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The Source and Risks of Polycellulose Contamination in GMP Cleanrooms Producing Cardiovascular and Neurological Implantable Devices

by | Jan 4, 2023

Maintaining a high level of cleanliness is of utmost importance for cleanroom facilities producing cardiovascular and neurological devices. Any contamination in the cleanroom can lead to foreign material (FM) rejects, endotoxins, and inconsistent bioburden levels, which can ultimately impact the safety and efficacy of the finished products.

One type of contamination that can be particularly detrimental in medical device cleanrooms is cellulose because it holds onto moisture. Because we offer PolyCHECK foreign Particle identification service, we have carried out over 100 investigations for FM at GMP cleanrooms facilities to help close foreign particle-related CAPA’s we have discovered that the main source of moisture-containing cellulose particles is nonwoven polycellulose wipers. These wipers are widely deployed in GMP cleanrooms due to low cost and good absorbency. The downside of these wipers is that they shed huge volumes 100–1000-micron fibers that easily become airborne and infiltrate the entire cleanroom environment.

Work surface contamination, typical of a ISO 7 medical device assembly cleanroom that employs non-woven polycellulose and polyester wipes.

Polycellulose fiber embedded in a catheter that had been rejected for FM.

The red spectrum is the cellulose found in the catheter. The blue spectrum is the cellulose found in the work surface.

Cellulose particles shed in large volumes during cleaning and adhere to devices, surfaces, and equipment, leading to foreign material rejects. In addition, the moisture-holding properties of cellulose can harbor and spread micro contamination and generate endotoxins, which are toxic substances produced by certain bacteria. These endotoxins can cause serious illness in humans and can compromise the safety of the finished product.

Polycellulose wipe’s side profile after wiping a 316 stainless steel surface

UltraSORB’s side profile after wiping a 316 stainless steel surface

Furthermore, high moisture content FM can also lead to inconsistent bioburden levels in the cleanroom. Bioburden refers to the number of microorganisms present in a particular environment, and it is crucial to maintain consistent levels to ensure the safety and efficacy of the finished product. When cellulose-based FM are present in the cleanroom, they can harbor and spread microorganisms, leading to fluctuating bioburden levels.

It is important to implement strict control measures to mitigate the risks associated with cellulose particles and fiber contamination in cleanrooms. This should include using wipers that do not shed fibers and particles during use. Foamtec’s highly absorbent UltraSORB for wipers are widely deployed in ISO 5-8 GMP cleanrooms to clean and sanitize devices, surfaces, and equipment.

In conclusion, high levels of cellulose contamination in cleanrooms can increase the risk of foreign material rejects, endotoxins, and inconsistent bioburden levels. It is essential for cleanroom facilities producing cardiovascular and neurological devices to implement effective control measures to minimize the risks associated with cellulose contamination.

For more information about UltraSORB Cleanroom Foam Wipes or PolyCHECK Cleaning Validation Wipes:

https://www.foamtecintlwcc.com/products/cleanroom-wipes/foam/ultrasorb-wiper

https://www.foamtecintlwcc.com/products/cleanroom-wipes/cleaning-validation/polycheck-wiper

For any questions or inquiries, contact us today:

contact@foamtecintlwcc.com

www.foamtecintlwcc.com