So, who is this Guide for?
Manufacturing and Production is the beating heart of any pharmaceutical company. These critical teams are responsible for meeting often demanding market needs and adhering to strict regulations, all without compromising productivity and product quality. These tasks can often be demanding and overtly complicated to maintain, and the threat of an extended shutdown could mean loss of significant generated revenue. Having an incorrect cleaning procedure for any piece of pharmaceutical equipment can often be a root cause of these expensive shutdowns, specifically when it comes to the cleaning processes put into place for this equipment.
Fluid bed coaters can be very large pieces of equipment that create their product by using a vertical spray coating and drying process. The cleaning process of a fluid bed dryer is largely determined by size of vessel, the residue needed to be cleaned, and the limitations of cleaning equipment. Because of the vertical surfaces, the most common challenge for a fluid bed is getting the detergent solution to stick to the vertical walls and/or to maintain contact of solution to walls. This can create the need for manual cleaning action. CIP cleaning, if available, should be considered as the consistent spray can help keep the vertical surfaces coated with detergent solution. Additional cleaning variables that should be looked at when developing this cleaning process are:
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Developing a cleaning process for a tablet coater, or coating pan, can be simpler than a fluid bed because of the smaller size and the ability to implement clean-in-place for additional action. The standard cleaning process for tablet coaters is to fill the tray with the detergent solution, soak and rotate the perforated pan.
However, often the coatings being used in the process can be very difficult to clean. A classic example of this is the cleaning of pigmented HPMC based coatings. Where the HPMC is itself not difficult to clean, the water or alkaline detergents strip off the polymer, leaving behind the pigment (usually iron oxides or titanium dioxides). This results in coloration or haze formation which is tough to clean and often time tough to see on the surfaces of the tablet coater because of the dark tank. An LED light may need to be used to see this haze and often requires strong corrosive acids and manual cleaning to physically scrub it off the surface of the equipment, which is not desired.
Selecting the optimal detergent for your tablet coating soil that readily removes the entire formulation in a single detergent step is often the solution for cleaning the coater pan. The detergent solution can prevent the pigment from bonding to the equipment surface and eliminating the need to re-clean.
From ribbon blenders to V- blenders, these critical pieces of equipment also have unique cleaning challenges. Most of them center around the limitations of automated cleaning. The most common cleaning process for these pieces of equipment are to fill the mixing vessel with detergent solution, soak and agitate the vessel for a previously determined amount of time. Parts that can be removed, like mesh screens and blades, are often cleaned via a clean out of place procedure such as manually scrubbing. This manual action is best avoided in a GMP cleaning process as it is operator dependent and inconsistent. Also, due to safety and ergonomic issues, manual cleaning action must be minimized or eliminated in cleaning of production scale equipment.
