Bracketing installations based upon Cleaning procedures

GOOD VALIDATION PRACTICE (cGVP) CLEANING VALIDATION
1

Hi everyone,

I am conducting the cleaning validation of a Non-dedicated API line, where two products are being produced. Both products use the same cleaning procedure for every single installation. But due to the fact that different installations have different cleaning methods e.g. Reactors, centrifuges, compactoers etc etc, I bracketed the Line according to these cleaning procedures into eight separate cleaning validations.

My questions is this. I am now calculating the swabbing limits using MACO and MACOppm. The limit I am working with is: 10ppm of the following products batch size. Can i estimate a swab limit for each bracket by only considering the surface area of the equipment of that bracket e.g. Synthesis line surface area only? OR do I still have to take the cumulative surface area of the whole line?

Hope someone can help me :),

Jean

2

Hi Jean,

In my opinion, I think this is dependant on your cleaning validation strategy. If you decided to bracket individual installations, you should calculate limits based on that. Otherwise, you shall define limit for entire line.

Hope this helps.

3

You are applying 8 kinds of cleaning procedures (with same cleaning agent) on different equipment. Means, you need to derive 8 MACO values. Hence, no need to consider entire contact surface area. consider the surface area of your target installation only!

4

Hi Tangkakj and Ramyaraj725,

Thanks for all the help and calirfying this problem for me.

Much appreciated !