Starting Later this season, A2C2 will start a multi-part series on ecological bioburden testing for clean rooms and their connections to placing alert and action limits both for products and environments. The articles by Gregg A. Mosley, lead teacher for the AAMI class, Industrial Sterilization of Medical Devices, will focus on the significance of the information collected by present practices. Second, the problem of the connection between ecological information from clean room monarchizing along with the real product characteristics will be discussed, along with applicable alert and action limits. Last, the resources of common contamination that permits ingress of organisms with abnormal levels of immunity both for terminal product sterilization and regular facility sanitization will be discussed. The following are excerpts about some of the topics to be discussed.
‘The Issue of using settle plates is identified in respected references and the passive capture of settling microbes represents one of the earliest measurement methods for collecting bioburden testing. One article stated, Due to air turbulence and random particle settling, settling plates aren’t quite accurate. This statement is simply not correct. Settle plates quantify precisely that phenomenon for which they are intended; the arbitrary settling of biologically active particles BAPs. As will be shown, the significance of settle plates equates directory into the possible effect of BAPs on the process and product, while the significance of active sample outcomes is unclear. Settle Plate dimensions may be more relevant to analysing possible distribution of BAPs on merchandise than either surface or air sampling. Irrespective of which method or combination of methods are employed, one conclusion is certain; all the 3 methods measure different contaminating attributes and there is no direct correlation between both as a rule of thumb.
The use of active samplers is often implemented without due consideration of their potential impact, both on the sample itself and about the process and products. Active samplers should not ever be hand held during the sampling procedure. Companies Often apply alert and action limits based only on the ecological biological sampling data. This might cause frequent alert and activity responses because the data collecting sequence was too short. The Escape from this cycle would be to float limitations upward dynamically based on correlation of new ecological information with product information collected at exactly the exact same time. This approach enables a two way road within which manufacturers can function.