MACO Formula

GOOD VALIDATION PRACTICE (cGVP) CLEANING VALIDATION
1

May i know which is the latest formula for calculating the MACO Value which includes contact surface area.?
During MACO Calculation we have to take a single equipment surface area or total surface area of all equipments area?

we are using 5 cepha molecules i.e ,Ceftriaxone,Cefotaxime, cefepime , cefaxolin , ceftazidime cefuroxime All 5 molecules having 1gm strength and Daily Dose including same physical properties.Please advice how to identify the worst case scenario.

What is the safety factor for parenterals.( specially in this case )

2

In the above matrix, the less soluble High potent Active cam be considerd for Worst case.
Safety factor for Parenterals shall be 1/10000.

3

Dear Mr. Arun thanks for reply,here all the molecules are freely soluble in water and the potency is almost same. please advice.

4

fine, in this case you can see the worst case with respect to LD50. you can take it as worst case.