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Transcript of EnviroTest Training Deck - Q.I. MEDICAL, INC. · EnviroTestTM is available in two media...
![Page 1: EnviroTest Training Deck - Q.I. MEDICAL, INC. · EnviroTestTM is available in two media formulations • Malt Extract Agar (MEA) for targeting yeast, mold, and fungal contamination](https://reader031.fdocuments.us/reader031/viewer/2022022605/5b71024d7f8b9a1c4d8e407b/html5/thumbnails/1.jpg)
Q.I. MEDICAL, INC.
EnviroTestTM Training
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EnviroTestTM
• Used for monitoring the microbiological quality of controlled environments and compounding personnel
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EnviroTestTM is available in two media formulations
Trypticase Soy Agar (TSA) for general microbial contamination
ET1000
• The TSA of the ET100 is supplemented with lecithin and polysorbate 80 to inactivate residual disinfecting agents on surfaces – allows best microbial recovery
• Also known as Microbial Content Test Agar, this medium is shown to be as nutritive as TSA
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EnviroTestTM is available in two media formulations
• Malt Extract Agar (MEA) for targeting yeast, mold, and fungal contamination• Includes antibiotics to reduce bacterial overgrowth of fungal colonies
ET3000
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Comprehensive kit for testing
• Contents of each box:-10 Double sided agar paddles-10 Gummed labels-1 Directions for use-1 Test results log
• Certificate of analysis:-available for download at www.qimedical.com
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Key features of the EnviroTestTM
• 2cm separation between agar and fingertips, helps prevent accidental contamination
2cm
• Built in hinge to aid in reaching difficult surfaces
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Follow guidelines set forth in USP chapter <797>
USP chapter <1116> also a good reference in establishing protocols
Outsourcing facilities should review CGMPs for specific testing requirements
Proper testing is critical for sterile compounding
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Testing gloved fingertips and thumb prints of both hands immediately after gowning/garbing
Test key surface areas of compounding environment
(Hoods, Pass thrus, Carts, Shelving)
Test surfaces of key components
(Handles, buttons, key pads)
Frequency of testing see USP <797> for minimum requirements
Key factors in a sampling plan
*Information references common practice based on feedback. For specific requirements/recommendations see USP <797> and USP <1116>
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Developing a written sampling plan
Ante Room
Buffer Room
LAFWLAFW LAFW
ISO
LATO
R
Counter
She
lvin
g
Pass Thru
Ca
rt
Shelving
Pass Thru
Door
Door
= Surface Sampling
*Diagram is meant to illustrate an example sampling plan. Each facility will vary in terms of layout
= Gloved FingertipSampling
• Must include sterile gloved fingertips and ALL ISO classified areas• Clean surfaces after testing with 70% IPA and non-shedding wipe
Door Knob
Wall
Floors
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EnviroTestTM is ideal for meeting sampling requirements
High traffic entrance button
Pass Thru surface
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EnviroTestTM can access hard to reach areas better
Front and backside pass thru handle that is curved could easily
harbor bacteria
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EnviroTestTM can access hard to reach areas better
Pass Thru handle on barrier isolator
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Commonly used plates cannot access the same areas
Plates are also awkward to handle in these areas
Gap
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Hinge makes testing high traffic areas easy
Isolator button Floor area
Key pad panel
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EnviroTestTM is superior in testing corners of hoods
Air circulation within hoods often deposits particles in the edges and corners of the hood where a circular plate cannot
reach
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Edges are another issue for plates
Recessed surface of a plate makes it impossible to access raised edges
Gap
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Place paddle in tube and incubate
USP <797>: Temperature and duration vary depending on agar used
• ET1000: 30-35ºC for 48-72 hours (2-3 days)• ET3000: 26-30ºC for 120-168 hours (5-7 days)
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Observe and document results
• Positives (if any), Number of colonies (CFU)• Identification of Microorganisms• Evaluate and implement corrective action if necessary
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Disposal
• Discard in a manner consistent with State & Federal regulations as this may vary
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Q.I. Medical would like to thank Mercy San Juan Hospital Pharmacy Department for the use of their time and facility during this process
Special Thank You
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www.usp.org
www.qimedical.com
Reference Links