Batch size in API

TEMPLATES & PRESENTATIONS
1

Can any one help us to define the batch size in API. also if case like “input is fixed 15 kg of key starting material & the output of API is varying in between 20 to 22 kg” so what should be called as batch size, “INPUT or OUTPUT”.
please share if any guideline reference.

2

Anybody any opinion…

3

OUT PUT

A+B---->C

A,B raw materials

C is the material you want to maufacture.

Then C would be the batch size

4

Dear sir,

Thanks for the response. But if we are using one key raw material fixed qty. And the output is a range. Then this batch size will never be fixed. So will it be acceptable to have every batch with different batch size. Eg one of our product batch output varies between 20.2 to 20.7 kgs. So please explain what will be the bstch size.

5

You can consider input only for batch size, if i am not wrong you are asking about API. If you are API manufacturing in multiple stages then every stage will have batch size according to input. But in cleaning validation to derive the stringent limit we can use output also. These are only exceptions. If you mention for what purpose you are asking about Batch Size then i can guide you exactly. Output will be vary always according to conversion, rate of reaction and purity of the incoming material. Not only these factors some of other factors also there in chemistry way.

Pulla Reddy Karnati

6

Thanks Dear Pulla,

Great to see your response. definitely question is for APIs. As a batch is always known with its size & cases can vary like STABILITY, PROCESS VALIDATION or you can say DISPATCHES. Also comment if any formula is there for fixing the standard batch size from variables or from its trend/ development batches.

Pradeep Kudeshia