Efficient and flexible Real-Time Cleanroom Monitoring

A cleanroom is a manufacturing or research environment that is purposely designed to have a very low level of environmental pollutants such as dust, airborne microbes, aerosol particles and chemical vapors. The air inside is constantly recirculated through High Efficiency Particulate Air (HEPA) filters. The presence of people is by far the greatest source of microbial contamination! Other environmental conditions can also be monitored and controlled including relative humidity, temperature, particles, differential pressure and airflow.

Cleanrooms are used extensively by semiconductor manufacturers and increasingly by biotechnology, life sciences, health care, aerospace, data centers and research organizations working with materials and substances that are sensitive to environmental contamination. Some are entire manufacturing facilities and can cover thousands of square meters.

To define which parameters should be controlled/monitored a risk assessment needs to be carried out, reviewing the effects of each parameter on the product.

Regulations for Cleanrooms

The various regulations governing medicinal products in the European Union is determined by EudraLex, included is ISO 14664. The classification of a cleanroom must be performed periodically based upon risk assessment of the application. The installation must be equipped with continuous environmental monitoring of air quality. Deviations must be detected as soon as they occur. ISO 14644-1 defines the number of sampling locations based upon the size of the cleanroom.

Humidity and Temperature Control

The effects caused by humidity include expansion, contraction, hardening/softening of materials, viscosity change of liquids, the growth of microbes and an increase in static electricity which can destroy the production batch as well as expensive measurement equipment.

A regulated process requires the control and recording of temperature and humidity according to GMP and internal quality guidelines. Semiconductor and electronics manufacturing processes require very accurate control in their cleanrooms. In the food industry it is important that the relative humidity stays under 40% thereby restricting the growth of bacteria and germs.

Air Particle Measurement

A light-scattering airborne particle counter determines the concentration of particles and is capable of counting and sizing single airborne particles and reporting size data in terms of the equivalent optical diameter. The main sizes monitored are 0.5 µm and 5 µm and are reported as particles/m3 or particles/ft3; the ISO 14664-2 standard specifies a flow rate of 1 cfm for counter particles that are equal or larger than 5 µm. Lighthouse, Particle Measuring Systems, Beckman Coulter and Climet are just a few manufacturers of precision measurement particle counters.

ISO 14664-2 states that continuous environmental monitoring provides significant benefits with a detailed overview of cleanroom performance; alerts and alarms must be defined.
The implementation of continuous monitoring will help to achieve the ISO 14644-1.
Continuous monitoring confirms consistent, high quality environmental conditions with any changes detected as soon as they happen.

The Rotronic Monitoring System Solution - RMS

The Rotronic continuous environmental monitoring system (RMS) is a GAMP©5 category 4 software combined with category 1 hardware, helping users monitor their GxP compliant applications, looking into the critical quality attributes and monitoring critical process parameters, focusing on patient safety, product quality and data integrity with compliance to EudraLex Annex 11 and FDA 21 CFR Part 11. It has been developed with the Pharma Industry for the Pharma Industry.

Using the analog output or the MODBUS TCP protocol, third party products – such as particle counters - can easily be integrated into the Rotronic Monitoring System. This makes RMS one of the most flexible real-time online-monitoring systems.