The balancing act between efficiency and patient safety in the manufacturing process of medical devices is an important consideration for many companies. Jamie Bell examines the role of medical device cleanrooms in the industry — and the impact that new technologies are set to deliver. 


Medical devices are built for use in healthcare settings where hygiene and the need to prevent contamination are paramount.

The presence of bacteria and other microorganisms will increase the likelihood of infection and bring serious implications for patient safety if cleanliness is not fully controlled.

Air pollutants can also get into the mechanisms of smaller devices and prevent them from functioning properly.

One way that cleanliness is ensured, is by manufacturing these products in a controlled and sterile environment.

This is where cleanrooms — spaces specially designed to keep exclude bacteria and air pollutants — become a key element of the production process.


How medical device cleanrooms are regulated

Companies that make these medical devices are subject to comprehensive regulations, from various bodies, designed to ensure cleanliness throughout the manufacturing process.

The ISO (International Organization for Standardization) is a group of non-governmental national bodies working in 164 countries, setting and enforcing standards for a variety of commercial markets.

In 2016, it published the latest edition of its ISO 13485 to ensure patient safety by regulating cleanliness and contamination control in the development of medical products.

Similarly, in 2015, the ISO introduced ISO 14644, outlining the expected standards on air quality in the spaces where these devices are manufactured.

The World Health Organisation (WHO) also has its own set of recommendations for general medical device cleanliness.

medical device cleanrooms fda regulations
The US Food and Drug Administration is based in Maryland, and regulates a wide range of products including foods, drugs and medical devices (Credit: FDA)

The most comprehensive and prescriptive guidelines for medical cleanrooms come from the US Food and Drug Administration (FDA) — in a set of regulations entitled FDA 21 CFR 211.42.

According to these regulations, manufacturing spaces must be a certain size and in a suitable location, so that cleaning and maintenance can be properly performed, and mix-ups risking cross-contamination are less likely to occur.

The temperature and humidity in cleanrooms must also be controlled, and the air must be filtered and kept at an appropriate pressure.

These conditions need to be monitored constantly, and surfaces and equipment inside cleanrooms must be cleaned and disinfected thoroughly.


Removing air pollutants from cleanrooms

The main concern when it comes to designing cleanrooms is how well they deal with air pollutants.

Filtration units are used by manufacturers to control the airflow into the space, and prevent airborne particles any bigger than a pre-defined size entering.

There are a number of devices used to perform this function, such as carbon filters, ionisers and non-filter purifiers.

High-efficiency particulate air (HEPA) filters are often the tool of choice in medical device cleanrooms because they remove 99.97% of particles from the air — efficient to at least 0.3 microns (0.0003mm) in size.

However, ultra-low particulate air (ULPA) filters are even more effective, removing at least 99.999% of dust, pollen, mould, bacteria and any other airborne particles of up to 100 nanometres (0.0001mm) in size.

The other way manufacturers can prevent contamination in cleanrooms is by ensuring staff wear gowns, hairnets and overshoes to cut the chance of them introducing bacteria attached to their clothing and bodies.


Other ways of keeping medical device cleanrooms sterile

Medical device manufacturing companies are encouraged to hire the right personnel — meaning people with a high level of personal hygiene and attention to detail.

Adequate training for staff is also seen as an important part of keeping cleanrooms free from contaminants.

This can mean anything from putting their protective items of clothing on in the right order to taking proper care and following behavioural standards at all times while in the cleanroom.

Manufacturers are also encouraged to keep the correct supplies and equipment present in clean spaces, making sure they are used and disposed of properly, and sterilised regularly.

Keeping a cleanroom schedule can help to maintain all of these expected standards, and regular risk assessments mean improvements can continuously be made to keep up to date with fresh contamination threats caused by newer technologies.


How the latest technologies can make cleanrooms cheaper and more efficient

New developments and more complex products — including nanotechnologies and the miniaturisation of devices — will present fresh challenges for manufacturers in the near future.

Mike Tendick, market sector vice president at Plexus — a US-based electronics design and manufacturing company — believes the biggest challenge in the future will be hitting cost targets while still achieving the required standards in medical device cleanrooms.

He said: “One thing is for certain, the rise of innovation and technology in the medical sector offers huge potential.

“Manufacturers will need to figure out how to do things cheaper and more efficiently with the help of automation, or find a way to leverage manufacturing in low-cost regions.

“Embedding more automation into the assembly process, either by taking advantage of smart testing and inspection systems or robots, is a starting point.

“AI and machine learning may also increase quality standards, reliability and early detection even further.”