The medical device market is rapidly growing, and more companies are looking to outsource their production. A cleanroom environment is one of the keys to producing medical devices that meet today’s regulations for quality and safety. In this blog post, you will learn the basics of cleanroom production and why it is so important in the medtech industry.
What is a cleanroom for medical devices?
Medical devices intended for critical procedures shall be handled in a strictly controlled cleanroom environment. Medical devices that are not clean can lead to severe infections and put patients’ health at risk if they are not disinfected or sterilized before usage.
A cleanroom for medical devices is a controlled environment where the air is filtered from particles and pollutants to provide an area as clean as possible. Temperature, airflow, and humidity shall also be monitored in a cleanroom. A cleanroom is critical when establishing an aseptic workflow, ensuring traceability and tracking of medical devices, and monitoring air quality to identify and eliminate sources of contamination.
Classification of medical devices
Medical devices are classified depending on the harm they may pose to patients. Each class indicates the level of sterilization and disinfection needed.
- Class 1 medical devices are considered low-risk and include devices that only contact the skin, such as medical tape, elastic bandages, and handheld surgical instruments.
- Class 2 medical devices are considered to be of greater risk and include devices that contact mucous membranes, such as drill guides for dental work, absorbable sutures, surgical robots, and computed tomography (CT) scanners.
- Class 3 medical devices are considered high-risk and include devices that contact sterile tissue, such as implanted prosthetics, pacemakers, and automated external defibrillators. These devices support or sustain human life, may prevent or impair human health, or present a potential risk of illness or injury.
What are the requirements for medical device manufacturing in a cleanroom?
All cleanrooms shall be classified according to ISO 14644-1:2015, and the class is based on the amount of particles allowed in the space per cubic meter.
Medical device packaging can be performed in a cleanroom with ISO Class 7 or ISO Class 8. All cleanrooms must meet the requirements against which they are classified.
Achieving a clean room environment that meets the ISO standard places great demands on the quality of rooms, equipment, materials, personnel, and practices:
- Air supplied to a cleanroom must be filtered, and particle concentrations need to be monitored.
- Equipment and areas must be easy to clean and maintain.
- Procedures for gowning, cleaning, and general cleanroom behavior need to be established.
- Personnel and materials can only enter a cleanroom through lock rooms.
- Injection molding machines and other equipment must be designed to minimize contamination.
- Highly motivated and competent personnel is of great importance.
Increased demand for cleanroom production
In the past few years, we have seen an increased demand from the medical device market in general and the diagnostics market in particular. Several medtech companies are searching for suppliers who can offer production of medical devices in a cleanroom environment.
Focusing on the core business and reducing time to market has become more important. This is a major reason why more medtech companies outsource cleanroom production to a CDMO with specialized expertise and manufacturing capacity.
Expanding our cleanroom production facility
Elos Medtech has been offering cleanroom production of medical devices for many years. Our production site in Skara, Sweden, specializes in injection molding in high-tech polymers and supplies global customers operating primarily in the growing diagnostics market.
To meet the increasing market demand for cleanroom production, we are expanding our factory. The production site, which currently spans 3 300 square meters, has been expanded by a further 2 400 square meters, doubling the production area. Of these 2400 square meters, 1300 square meters are dedicated for ISO Class 8 productions. This will significantly increase opportunities to meet the needs of the medical device and diagnostics market.
Our focus on injection molding in polymer materials for the diagnostics market has evolved over time to encompass more advanced and automated production. We have gradually added more processes such as insert molding and automated cleanroom production to increase customer value. Construction has gone according to plan, and the classification of the new production area is scheduled for October 2021. We are very excited about the new expansion and look forward to the opportunities it will bring to the medical device and diagnostics market.
Are you looking to outsource cleanroom production of medical devices?
We have the competence and an offering that global medical device companies find attractive when looking for a CDMO. We can offer cleanroom production of medical devices in ISO Class 8 cleanroom areas, but also assembly and sterile packaging in ISO Class 7 cleanroom. Our processes for manufacturing, assembling, packaging and validation provide a highly reliable and efficient production. Through monitoring and daily controls, we ensure traceability, high quality, and product performance.