Radiopharmaceutical Dispensing Isolators
To ensure compliance with aseptic distribution and elution of radioisotope products per generator, the use of radiopharmaceutical distribution isolators has become essential. These containment solutions offer a working environment compliant with Class A Good Manufacturing Practice (GMP).
The conditions inside can be parameterized according to the specificities of the process. To protect your products and personnel, EREA designs and manufactures innovative, high-performance isolators offering a high level of safety.
Purpose of radiopharmaceutical dispensing isolators
Operators are exposed to high levels of risk during the manufacture of radiopharmaceuticals, as they have to handle highly active or hazardous products. The level of risk to which they are exposed depends on the types of radiation energy, the radiation and the half-life of the radioactive isotopes. To protect personnel and the environment in which they work, standards and regulations require that radioactivity, particulate and microbiological quality be monitored.
Radiopharmaceutical dispensing isolators are currently in widespread use. They are used in a variety of applications, such as radiopharmaceutical quality control and radiolabeling. They can be fitted to equipment used to dispense radiopharmaceuticals and other processes requiring aseptic handling. Isolators also incorporate other features, such as :
- Class A-compliant dispensing chamber.
- Class A transfer system for product introduction and retrieval.
- Class B waste compartment with door.
Conditions for compliance with Good Manufacturing Practice (GMP)
Radiopharmaceuticals must be protected from contamination in order to safeguard patients. Their manufacturing process must be carried out in a sterile, highly confined environment to prevent contact with particulate and microbiological elements in the ambient air. The deployment of these containment solutions also aims to protect personnel and the environment from radiation.
For optimum protection, Good Manufacturing Practice (GMP) sets out the characteristics of good radiopharmaceutical dispensing isolators. They must include the following features:
- A particle monitoring system.
- A shielded door to effectively confine radioactive products.
- Various sensors, such as humidity, temperature and particle counters.
- A certified Class A laminar-flow work enclosure.
- A retro-contamination-free extraction system.
- An insulated, solid waste system with the capacity to accommodate all waste during process operation.
Isolators can be designed to meet the company’s flexibility requirements when distributing radiopharmaceuticals. They must be fitted with a high-performance decontamination system to maintain sterility between each process.
EREA Pharma, solutions tailored to the needs of the pharmaceutical industry
When it comes to integrating isolators for the distribution of radiopharmaceutical products, let EREA pharma help you. For over 30 years, we have been setting the standard in the design and manufacture of containment solutions for various sectors. We offer solutions tailored to the needs of the pharmaceutical and medical industries. To effectively protect your products, personnel and the environment, EREA isolators offer a high level of containment, particularly when handling radioactive products. Certified Class A (Iso 5), they feature a high-performance decontamination system, as well as an efficient air treatment and filtration system. What’s more, the internal environment can be monitored and its parameters recorded.
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