Pharmatech Cleanroom Division designs and realize controlled contamination areas for PRODUCTION PROCESS (view pdf documents) in compliance with ISO e GMP (Good Manufacturing Practice), and ATMPs facilities (Advanced Therapy Medicinal Products - view pdf documents)
Controlled Contamination Environment is defined as an environment able to guarantee that the air, with which the product is or could be in contact, has a polluting agents concentration (inert particles or microorganisms) lower than a determinate number per volume.
ISO 14644 “Cleanrooms and associated controlled environments”
The application of the ISO 14644 international standard is concerned with “cleanrooms” and associated controlled environments. In particular the control of the polluting agents concentration is critical for activities liable to air contamination. The problem can involve various types of industries, i. e. aerospace, microelectronic, alimentary, pharmaceutical etc..
From EU GMP volume 4, §3.1, “Good Manufacturing Practices – Medicinal products for human and veterinary use”: premises should be situated in an environment which, when considered together with measures to protect the manufacture, presents minimal risk of causing contamination of materials or products