Cleanrooms

cleanrooms

A cleanroom is a controlled environment used to provide high safety regulation activities. In a clean room the air is permanently filtrated in order to remove the impurities and small particles which can cause the regular productivity processes. The temperature and humidity are also carefully controlled protecting so the equipments sensitive to environment differences. Also the absolute pressures (relative to atmospherical presure) forms the clean rooms are different so the air flows in one way only, decided based on necesities.

According to ISO 14644-1 Standard enclosed space named cleanroom is a room in which particle concentration is controlled and is build and used in such way so that the particle generation and introduction is reduced inside. Other relevant parameters as are temperature, humidity, and pressure are controlled in accordance with requirements.

Contamination Control
The environment control in a cleanroom is closely related with the assessed standards for the cleanrooms. Therefore in Romania are standards for the contamination control.

Cleanrooms and Utilities Standards
In Romania the legislation regarding cleanroom standards is scheduled under Ghid privind Buna Practica de Fabricatie pentru Medicamente de Uz Uman and rounded by ISO 14664 and ISO 14698 standards.
For laboratories the standard is Good Laboratory Practice.
For compressed air the standard is Ghid privind Buna Practica de Fabricatie pentru Medicamente de Uz Uman and rounded by ISO 8573 and PIC/S - Pharmaceutical Inspection Convention PI 009-2.