A Cleanroom or Clean Zone is an area wherein airborne particles and cleanliness are controlled to specifications and other relevant parameters are controlled, monitored and recorded (i.e. temperature, humidity, pressure, airflow and particulates). If your cleanrooms comply with strict quality management guidelines and undergo regular vendor audits, you require comprehensive reporting, real-time alarming, and easily managed monitoring.
The Vaisala viewLinc monitoring system aids in classifying cleanrooms, and cleanroom certification with user-friendly software, accurate calibrated devices, and simple reporting. All cleanroom testing report documentation can be customized to your specifications.
Ideal for cleanroom uniformity testing, Vaisala data loggers meet all cleanroom certification and uniformity testing requirements for range, accuracy and resolution. Data loggers have on-board temperature and humidity sensors, and can take analog pressure, airflow velocity, and particulate sensors to manage and monitor all parameters in one reporting software.
With viewLinc, all cleanroom test protocols and report documentation can be customized to your specifications and aid in compliance with IEST, ISO, WHO, PIC/S GMP guides and other standards and guidance.
Global regulators of cleanroom standards and their regulations include:
-USA FDA 209E
-EU GMP standard
-Britain BS 5295
-Australia AS 1386
-France AFNOR X44101
-Germany VD I.2083
-ISO standard 14644-1
In the EU, the recent “Revision of the Annexe to the EU Guide to Good Manufacturing Practice-Manufacture of Sterile Medicinal Products” is used to outline “in operation” conditions in the four classes of clean rooms, regulated by EMA (Relevant annexes include 1, 2, 14 and 18.) In the US, FDA regulations regarding clean rooms can be found in “CFR PART 210--Current Good Manufacturing Practice In Manufacturing, Processing, Packing, or Holding of Drugs; General” and “CFR PART 211--Current Good Manufacturing Practice For Finished Pharmaceuticals for administration to humans or animals that stipulates monitoring”. More specifically in terms of the monitoring of temperature, humidity and other parameters, section 211.42 “Design and construction features” part iv calls for “monitoring environmental conditions.”
However, the regulations are quite broad, stating the end result, rather than the methodology of cleanroom compliance. For more specific guidelines, the ISPE guidance contains recommendations on maintaining a written monitoring program, specifically sampling of air quality, floors, walls and equipment surfaces. In addition, the ISO/TC209 Standard (under ISO 14644-1), addresses the many factors that, along with airborne particles, contribute to the cleanliness of controlled environments.
Key to compliance with the above regulations and guidance is the ability to respond to, record and report on conditions in controlled environments. The Vaisala continuous monitoring system allows cleanroom personnel to receive alerts if any environmental parameters go out of specification or if sensor communication with the system is lost. This solves the problem of having to schedule checks of the monitoring equipment.
The viewLinc software is browser-based and accessible from any network location. Reports are customizable and easily exported to Microsoft Excel for analysis and manipulation. Many viewLinc users report that trend and historical reports that are easy to generate often becomes an important aspect of their audit process, whether the audit is conducted by a customer or an enforcement agency.