Does anyone know if there is any harmonized standard that defines a specific periodicity for the qualification of sterilization cycle (by moist heat) apart from GMPs?
Many thanks in advance for your attention,
I am so glad we have a new space for discussion and to share expertise, after the end of Eslmars Cove.
I had some difficulties to receive the activation email, but fortunately Marcelo helped me to solve the problem.
I am not to familiar with IEC 62366, since I work mainly with borderline devices (in the pharmaceutical area), but…[Read more]