How to prepare a equipment matrix which covers a entire equipment train in the facility??.
If i want to prepare separate equipment train for wet granulation & dry granulation process should i select 2 different products for clening validation which come across those equipments??
Example: if product A (previous) is manufactured by using sifter + co-mill + blender + compression machine + coating machine + bottle packing M/ C = cumulative surface area is 152608cm2
if my second product B (Next) product is manufactured By using sifter + blender+ compacter+ compression machine + bottle packing M/ C.= 145680cm2
Should I select a 2 different product for both equipment trains?
Should I consider 145680 cm2 as common surface area b/w A & B product. If yes what about the compacter contact surface area which is used in product “A”?
Hope I understood you correctly. To clarify: A is the product which contains your worst case contaminant. B is your worst case contaminated product. Is that correct?
If so, B can only pick up contamination from A in the sifter, blender , compression machine and bottle packing. In the co-mill, the coating machine and the compacter, B cannot pick up contamination from A because the co-mill and the coating machine are not in contact with B, and the compacter is not in contact with A. Summarizing, the surface to take is the sum of the individual surfaces of the pieces of equipment shared between the two processes (sifter, blender, compression machine and bottle packing).
In my opinion, The surface which is in contact with both the product should be considered. In your case A is going to contaminate the product B if it comes in contact with B.
So, the only surface area to be considered where product A is used previously and again the same surface area going to share for product B.
[quote=prashant.chawla]In my opinion, The surface which is in contact with both the product should be considered. In your case A is going to contaminate the product B if it comes in contact with B.
So, the only surface area to be considered where product A is used previously and again the same surface area going to share for product B.[/quote]
Thanks Alfred
• Can I know how to prepare equipment matrix which covers all equipments?
Currently i am doing by selecting 3 worst products which is manufactured in different equipments and covers all the equipments in the facility and perform a validation for all 3 products (each 3 batches).
Am i doing correct?? Is there any other option to reduce the products from 3 to only one??
• One more query is shall i consider dispensing area in my equipment train?? Since no where my product is contact equipment.
there is no problem in preparing a matrix. I have made up one (which unfortunately I cannot send out, first because it contains proprietary information about our products and processes, and second because it is in spanish) based on a huge Excel file. Our approach is to select the tracer analyte for each product (basically the most soluble/most potent component of each formulation), and then the worst case among all the tracer analytes, in each piece of equipment. This to select for each piece of equipment the worst case contaminant, and the worksheet proposes this worst case based on the solubility and potency data, but the selection itself is performed manually in order to allow for decision taking on special cases (e.g. Vitamin E is the worst case, but a contamination with Vitamin E is far less risky than a contamination with Glimepiride even if Vitamin E is more insoluble and has a lower active dose than Glimepiride). Another worksheet sums the individual surfaces of each piece of equipment for each product to determine the surface of the equipment train, and a third worksheet (the core worksheet) performs a lookup function for each piece of equipment, each product and each tracer analyte. This worksheet calculates the factor [batch size/(maximum daily takings*equipment train surface)], selects the product which minimizes this factor (which is the worst case contaminated product) for each piece of equipment, and with the minimum daily dose of the worst case contaminating analyte calculates the maximum allowed contamination for each piece of equipment. It requires a lot of lookup function use, but can be done with little more than basic Excel knowledge. The disadvantage of this approach is that the contamination is calculated as a function of the whole equipment train and not for the shared equipment, but as this only lowers the maximum allowed contamination there is no formal issue other than needing somewhat more sensitive analytical methods. The number of products to consider depends on your specific case, but the only way to have only one worst case analyte is that every piece of equipment is dedicated except for the ones that are part of the equipment train where the worst case analyte is processed, which is highly improbable. The dispensing area needs not only to be considered in the equipment train but is one of the most critical parts, because it comes in contact with the pure API. Because of that, in the dispensing area we are using disposable scoops for the API’s, weigh the materia prima for only one product at a time and with the API’s as the last weighed components of the formula, and covering the balance plates with polyethylene sheets which after dispensing are discarded.