EviSight Compact System Environmental Monitoring and Growth - PowerPoint PPT Presentation

EviSight Compact System Environmental Monitoring and Growth Promotion Testing Analysis Susan McDonagh

EviSight Compact System • Kinetic reading every 30min • Analyses with highly specified algorithms • High resolution pictures • Detection and counting in real time • Compliant with 90mm-, CT- und R2A plates, white filters

Smart Incubator • Incubation at 20-25 ° C or 30-35 ° C • 2 different temperatures are configurable within 1 incubation cycle • 4 readers with 6/12 plates+ PC • The readers can be configured independent from each other • Alert and alarm function for OOS results • 21 CFR part 11 compliant

Instrument Overview

Objective • Study • Environmental monitoring and the growth promotion testing

Method • Strains were tested in several replicates at 5, 25 and 50 CFU/ Plate • The detection was performed by the Evisight Compact instrument and by 3 different operators manually.

• TSA culture media was used with a 90mm plate format and the microorganisms tested, for the environmental monitoring and the growth promotion testing were : • A.Brasiliensis • B.Subtilis • C.Albicans • P.aeruginosa • S.Aureus • B.Cereus (only for GPT) • Micrococcus luteus lylae (only for GPT)

Results Comparison • Linear Regression • Bland Altman • Box Plot

Linear Regression EM

Linear fit CFU EviSight = 0,1922364 + 1,0025008*CFU manual_mean Summary of fit RSquare 0,996937 RSquare Adj 0,996828 Root Mean Square Error 0,938275 Mean of Response 16,66667 Observations (or Sum Wgts) 30 It can be noted that the results are satisfactory according to the PDA at 24-30h/50h: - Intercept estimate is very close to 0, - slope estimate is comprised within the acceptance range of 0.8-1.2, 2 value is higher than the acceptance criteria 0.9. - R

Bland Altman

CFU manual_mean 23,3542 t -2,07265 CFU EviSight 24,125 DDL 31 Mean difference -0,7708 Prob. > |t| 0,0466* Std Error 0,37191 Prob. > t 0,9767 Upper 95% -0,0123 Prob. < t 0,0233* Lower 95 % -1,5293 N 32 Correlation 0,99597 The results show that, on average, the Evisight instrument measures more colonies than the operators.

Box Plot EM

21 CFR Part 11- DATA INTEGRITY • Attributable • Legible • Contemporaneous • Original • Accurate

ALCOA • Different user access levels/unique identifier • Readable/permanent Audit trail • Activities captured with date/time stamp • Real time reading/recording using date/time stamp • Automated generated report including all data for traceability • No modifications w/o documented amendments

Back in Time

Reports

Benefits • Early warning for production for alert levels saving production time acceptance specification pre set. • Micrococcus can be detected and read after 24hours where the analyst couldn’t read until 48hours as colonies to small and not visible for analyst. • Bacillus and Mould the photographs Distinguish two bacterial colonies growing together

Benefits • User friendly • Qualitative - Provides a presence/absence result • Quantitative - Provides a numerical result • Limit human error • Remove discrepancies

Comparison to current method Traditional Using EviSight Load plates/Verification of plates into the Load plates onto the GDII system by a single traditional incubator by two qualified qualified analyst • analyst System verifies all required EM samples were taken and loaded per EM schedule Manual reading/verification of plates by Automatic reading of plates every 3 hours qualified analyst by EviSight • • Manual transfer Interim reports • • Plates on screen Results in 7 days • Automatic entry of results in LIMS • Manual entry of result in LIMS

Uses