Pharmaceutical products are manufactured to adhere to exacting standards of efficacy and quality. All aspects of quality are evaluated, taking into account the hazards connected with the delivery ...

Both the USA cGMP 1 and EU GMP 2 dictate that cleanroom classification must be carried out according to ISO 14644-1. The version of this ISO standard released in 1999 4 was rewritten by a group of ...

Freudenberg Medical, a Kaiserslautern, Germany-based contract design manufacturing partner, launched CleanAssure, a new ISO Class 5 controlled cleanroom designed to deliver clean and sterile ...

To guarantee the safety and efficacy of products manufactured in cleanroom environments, organizations such as International Organization for Standardization (ISO) and regulatory bodies such as the ...

The various GMP guidelines and International ISO standards around GMP cleanrooms are complex and often appear to give conflicting advice, leading to confusion and sometimes incorrect interpretation.