By Sean on Thursday, March 15, 2001 - 04:46 pm:
Can anybody give me the formulas to calculate cleaning validation based on LD50 of the compound.
Sean
By I.D. on Sunday, March 18, 2001 - 07:26 am:
Cleaning validation is usually calculated on the basis of LTD.
The maximum allowable amount of residual active material per swab (MA), in a specific piece of equipment, is determined as follows, using the WORST CASE parameters:
MA mg/swab = (LTD/1000)/D * Wb/Wt * Ss/Se * R
LTD -- Lowest Therapeutic Dose of product A (former) (mg)
D -- Highest daily dose of product B (subsequent) (No. of dose units)
Wb -- Smallest batch size of product B (kg)
Wt -- Highest dose weight of product B (mg)
Ss -- Swab area (cm2)
R -- Recovery coefficient of active material with lowest solubility (%)
If you still need LD50 based calculation, you should find the connection between LD50 and LTD.
By B.Buglio on Monday, March 26, 2001 - 07:10 am:
Agree with the above- better yet if there is tox
data availble you should set limits on the
toxiologically insignificant values(TIEL numbers).
By Sean on Sunday, April 22, 2001 - 09:29 am:
Hey!! I.D. YOU FORGOT TO DESCRIBE Se in CLEANING VALIDATION FORMULAS (DATED MARCH 26)
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