cleaning validation maco and noel calculation formula
INTRODUCTION OF CLEANING VALIDATION:
The cleaning validation is to verify the effectiveness and consistency of the cleaning procedure for removal of product
residues as well as the control of potential microbial contaminants in product. Selection of “Worst case” product is on the
basis of Potency, solubility, Toxicity and Pharmacological action of Active pharmaceutical Ingredients (API).
Three consecutive applications of the cleaning procedure shall be performed during cleaning validation to
justified effectiveness & reproducibility of the cleaning procedure.
If any product introduced or discontinue into the line then revise the product matrix and perform cleaning
validation accordingly if get any change in ‘Worst case’.
CALCULATION OF MAXIMUM ALLOWABLE CARRYOVER (MACO) in mg:
Cleaning Limit Selection Criteria based on Maximum Allowable Carryover (MACO).
Cleaning Limit Selection Criteria based on LD50 and Maximum Allowable Carryover (MACO).
The MACO can be based upon LD50 data.
MACO Maximum Allowance Carryover: Acceptable transferred amount from the previous product into your next product (mg)
NOEL previous: No Observed Effect Level (mg/day)
LD50: Lethal Dose 50 in mg/kg animal. The identification of the animal (mouse, rat etc.) and the way of entry (IV, oral etc.) is important (mg/kg)
BW: Is the weight of an average adult (e.g. 70 kg) (kg)
2000: 2000 is an empirical constant
TDD next: Standard Therapeutic Daily Dose for the next product (mg/day)
MBS next: Minimum batch size for the next product (s) (where MACO can end up)
1000 = conversion of milligrams to micrograms
SF next Safety factor
The safety factor (SF) varies depending on the route of administration (see below).