When we go to the pharmacy on Monday morning to buy medicine for our colds, or while hoping to get the sporting spirit back instead of glasses we decide to wear contact lenses, finally, when watching the historical achievements of astronauts on television with our eyes wide open, certainly, even for a moment, we do not think that all these stories are closely linked that they share one common denominator – a clean room.
Clean rooms, controlled zones- many terms one type of rooms, where the amount of particles in the air is strictly controlled. In the controlled zone parameters such as temperature, humidity and pressure are constantly monitored and maintained at a certain level. Someone might say – OK! The same parameters are the subject of monitoring in my store in my the yard, does it make it a clean room? Of course not! Cleanrooms are more than just monitoring critical parameters. It is monitoring the amount of air exchanges in the room, monitoring the pressure difference between the areas of cleanliness, is finally continuous control of microbiological cleanliness of the air and the work surface, equipment, personnel, and finally monitoring of refrigeration equipment, machinery, equipment responsible for the quality of the supllied air. But before we get into details – let’s have a look for a moment at the history of the legal aspects of the idea of a clean room.
THE BEGINNINGS OF A CLEAN ROOM TECHNOLOGY
When we think of the clean room – we think about the twenty-first century, the time of advanced technologies and procedures. However when we take a closer look at the idea of the functioning of the clean room – we see that at the beginning of the nineteenth century many of our friends, scientists have wondered about the need of “sterilization”, „improving the quality” of air in which they had to work. And so, the first man to be named is Mr Joseph Lister. His spray phenol machine, used for air’s decontamination in the operating room was ultra-modern for those years. To understand the importance and size of this invention, we must go back to the time when the operating rooms were rather small rooms, with no openable windows and full of stale, polluted and hot air. Lister engine, designed to clear the air from bacteria and viruses emitted poisonous fumes, but very effective disinfectant. Lister’s times are also beginnings of the use of personal protective equipment – masks, caps, gloves. At this time people started paying more attention to the need for cleaning and disinfecting hands.
Of course, modern clean rooms are completely different to those built years ago. Advanced technologies, greater awareness and knowledge make these clean rooms are possible to implement the most advanced designs and technologies.
REGULATIONS RELATED TO CLEANROOMS
With the idea of creating a space with stricter requirements for the quality of air circulating in them, also the first legal regulations were written. Of course, if someone had to be first, it should be Americans 🙂 and so it was – the first standards for clean room areas were published in 1961 by the US Air Force and had an honorable name – Technical Manual (TO) 00-25- 203. Next years means another American documents – Federal Standard 209 and ISO 14,644th. In Europe the American standards are implemented within 6 months counting from the day they were announced. This does not mean that the old continent does not have its own guidelines and regulations. In Poland, for example the main documents on the manufacture market of medicinal products used in a therapy for human is the Pharmaceutical Law of 6 September 2001. and the Minister of Health ordinance dated 9 November 2015 on the requirements of Good Manufacturing Practice. Also, special forms of pharmaceutical drugs that are not produced by the pharmaceutical industry but in the hospital pharmacy, such as nutritions for patience with parenteral treatment, cytostatics solution, mixture of antibiotics, mixtures of injectable liquids, solutions for hemodialysis and peritoneal dialysis, etc. they fall under the guidelines mentioned above.
Discussed standards, laws and rules allow us to get a high quality medicinal products by meeting the standards for production facilities, personnel, and production processes. Detailed quality control of raw used materials, production and packaging as well as a risk management provide high quality, safety and efficacy of medicinal products, and thus protect human life and health.