Pharmaceutics

The internationally recognized document setting standards for cleanrooms, as well as dividing them into cleanliness classes is a series of standards ISO 14644 and ISO 14698 under the general title "Cleanrooms and associated controlled environments", developed by the International Organization for Standardization (ISO).

In medicines production, the content of various microorganism and virus types in the clean rooms air and on working surfaces is crucial, although it does not directly or indirectly affect the medicines quality during their manufacture and storage. The cleanrooms layout and the technologies / equipment used should be chosen with regard to ensuring the infectious safety and disinfection measures, as well as minimizing the possibility of cross-contamination.

The specifics of infectious safety in cleanrooms of pharmaceutical companies

• Necessity to create aseptic conditions for pharmaceutical production;
• Constant confirmation of the room cleanliness class;
• Required monitoring of the pharmaceutical products manufacturing process (content of microorganisms and viruses on the products surfaces, in the air and on the room surfaces);
• Measures / protocols to prevent the products and manufacturing facilities contamination by microorganisms and viruses;
• Risk of introducing microorganisms and viruses with cargos delivered to the cleanroom;
• Possibility of cleanrooms and pharmaceutical products contamination with human pathogenic microflora;
• Possibility of cross-contamination among the working personnel with infections and viruses.

The specifics of disinfection measures in cleanrooms of pharmaceutical companies

• Need for repeated disinfection to preserve and constantly maintain microbiological purity with the 99.9 % or more efficiency;
• Limitations for using most chemical disinfectant classes and physical disinfection methods in areas with a high visitor flow;
• Corrosive effect of the used inventory and equipment on working surfaces;
• Lack of official regulations on scheduled and emergency cleanrooms disinfection, especially in cases of identifying various "undesirable microorganisms" in the pharmaceutical products.

Pulsed ultraviolet units allow the pharmaceutical factories to successfully cope with a whole number of problems:

• Disinfection of pharmaceutical company premises with 99.0 % or higher efficiency within shortest time;
• Rapid disinfection of a large rooms’ number within one working shift during a routine break, without disrupting the work schedule;
• Ensuring microbiological cleanliness of products and production facilities, including inactivation of such microorganisms and viruses that are highly resistant to traditional disinfectants, i.e. mold and yeast fungi, highly resistant viruses;
• Increasing the products shelf life;
• Reducing financial losses associated with losses during production, returns from buyers;
• Individual and collective protection of patients and working staff from bacteria and viruses, including the new SARS-COV-2 coronavirus;
• Financial expenses’ reduction by avoiding payments for temporary disability certificates of the personnel, as well as for the infection foci elimination;
• Enhancing the manufacturer image as an organization that cares about providing high quality services by ensuring the infectious safety of visitors and staff.

Choosing our products, you get the optimal solution for guaranteed highly effective disinfection of premises of pharmaceutical industry enterprises, including cleanrooms of all cleanliness classes; increase the microbiological safety of manufactured products, equipment, the premises itself and working personnel and, as a result, ensure the basic principle of clean rooms standards – “Quality as part of the design”.

We are convinced that pulsed ultraviolet units used in various areas, including pharmaceutical companies, not only during the COVID-19 pandemic and seasonal outbreaks of other viral diseases, but also in "peacetime" are not a luxury, but a necessity that is here to stay.