Manufacturers across many sectors use ISO classified cleanroom environments to conduct critical processes that demand protection from harmful contamination. The only way companies can ensure they are consistently meeting ISO classification parameters is to monitor the environment regularly.
However, despite the critical process and expensive investment in a cleanroom, many companies rely solely on their annual or bi-annual validation visit from contractors to check that the cleanroom is meeting its specified ISO classification parameters.
Benefits of regular environmental monitoring
Every day, contamination risks are generated from production staff, processes and products that may not be present during the annual validation visit:
- Filter blockages
- Airflow rate too low
- Poor operator practice
- Product/packaging
These risks have the potential to increase product failure rates and expensive recalls. This could have a negative impact on and cause long term damage to an organisation’s PR. For pharma, medical or food markets, contamination issues could even be fatal.
Regular environmental monitoring promotes cleanroom class confidence to satisfy internal or external audits. It also allows organisations to detect and address contamination sources quickly, before they cause issues.
Handheld particle counting
The good news is that particle counters are no longer too expensive, too large or too inaccessible for organisations to invest in. Cleanroomshop.com has recently launched a new range of particle counters that offer great value. The online cleanroom supplies specialists confidently claim that the three-channel particle counter from Airy Technology is the best value particle counter in the market; due to its low price, accuracy, functionality and ease of use.
ISO 14644-1 specifies maximum limits for a range of particle sizes, which is why this particle counter monitors three channels simultaneously:
- Channel 1: Choice of 0.3 or 0.5μm
- Channel 2: Choice of 0.5, 1.0, 2.0 and 2.5μm
- Channel 3: 5.0μm
For users monitoring ISO Class 7 or 8 cleanroom environments, the most popular channel combination is 0.5, 1.0, and 5.0μm. This particle counter is easy to use with a colour display and saves up to 8,000 data set records, which is higher than average for a handheld unit.
When ISO mode is selected, this three-channel particle counter automatically calculates average, standard deviation, and UCL, speeding up the process and improving accuracy by reducing manual calculations. ISO 21501-4 calibration with ongoing calibration service offered and a carrying case is included to protect the investment.
To offer a higher level of environmental monitoring, Cleanroomshop.com also offers a six-channel particle counter that calculates minimum sampling locations and minimum sampling time, as well as simultaneously monitoring six channels.
