OSF: ISO 7 Cleanroom Capabilities

To manufacture medical device components in an ISO 7-rated cleanroom, it is essential that the room meets certain specific capabilities and features to ensure that the components are manufactured under contaminant-free conditions.

The most important aspects to take into account are:

1. Particulate Matter Control

- Particulate Matter Limit: In an ISO 7 clean room, a maximum of 352,000 particles larger than 0.5 micrometers per cubic meter of air is allowed.

- Filtration: Must have HEPA (High Efficiency Particulate Air) filters to ensure the removal of particles from the air.

2. Temperature and Humidity Control

- Temperature Range: Generally, it should be maintained between 20°C and 22°C, although this may vary according to the needs of the process.

- Relative Humidity: Should be controlled between 30% and 60% to avoid problems such as static electricity build-up or contamination. 

3. Air Flow 

- Positive Pressure: The room should maintain a positive pressure in relation to adjacent areas to prevent the entry of contaminants.

- Ventilation System: An adequate system that allows laminar airflow is crucial to minimize turbulence and contamination. 

4. Materials and Surfaces

- Non-Porous Materials: Surfaces should be smooth, non-porous and easy to clean, such as stainless steel, some plastics, laminated surfaces, tempered glass, generally antistatic materials.

- Design: Corners should be rounded and surfaces should be designed for easy cleaning. 

5. Equipment and Procedures 

- Appropriate Equipment: All equipment used in the cleanroom should be compatible with the controlled environment, avoiding materials that generate particles or contaminants, such as avoiding fabrics, wood, metals that oxidize and elements that generate static electricity. 

- Cleaning Protocols: Strict procedures should be followed to clean and disinfect the room before and after each use.

6. Environmental Monitoring 

- Sensors and Continuous Monitoring: Systems should be in place to continuously monitor air quality, temperature, humidity and pressure. 

- Records: Keeping detailed records of environmental conditions and any deviations is essential for regulatory compliance. 

7. Personnel Training

- Specific Training: Personnel should be trained in proper procedures for working in a controlled environment, including the correct use of personal protective equipment (PPE).

 8. Controlled Access

- Access Controls: Only authorized personnel should have access to the cleanroom, which helps minimize the risk of contamination. 

Complying with these requirements ensures that components manufactured in an ISO 7 cleanroom are safe and effective for use in medical devices. 

Cleanroom Manufacturing Capabilities  

At OSF we have the following capabilities within the 100 m² ISO 7 classified Clean Room space: 

• Plastic injection molding on 50Tn and 240Tn machine.
• Silicone injection (LSR) in 80 Tn machine.
• Peripheral equipment such as dosers, temperature control units, necessary for injection.
• Post-curing oven for silicone.
• Handling area for assembly and complementary works. 

We have machinery of recognized brands such as Arburg, Wittmann Battenfeld and Engel, thus guaranteeing the highest quality in our processes. 

Quality and safety of medical equipment: ISO 13485

ISO 13485 is a globally recognized quality standard that guides organizations in the production and marketing of medical devices. 

ISO 13485 allows manufacturers of medical devices and related services, such as OSF, to increase their access to international markets, thus demonstrating their compliance with regulatory requirements and customer expectations.