Minimizing Particulates in Single-Use Systems
Operators need to take extreme care when closing their single-use systems. That’s because particulates in single-use components are under increasing regulatory scrutiny. Particulates can also impact the biomanufacturing, storage, and transportation of high-value final products. These concerns can bring a halt to drug manufacturing and delay patients from getting the medicines they need.
Reasons particulate levels give cause for concern include:
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Clinical impacts
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Immune system effects
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Lower production yields
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Cell growth interference
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Drug product quality, toxicity, and safety
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Processing interference
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Risk to the patient from possible micro blood vessel obstruction
From a regulatory standpoint, the FDA recently flagged a company for selling a therapy that was contaminated with foreign particulates including wood, cellulose, brass, and steel. It was cited that these particulates were introduced by sampling and testing errors during cryobag freezing.
Life Sciences Performance Driven by Semiconductor Standards
As a supplier to the semiconductor industry, Entegris has more particulate removal expertise and broader experience than other pure life sciences companies. That’s because nano-scale contaminants – which life sciences suppliers might not be able to detect – can destroy semiconductor wafers. For these semiconductor applications, we pride ourselves on providing clean products that have systems and testing in place to provide the highest-quality outcomes.
What does it look like when we take standards and best-practices from semiconductor industry contamination control and apply them to the life sciences industry?
Study: Comparing Single-Use Bags
In a recent study from Entegris, it was shown that particulate contamination levels were reduced in Aramus™ fluoropolymer bags compared to two varieties of ethylene-vinyl acetate (EVA) material bags. The fluoropolymer bags meet the USP standard for less than three counts of particles/mL larger than 25 µm and less than 25 counts of particles larger than 10 µm. Meanwhile, the two types of EVA bags occasionally surpassed the limits set by USP <788>.
To meet USP standards, Aramus fluoropolymer bags are fabricated to the highest level of cleanliness and carefully tested for particulate contamination. They are manufactured in class five cleanrooms and are 100% visually inspected for particulate contamination. In addition, we have over six years of USP <788> test data that has far exceeded acceptance criteria.
Entegris produces both Aramus fluoropolymer bags as well as AccuSizer® liquid particle counters that used for quality control testing. Because of this, we are especially qualified to supply single-use systems that significantly reduce particulate contamination.
Protect Patients with Single-Use Performance
Minimizing particulates is a critical aspect of pharmaceutical research and production. Failing to address safety risks could result in a letter from the FDA or worse, harm to patients. You can help prevent this risk by using the purest single-use solutions available.
Aramus fluoropolymer bags provide a higher standard of cleanliness than competing devices. These devices routinely meet or exceed the USP standard.
Entegris solutions can deliver more consistent performance across different fluoropolymer bags, providing customers with quality assurance. Our study indicates that Aramus fluoropolymer bags are two to three times cleaner in the submicron particle range when compared with competing EVA bags. As such, they represent excellent single-use systems for biopharmaceutical industry applications.
For more information, view our on-demand webinar regarding this topic: Particulate Contamination in Medical Devices and Single-Use Systems
