During preparations for the construction of two new cleanroom facilities, NorthX Biologics, a leading Swedish biological drug manufacturer and process developer, reviewed its environmental monitoring and control procedures, and decided to switch to a new Vaisala system, including almost 150 monitoring locations within cleanrooms and associated facilities.
“Obviously, the management of cleanroom environment forms a critically important component of our GMP – good manufacturing practice,” explained Dr Fredrik Amlinger Edin, lead validation engineer. “We therefore took this opportunity to undertake a review of our existing monitoring systems, because when your only tool is a hammer, there is a danger that every problem you see is a nail, so instead of persisting with our older systems, we explored a wide variety of alternatives.
“Our cleanrooms must comply with the strict GMP guidelines provided by EudraLex – Volume 4 – for medicinal products, laid down in Commission Directives 91/356/EEC, as amended by Directive 2003/94/EC, and 91/412/EEC. In addition, our facilities undergo regular audits, so it is vital that we employ a comprehensive reporting system with real-time alarm capability. However, for us, reliability and ease of use were also of particular importance, and we were keen to minimize the requirement for wiring.”
The monitoring requirements of NorthX Biologics initially included temperature, humidity and differential pressure. However, as Janne Halonen, Vaisala sales manager, explained: “We also offer a wide range of instrumentation for other measurement parameters which can be easily added to a Vaisala continuous monitoring system (CMS). For example, at NXBio, we added temperature loggers for freezers and refrigerators, carbon dioxide loggers for incubators, and hydrogen peroxide loggers for monitoring during decontamination.”
Vaisala was originally recommended by the cleanroom supplier, and initial discussions included a demonstration of viewLinc software, which highlighted the advantages of Vaisala’s continuous monitoring and alarming system. “The viewLinc software made our previous supplier’s system look very old-fashioned, so we were excited by the new capabilities offered by Vaisala,” Dr Edin explained. “The old system was more complicated to manage and was only applicable to cleanrooms, so it was a major advantage to be able to include product and agent storage facilities such as warehouses and refrigerators. “One of the most important features of viewLinc is the Administrative control which enables us to compartmentalize the system into user groups. With this tool we are able to specify the data which each user group is able to see, and which alarms are allocated to certain users. As a result, we are able to tell our staff: ‘If you can see it and you can do it… you are allowed to do it!’”
The cleanrooms at NorthX Biologics employ pressure cascade techniques to ensure that the flow of potential contamination is from clean areas to less clean locations. Hence the requirement to monitor pressure differentials between different zones. Dr Edin said: “A further advantage of the viewLinc system is that we can review periods when nobody has been working in a particular zone, and if the pressure cascade has been unaffected it means that we do not have to re-clean.”