PT  - JOURNAL ARTICLE
AU  - Jones, David
AU  - Cundell, Tony
TI  - Method Verification Requirements for an Advanced Imaging System for Microbial Plate Count Enumeration
AID  - 10.5731/pdajpst.2017.007955
DP  - 2018 Mar 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 199--212
VI  - 72
IP  - 2
4099  - http://journal.pda.org/content/72/2/199.short
4100  - http://journal.pda.org/content/72/2/199.full
SO  - PDA J Pharm Sci Technol2018 Mar 01; 72
AB  - The Growth Direct™ System that automates the incubation and reading of membrane filtration microbial counts on soybean-casein digest, Sabouraud dextrose, and R2A agar differs only from the traditional method in that micro-colonies on the membrane are counted using an advanced imaging system up to 50% earlier in the incubation. Based on the recommendations in USP <1223> Validation of New Microbiological Testing Methods, the system may be implemented in a microbiology laboratory after simple method verification and not a full method validation.LAY ABSTRACT: The Growth Direct™ System that automates the incubation and reading of microbial counts on membranes on solid agar differs only from the traditional method in that micro-colonies on the membrane are counted using an advanced imaging system up to 50% earlier in the incubation time. Based on the recommendations in USP <1223> Validation of New Microbiological Testing Methods, the system may be implemented in a microbiology laboratory after simple method verification and not a full method validation.