Handheld, portable and remote / fixed non viable particle counters are widely used throughout Australia and the world across many industries (pharmaceuticals, hospitals etc) and they have always been available in different flow rates options. Handheld particle counters operate at typically 2.83 LPM, portable particle counters generally come in 28.3, 50 and 100 LPM variations and remote fixed particle sensors are generally available in 2.83 and 28.3 LPM variants with 28.3 LPM being the default most suppliers have used for some time now.
In PIC/S PE009-16 (Annex 1) and earlier versions these documents have described in detail how particle monitoring should be undertaken in grade A, B, C, D controlled environments and how a suitable sample size should be monitored. Particle counter users have been able to use their fixed or portable instruments to collect a suitable sample size with some instruments taking longer to collect samples than others due to the instruments flow rate.
PIC/S PE 009-17 Changes
In the latest version of PIC/S PE-009-17 (Annexes) which the TGA will be auditing facilities to soon, there is one important change that many organizations still appear to be unaware of and that is:
Section 9.17 – Stipulates that a suitable sample flow rate of at least 28 liters per minute be used when monitoring in grade A environments.
What Does This Mean for Industry ?
It means that if you are using handheld particle counters and or are planning to buy handheld particle counters then these will be non compliant with this new PIC/S PE-009 requirement, as most handheld instruments operate at only 2.83 LPM. The same would apply to any fixed particle sensors operating at 2.83 LPM. It may be time to look at upgrading to a suitable portable particle counter if you need to meet these requirements.
Handheld particle counters still remain very useful to many organizations and these may be used for a wide variety of applications.
For more information in relation to these new changes, particle counting and or monitoring controlled environments, feel free to contact Alpha Scientific on (03) 9124 9886 or email sales@alphascientific.com.au