ISO 6 and ISO 8: FL Medical’s choice to ensure quality and safety.
Controlled production for superior standards
FL Medical decided to produce in ISO 6 and ISO 8 certified cleanrooms to ensure superior standards of quality, safety, and reliability for its customers. These controlled environments are essential for minimizing the risk of contamination and ensuring compliance, even for applications in sterile environments. It is a conscious, daily choice that prioritizes the protection of the product and the end user.
ISO 6 and ISO 8: technical characteristics and applications
ISO 6 cleanrooms guarantee a high-purity environment, with a maximum of 35,200 particles ≥0.5 µm per cubic meter of air and an air exchange rate between 90 and 180 times per hour. They are used in the most critical production stages, where even minimal contamination can compromise the safety or effectiveness of the product.
ISO 8 cleanrooms, with a particle limit of 3,520,000 and approximately 20 air exchanges per hour, are employed for less sensitive operations such as packaging or labeling, while still maintaining essential environmental control.
Both classifications follow the requirements of the ISO 14644-1 standard and require careful structural design, coded operational protocols, and disciplined staff behavior. This balance of technology, method, and operational rigor ensures the quality and repeatability of processes.
Strict controls, complete traceability, real benefits
ISO periodic requalification to ensure the maintenance of environmental conditions in accordance with the ISO 14644-1 standard. The checks include verifying air flow rate, air exchange frequency, thermo-hygrometric parameters, and particle and microbial contamination, both in the air and on surfaces.
Products are also tested to verify their functionality and compliance with environmental and regulatory standards, such as CE marking. Every phase is traced and documented, ensuring control and transparency throughout the entire production process.
The result? Safe and reliable products that comply with international standards.
This is how FL Medical ensures constant quality, safety, and long-term value.
The decision to operate in ISO 6 and ISO 8 environments reflects our ongoing commitment to high production standards, safety, and traceability.
Every technical decision made by FL Medical is aimed at ensuring consistent quality and long-term reliability.
To learn more about all the certifications obtained, please visit the Quality section of our website.