Clean Room Measurement and Monitoring in Life Science - Vaisala

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

​If your clean rooms comply with strict quality management guidelines and undergo regular vendor audits, you require comprehensive reporting, real-time alarming, and easily managed monitoring. The Vaisala continuous monitoring system, comprising best-in-class instrumentation and easy-to-use viewLinc software, is a secure, flexible platform from which you can monitor and report on a variety of clean room parameters, including: temperature, relative humidity, differential pressure, flow, door switches, and more. Monitoring of these conditions will ensure against excess static and out-of-tolerance microbial growth.

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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.”

​ However, the regulations are quite broad, stating the end result, rather than the methodology of clean room 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 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.