Pharmaceutical manufacturing typically take place in regulated and stringent
environments such as cleanrooms. Cleanrooms are basically controlled spaces
that are measured by their particle and microbial counts according to the
cleanroom ISO standards and regulated under the GMP guidelines.
The integrity of medical devices manufactured is critical and needs to be
upheld for the products to be safely used by consumers. Any contamination
to the medical products, whether during manufacture, cleaning or handling,
would render their performance to be subpar and may even cause undesirable
consequences for the user. This is why medical devices are highly regulated
for their cleanliness and validation.
One of the ways in which medical devices and pharma products can be contaminated
is surface residue. Any form of residue that is foreign to the device can
alter its geometry; thereby impacting the performance. Residues may sometimes
be retained on devices during cleaning and upkeeping of production tooling
and equipment. During cleaning, any forms of cleaning agents that are used
must be completely wiped off. There are however also other cleaning challenges
that may arise. Complex and small geometry in micro-tooling can render cleaning
to be challenging. One example of cleaning contaminated tooling would be
pill powder remnants in pill turret presses used during production.
It is therefore paramount for manufacturers to maintain utmost product
quality as well as clean manufacturing equipment at their premise.
A non-toxic and highly precise cleaning solution like dry ice cleaning
can help to address all these cleaning challenges faced by pharma and
medical device facilities managers.
AmpTec leverages on Cold Jet MicroClean Dry Ice Cleaning system technology
to thoroughly clean small and deep cavities of micro-tooling; effectively
removing all sources of contamination from surface areas.
Dry ice cleaning utilises recycled frozen pellets or shaved ice to lift
contaminants off surfaces. Because there are no cleaning agents being used,
there is no risk of residues left on surfaces after cleaning. This hence
removes the possibility of harmful chemicals being left behind that can
affect the integrity of final product or device produced.
The dry ice cleaning process is also non-abrasive and hence maintains
the integrity of delicate tooling components from possible corrosion;
this is important because corrosion can alter the surface geometry of
tooling which affects the production process.
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