by Phil Smart

Clause 6.4 of DIS ISO 13485:2003 states that "the organization shall determine and manage the work environment needed to achieve conformity to product requirements". In particular, "If environmental conditions can have an adverse effect on product quality, where approriate, the organization shall establish documented requirements for the environmental conditions and documented procedures to monitor and control these environmental conditions."

The Medical Device Directive, Annex I section 8.5 states that "devices intended to be sterilized must be manufactured in appropriately controlled (e.g. environmental) conditions." Other direct references to controlled environments can be found in the introductions to MDD harmonized standards for sterilization, EN550, 552, 554, 556 and EN1174-1.

And here at home 21 CFR Part 820.70:1996 (c) and (e) discuss environmental control and contamination control. Clearly there is a need for an appropriately controlled and monitored environment in the manufacture of sterile medical devices.

In the past, however, there has been little in the form of standards to rely on for non-classified cleanrooms, e.g. "controlled environments." With the publication of ISO 14644, Parts 1 and 2, the situation has changed:

ISO 14644-1:1999 Cleanrooms and associated controlled environments - Classification of air cleanliness

ISO 14644-2:2000 Cleanrooms and associated controlled environments - Specifications for testing and monitoring to prove continued compliance with ISO 14644-1.

Now you have recognized standards to refer to, and your notified body has them as well. You can expect that these standards will be taken more seriously by most notified bodies in the future.


Solution:

Our suggestion? Perform a gap analysis of your current environmental monitoring and control system to the above standards, then implement preventive measures if deemed necessary.
Contact us to discuss your particular situation. From the perspective of active Notified Body Auditors, RA/QA International can help you in the following ways:

ISO 13485/ISO 14969 and ISO 14644 training to ensure thorough understanding of requirements of the standards and thereby compliance to environmental requirements;

ISO 13485/ISO 14969 and ISO 14644 gap analysis and consultation on implementing any necessary corrective actions

Internal auditing of your facility to ensure regulatory compliance across all environmental requirements