Controlled environments, or clean rooms, are fundamental to medical device manufacturing processes. Their purpose is to ensure that medical products are manufactured and packaged under sterile conditions.
Long-term production planning is becoming increasingly difficult, especially in the medical technology and pharmaceutical industries. Globalised markets are becoming increasingly dynamic. Competitive pressures are increasing and regulatory requirements are becoming more stringent. This makes it all the more important that medical technology production is as optimised, safe and scalable as possible within these parameters. This includes being able to respond to global dynamics and regulatory requirements with flexible production processes. The clean room concept plays an important role in this, meeting all applicable standards and regulations for clean rooms in medical technology, from planning and construction to certification.
Manufacturing and packaging medical devices under sterile conditions is standard practice for many manufacturers today. But it is likely to become even more so in the future, not least because of national and international regulatory requirements.
Definition of Clean Rooms in Medical Technology
A clean room medical technology is an area where the concentration of airborne particles is extremely low. Airborne particles are any particles, dust, micro-organisms or germs suspended in the air, most of which are invisible to the naked eye. They must be filtered to protect personnel, products and processes. Clean rooms are needed wherever particles in the air would interfere with work. All materials used must also comply with the specified limits.
“A clean room is an area where the concentration of airborne particles is kept very low. Clean rooms are needed in areas such as medical technology, where ‘contaminants’ found in normal ambient air would interfere with the sterile manufacture and packaging of medical devices.”
Four basic rules apply to clean rooms in medical technology
- No pollution or contamination from the clean room area must enter the controlled environment.
- The device or equipment must not cause environmental contamination within the controlled environment.
- Care must be taken to ensure that no contamination accumulates in the controlled environment.
- Any contamination must be removed as soon as possible.
In addition to particle measurement, many other additional aspects must be taken into account in the planning, specification, operation and control of clean rooms in medical technology. In addition to the strict separation of personnel and material flows, this also includes a hygienic airlock concept. An equally important component of a clean room concept is that possible contamination at the various interfaces is effectively prevented.
Regulatory Requirements for Clean Rooms in Medical Technology
The extent to which clean room technology penetrates medical technology is determined by the requirements of GMP standards (Good Manufacturing Practice), ISO standard 14644 and the supplementary and American FDA.
For ISO clean rooms, the focus is on airborne particles. Clean rooms are divided into 9 classes, with class 1 being the cleanest and thus having the lowest particle concentration per m³ of air. This standard applies predominantly in the field of semiconductor technology. VDI Guideline 2083 sets specific requirements for the cleanliness of the room, the process media, employees and the workplace.
For clean rooms in medical technology, the GMP standard is often binding, as this focuses on microbiological and airborne contaminants. Classes A, B, C and D are used, with class A having the strictest requirements.
Clean Room Classes in Medical Technology:
- Class A:
Resting condition: 3,520 particles greater than or equal to 0.5 µm and 20 particles greater than or equal to 5 µm; operating condition: the same
– It is characterised by the highest requirements
– Provides a critical manipulation area
– Complete sterility - Class B:
Resting condition: 3,520 particles greater than or equal to 0.5 µm, 29 particles greater than or equal to 5 µm; Operating condition: 352,000 particles greater than or equal to 0.5 µm, 2,900 particles greater than or equal to 5 µm
– Area around Class A zone
– Designed for the manufacture of products under aseptic conditions. - Class C:
Resting condition: 352,000 particles greater than or equal to 0.5 µm, 2,900 particles greater than or equal to 5 µm; Operating condition: 3,520,000 particles greater than or equal to 0.5 µm, 29,000 particles greater than or equal to 5 µm.
– For production processes where the risk of air contamination of the final product is of minor importance. - Class D:
Resting condition: 3,520,000 particles greater than or equal to 0.5 µm, 29,000 particles greater than or equal to 5 µm; Operating condition: undefined.
– Minimum clean room requirements
Function of clean rooms in medical technology
Function of Clean Rooms in Medical Technology
The clean room must be designed to minimise the number of airborne particles in the room. Depending on how the clean room is used, the number and/or size of particles, germ count and other parameters are monitored. Temperature, humidity and pressure must be maintained. To ensure this, special principles of clean room technology are applied in clean rooms. The processes and types of air conditioning used are designed to ensure that contaminants are immediately removed from the air.
“Humans are the most common cause of contamination of clean room environments in medical technology”.
In most cases, people are the source of many particles and contaminants. For this reason, special garments, known as clean room garments, are required. This, in turn, must be adapted to the appropriate clean room class. Work equipment, tools and techniques are also regulated. For example, hats and shoe covers must be used. The stricter the clean room class, the more requirements must be met. If people move between different areas, their clothing must be changed between each area. Other specific measures must also be observed. Binding specifications apply not only to personnel, but also to the materials used in clean rooms. For example, equipment and devices that are set up must not interfere with the airflow. Parts and machinery that are brought into the clean room must be cleaned beforehand.
Working in Clean Rooms in Medical Technology
Working in a clean room is only possible after donning clean room garments. It must also be thoroughly cleaned and disinfected, and people must only enter the clean room through specially installed airlocks. Everything must be carefully documented so that the causes of contamination can be traced and avoided in the future. For this reason, the clean room and access areas are usually monitored. Equally stringent requirements apply on exit, including disinfection of materials and equipment.
Code of practice for medical device clean rooms
There are strict rules of conduct for working in clean rooms.
These include:
- Performing slow and steady movements
- Removing all personal items such as bags or jewellery
- No food or drink
- Access by qualified personnel only
- Use only appropriate tools and equipment
- No access for employees who are ill
Conclusion: It is important for medical device companies to understand and comply with the applicable standard. This is the only way to achieve certification and lay the foundations for successful and competitive production in the long term.
Are you looking to recruit or develop your career in Clean Room? Contact us and we will find the perfect match for you in your specific area.
