Project services in the field of radiation sterilization and radiopharmaceuticals
Having many years of experience in the design and implementation of clean rooms, INEX has opened a specialized department for the development of design and planning solutions for medical laboratories manufacturing radiopharmaceuticals (RPs), as well as for clinical research laboratories for radiopharmaceuticals, while ensuring the standards and requirements for the safe placement and work with radioisotope sources . INEX Department – Radiation Sterilization offers a first-class service for the development of planning solutions production sites and the safe placement of electrophysical installations at medical and pharmaceutical industry enterprises for the implementation of the process of radiation sterilization of medical devices, pharmaceutical products (including raw materials and substances), and a number of cosmetic medicine products. INEX's design solutions provide high-quality and reliable sterilization processes for single-use medical devices and pharmaceuticals, as well as safe operation of radioisotope medical laboratories for personnel and the environment.
Among the implemented projects of the INEX Company are design solutions for the creation of installations and sites for the decontamination of pharmaceutical raw materials, medicines and cosmetics.
Pharmaceutical raw materials of plant origin often also serve as a source of raw materials for cosmetic preparations. The problem of ensuring the microbiological purity of such raw materials and intermediate products (extracts, dry powders, combined mixtures) is the limited means for cleaning and decontamination. The same applies to a number of pharmaceutical substances - the basis for medicines. Such as antibacterial drugs and antibiotics.
The use of traditional thermal, steam and chemical disinfection methods is extremely difficult, and often completely unacceptable. And here we apply the method of radiation decontamination, which allows us to ensure compliance with the standards of permissible contamination according to SanPiN or the sterility of substrates. Choosing the optimal range of radiation doses for processing allows you to effectively meet the necessary requirements for the microbiological purity of raw materials.
When designing radiation sterilization facilities, INEX Company specialists take into account aspects of ensuring the microbiological purity and/or sterility of the final forms of medicines and cosmetics: the cleanliness of the primary packaging for their packaging before shipping to the consumer. Radiation sterilization of packaging for medicines and cosmetics can improve the quality and safety of these products. When designing medical, pharmaceutical or cosmetology facilities, we take into account and agree with the Customer the possibility of ensuring the process of sterilization of packaging using radiation sterilization installations.
As part of a project that requires the inclusion of a radiation sterilization system, our Customer can choose any option for INEX Company services:
- Selection of equipment, development of accelerator complexes for the purpose of sterilization of medical devices;
- Development, installation/operation of an accelerator complex for radiation purposes
- Sterilization;
- Design and/or construction of a center, complex or workshop;
- Development and implementation of projects from small workshops to universal centers of radiation technologies / radiation sterilization of medical products;
- Licensing, examination and protection of the project;
- Technical and technological support of the project;
- Comprehensive project support after its launch. Extended warranty and consulting options.
- Lifetime support and assessment of the condition of the supplied equipment