Kindly explain cleaning hold time duration and dirty hold time duration
Develop the cleaned and uncleaned equipment hold time study by taking swab smaple .
While validating the Clean equipment validity period, Is it required to perform Surface sampling and air sampling for area also?, area has also the impact, or need to focus only in swab sampling of equipment?!!
What is the procedure to select the worst case equipment and area or you can only take a simple equipment…
U take swab from all i.e floor, wall, windows, equipment. Perform all for analysis and u prove no traces of previous product.
Dear Sabbineni, its ok for Cleaning validation of area and equipment for traces of previous product.
But , my subject matter is with respect …what i was asking regarding the “Validity”
Air saming is not needed equipment swab sample is taken.
For worst case select less soluble n more toxic material
Dear .Md.Asif Hussain
After cleaning, sample from the surface are collected. Its microbiological parameters are measured and recorded.
This sampling will be repeated same time everyday. One day will come when the reports show deterioration.
Now, from the day of cleaning to the day before deterioration is your holding period.
This test have to be done thrice. You have to average he result.
Prepare the protocol for cleaned and uncleaned. Equipment in that u plan for how many days u take the swab.
This procedure is correct.
what is cleaning hold time duration and dirty hold time duration?
it is determined practically
This is very correct answer
In this i have one doubt sir. is it required to daily monitoring of the incubated plates
Cleaning hold time study and dirty hold time study there is no time bonding that is depend upon the product degradation.
Example if u want prove your dirty and cleaned hold time study for one month performance of your dirty and cleaned hold study for 45 days and ensure that your product dirty condition will not degrade and after cleaning ensure that there is no impurity degradation and microbial growth up to 45 days.
Based on the performance study if no degradation you can keep your equipment up to 1 month and after cleaing if there is no microbial growth and impurity study you can keep your cleaned equipment 1 month.