There this liquid filling machine that I have to do Perform the IOQ. Innoted that inside of the equipment where the filling of the bottles occurs there is the system for the tightening arm of the bottles. And the cover of the motor only cover the side and the top, but it doesnt cover the bottom, so the motors is not concealed. I took the cover off and it had a lot of a black powder that is coming from the friction between the pulley and the strap. Is that acceptable to have in a GMP area?
Cleaning question for the cleaning section of the SOP. The filler has two piston which pump the product. Is it enough to consider flushing the lines with plenty of purified water and then with alcohol 70% solution a good cleaning method? The ideal is not to have any remaining product in the lines in case we switch from one product to the other.
[COLOR="#000000"][COLOR="#000000"]All the machines in the areas of Manufacturing, packing and testing must be concealed. This is as per regulations of GMP. The reason is for both process safety, process cleanliness , operator safety and cleanliness of machine.
You need to identify the black powder you have and source of that powder in the GMP area.
The bigger question is that a metal particle dust that is generated due to the result of friction between pulley and strap?
If it is so you need to change this design immediately as it might result in break down of machine during future qualifications and process runs.
Identify the specific root cause and make necessary corrective actions so that these corrective actions further do not pose mechanical failure or any risks to operations of machine.
Cleaning is an important issue. The cleaning agent you must be looking should make your Drug product soluble in that solution as per permissible and detectable limits. This is left to the manufacturer to chase based on dissolution charecterestics of Drug substance and also corrosion and stain considerations on the machine or moving parts of machine.You need to involve your QC and QA into this subject to design, formulate and test proper cleaning agent. Your R&D might have a proper cleaning data too.[/color][/color]
The way we have tackled the cleaning issue in a liquid filling operation was to eliminate all product contact from the filling machine. This entailed the use of servo driven parastaltic pumps. When it’s time to change products, lots, batches, etc, just pop out the tubing and pop in new and …presto! no cleaning issues.