Clean rooms and other critical environments require high performance environmental monitoring to operate consistently and within product and process specifications. Humidity measurement can be especially challenging and important in clean room environments, which can be negatively impacted by or mold spores and other microbes. Vaisala’s high performance instruments and continuous monitoring solutions reduce the risk of out-of-specification conditions and help keep your facility audit-ready and compliant.
With state-of-the-art measurement technologies, expert guidance, and a wide range of services to support your operations, the Vaisala clean room monitoring solution measures humidity, temperature, differential pressure, flow, particulate and more. Our monitoring system provides gap-free data recording designed for creating the secure records that are required in GxP environments. Services include installation, accredited calibration, on-site service, and training to use the system.
Increase Clean Room Integrity with Monitoring Efficiency
Clean Room Regulations & Guidances
Global regulators of Clean Room 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.”
Key to compliance with the above regulations and guidances is the ability to respond to, record and report on conditions in controlled environments. The Vaisala continuous monitoring system allows clean room 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.