3 Types of Medical Industry Cleanroom

What is a Medical Industry Cleanroom?

A medical industry cleanroom is a controlled environment used in the healthcare, pharmaceutical, and biotechnology industries to manufacture medicinal products, to produce medical devices or to conduct sensitive procedures. These environments are meticulously designed to minimise the presence of contaminants, for example dust, airborne microbes and aerosol particles.

Medical Industry Cleanroom Classifications

Cleanroom classifications are always an important consideration for any type of cleanroom, medical industry cleanrooms are no exception to this.

Medical devices are given a classification depending on the level of risk associated with the device. They range from Class 1 which is generally regarded as low risk to Class 3 which is considered high risk. As such, the level of risk associated with the manufactured product will influence the required ISO class or GMP grade of cleanroom, with higher risk processes requiring a more stringent classification.

The ISO or GMP requirements will be determined by the manufacturer’s risk assessment and user requirement specification (URS); if you do not have this, Angstrom Technology can assist you in creating one and in turn, identifying the relevant classification, and supporting you through the process.

Find out more about the different cleanroom classifications within the ISO standards and their GMP equivalent here.

Find out more about medical devices and their specific classifications here.

Medical Research Cleanrooms

Medical research cleanrooms are used for conducting sensitive medical and biological research, where contamination control is critical. This means that they will likely need to achieve a higher class of cleanliness to protect personnel working within them, as well protecting their work from potential biosecurity risks.

Medical research cleanrooms usually fall within ISO 14644-1:2015 class 5-7, which is determined by the contaminant risk levels within the space.

No matter the use for the cleanroom, for example, the study of infectious diseases and viruses, cancer research or vaccination development, medical research cleanrooms must be fully equipped with the correct, ergonomic furniture, relevant specialised equipment and safe storage that the process and personnel require.

Medical cleanrooms are often designed with a monobloc system, which can meet even the most stringent classifications. They are also highly modifiable to any application’s unique needs and are fully customisable depending on the unique requirements of the facility.

Medical Device Cleanrooms

Medical device cleanrooms are designed for the manufacturing, assembly and testing of medical devices, where minimising contamination is critical to ensure product safety and compliance with regulatory standards. Medical device cleanrooms are essential in the production of devices that will come into direct contact with patients or are implanted into the body, such as surgical instruments, implants, catheters and diagnostic equipment.

The different stages of medical device production, assembly and packaging have different cleanliness requirements and often fall under separate classifications. For example, most medical device manufacturing cleanrooms must comply with ISO class 5-8 standards. Medical device cleanrooms manufacturing non-critical and semi-critical devices fall in the ISO Class 7-8 range, while devices with critical disinfection levels require the cleanest environments and must comply with ISO Class 5 or greater. Medical device packaging cleanrooms generally operate within ISO Class 7-8 standards.

In the UK, medical devices are regulated by the Medical Devices Regulations. (MDR) 2002. All medical devices are given a classification depending on the level of risk associated with the device and understandably, the strictest control is for products with the highest risk.

The type of cleanroom used for medical device manufacturing and packaging can range from something as small as a 6m² softwall cleanroom to a multi-room monobloc facility, depending on the risk associated with the manufactured product.

Pharmaceutical Cleanrooms

Pharmaceutical cleanrooms are used in the production of medicinal products, where once again the allowed level of contamination is strictly regulated. This type of cleanroom is critical for maintaining the purity and safety of medicinal products. By providing a controlled environment, these cleanrooms help ensure that products meet the stringent quality standards required by regulatory authorities, protecting patient safety, maintaining the integrity of the pharmaceutical supply chain and reducing the risk of product recalls.

Pharmaceutical cleanrooms require varying levels of cleanliness, depending on the type of product and procedures involved in their operation. The standard for pharmaceutical cleanrooms is GMP, and the cleanrooms and cleanroom devices are graded as A, B, C or D, with Grade A being the highest grade (equivalent to ISO Class 5). For example, Aseptic Processing must be in the Grade A environment whereas secondary packaging could be in a Grade D environment.

Due to the high level of control needed in a pharmaceutical cleanroom, monobloc cleanroom systems are a popular solution. Monobloc cleanrooms offer a reliable structure for pharmaceutical cleanroom design and can maintain strict environmental parameters, allowing control of temperature and humidity, when this is critical to the process.

In Summary

All three types of medical industry cleanrooms are vital investments to businesses pursuing research or creating and preparing instruments and devices to improve health and save lives.

Whether your project is biotech, laboratory-based, or large-scale medicine manufacturing facilities, Angstrom Technology has the knowledge and experience to support a regulatory-compliant project.

We can support you in setting out the requirements for your cleanroom environment and assist in the management and delivery of the project, ensuring that it is technically appropriate and delivered to specification.

Unsure of which option might be best for you? Talk to our GMP experts today, who can assist you from day one of your next cleanroom project.