Cleanrooms play a critical role for medical device manufacturers in ensuring the safe introduction of their products into the marketplace. Medical devices are designed for healthcare environments where hygiene and contamination prevention are top priorities. These devices work together to help healthcare providers diagnose and treat patients and improve their quality of life.
Medical cleanrooms are critical to finding medical solutions, developing vaccines and treatments through pharmacological products, manufacturing life-saving medical devices, and other important applications. The three main types of medical cleanrooms are medical research cleanrooms, medical device cleanrooms, and pharmaceutical cleanrooms. The design of each type of cleanroom will vary depending on the goals of the facility and its cleanroom classification requirements.
Medical research cleanrooms are used in the pursuit of medical understanding, research and experimentation, and the development of therapies. Medical research cleanrooms typically require biosecurity and have additional protections to protect employees and their critical work from potential biosecurity risks.
Cleanroom environments must be highly sterile. Medical research cleanrooms typically fall under the ISO 14644-1 5-7 category. The stringency of this standard depends on the level of risk that contaminants pose to cleanroom operations and safety. For example, for research involving blood or stem cells, an ISO Class 5 cleanroom environment may be required. This means the cleanroom must be equipped with a robust filtration system that allows for a particle count of less than 3,520 half-micron particles or larger.
Medical research applications that deal with infectious or toxic fumes or substances often require a negative pressure cleanroom. This additional protection prevents contaminants from escaping from the cleanroom and causing harm to the environment outside the cleanroom.
Whether used for cancer research, infectious disease and virus research, or the pursuit of effective vaccinations, medical research cleanrooms are equipped with all the specialized equipment, secure storage and ergonomic furnishings needed for researchers to do their jobs comfortably and efficiently. Medical research cleanrooms are often designed with hard walls, and ZhongJian South cleanrooms can meet even the most stringent classifications that these types of medical cleanrooms can require, and can be highly modified to meet the unique needs of any application.
Medical devices are specialized products used to diagnose, treat and cure patients. Unlike pharmaceuticals, medical devices are not metabolized. Instead, they can be used as tools by medical professionals both internally and externally, and can even be implanted as long-term solutions. Because they come into contact with tissue and membranes, medical devices must be contamination-free or able to be thoroughly sterilized to prevent the possibility of infection or other risks. For this reason, the production, assembly and packaging of medical devices require controlled cleanroom environments that are validated and monitored through strict requirements and quality controls.
The different stages of medical device manufacturing, assembly and packaging have different cleanliness requirements and often fall into different classifications. For example, most medical device manufacturing cleanrooms must meet ISO Class 5-8 standards.
More specifically, medical device cleanrooms that manufacture non-critical and semi-critical devices fall into the ISO Class 7-8 range, while devices with critical levels of sterilization (such as surgical and implantable devices) require the cleanest environments and must comply with ISO Class 5 or greater. Essentially, as device component sizes become smaller and more complex, the stringency of requirements increases.
Medical device packaging cleanrooms, while still closely monitored to prevent contamination, typically operate within ISO Class 7-8 standards.
The best cleanroom type for medical device manufacturing and packaging is the hard wall cleanroom. This cleanroom type is able to meet strict classification requirements and maintain a stable, contamination-free environment during all phases of device production.
Pharmaceutical cleanrooms are used to develop chemotherapeutic and therapeutic approaches to improve health and save lives. In the development and testing of drugs, even the slightest contamination can have serious consequences on medical research results or therapeutic efficiency, and may even lead to life-threatening consequences. As a result, the pharmaceutical industry is strictly regulated.
Pharmaceutical cleanrooms typically require different levels of cleanliness, depending on the type of substances, chemicals and procedures involved in their operation. The minimum standard for a pharmaceutical cleanroom is typically ISO 7, with increasing requirements for ISO 5 or higher, requiring 240-600 air changes per hour and 35-70% ceiling coverage to maintain an environment of 100,000 0.1μm particles per cubic meter.
Pharmaceutical cleanrooms are also subject to additional requirements of the U.S. Pharmacopeia or USP standards. Pharmaceutical mixing spaces follow the USP 797 standard for sterile and non-hazardous compounds or the more stringent USP 800 standard for sterile and hazardous compounds. the USP standard specifies layout options based on optimal airflow patterns, cleanroom organization, operator skill and sanitation levels for each standard.
Since pharmaceutical cleanrooms require a high level of control, ZhongJian South cleanrooms are the obvious solution. Able to maintain strict environmental standards and eliminate errors caused by temperature, humidity or contamination, ZhongJian South cleanrooms provide a reliable structure for any medical cleanroom design.
These three types of medical cleanrooms are critical and valuable investments for companies engaged in research or creating and preparing compounds and devices to improve health and save lives. The critical work of the healthcare industry requires high-performance medical cleanrooms to protect projects and employees.
From drug development to medical device manufacturing and packaging, ZhongJian South designs, builds and installs medical cleanrooms that meet any classification standard. If you are ready to start designing your new cleanroom, contact ZhongJian South's team of professionals today.