Cleanrooms or clean zones are critical applications found within industries such as pharmaceuticals, medical devices, healthcare, aerospace and microelectronics. The applications are known as aseptic processing or manufacturing in a sterile environment.
All environmental conditions can be critical parameters that can affect product quality. In cleanrooms, air contamination is controlled to assure product quality and process integrity. In all cases the human operator is by far the greatest source of microbial contamination within a cleanroom! Various other environmental conditions can also be controlled/monitored within a cleanroom such as relative humidity, temperature, differential pressure and airflow.
To define what parameters should be controlled/monitored a risk assessment needs to be carried out, reviewing the effects of each parameter on the product.
The classification of a cleanroom may be performed periodically based upon risk assessment of the application and typically on an annual basis. When the installation is equipped with a continuous monitoring of air cleanliness, the time intervals between classification may be extended. ISO 14644-1 defines the amount of sampling locations based upon the size of the cleanroom:
How to measure particles:
A light scattering airborne particle counters is the basis for determination of the concentration of airborne particles and is capable of counting and sizing single airborne particles and reporting size data in terms of equivalent optical diameter. The main sizes monitored are 0.5µm and 5µm and are shown in particles/m3 or particles/ft3 and the ISO 14664 standard specifies a flow rate of 1 cfm for counter particles that are equal or larger to 5µm. Lighthouse, Particle Measuring Systems, Beckman Coulter and Climet are just a few suppliers of particle counters.ISO 14664 -2: Monitoring to provide evidence if cleanroom performance related to air cleanliness by particle concentration
The ISO 14664-2 states that the continuous monitoring offers various benefits and a detailed view of the cleanroom performance and that a monitoring plan should be created with an appropriate risk assessment tool, implemented and maintained.
The monitoring plan will define what parameters need to be monitored as well as the number of measurement devices and their bespoke location within the cleanroom together with the alert and action levels required.
The implementation of continuous monitoring will help to achieve the ISO 14644-1.
USP<1116> is only for guidance and states the requirement of an environmental monitoring program that can be compared to the ISO 14664-2 monitoring plan.
The value of continuous monitoring is the ability to confirm consistent, high quality environmental conditions at all times and that changes can be detected as soon as they happen.
The Rotronic Monitoring System solution
The Rotronic 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, helping focus on patient safety, product quality and data integrity and compliant to EudraLex Annex 11 and FDA 21 CFR Part 11.
Reliable measurements in clean rooms.Learn More