Pharmaceutical factory gmp purification engineering isolation system
Pharmaceutical factory gmp purification engineering isolation system
The isolator used in the pharmaceutical factory's gmp purification project is usually a cabin, box or space that is isolated from the surrounding environment. In the field of products, depending on the process application, the purpose of using an isolator is to isolate the source of contamination from the environment of the object that needs to be controlled or protected. In non...
Text label: Pharmaceutical factory gmp purification engineering, purification engineering isolation system
Pharmaceutical factory gmp purification engineering isolation system
The isolator used in the pharmaceutical factory's gmp purification project is usually a cabin, box or space that is isolated from the surrounding environment. In the field of products, depending on the process application, the purpose of using an isolator is to isolate the source of contamination from the environment of the object that needs to be controlled or protected. In the production process of non-terminally sterilized preparations, with the continuous improvement of GMP's awareness of risk control, the application of isolators has attracted more and more attention.
1. Development History
To trace the development history of medicinal isolators, we need to pay attention to the development of technology in three aspects.
The first is medical technology, which opens up awareness of microbial contamination. In 1865, Lister discovered that the cause of wound infection was bacteria, and the use of carbonic acid could reduce the probability of disturbance. In 1900, surgeons began wearing surgical gloves, gowns and masks. The operating clean room modular is designed to be closed, with rounded corners for easy cleaning. In 1960, when operating rooms were designed with one-way downward airflow and improved surgical gowns, data showed that the infection rate for a single hip operation dropped from 10% to 1%.
The second is containment technology (Ccontainment), a technology that seals special substances in an environment that is isolated from the external environment and personnel. The isolator was first called a glovebox, which is used for personnel protection in radioactive materials and biochemical research, and is mainly used to seal hazards in the isolation chamber to avoid harm to the environment and personnel. Usually this type of isolator is a fully sealed design, the inside of the box is negative pressure relative to the external environment, and a corresponding inactivation device is configured according to the substances processed inside. When dealing with radioactive material, leaded steel plates are used in the isolator's chamber to prevent the spread of radioactive material.
The third item is unidirectional clean airflow technology. With the use of high-efficiency air filter (HEPAfilter) applied to clean room to form unidirectional airflow (unidirectionalairflow), in the clean room of gmp purification project installed with high-efficiency filter, in Under one-way airflow, training personnel in clean clothes how to ensure cleanliness and control actions was considered a clean process to be performed at the time.
The concept that people are a big 'contamination source' in aseptic production is gradually recognized. In the early isolators, soft plastic material was used as the isolation barrier of the isolator, and half-body suits were used. The prime flow design was the characteristic of the isolator at that time. With the advancement of equipment automation and the improvement of the stability of production equipment, the intervention of personnel has been reduced to a considerable extent, so that the isolator is used by more pharmaceutical factories. The core area in the production process of sterile preparations is protected by one-way airflow inside the isolator, and the isolator is at positive pressure relative to the background clean clean room modular; process intervention is performed by installing gloves at specific locations; corresponding devices are configured for the transfer of sterile items (incoming/outgoing); the isolator integrates the sterilization function of vaporized hydrogen peroxide; the temperature and humidity of the internal production environment of the isolator are adjusted through an independent air conditioning system. All controls imparted to the environment within the isolator are based on the product manufacturing process and the needs of the product characteristics for the environment.
2. Classification
(1) Classification of protection objects according to the application of isolators
①Airtight isolator (containment
isolator): The object of protection is the operator and the environment, and protective and containment measures need to be taken to protect the operator.
②Aseptic isolator
isolator): The object of protection is sterile products, isolating the operator and the background environment from the aseptic process production environment. Reduce the risk of product contamination during production.
③Septic closed isolator (aseptic
u0026contanmnentiolato): This type of isolator must not only ensure that aseptic production is not contaminated, but also consider the safety of operators and the environment. This type of isolator is relatively demanding and complex in design. Zhongjing Global Purification can provide consulting, planning, design, construction, installation and transformation of GMP workshops, purification projects and other supporting services.
(2) Classification according to aseptic process
①Closed isolation
isolator): Material transfer is accomplished by aseptic connection to ancillary equipment, rather than using an opening to the surrounding environment, thereby isolating external contamination inside the isolator. Keep the isolator closed throughout the operation, such as a sterility check isolator.
②Open isolator (open
isolator): designed to allow continuous or semi-continuous entry and/or discharge of material through one or more openings during operation. Design openings (eg, using continuous overpressure) to prevent external contaminants from entering the isolator. Such as sterile injectable line isolators.
(3) Classification according to the operation performed in the isolator
Weighing, subpackaging and sampling isolators for weighing, subpackaging, sampling and other operations on APIs; sterility testing isolator for sterility inspection of sterile preparations before leaving the factory.
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