Biomedical Engineering Reference
In-Depth Information
Unremoved product residue or other contaminants can pose a risk of introduc-
ing the contamination to the next batch when left on room surfaces or equipment.
Dried product residue that builds up on surfaces may eventually flake off dur-
ing subsequent manufacturing operations. Cleaning agents that are appropriate
for pharmaceutical use, safe for the environment, and are able to dissolve any
residual product or other soil generated during manufacturing operations should
be selected. Likewise, where microbial bioburden control is important, sanitizing
agents that are effective against the types of microbes found in the manufacturing
environment should be chosen. Otherwise, the product is potentially at risk of
microbial contamination from uncontrolled microbial levels in the manufacturing
environment. For both cleaning agents and sanitizing agents, it is important to
demonstrate that the agents selected at their use-concentration are effective.
In addition, there are risks that the agents could be rendered ineffective if not
handled or stored properly. Handling and storage practices should be assessed
and designed to ensure that the agents will be effective when used. For example:
• Are the handling practices designed to avoid contaminating the agents during
preparation, use, or in storage?
• Are the agents stored under conditions that support their stability and efficacy
at the time of use?
• Are there self-life expiration dates needed for in-use containers?
Just as there may be a risk with product contamination if cleaning and sani-
tizing agents are not used, using them may pose another risk. In all cases, risks
introduced by taking measures to mitigate other risks need to be considered. In
this case, agents are being used to reduce the risk of product contamination.
However, some agents have been known to leave a residue after use that could
potentially contaminate product if not controlled.
Just as important as the agents chosen is the techniques used to clean. The risk
is introducing contamination to the manufacturing environment. These techniques
should be designed to avoid redepositing contaminants onto already cleaned sur-
faces. Some examples that the risk evaluation would consider are the following:
• Order of rooms to be cleaned. What is the risk of introducing contamination
if the most-soiled areas would be cleaned first followed by the least soiled
ones or vice versa?
• Order and direction of surfaces within a room. What is the risk of introducing
contamination if the floors rather than the walls are cleaned first or if they
are cleaned starting at the back of the room rather than the front, from
top-to-bottom or left-to-right?
• Number of passes of the mop, cloth, or rinse water before it is refreshed
or replaced. What is the risk of introducing contamination if the mops are
not rinsed, changed between rooms, or changed after a defined number of
passes?
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