When installing cleanrooms in hospitals, it is important to bear in mind that the healthcare sector is particularly complex, as it deals with public health. Consequently, biosafety in hospitals is highly regulated in order to ensure the safety of patients; it is therefore essential to be familiar with the regulations governing the design and installation of cleanrooms in hospitals before embarking on a project of this kind.
The installation of cleanrooms in the hospital sector is a complex process that should be entrusted to professionals with extensive experience in the field. Complying with hospital biosafety standards means that, from the initial stages of the project—where advice must be rigorous and technical—through to the moment of commissioning and throughout the entire implementation process, the installation of hospital cleanrooms cannot be carried out by just any company. Not if good results are desired.
Broadly speaking, the ISO 14644 (2014) standard forms a key part of the set of standards governing the installation, maintenance and proper operation of cleanrooms in both hospitals and other sectors, standardising the manufacturing process whilst safeguarding the environment. Regulated globally by the International Organisation for Standardisation (ISO), it consists of eleven key points, set out in the relevant sections of the parent standard:
1. On the tolerable concentration of microparticles in the definition of a clean room.
2 and 3. Addresses the tests carried out on a regular basis and the methodology applied.
4. Specifications for the design and installation of the facility. Standardisation of commissioning.
5. On the various operating patterns.
6. Definition of all specific terms relating to the process and the standard, which is essential for all parties involved in the process to grasp and understand the concepts.
7. Concepts regarding the various barrier or separation mechanisms are clarified.
8. The issue of potential contamination at the molecular level that may exist in the air is addressed.
9 and 10. These cover the chemical definition of surfaces and their treatment for proper cleaning and disinfection.
11. Cleaning of ambient air from the perspective of nanoparticles.
In addition to these general regulations applicable to all cleanrooms, there are other features that a hospital cleanroom should possess. This is particularly important given that we are talking about the healthcare sector, where biosafety is of paramount importance due to interaction with third parties.
At Labsom, we specialise in cleanrooms and handle their design and installation for all sectors, including, of course, the healthcare sector. Our services encompass extensive expertise in the production process for cleanrooms, supervised by professionals. We offer consultancy, engineering and architectural services for cleanrooms, both for hospitals and any other sector, ensuring that all requirements are met to guarantee biosafety.
If your company is looking for reliability, experience and professionalism, based on a relationship of absolute trust, communication and transparency, we are your guaranteed choice. It is no coincidence that our team has been installing cleanrooms across various sectors for 15 years; our aim is to guarantee quality and provide our clients with solutions that are 100% tailored to their needs. Our work is not complete until your cleanroom is operating at full capacity.
On the one hand, all cleanrooms must comply with a set of standards to ensure they function properly, such as ISO 14644. In addition, depending on their intended use, there are likely to be specific requirements that must be met in order to ensure safety throughout the process.
Yes, it is essential to follow the various guidelines laid down by law regarding biosafety in hospitals in order to protect both the staff working within the cleanroom and the patients. Both the regulations applicable to cleanrooms in general and those specific to cleanrooms in hospitals must be strictly adhered to.
Yes, at Labsom we have the equipment needed to carry out every stage of cleanroom construction, whether for hospitals or any other sector, from design and architecture through to construction and subsequent maintenance of the cleanroom.
ISO standards set out the environmental contamination and safety limits that all cleanrooms must comply with, whether in hospitals or in any other sector where it may be necessary to use a cleanroom of this type to carry out a process.
