Dry Ice Cleaning for Medical Devices

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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