Isolator device for pharmaceutical process How do Raymon group
pharmaceutical isolators work?
Pharmaceutical isolator is a sealed bacteriological container used in medical and pharmaceutical environment for toxic processes and aseptic filling process. It consists of a fully sterile main separator where the products are stored, or packed, using gloves placed on one of the walls. It also includes transfer systems that allow the entry and exit of products and the removal of waste without breaking aseptic conditions.
The pharmaceutical isolator is designed to meet two basic requirements:
At manufacturing sites, an isolator allows for containment of pharmaceutical processes. They need a protected environment free of living microorganisms. The isolator ensures that the production area and the personnel environment are separated. Its role is to prevent the spread of pollution from one area to another. This technology provides a higher level of containment than a traditional cleanroom and uses an integrated disinfection system.
Generally, the separator is sterilized by a sterilizing gas: hydrogen peroxide or H202It is anti-pollution. It uses very high performance filters for maximum product protection. The aim of these systems is to remove microbes and particles from all possible sources of contamination such as the external environment and operators.
Even when products are introduced into or extracted from the enclosure, it must be contained and the atmosphere must be protected from any contamination. This is where the transmission lock comes in. This system simplifies not only the transportation of products and materials, but also the disposal of waste, thus ensuring that the asepsis of the environment is always respected. Pharmaceutical industry separators must meet Class A standardsIn accordance with the classification of the European Union GMP OJ 07/01/97to match
The separator can be equipped with many optional accessories such as hook on connecting rods, welders, cooling trays, cleaning supplies.
Applications of pharmaceutical separator
There are many uses of isolators for the pharmaceutical industry, mainly for production and control purposes. For example, it is useful when handling, transporting or packaging solid, semi-solid or powdered pharmaceuticals, or handling and filling solutions and infusions. It is also used for sterility testing, purification, drying and weighing of cytotoxic principles, aseptic handling of tissues or biological production systems or pathogenic samples, etc. It can be used to produce and control drugs and pharmaceutical products.
In the medical-pharmaceutical industry, the sterile manufacturing process must be carefully followed. Non-sterile pharmaceutical products pose serious risks to patients. Failure to follow the approved process can affect product quality and negatively impact patient and staff safety.
In addition, personnel must be protected from hazardous manufacturing processes, especially if with highly active pharmaceutical compounds APIs work. Protection is mandatory when the products, agents or active ingredients used pose health risks. In these cases, it is recommended to use more effective protective devices such as medical isolators. What are the reasons for this?
Its anti-contamination system is more efficient. Gas sterilization allows surfaces to be treated in a controlled environment, thus limiting particulate and microbiological contamination. The air purification system ensures optimal particulate cleanliness. An insulator for the pharmaceutical industry as well as systems It integrates air purification and filtration. They renew the air inside the chamber. Pre-filters at the inlet and filters at the outlet remove particles, microbes or other elements that can break asepsis more efficiently.
Interior conditions can be adjusted and easily controlled. All atmosphere controlled areas such as separators and glove boxes are equipped with controllers. These systems provide the possibility of controlling, monitoring and tracking atmospheric conditions, including pressure maintenance, temperature control, humidity control, etc.
What are the advantages of pharmaceutical separators?
The drug isolator is a modern medical technology that has several advantages for the pharmaceutical industry. It provides a superior sterile environment compared to conventional environments such as sterile clean rooms. Positive or negative pressures inside the chamber prevent contamination of the operator or the external environment in case of abnormality. In accordance with pharmaceutical regulations, it guarantees long-term sterility. This is especially effective in aseptic processes, method validation, sterility testing, etc.
Various controls and monitoring are facilitated due to the options and integrated software. Adjustment and recording of temperature, pressure, humidity level, etc., as well as leakage and sterility controls are possible.
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