Developing Sampling Plan for New Continuous Manufacturing Process of Bulk Chemical

[Elizabeth Curran]

Hello Everyone - Looking for advice how to approach developing a sampling plan for a new continuous manufacturing process producing a bulk powder chemical. The current proposed packaging is 1000 kg FIBC. We are still working on determining what will be considered a batch size.

 

[Jen Kirley]

Hello Elizabeth,

I have seen continuous chemical sampling done based on process stability, cost of batch failure, what must be done in case of out-of-spec result (can the formulation be reworked or blended into further product?) cost of disposing of out-of-spec product, and as always regulations - what would the repercussions be if out-of-spec powder got to the customer? Would there be potential of harm?

 

[ChrisM]

What is the sampling plan hoping to identify? Changes in chemical composition, color, weight/density/consistency of product?

 

[Bev D]

AQL attributes sampling plans are not typically appropriate for continuous processes as there are not unique separate units to sample from.
Unless your lot sizes are the size of soup cans…

Continuous processes are typically sampled (n=1; c=0) at planned and unplanned change points.

 

[Elizabeth Curran]

Hello Elizabeth,

I have seen continuous chemical sampling done based on process stability, cost of batch failure, what must be done in case of out-of-spec result (can the formulation be reworked or blended into further product?) cost of disposing of out-of-spec product, and as always regulations - what would the repercussions be if out-of-spec powder got to the customer? Would there be potential of harm?

Hi Jen - Thanks for the input. Since it's a new process no stability data. We can determine cost of failure and we have a good handle on the points in the process where we can rework/blend any off spec. We also have DFMEA and understand the failure modes at customer.

 

[Elizabeth Curran]

What is the sampling plan hoping to identify? Changes in chemical composition, color, weight/density/consistency of product?

Hi Chris - The sampling plan would be used to for final product testing which includes characteristics such as: Chemical composition, tap density, trace metals.

 

[ChrisM]

Is it a continuous production process or is there a production batch size?

 

[Jen Kirley]

OP said it was continuous production but then they are still working on determining what will be considered a batch size. (?)

 

[Bev D]

Not unusual. We would make huge batches of stuff in a continuous process that would last days. We would then create 50000-100000 doses or test units out of the batch of stuff. We would then sample the completed lot of the individual units. But given the size the consequence of a bad batch was extremely costly and could result in stock out. Then our customers would have to buy from our competitors. So we really relied on in process testing at planned and unplanned change points to ensure the lot would be good.