

2. Assessment of Supply Chain Risks

- Prioritize suppliers that have passed the ISO 13485 certification.

- Check whether they have a complete extractables/leachables (E&L) research report.

 

3. Calculation of Life - cycle Costs

- Calculate the unit - volume processing cost (including waste disposal fees).

- Evaluate the balance point between the cost of customized molds and long - term usage volume.