討論區
發文主題：手部菌落&空氣落菌標準
http://www.emlab.com/s/services/USP_797.html
此為藥劑的落菌落塵均有標準,且大部份的JCI評鑑均被要求要做
How Do I Sample For Viable Particulates For USP 797 Compliance?
Air Sampling: Using an impaction sampler collect as much air as possible without drying the media. The 2008 revision bulletin requires a sampling volume of 400 to 1000 liters of air, subject to recommendations by the manufacturer of the sampling device and the volume needed to meet the limits of detection for the ISO rating of the area being tested.
Surface Sampling: Surface sampling can be accomplished using contact plates and/or swabs. When swabbing is used in sampling, the area covered should be at least 24 cm2 but no larger than 30 cm2.
Gloved Finger Sampling: TSA plates should be used to sample gloved fingertips after compounding CSPs immediately after exiting the ISO Class 5 environment. Glove fingertip sampling must occur outside of the ISO Class 5 environment. Do not disinfect gloves with Isopropyl alcohol immediately prior to sampling. Personnel should "touch" the agar with the fingertips of both hands in a manner to create a slight impression in the agar.
According To USP 797, What Levels of Viable Colony Counts Are Considered Elevated?
The following table lists the action levels adapted from the Pharmaceutical Compounding - Sterile Preparations <797>, that when exceeded must initiate further investigation.
| ISO Class | Active Airborne (cfu*/m3) | Glove Fingertip (cfu/contact plate) | Inanimate Surfaces** (cfu/contact plate) |
| 5 | > 1 | > 3 | > 3 |
| 7 | > 10 | not required | > 5 |
| 8 | > 100 | not required | > 100 |
** Contact plate areas vary from 24 to 30 cm2. When swabbing is used in sampling, the area covered should be at least 24 cm2 but no larger than 30 cm2.
Regardless of the cfu counts, corrective actions must be dictated by identifying the microorganisms recovered. If pathogenic microorganisms are found, you must be immediately remedy the situation
1.洗手確效的評估,國內有應用及國外文獻洗手前後菌落數的比較
如: http://www.labmed.org.tw/UpFiles/Issues/201076144729.pdf
http://www.psmid.org.ph/vol27/vol27num2topic2.pdf
2.主要是要看您實驗的目的要做什麼,如果是固有菌及暫時細菌數?,則變異因子很大,每個人手上的細菌負荷量不同,所以一般都以洗手的前後做比較,評估其成效,是相對比較,而非標準值
3.群突發時不同,而以定性為主,只要與流行相同菌均保留,進一步比對
非常感謝~~謝謝~~
