You may have noticed that our gasket prices are higher than some of our competitors. What you may not know is that not all gaskets are created equal. The gaskets offered by Sanitary Fittings are Class VI Certified which means they have passed the most rigorous testing for biocompatibility. Class VI testing ensures that the plastic materials of the gasket will not leach out chemicals that can cause harmful reactions or impact the body long-term; this testing extensively investigates the reaction in the body, skin, and living tissue to ensure safety.
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For a product to pass the USP Class VI standards, it must exhibit a very low level of toxicity by passing all requirements of three key tests: acute systemic toxicity, intracutaneous, and implantation tests. All three tests are in vivo, or performed in a living organism, such as mice or rabbits, to mimic use in humans. In addition to demonstrating a very low level of toxicity, the material is subjected to multiple temperature assessments for set periods of time.
Materials that meet USP Class VI standards generally ensure a high-quality level and better acceptance with the FDA and USDA because the materials are believed to substantially reduce the risk of causing harm to patients from reaction to a toxic material. Many plastics manufacturers find that it is beneficial to be USP Class VI certified, especially if the gasket is used within a medical device or biopharmaceutical process equipment. However, these benefits also extend to the food and beverage industries as well.
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This additional level of product certification comes with a higher price tag. At Sanitary Fittings, we are committed to providing our customers with the highest quality available – which is why this the only type of gaskets that we offer.
If you would like a copy of a gaskets certificate, please ask for them at the time of order. Certificates are specific per lot of gaskets. Much like a heat number for fittings, gaskets have what is called a lot number. We don’t log these numbers at the time of order but we do include them on the packaging if you need the certificate after receiving them.
Before purchasing a cheaper gasket from another distributor, it’s important for customers to understand how gasket selections can impact the people who ultimately consume their products. Sanitary Fittings customers can rest assured that they are only receiving the highest quality gaskets – USP Class VI rated.
For more information or additional questions, please contact us.