Manufacturers of medical devices are responsible for keeping their facilities clean. This is crucial because the presence of any organisms or pollutants can put patients at risk.
Manufacturers of medical devices must also take precautions to prevent airborne pollutants from accumulating on tiny parts and disrupting their performance. Assembling medical devices in a sterile environment is essential for ensuring that they are free of any harmful bacteria or viruses.
This is where a cleanroom comes into play. A cleanroom is a specially equipped room in a factory that has been designed to eliminate the presence of airborne contaminants such as dust, microorganisms, and aerosols.
Cleanrooms are frequently used in the assembly of electronics, drugs, and medical equipment. Temperature, airflow, and humidity are just some of the factors that cleanrooms regulate to ensure the highest possible quality in the final product.
The Monitoring of Air Quality in Cleanrooms
U.S. Federal Standard 209 categorizes cleanrooms by the particle count larger than 0.5 mm per cubic foot of air (A to D). Before 1999, clean zone and cleanroom classifications were based on Federal Standard 209E. However, this was superseded by a new international standard (ISO 14644-1).
To guarantee the quality of the finished product or the efficacy of the process being carried out in the cleanroom, it is imperative that the air quality in the cleanroom be maintained at an acceptable level. In order to ascertain whether or not the cleanroom meets the international standard, air samples must be taken.
The contributions of particulate levels, sampling technique, and inconsistent maintenance of instruments all contribute to a great deal of variability in readings of airborne particles in cleanrooms. Cleanroom ISO standards, on the other hand, provide a thorough framework for managing this kind of variation in instruments.
A cleanroom, as defined by ISO 14644-1, is a space where the presence of particles cannot be tolerated. Depending on their level of cleanliness, cleanrooms can be ranked from ISO 1 to ISO 9 according to ISO 14644-1.
According to the number of particles allowed per square meter or square foot, cleanrooms are categorized into different categories. ISO 8 is the second-least in the classification of cleanroom, and it’s also the least sterile.
Making Sure New Medical Devices Are Made in Accordance With Federal Law
Medical device manufacturers are subject to stringent rules regarding the accuracy of their product descriptions and the safety of their products overall. Manufacturers of medical devices are responsible for maintaining a clean environment throughout the entire production process, regardless of the device’s classification with the FDA.
When it comes to the quality of medical devices, the bar is set by the International Organization for Standardization (ISO). The production of clean and contaminant-free medical devices is essential, and ISO 13485 certification demonstrates that a company has the resources to make that happen.
Have You Considered Using a Cleanroom?
Many businesses have questioned whether or not they really require their own cleanroom. A cleanroom is essential for companies that manufacture medical devices to guarantee the highest possible standards of quality and safety in their end products. However, it may be difficult to secure the necessary space and funds to build a cleanroom.
It can be difficult for small and medium-sized businesses to justify investing in cleanroom operations. The production of these vital tools requires a large number of trained individuals. Benefits can be gained by contracting with a contract manufacturer that has achieved ISO 13485 certification to produce medical devices on behalf of a company.
The Necessary Elements of a Cleanroom
Manufacturers and research facilities are responsible for adhering to regionally relevant minimum requirements and standards. As international standards evolve, manufacturers and research facilities must be prepared to adapt. There are a set of rules and regulations that must be followed.
As the quality of air is a critical predictor of purity and air circulation, a cleanroom air quality monitoring system can help ensure that particle thresholds, and hence standards, are satisfied.
A normal person in a cleanroom can bring up to 100,000 0.3 microparticles per minute just by existing in the room, so continuous testing for contaminant particles is essential. Testing particles to establish strategies to prevent the accumulation of excess particulates is the first step in mitigating the risk created by particle production.
Which filtration systems are installed in a cleanroom is determined by the nature of the work being performed there, the number of workers in the space, and the amount of dust and debris produced.
Documenting Methodologies
Documenting and submitting contamination prevention measures taken in a cleanroom to the relevant regulatory body is essential for ensuring the safety of the end users of any products made in such a setting.
Documentation showing that measures were taken to prevent contamination in both the product and the manufacturing process is necessary for regulatory agencies to approve the product for sale.
The conditions in a cleanroom are very different. They bring with them unique issues and needs according to their structure, categorization, and purpose. Every person who accesses the controlled environment, not only you and your cleaning staff, must be fully conversant with the rules governing its use.
To minimize the amount of particulate in the room, disruption of particles, and overall pollution, you must develop a clear set of regulations.
