How to Prevent Silicone Contamination from Cleanroom Products

Silicone is a widely used material in manufacturing processes, with many valuable properties. It is most commonly utilized as a lubricant coating in all sorts of machining.

While it is present and not an issue in most industrial processes, it represents a significant risk when used in cleanroom product manufacturing—once it is present in an environment or product, it clings, bonds, and attaches in a way that is almost impossible to remove. Despite post-production washing and packaging effectively removing most particle contaminations from a glove or wiper, silicone stubbornly persists.

Once silicone is present in an environment or product, it clings, bonds, and attaches in a way that is almost impossible to remove. 

As a result, this “nuisance” particle can present serious contaminant risk in critical cleanrooms, particularly where aerospace, semiconductor, and microelectronic products are manufactured.

If silicone particulates are exposed in these environments, they can re-deposit on finished goods and components, become extremely difficult to remove, and ultimately cause defects, rejected lots and product failure. 

It is silicone’s durable properties that make it such an issue in advanced material cleanrooms – it puts product quality and performance at risk and its adherent, “sticky” properties make it exceedingly difficult to remove.

From its disproportionately negative impact on product quality to its stubbornness in sticking around, silicone contamination—more so than many other forms of contamination—can be catastrophic in certain cleanrooms.

Cleanroom Products Can Be A Direct Source Of Silicone Contaminants

There are many potential sources of silicone contamination. In the manufacturing of cleanroom products, silicone can be used to lubricate sewing needles that knit, sew or stitch apparel or wipers. It also provides a non-stick surface to remove gloves easily from the formers used in the dipping process.

Finally, it is commonly found in adhesives used in floor mats in gowning areas. In these examples, silicone is incorporated indirectly in the production process or directly in a product that can make its way into a cleanroom. 

How Do You Keep Out Silicone From Cleanroom Products?

There are two steps to keep silicone contamination from cleanroom products out of your controlled environment:

1. Specify silicone-free products from an experienced, cleanroom specialized manufacturer that provides test results and a Certificate of Analysis.
2. Rely only on manufacturers who use published, standardized, repeatable testing methods such as IEST-RP-CC005.4 for testing particles and extractables.

While many “PPE” or “medical grade” products use silicone in their manufacturing processes without negative impacts, “cleanroom” products are different—make sure your manufacturer is providing documentation that your products are made in a silicone free process and environment.

To identify silicone in particular, does your product manufacturer conduct FTIR (Fourier Transform Infrared Spectroscopy) analysis, according to IEST’s industry standard test method? In place of lot-specific test data, some cleanroom product manufacturers provide only TPV’s (typical published value) which is a calculated average for their critical cleanroom product.

For the products you use in your most critical processes, relying on a manufacturer TPV is not a recommended practice for the best outcomes. Verify that your manufacturer can provide Certificate of Analysis test data for critical products on a lot-to-lot basis.

Build A Relationship Of Trust With Your Cleanroom Manufacturer

The detection of trace silicone starts with the commitment and experience of your supplier—from the raw materials to the manufacturing process to the finished product. Valutek employs dedicated, internal quality personnel at an on-site quality lab using state-of-the-art equipment for continuous product testing and data analysis.

We don’t outsource quality to contractors or third parties, allowing us to keep quality control and inspections by in-house, cleanroom product experts as part of our process. For decades, Valutek has built the processes required to supporting leading organizations with increasingly critical products—when we say a product is silicone (or another specified contaminant) free, we have the data to support it.

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