good afternoon,
we have many difficulties in removing residues of nitazoxanide from a tableting machine.
How to ensure that the cleaning has been effective?.
We have the added problem: the use of acid and alkaline detergents deteriorate machine.
Many thanks for your comments
paul
There are a few mechanisms for cleaning, this involves physical (scrub real hard), chemical (acid or alkaline), or heat/cool (used to soften some oils/greases).
So you have to pick your approach with those things in mind. Often cleaning in pharma/bio industry used a combination of physical and chemical. It is unfortunate that your equipment deteriorates with chemical. This is actually pretty common, and there are ways to help recover the equipment (passivation), and people still use the cleaning agents, and mitigate the damage to the equipment with passivation or parts replacement.
But fIrst and foremost speak to the manufacture of the API and see what they do. This can be the easiest quickest, cheapest, and fastest way to solve this problem. They likely have a similar problem, and have had many smart people work on a solution/fix.
After you have spoken to the API manufacturer, I would ask the following questions in this order.
1 - Is there a way to physically clean better? Are there tools that might help with scrubbing and scraping? Will a pressure washer (wet) help, will an air blower (dry) help? Can we put parts in a CIP or COP parts washe for automated cleaning? Is there a better way to clean using automation cycles (again CIP)
2 - Can you make the machine easier to clean? Would electropolishing help? Would a substitute part that is less porous help? Do you want to use single-use (disposable parts) so you don’t even have to clean?
3 - Can you live with some equipment deterioration? Could you use a dilute cleaning agent (even a little bit helps often)? How much acid/alkaline is acceptable before we start to get deterioration? Is the equipment damaged because of poor cleaning practices, that is, do you leave the cleaning agent on too long, or fail to remove the cleaning agents altogether? Leaving the cleaning agent on the equipment can really damage the equipment, but if it is removed immediately I wonder if you would see the damage to equipment as much (or at all).
Thank you,Jared
you are very kind for your insights and concepts and surely they will be very useful in our organization
many thanks
paul