Eleyda

Oh! I DO agree on that. As far as I go with BSC I know you can use Biological Indicators (BI) for BSC. Usually the vial equivalent is used when you decontaminate your BSC and thereafter you do your Surface, Vaiable and Non-Viable air samples on a monthly basis. (Be aware I worked for 4 years in Clinical Micro and 2 years in Environmental Microbiology, doing QA for clean rooms, BSC and what not). I am just trying to make sure there is no other way that may escape to me that we may be able to do a BI as my boss is requesting. Then again - it is my boss requesting it so I need to accumulate ALL the info that proves it is NOT doable in a safety manner. What I also proposed (as this is based on some positive pre and post testing from the past that I am 100% sure it was because the patient him/herself was infected) is to include the use of sleeves over the lab coats and in any case settle plates during processing. Maybe 2 people per hood as a stress test.

I have been requested to (re) validate our cleaning procedures for our BSC's. My supervisor wants some kind of controlled live organism we can use inside the hood and then clean it after to see if it truly was clean. In in theory should be: 1.) regular cleaning 2.) surface sample of BSC 3.) usage of microorganism 4.) surface sample of BSC 5.) regular cleaning 6.) surface sample of BSC My question is, how do I manipulate the microorganism? Is there anything I can prepare/buy for that matter? Is there any other way to do this ultimately? Thanks!

We do not use an LIS per se, and also we do not use electronic signatures (yet). We do save patient documentation from loggers and controlled rate freezers in our computers and also have electronic documents (SOP's and other forms) that we use. I think that more than anything we want to know especifically what would " trigger" part 11 on the way we use computers and what we should be doing to validate, or, if there is an alternative to stop " triggering" part 11 (if that makes any sense).

We are currently in pre process to review our SOP on Disposition of Unused Cellular Therapy Products and we do have a question. Currently we are requesting for any of the following documents if the patient has deceased: 1.) Copy of Death Certificate (From County, Hospital, or next of kin) 2.) Death Pronouncement from hospital (in the form of autopsy report or clinical attending note in patient chart). Is this information OK or what is the trend to document the disposition? Is a letter from the recipient Doctor and either the recipient or donor (in this case relative) enough?

Just a note to say hi. My name is Eleyda and I am currently working in a Stem Cell lab in California. Hopefully I will meet new people and answer many, many, many questions I have... (And maybe answer a couple too).

We tried to validate igloos for transport and if you are using a data logger during transport, after our validations it was not stable enough to keep product in range. So far he wave been using Credo (previously Golden Hour) products from Minnesota Thermal Science http://www.mnthermalscience.com/Index.aspx and those boxes are extremely reliable.

We are trying to get our act together in relation to computers/software and FDA 21 CFR part 11 at our Cellular Therapy Product lab. Does anybody have any pointers or validation plan that may help us to start planing ours?