As well as Clean Rooms, Galvani specialises in the planning, design and creation of Sterile Rooms used predominantly for the pharmaceutical, medical and food sectors.
Combining technology, efficiency and safety, Galvani’s Sterile Rooms adhere to the highest regulatory standards and feature exceptional directly manufactured components throughout.
Once validated, the Sterile Room is ready to use, without any further action required.
As well as Clean Rooms, Galvani specialises in the planning, design and creation of Sterile Rooms used predominantly for the pharmaceutical, medical and food sectors.
Combining technology, efficiency and safety, Galvani’s Sterile Rooms adhere to the highest regulatory standards and feature exceptional directly manufactured components throughout.
Once validated, the Sterile Room is ready to use, without any further action required.
A Sterile Room is a microbiologically controlled Clean Room built in such a way as to prevent micro-organisms, bacteria, viruses or parasites from being present. Chemical-sterilisation systems, microbial testing and bacterial-load analysis are all used to create this sterile environment.
Perfect sterility is fundamental in all areas in which the growth and development of pathogenic bacteria can pose serious risks, like in the pharmaceutical and food sectors.
What is the difference between a Sterile Room and a Clean Room? As the name suggests, a Sterile Room is an environment in which living organisms, such as micro-organisms, bacteria, germs and viruses, are not present. Because of this characteristic, Sterile Rooms are used in sectors where the presence of these contaminants can be dangerous.
Firstly, in the pharmaceutical and medical sectors, the presence of bacteria can compromise both drugs and the safety of patients kept under observation.
Secondly, every step involved in the Food and Beverages sector, where these are processed, requires maximum cleanliness and sterility.
Processes carried out in the micro-electronics, semiconductor, optical and aerospace sectors do not require a Sterile Room. In these areas, controlling the amount of suspended particles in the Clean Room is all that is needed to ensure that operations run perfectly.
When creating a Sterile Room, the first step carried out is an analysis of the client, their needs, the processes that will take place within and the sector concerned.
Where necessary, our consultants carry out on-site visits, so they can see for themselves the area in which the Sterile Room will be installed. Once all this information has been gathered, our representatives are able to provide the ideal solution to meet the client’s needs.
When planning and designing a Sterile Room, we first consider the sector concerned, the type of use and current regulations.
Then, a layout with these aspects taken into account, which adheres to the highest standards of quality, efficiency and safety, is designed.
The planning and design stage also takes into account the area in which the Sterile Room will be installed, so that it can be seamlessly integrated into the facility’s existing processes.
The components identified during the planning and design stage are manufactured in our own workshops. We chose to produce these components in-house to ensure maximum efficiency, quality and safety of the end product. For anything we cannot make ourselves, we turn to carefully selected suppliers.
After planning, designing and creating the Sterile Room, it is installed: to ensure that maximum attention is paid to every single detail, we use teams of our own specially trained expert installers.
Each step in the project is followed to the letter under the strict supervision of the Site Manager and Project Manager. In addition, we follow exclusive Clean Process Protocols, which set out specific, detailed cleaning procedures to be carried out during installation, so that the Sterile Room is free from dust prior to startup.
After the manufacturing and installation stages, the Sterile Room is validated. Our technicians carry out certain tests required by current regulations and check parameters such as sterility, temperature, humidity, pressure and level of cleanliness (dust particles in one m³ of air).
It is also ascertained that specifications such as contamination class, air-movement speed, pressure levels and flow rate correspond to those required.
Once the process is complete, a test report certifying that the specifications are up to standard is issued and the room is ready to be used.
The validation service can also be requested by itself, without having a new room manufactured.
Galvani provides another fundamental service to ensure the Sterile Room remains in excellent working order: maintenance.
Having regular maintenance work—preferably scheduled—carried out ensures that the Sterile Room remains efficient, while saving both time and money. It saves money because the client does not need to hire their own maintenance technician and saves time because the inconvenience of production stops, caused by damage and/or malfunctions, is avoided.
Offering an all-inclusive service, we are experts in planning, designing, directly manufacturing, validating and installing Sterile Rooms. Choosing Galvani means choosing a partner who understands your needs and can provide you with effective, customised, certified and ready-to-use solutions.
Watch the video
Knowledge is limited if you do not branch out. At Galvani, we bring our know-how and expertise to different fields, allowing us to find the best solution for any need. Discover the solutions we have come up with for each different sector, or ask us for one tailored to your business.
