Clean Room for Pharmaceutical Manufacturing
Activities in the pharmaceutical sector include the manufacturing and marketing of drugs, the study and creation of vaccines, and other research and development activities.
In this field, contamination control is absolutely vital, because it directly impacts people’s health and well-being.
For this reason, when manufacturing Clean Rooms for the pharmaceutical industry, Galvani pays meticulous attention to every single detail and scrupulously adheres to the relevant standards, which, in addition to ISO 14644, include GMP (acronym for Good Manufacturing Practice).
Thanks to our experience, know-how and expertise, we have gained the trust of pharmaceutical companies in Italy and abroad, who continue to work with us over time, entrusting us to create their Clean Rooms.
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Clean Rooms for Pharmaceutical Sector
Activities in the pharmaceutical sector include the manufacturing and marketing of drugs, the study and creation of vaccines, and other research and development activities.
In this field, contamination control is absolutely vital, because it directly impacts people’s health and well-being.
For this reason, when manufacturing Clean Rooms for the pharmaceutical industry, Galvani pays meticulous attention to every single detail and scrupulously adheres to the relevant standards, which, in addition to ISO 14644, include GMP (acronym for Good Manufacturing Practice).
Thanks to our experience, know-how and expertise, we have gained the trust of pharmaceutical companies in Italy and abroad, who continue to work with us over time, entrusting us to create their Clean Rooms.
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Turnkey Clean Rooms for Pharmaceutical sector
The Turnkey Clean Room is an all-inclusive service beginning with an initial analysis followed by the planning, design, manufacturing and validation stages, after which the end product is delivered and ready to use.At each stage, every single detail is closely monitored and scrutinised by our experts in order to provide an efficient, high-quality product that is in step with the latest innovative technologies and complies with the relevant standards.
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Characteristics of Clean Rooms for the Pharmaceutical Sector
All processes in the pharmaceutical sector require a sterile and decontaminated environment. The strict air contamination-control parameters and regulations governing Clean Rooms, as well as the certifications required, make these solutions ideal for manufacturing any type of pharmaceutical product.
Technical requirements and relevant standards
The fundamental technical requirements for a Clean Room made for pharmaceutical use include the cleanliness criteria established by the classes in the ISO 14644 standard (ISO 1 to ISO 9), as well as operating parameters such as the number of particles per m³, temperature, pressure and humidity.
These requirements can be tailored to the needs of the client and the type of process carried out inside the room, creating an effective, bespoke solution.
In addition to these standards, Pharmaceutical Clean Rooms must also comply with GMP (Good Manufacturing Practice). This is a set of rules followed to minimise risks when manufacturing medical and pharmaceutical products (medicines, cosmetics, medical devices etc.).
Uses of Clean Rooms for the pharmaceutical sector
Drugs
Vaccines
Additional
Services
Training
Our specialist technical consultants are available to provide a post-sale training service. The aim of this is to ensure that the end user is able to use the room properly by themself.
The training includes instructions for the client to follow and best practices to abide by for day-to-day Clean Room operations to ensure that it functions properly.
Maintenance and Remote Assistance
As the word suggests, Maintenance encompasses all actions taken to keep the Clean Room functional.
At Galvani, we only use our own teams of specialist operators who carry out periodic tests with sophisticated, high-tech equipment.
Regular Scheduled Maintenance work is the best way of ensuring the Clean Room remains in excellent working order, preventing serious damage that may cause production stops and keeping quality standards high at all times. It also saves a great deal of time and money, because when you choose Galvani, you liaise with one partner who knows what to do in any circumstance and prevents you from having to hire your own in-house maintenance technician.
In addition, a Remote-Assistance service is also available: with a basic internet or telephone connection, our specialists can view, modify and log the Clean Room parameters directly from our offices. This enables us to take action quickly and ensures optimum performance at all times.
Comfort Rate
Generally speaking, operators in Clean Rooms enjoy better conditions than in traditional working environments, but the need to continuously ventilate the rooms to keep contamination under control can cause discomfort due to excessive ventilation.
This inspired Galvani to introduce the Comfort Rate, a tool used to assess the level of comfort inside an environment subject to forced ventilation.
Ranging from 1 to 6, the classes take the following parameters into account: the temperature of the air fed into the Clean Room, the desired room temperature and the coverage factor.
This focus on the well-being of operators translates into increased productivity.
Solutions
In the pharmaceutical sector, a Clean Room is an environment that provides exceptional levels of cleanliness. This is the ideal solution for processes and products used to treat people, which must comply with very high safety and hygiene standards.
Galvani Clean Rooms
A Clean Room is a closed, controlled-contamination environment: air cleanliness, temperature, humidity and pressure levels are kept under constant control, so that processes and operations that require a clean and well-monitored environment can be carried out inside.
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Our Clean Rooms
