Abstract

Background
Materials and Methods
DET
300-9999-TER-013 Disinfectant Efficacy Test for LpHse, Vesphene IIse, Spor-Klenz
RTU and 70% Decon-Alcohol
SOP Q12427 Disinfectant Efficacy Test
List new protocol
Method (Reference Q12427):
-Prepare Organism suspension
-inoculate coupon with suspension
-let the inoculum sit for set time
-expose the coupon with disinfectant
-let sit for a few minutes
-place the entire coupon in neutralizer (explain why?)
-mention vortexing and sonication
-perform 1:10 dilution until the 10-3
-plate each of the original and the dilution with pour plate method
-let the samples incubate for 3 days
-colony counting
-calculations to assure that there is a 3 log reduction for vegetative and 2 log
reduction for the
Spore formers
EM
GSP054: Biotech Drug Substance Zone Concept
SOP3800.107 Environmental Monitoring of the OCN Production Operations (OPO)
SOP00596: Determination of Alert Levels and the Performance of Trend Analysis for
Controlled Environments and Utility Systems
GSP090: Environmental Monitoring and Trending
SOP01672: Determination and Review of Biologics Microbial Action Limits and Alert
Levels for Non-Sterile Process Steps
SOP3800.037 Microbial Colony Counts
Method:
-Process of EM Excursion (covered in GSP090)
-Collect Data from Jan 2014-Dec 2014
-Covert Data from LIMS to Excel
(Talk about LIMS in relation to EM)
-Organize Data
-Graphing Trending

Results and Discussion

DET
EM
Conclusion
Acknowledgements
DET
-Lourdes
-Nick
-Ashley
-Scott
EM
-Ciara
-Damian
-Alan
-Beatrice
-Tom
-Mark Lee