Pharmaceutical manufacturing environments have traditionally seen particle counting as a burden required to demonstrate compliance to a cleanroom standard. Now, however, Process Analytical Technologies (PAT) changes the focus to be on the final quality of the product…
Understand the technology behind aerosol particle counters and how it affects results. Learn what particle counters actually count. Graphics provided to support technological explanations.
The AirSentryĀ® II AMC Multipoint Monitoring System can be configured such that AMC point-specific concentration tags (sample location concentration data) are visible and managed by FacilityNet, not just in the onboard Supervisory Control and Data Access (SCADA) software, iFixā¢. Once configured properly in FacilityNet, all the FacilityNet features such as status indicators, graphical tools, and automated notifications can be utilized to their fullest extent. This paper will provide directions to add these point-specific concentration data tags into the local FacilityNet OPC Driver application on the integrated industrial computer.
With the release of the new EU GMP Annex 1, a review of current practices is required to ensure that the installed monitoring system, chosen to meet the needs of Annex 1, complies with the requirements. This chapter will review the needs of Annex 1 with systems designs currently being installed.