1. Scope
This guide will cover the methods used to characterize the relevant properties of bacillus spore suspensions. This document will provide the user with the recommendations for the measurement methods, and conditions that should be controlled to ensure that reliable and high-quality data are obtained. The guide will help assure that the results obtained from the characterization are done and reported in a uniform manner. This will allow others to replicate the measurements and facilitate the comparison of different lots of bacillus spore suspension materials used as reference materials. The guide is intended for both manufactures and end users of bacillus spore suspensions. The results of the characterization measurements presented in a report of analysis (ROA) would provide sufficient detail about the measurement technique to enable the customers to replicate the measurements, allowing them to determine if the properties of the bacillus spore suspension had changed during shipping and storage. The guide contains a number of measurement methods, but does not make specific recommendations for the number or specific measurement method that should necessarily be used. The guide also contains additional recommendations on reporting the methods used to produce and purify the spores. If this information is provided it would be of value to those seeking to produce spore preparations with similar properties, since these processes may influence the final properties of spore suspensions.
Currently, there are no uniform standards or guidelines that define how to adequately characterize the reference materials for Bacillus anthracis (BA) spores. The major focus will be on BA spores, but since simulants are extremely important for testing and development of new technologies, the standard will also apply to spores from other species of Bacillus. The properties of biological materials influence their response to detection devices, their surface interactions, and disinfection characteristics. Methods to characterize the biological, chemical, and physical properties of the spores will be considered in the standard. Standards to fully characterize reference materials, used to test detection devices, sampling methods, and remediation techniques, will ensure that companies producing testing instruments, manufactures of reference materials, reference laboratories, and first responders are using the best materials. The improved data will increase the confidence of the results obtained and allow meaningful comparisons to be made between results are obtained from different labs, trials and companies.
Keywords
bacillus; spore; anthracis; anthrax; reference material; biological threat; detection
The title and scope are in draft form and are under development within this ASTM Committee.
Citing ASTM Standards
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