Manufacturing pharmaceuticals and medical devices that save lives both require the sterile conditions provided by medical cleanrooms.
There are three distinct categories of medical cleanrooms, each serving a different purpose in the healthcare industry: research, device, and drug manufacturing. Each type of cleanroom requires a unique layout, one that takes into account the specific needs of the facility and the applicable cleanroom standards.
Let’s take a closer look at these three distinct categories of medical cleanrooms and compare how the classification of cleanrooms, size, and building plans vary.
Institutional Cleanrooms for Therapeutic Studies
Cleanrooms are essential for medical research, experimentation, and the development of new treatments. To ensure the safety of the employees and the integrity of the work being done, extra measures should be put in place to ensure biosecurity.
The environment in the cleanroom must be absolutely germ-free. Cleanrooms used for medical research are typically in the ISO 14644-1 Class 5-7 range. The potential threat that contaminants pose to cleanroom operations and safety is used to establish the standard’s level of stringency.
In medical research settings, cleanrooms with negative pressure are typically needed when working with infectious gases or chemicals. With this added barrier, contaminants within the cleanroom cannot escape and potentially harm people in the outside world.
Medical research cleanrooms have all of the specialist tools, safe storage, and ergonomic soft furnishings that researchers require to perform their jobs comfortably and well, whether they are studying cancer, infectious diseases, and viruses or trying to find strong and effective vaccines.
Because of their versatility and ability to be tailored to the needs of any given application, softwall cleanrooms can meet the stringent classifications necessary for these kinds of medical cleanrooms.
Cleanrooms For Medical Equipment
To eliminate the risk of infection or other complications, medical devices must be sterile or thoroughly cleaned before they come into contact with human tissues and membranes. Therefore, the manufacturing, installation, and distribution of medical equipment must take place in a cleanroom that has been certified according to rigorous requirements and quality control.
There is a propensity to classify the activities in different ways. Businesses that specialize in cleanroom manufacturing will already have the necessary expertise in setting up a suitable environment and meeting all of the necessary standards.
The entire process, from lamination to production to assembly, takes place in-house, and they have a wide range of automated machinery at their disposal. The benefit is that they can meet all of your cleanroom specifications, including those for the walls, floors, ceilings, and HVAC systems, to extremely tight tolerances.
ISO Class 7-8 is the range for cleanrooms used in the production of non-critical and semi-critical medical devices, while ISO Class 5 or higher is required for the production of critical medical devices such as surgical equipment and implanted devices.
In essence, the requirements become more stringent as device component sizes shrink and become more complex. Cleanrooms for the packaging of medical devices still must adhere to stringent standards for contamination control, but they can typically operate at an ISO classification of 7-8.
When it comes to producing and storing medical devices, a softwall cleanroom is the most suitable environment. This category of cleanrooms is capable of maintaining a consistent, contamination-free environment throughout the entire device-making process, which may help it to meet stringent classification criteria.
Pharmaceutical Industry Cleanrooms
Chemical therapies and cures are developed in pharmaceutical cleanrooms to extend human longevity. Even trace amounts of contamination during drug development and testing have the potential to severely compromise research results or treatment efficacy and, in extreme cases, even lead to death.
Therefore, there is a lot of oversight in the pharmaceutical industry. The global market for cleanroom technology is expected to grow from its 2020 valuation of USD 4.0 billion at a CAGR of 5.4% between 2021 and 2028.
The processes utilized in a pharmaceutical cleanroom may necessitate varying degrees of cleanliness. ISO 7 is the bare minimum requirement for pharmaceutical cleanrooms, with increasingly stringent standards starting at ISO 5. These cleanrooms must have between 240 and 600 air changes per hour and 35 to 70 percent ceiling coverage to keep the air quality at 100 x 106 particles per cubic meter.
Additional rules for pharmaceutical cleanrooms are established by the USP Standards, also referred to as the US Pharmacopeia. Safe pharmaceuticals are created in pharmaceutical compounding facilities because they adhere to USP Standards 797 for sterile non-hazardous chemicals as well as USP 800 for sterile toxic components.
The USP standards include potential designs according to the ideal cleanroom layout, cleanroom organization, operator procedures, and sanitation requirements of each standard.
Because of the stringent regulations that must be followed in a pharmaceutical cleanroom, softwall cleanrooms are the obvious choice. Cleanrooms offer a solid foundation for any medical cleanroom design, allowing for the maintenance of stringent environmental conditions and the prevention of errors brought on by fluctuations in temperature, humidity, or contamination.
In order to improve healthcare and save lives, businesses must invest in medical cleanrooms of all three types. High-performance medical cleanrooms are essential for protecting critical healthcare industry projects and employees.