In the pharmaceutical industry, isolators are widely used as an efficient closed system for the protection of sterile environments and the protection of hazardous substances. With increasing environmental control requirements for drug development and production, isolator technology has become a key device for ensuring the cleanliness of the work area and the safety of operators.

[JIEHAO] Jie Hao isolator

In the pharmaceutical industry, isolators are widely used as an efficient closed system for the protection of sterile environments and the protection of hazardous substances. With increasing environmental control requirements for drug development and production, isolator technology has become a key device for ensuring the cleanliness of the work area and the safety of operators.

isolator is a device that can provide a closed environment, strictly control the air through a high-efficiency particulate filter (HEPA), and support decontamination and pollution protection. The environment inside the isolator can be positive pressure (for sterility protection) or negative pressure (for hazardous substance protection), and its core goal is to prevent the diffusion of contaminants and the entry of external contamination.

According to the application requirements, isolators can be divided into two categories:

• flexible wall isolator: Made of flexible materials, suitable for light and portable applications.

• Rigid Wall Isolator: Made of strong materials such as stainless steel, suitable for high-grade protection needs.

In pharmaceutical production, rigid wall isolators have become the mainstream choice due to their strong puncture resistance and easy cleaning.

[JIEHAO] Rigid Wall Isolator

Shanghai Jiehao isolator is designed to meet strict airtightness and safety requirements as the core, its main design principles include

• closed system

isolator separates the operator from the work environment through a physical barrier to prevent the spread of hazardous substances. The air in the working environment is HEPA filtered to ensure ISO Class 5 (Class A) cleanliness.

HEPA filter

• Versatility

isolators can be used both for the protection of sterile environments and for the isolation of hazardous substances. For example, in the isolation requirements of OEB (Occupational Exposure Classification) Level 4, isolators can be used as physical barriers between operators and materials, while OEB5 requires that enclosed material handling and transfer should be carried out through glove ports in isolators and restricted access barrier systems (RABS).

OEB

• Material Selection

isolators are usually made of SUS 316L stainless steel, and the inner surface finish reaches Ra<0.4 & micro;m to ensure easy cleaning and disinfection. At the same time, the inflatable closed isolation door and flexible glove system make the operation more convenient.

[JIEHAO] Jie Hao isolator

• Environmental Monitoring

isolator is equipped with a real-time monitoring system that can monitor pressure difference, temperature and humidity, and particulate matter concentration to ensure that the working environment is always under control.

isolators makes them indispensable in pharmaceutical production. The main application scenarios include:

• Sterility Test

Shanghai Jiehao can provide ISO 5 clean environment for sterile testing of pharmaceutical products to ensure that the risk of microbial contamination of samples is minimized.

air cleanliness classification by particle concentration

• Dangerous drug preparation

Negative pressure isolators are used to handle highly toxic or cytotoxic drugs and protect operators from exposure hazards.

• gene and cell therapy

In advanced medical technologies such as cell therapy and gene editing, isolators provide a sterile environment for reagents and samples.

• small batch production

isolator is suitable for the production of small batches of high value-added drugs, ensuring the safety and flexibility of the production process.

• drug synthesis

isolator can be used for environmental protection during chemical reactions and reduce the leakage of harmful substances.

Jie Hao isolator used in the pharmaceutical industry

In the pharmaceutical industry, the preparation and handling of certain highly toxic drugs requires a higher degree of protection (e. g., OEB 4 and OEB 5 mentioned earlier).

1. isolator

• Double HEPA filter: Both intake and exhaust pass through the H14 filter to ensure that the air quality meets the standard.

• RTP and continuous lined bags: material transfer through a closed system to avoid contamination and leakage

• negative pressure turbulence design: to ensure that hazardous substances will not spread to the outside of the isolator

2.Verification Method

The protective performance of Jiehao isolators is evaluated through strict verification methods, including simulation tests using alternative substances such as lactose or paracetamol to detect indicators such as particle concentration and surface contamination to ensure that the tightness and safety of the equipment meet OEB standards.

isolator include:

Diagram of Isolator Composition

• Cavity Design

generally adopts a double-cavity structure, in which the buffer compartment is used to load materials, tools and instruments, and plays a role of buffer and isolation before the materials enter the operation compartment to avoid external pollution directly entering the work area. The operating compartment is the core working area for operators to perform actual operations through the glove interface to ensure the tightness and safety of the operating process. The interior of the operating compartment can also be equipped with a load cell or weighing table for precise material handling.

• filtration system

   

double HEPA H14 filter can filter the air entering the cavity to ensure that it meets the ISO 5 (Class A) cleanliness standard while filtering the air discharged from the cavity to prevent pollutants from spreading to the external environment.

• control system

Jiehao isolator adopts an automation system based on Siemens PLC control, which can adjust the negative pressure mode and environmental parameters in real time, monitor and record key environmental parameters (such as pressure difference, temperature and humidity) to ensure that the working environment is always under control.

SIEMENS CONTROL SYSTEM UTILIZED IN JEHAO ISOLATOR