# 10ppm calculation

Hello,

We are trying to understand the calculation for the swab limit using the 10ppm method. For multiple equipments that are used in a manufacturing train, would the minimum batch size used in the calculation be for the equipment that is the smallest?

For example, a manufacturing train involves a tableting machine and a coater, meaning the tablets are coated after compression. The minimum batch size for the tableting machine is say 50000 tablets while that of the coater is 150000 tablets. The surface area for the tableting machine is say 10000 sq. cm while that of the coater is say 30000 sq cm.

While calulating 10ppm and the swab limit per sq.cm, would these equipments be considered individually or would the total surface area be considered? If the total surface area of both equipments is considered, what would the minimum batch size then be?

Thank You.

Dear

10 ppm criteria means 10 ppm API allow in to the subsequent product.
So, shared surface area of all the equipments shall be considered in the calculation.
moreover, if you can give more elaborated example, I can give exact answer or calculation

[quote=Himansu]Dear

10 ppm criteria means 10 ppm API allow in to the subsequent product.
So, shared surface area of all the equipments shall be considered in the calculation.
moreover, if you can give more elaborated example, I can give exact answer or calculation[/quote]

Pls correct the statement, 10 PPM criteria means not exactly 10 PPM allow in to the subsequent product, It will be varies with the minimum batch size of next product [Where MACO can end up] .

MACO as per 10 ppm criterial means 0.001% of the minimum batch size of next product.

For more details pls see APIC guide line on cleaning validation page no:7

Thanks and regards

When considering different products, I suggest you use the smallest batch size of the product rather than the smallest batch size in the train. Based of the smallest batch size, you will get a limit for each previous product in the next product on 10 ppm criteria. There will be different limits. From these limits you may choose the lowest limit as the criteria that will apply for both equipment (accross the equipment) and the worst case product.

Jay

we are calculating MACO for our tablets manufacturing facility and we get MACO limit less than our LOQ value then which limit we select for our cleaning validation. pls. guide & provide guideline references for these…

Hi
Just wonder why are you constrainting yourself by using 10ppm instead of the more scientific approach of TDD dosage. Suggest you keep to the APIC guideline for your MACO calaulation.

Good luck
Amateur

sir,can u send me one cleaning validation protocol and report