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How to Optimize Equipment Cleaning to Reduce Dark Particle Contamination in Medical Device and Pharmaceutical Manufacturing Facilities

by | May 19, 2022

Equipment cleaning is fundamental to controlling particle contamination in GMP manufacturing facilities.

In aseptic environments, automated filling lines are routinely cleaned between campaigns to decontaminate product contact surfaces. As part of clean out-of-place procedures in oral dose facilities, mixing, blending, coating, dispensing, tablet presses and packaging equipment undergo extensive wiping. In Medical device facilities, the entire production process and even the device itself are cleaned via manual wiping.


Process equipment in life science manufacturing facilities are typically cleaned with polyester knitted wipes or polypropylene and polycellulose non-woven wipes. Due to the poor cleaning efficiency of these wipes, cleaning and disinfection SOP’s can be lengthy and can leave contamination embedded in the grain of equipment surfaces.


MiraWIPE is a woven microfiber wipe developed to improve equipment cleaning efficiency and efficacy.


Operators are trained to clean the equipment until the wipes are free of visual contamination.


Metallic contamination was removed from the equipment by MiraWIPE after the surface was considered clean with polyester wipes.


Over-molded device contaminated with dark particles.


Dark particle contamination was identified as machine-generated stainless steel contamination, not removed during preventative cleaning.


Using SEM/EDX, the stainless steel in the device was an identical match to the stainless steel collected on the MiraWIPE.


In addition to bioburdens, proper equipment cleaning is vital in controlling nonviable or subvisible particles (FM) generated by the operation of the equipment. The friction-generated contamination from regular machine operation causes dark particles, which are often metallic in makeup and are a significant source of product rejects and related CAPAs.

While it is well documented that wiping is required to clean machine-generated contamination, less well understood is the number of particles that are embedded in the grain of equipment surfaces and how wiper selection can impact cleaning performance and productivity. The link below demonstrates how a cleanroom microfiber wiper can significantly improve cleaning SOP vs. standard lint-free wipers.

The link below demonstrates how a cleanroom microfiber wiper can significantly improve cleaning SOP vs. standard lint-free wipers.

How to Improve Aseptic Equipment Cleaning [Video]
https://www.foamtecintlwcc.com/video/how-to-improve-aseptic-equipment-cleaning

The link below demonstrates how a state-of-the-art cleanroom microfiber wiper can significantly improve cleaning SOP vs. standard lint-free wipers.

How to Reduce Turn Over Times in Aseptic Processing Areas [Video]
https://www.foamtecintlwcc.com/video/how-to-reduce-turn-over-times-in-aseptic-processing-areas

For more information visit our website at www.foamteinctlwcc.com or email us at contact@foamtecintlwcc.com