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,
• R

2 value is higher than the acceptance criteria 0.9.

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 traditional incubator by two qualified analyst Load plates onto the GDII system by a single qualified analyst

• System verifies all required EM samples were

taken and loaded per EM schedule

Manual reading/verification of plates by qualified analyst

• Manual transfer
• Results in 7 days
• Manual entry of result in LIMS

Automatic reading of plates every 3 hours by EviSight

• Interim reports
• Plates on screen
• Automatic entry of results in LIMS

Uses