A generic OSD manufacturer uses the same blender to prepare the final blend for making Wonderdrug Tablets (5 mg of API, total tablet weight 100 mg, take one tablet per day) and Superdrug Tablets (50 mg of API, total tablet weight 200 mg, take one tablet per day). The batch size for each product is 200 kg, and the internal surface area of the blender and associated product-contact components is 10 square meters.

a) How much Wonderdrug residue (in mg/cm2) may be found on the blender's surface during cleaning validation for the cleaning procedure to be considered acceptable? Assume uniform distribution of the residue on the blender surfaces and use the acceptance criteria based on 1/1000^th of the daily therapeutic dose.

b) How much Superdrug residue (in mg/cm2) may be found on the blender's surface during cleaning validation for the cleaning procedure to be considered acceptable? 

c) Please compare the residue limits in the two cases above (a and b) and comment on that.

This week instead of posting your answers in the discussion forum please submit those by using the "Homework 8 assignment" created with the "Assignment" tool.

 

Hint:

You have to be careful with using the MAC formula on slide 32.

The "lowest dose A" there means the API amount that a patient takes per day (if a doctor can prescribe from 1 to 3 tablets per day, we should take the lowest dose - 1 tablet). In this homework problem it is 5 mg. The total weight of the tablet A (100 mg) is not needed for the calculations.

The "max daily dose B" in the same formula is used to calculate the number of doses in the batch of product B. In that case the total batch size is given in kilograms of blend that includes both the API and excipients, so to calculate number of doses you should divide that by the total weight of each tablet B, not by the API content. In this problem such weight is 200 mg (let's say that a doctor can prescribe from 0.5  to 1 tablet per day, so in this case we would take the highest dose - 1 tablet).

Answer rating: 100% (QA)

To calculate the residue limits for the cleaning validation of the blender surface we will use the M... View the full answer