At MME Group, a division of Seaway Plastics, we are committed to delivering top-quality medical device manufacturing services. We are excited to announce a significant milestone in our journey towards excellence – the certification of one of our cleanrooms as ISO Class 7. This achievement opens up new opportunities to serve our clients, particularly those involved in producing critical and semi-critical medical devices. In this article, we will delve into the significance of this certification and how it enhances our capabilities to serve the medical industry.
Essential Medical Devices Require Cleanroom Production:
All invasive procedures involve contact between a medical device or surgical instrument and a patient’s sterile tissue or mucous membranes. A major risk of all such procedures is the introduction of pathogens that could lead to infection. Failure to manufacture medical equipment in the proper environment is a perilous risk in the case of a breached sterile barrier.
Environmental controls are dependent on the intended use of an object: items that contact sterile tissues are considered critical items such as surgical instruments or implantable devices. Semi-critical items which contact mucous membranes including endoscopes in medical fields or even drill guides for dental work. Items that only contact skin are considered noncritical items, such as blood pressure cuffs. Each of these categories designates a different threshold for the medical manufacturing environment.
Understanding Cleanroom Classes:
Cleanrooms are spaces that are kept particularly sterile or free of particles in order to provide a safe environment for anything that needs to be clean. These are measured from ISO Class 1 to 9, with 1 being the cleanest. Cleanrooms are classified according to the number and size of particles permitted per volume of air.
A typical room has between 2-4 air changes every hour. ISO Class 8 cleanrooms have between 10-25 air changes every hour, while ISO Class 7 have between 30-60. That means that in our ISO Class 7 cleanroom, the air is filtered at least thirty times every hour. Particles are consistently filtered out to provide clean air for medical device production.
Cleanrooms are also divided into classes based on the number of particles that are in the air. As a general rule, each class has ten times fewer particles than the class above it. While an ISO Class 8 cleanroom can have 100,000 particles per square foot of air, ISO Class 7 cleanrooms can only have 10,000.
Our Commitment to Excellence:
At MME Group we strive for excellence in every aspect of our business. Achieving an ISO Class 7 certification is a testament to our dedication to quality and service. We are excited about the opportunities this certification brings, and we are ready to take on new challenges in the medical industry.
Stay tuned for more updates and innovations from MME Group as we continue to raise the bar in the medical device manufacturing sector. Your trust in us drives our pursuit of excellence and we look forward to serving you with the highest level of quality and delivery.