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Transferred incubation, the new cost and time saving model to monitor your cleanroom
 

Transferred incubation, the new cost and time saving model to monitor your cleanroom

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Shawn Sherry, Business Development, Microtest Laboratories Inc.

Shawn Sherry, Business Development, Microtest Laboratories Inc.

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    Transferred incubation, the new cost and time saving model to monitor your cleanroom Transferred incubation, the new cost and time saving model to monitor your cleanroom Presentation Transcript

    • The Cost and Time Saving Model To Monitor Your Cleanroom
    •  Two media, single incubation system. ◦ TSA (bacterial growth), SDA (yeast/fungal) ◦ TSA incubated at 32.5 +/- 2.5oC for 2-3 days ◦ SDA incubated at 22.5 +/- 2.5oC for 3-5 days  Past Reasoning: ◦ TSA cannot capture fungal growth therefor a selective media is required. ◦ Selective media allows for yeast/mold growth while limiting ability of bacteria to grow.
    •  General Use Media (TSA) for all organisms.  Incubation Scheme: ◦ Incubation at 32.5+/-2.5oC for 3 days followed by 22.5+/-2.5oC for additional 2 days.  Reasoning: ◦ TSA has ability to capture most mold with correct conditions. ◦ Method should be qualified against appropriate environmental isolates (specifically yeast/mold).
    •  USP <1116> ◦ “A general microbiological growth medium such as soybean–casein digest medium (SCDM) is suitable for environmental monitoring in most cases because it supports the growth of a wide range of bacteria, yeast, and molds.” ◦ “The ability of any media used in environmental monitoring, including those selected to recover specific types of organisms, must be evaluated for their ability to support growth, as indicated in <71>.”
    •  Study should be performed showing comparability in media to pick up environmental isolates.  Study should target environmental yeast/mold that show predominance in trending and/or are slower growing organisms. ◦ No need to perform bacterial environmental isolates as they have already been captured on TSA and therefor do not need to be repeated.
    •  Target Media: TSA with neutralizers  Control Media: SDA with neutralizers  Target Organisms ◦ Aspergillus bransiliensis (env. Isolate) ◦ Aspergillus flavus (env. isolate) ◦ Candida albicans (ATCC 10231) ◦ Penicillium chrysogenum (env isolate) ◦ Chaetomium globosum (env isolate)  Target Growth ◦ Acceptable growth is 0.5 to 1.5 times the growth seen on control Agar.
    •  Positive Control Media incubated at 22.5+/- 2.5oC for 3 days.  Test Growth Media incubated at 32.5+/- 2.5oC for 3 days followed by 22.5+/-2.5oC for additional 2 days.  Acceptable growth is 0.5 to 1.5 times the growth seen on Positive Control Agar.  Negative Control Media to be negative for growth after 5 days of transferred incubation alongside samples.
    • Organism SDA 1 SDA 2 SDA 3 Avg SDA Acceptance Range A. bransiliensis 45 39 48 44 22-66 A. flavus 41 38 43 41 21-62 C. albicans 56 51 46 51 26-77 P. chrysogenum 44 41 48 45 23-68 C. globosum 42 49 52 48 24-72
    • Organism Acceptance Range TSA 1 TSA 2 TSA 3 Pass/Fail A. bransiliensis 22-66 39 48 44 Pass A. flavus 21-62 38 43 41 Pass C. albicans 26-77 51 46 51 Pass P. chrysogenum 23-68 41 48 45 Pass C. globosum 24-72 49 52 48 Pass
    •  Changes in Growth Promotion Testing. ◦ Modified from USP <71> listed organisms. ◦ Modified to include incubation scheme described in study. ◦ Incubation time based on worst case scenario.  Increased sampling scheme based on decreased resources required and a risk based approach.
    •  Time ◦ Length of time to sample is typically cut in half.  Cost ◦ Typical Cost savings range from 30%-50%.  Resources ◦ Lowered sampling time and plate analysis will decrease personnel requirements for sampling.  Space ◦ Decreased refrigeration storage space for sampling plates (pre-use) and incubation space due to plate count being cut in half.
    • Questions? Visit us at Booth 1008