05-24-2010 12:36 PM
I have a client who is working on implementing a sampling plan. They are getting what we will call "grief" from the lab as far as the action levels they are setting for CFU's. The lab is telling them that all samples from the hoods should have 0 CFU. They were planning on setting action levels so that for Air Sampling 1 CFU is allowable and for Surface Sampling up to 3 CFU are allowable. They wanted to know if any other facilities have this "0 CFU" rule and what comments others may have.
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05-24-2010 03:54 PM
Ideally, your ISO Class 5 environment should have zero CFUs. The chapter recommends an action level of greater than 1 cfu per 1000 liters (cubic meter) of sampled air. If the lab is telling them to set their level at zero CFUs then they can set it at that level. What that will mean is that any CFU growth will involve a complete investigation, which may turn out to be accidental contamination.
06-01-2010 03:00 PM
I completed a surface sampling last week as I do each month, except this time we grew bacillus on our countertop. I had lab analyze this for me and we are trying to changes things so that this does not happen again. I did find out that once bacillus comes up, it leaves spores behind that alcohol will not remove. Lab recommended a cleaner that they used called Envirocide. The only problem is that this does have any phenols and this is what is recommended for the IV room cleaning. Any suggestions or recommendations. Also I am trying to limit the chance of having multiple cleaners.
06-08-2010 06:18 PM
You need to make sure Envirocide is a sporicidal agent. If you have spores, you may want to use a dilute bleach solution to disinfect the affect area. Bleach is a very effective sporicidal agent. In reviewing information about this disinfectant, I don't believe it is a sporicidal agent. Steris makes a sporicidal agent called Spor-Klenz which is a very robust and less corrosive cleaning agent than bleach. Phenolic based cleaning agents are environmentally caustic and not recommended. You should look at using a quaternary ammonium disinfectant like Lysol IC, used daily with a dilute bleach solution once a week. If you use bleach will pit stainless steel and should be wiped off with sterile WFI followed by sterile 70% isopropyl alcohol.