Sterile Isolation Bags: Core Application Scenarios and Scientific Purchase Guide

 

As a key consumable for ensuring a clean environment, sterile isolation bags play an irreplaceable role in areas such as pharmaceutical R & D, biotechnology, medical operations, and precision manufacturing. Through the combination of physical barriers and filtration technology, they achieve the unity of environmental control, pollution protection, and operational safety, and are one of the core tools in modern industrial production and scientific research.

 

I. Analysis of Core Application Scenarios

1. Production of Pharmaceuticals and Biological Preparations

In key processes such as aseptic filling, raw material transfer, and semi - finished product sampling, isolation bags can effectively isolate microorganisms and particulate contaminants in the air, ensuring that pharmaceuticals meet the sterility standards stipulated in the pharmacopoeia. For example, in the packaging process of antibiotic powder injections, isolation bags need to meet strict requirements such as no chemical dissolution and zero introduction of foreign matter.

2. Medical Infection Control

Medical - grade isolation bags are required for the storage and transportation of surgical instruments after sterilization to prevent the risk of infection caused by pre - operative exposure of the instruments. The isolation kit system can achieve double protection for the instruments and the surgical area environment, complying with the infection control specifications of tertiary hospitals.

3. Biological Laboratory Operations

Experiments such as cell culture and gene editing require a cleanliness level of ISO 5 (Class 100 clean) or higher. Isolation bags made of multi - layer composite materials, combined with RTP rapid transfer interfaces, can maintain the stability of the internal environment of the incubator and avoid experiment failures caused by cell contamination.

 

II. Principle of Function Realization

- Four - level Protection System:

① Micron - level filtration membranes (0.22μm - 0.45μm) intercept microorganisms; ② Hot - melt edge - sealing technology ensures the integrity of the seal; ③ Anti - static layers prevent particle adsorption; ④ Some models are integrated with humidity indicating devices to monitor the integrity of the packaging in real - time.

- Cross - contamination Prevention and Control: Products with compartmental design can load multiple materials simultaneously, and the physical partition design can prevent the migration of components between different materials.

 

III. Product Types and Technical Parameters

1. Pharmaceutical - grade Isolation Bags

They need to comply with the USP<71> sterility test standard and be resistant to gamma - ray sterilization. The common materials are medical - grade polyethylene and polypropylene composite films. Versions with a light transmittance of less than 5% can be used for the protection of photosensitive drugs.

2. Expandable Isolation Systems

The modular - designed bag bodies can be seamlessly connected to isolators through RTP interfaces, which are suitable for the closed - loop production chain of cell therapy products, reducing the manual intervention link by up to 80%.

3. Intelligent Monitoring Products

Isolation bags integrated with NFC chips can record data such as temperature, humidity, and opening time, meeting the requirements of FDA 21 CFR Part 11 for electronic records compliance.

 

IV. Scientific Purchase Methodology

1. Material Certification System

Prioritize materials that have passed the ISO 10993 biocompatibility certification and the USP Class VI plastic test. Products that come into contact with cell culture media need to additionally pass the animal - derived component - free (ADCF) verification.

2. Performance Verification Indicators

Pay key attention to:

- Filtration efficiency (The filtration efficiency of H14 - grade HEPA filters is > 99.995%);

- Sealing strength (Burst pressure > 50kPa);

- Puncture resistance (≥4N in the ASTM F1306 standard test).

3. Compatibility Assessment

The measurement error of the equipment interface size needs to be controlled within ±1.5mm. Isolation bags used in freeze - drying processes should have low - temperature resistance at - 80°C, and models for high - temperature sterilization need to withstand 121°C high - pressure steam treatment.

 

V. Optimization Suggestions for Use

- After opening, material transfer should be carried out in a Class A environment.

- When operating in a laminar flow hood, the surface of the bag body should be kept parallel to the airflow direction.

- Conduct monthly sampling for the dye penetration method sealing test.

 

With the iterative upgrading of isolator technology, the new - generation isolation bags have realized intelligent linkage with automatic filling lines. In the future, they will integrate more IoT monitoring functions, providing basic support for Pharmaceutical 4.0 and precision medicine. When selecting, it is recommended to combine specific process requirements, verify the product applicability through GMP simulated filling tests, and establish a full - lifecycle quality management system.