Q: We are advising a mid-sized pharmaceutical company. If we use multiple cleaning agents within a facility, the cleaning program may be a bit difficult to manage (chances are that the operators may use the incorrect cleaning agent for the product) and also the cleaning validation will be a more complex exercise. What would you recommend for general cleaning? Which is preferred between acidic and alkaline cleaning agents to start with?
A: Thank you for your inquiry for a multi purpose detergent as this is certainly a common question. Typically most pharma companies use an alkaline cleaning agent where it will work and use an acidic detergent for those residues that are more labile to acidic cleaning. In some cases where a major product is more labile to acid, they use acid wherever possible and only use an alkaline cleaner where necessitated. In general, about 85% of pharmaceutical residues can be cleaned by an alkaline cleaner. There are indeed some companies that refuse to use more than one cleaning agent in order to simplify cleaning validations.
It is important to keep in mind, successful cleaning is accomplished not solely by the detergent, but by an entire spectrum of parameters. They are: before you clean, agitation, time, heat, orientation, chemistry (concentration), after clean, rinsing, and drying. At Alconox Inc., we have coined the mnemonic BATH-O-CARD. As such, in some cases it is possible to use a less than optimal cleaner and compensate by doing all the other things better (i.e. scrubbing harder, using hotter water, cleaning longer etc). It is easier to use the “wrong” cleaner and still clean successfully in manual cleaning. In manual applications, you can scrub harder, for example, than one can if it is in a sprayball CIP cleaning cycle or other automated application. In high pressure and automated cleaning, the chemical energy is a larger part of the total energy brought to bear on the removal of residues. In general, when only one cleaner is used, you use an alkaline cleaner. The exception, as stated earlier, is there is some high volume particularly acid labile residue being cleaned.
In robust cleaning systems, we recommend specified detergents, as it is always better to use the best chemistry for whatever residue you are cleaning. The use of a good emulsifying low foaming (or high foaming if manual cleaning) alkaline and acid cleaners can clean just about any pharmaceutical residue by just about any cleaning method desired.
So while in some applications, there can be a multi purpose detergent, it is typically not the best path forward.
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