Operators must exercise extreme caution when closing single-use systems, as particulates in these systems are receiving increased regulatory scrutiny.
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Particulates can also affect the biomanufacturing, storage, and transportation of high-value final products. These concerns have the potential to disrupt drug manufacture and postpone patients' access to necessary medications.
Particulate levels are a source of worry for several reasons, including:
- The risk of patients experiencing microvascular blockage
- Ensuring drug quality, toxicity, and safety
- Interference with cell development
- Immune system effects
- Reduced production yields
- Processing interference
- Clinical effects
From a regulatory standpoint, the FDA recently flagged a company for selling a therapy contaminated with foreign particles, including wood, cellulose, metal, and steel. It was claimed that these particles resulted from sampling and testing errors during cryobag freezing.
Life sciences performance driven by semiconductor standards
Life sciences suppliers may not be able to detect nanoscale contaminants that destroy semiconductor wafers; as a supplier to the semiconductor industry, Entegris has more extensive experience in dealing with such.
For these semiconductor applications, Entegris takes pride in offering clean products with processes and testing in place to ensure the best results.
Study: Comparing single-use bags
Entegris' recent study found that Aramus™ fluoropolymer bags lowered particulate contamination levels compared to two types of ethylene-vinyl acetate (EVA) bags.
Fluoropolymer bags fulfill USP standards as they have fewer than three counts of particles/mL bigger than 25 µm, and fewer than 25 particles larger than 10 µm. Meanwhile, the two varieties of EVA bags occasionally exceeded the limits stipulated by USP <788>.
To meet USP standards, Aramus fluoropolymer bags are meticulously cleaned and tested for particle contamination. They are made in class 5 cleanrooms and are completely visually screened for particle contamination. Additionally, Entegris has over six years of USP <788> test data that exceeds acceptance criteria.
Entegris manufactures Aramus fluoropolymer bags and AccuSizer® liquid particle counters used for quality control testing. As a result, Entegris is uniquely able to provide single-use systems that significantly reduce particulate contamination.
Protect patients with single-use performance
Particulate matter minimization is an important aspect of pharmaceutical research and production. Failure to address safety hazards may result in an FDA letter or, worse, human harm. This danger can be mitigated by using the purest single-use solutions available.
Aramus fluoropolymer bags outperform competitors in terms of cleanliness. These devices consistently meet or exceed the USP criteria.
Entegris solutions can give more consistent performance across different fluoropolymer bags, ensuring quality for consumers.
Entegris' recent study shows that Aramus fluoropolymer bags are two to three times cleaner in the submicron particle range than competitive EVA bags. As such, they are ideal single-use systems for biopharmaceutical sector applications.
About Entegris, Inc.
As a legacy semiconductor leader, Entegris brings unmatched sensitivity to purity and particle contamination, backed by robust quality systems, advanced contamination control technologies, and proprietary particle detection and sizing platforms - delivering a comprehensive, validated approach to particle risk mitigation. This holistic expertise is increasingly vital in the Life Sciences industry, where controlling particulate contamination is critical to ensuring product safety, regulatory compliance, and process integrity.
Enabling the technologies that transform the world
Entegris, As a global company working with leading manufacturers to enable ongoing advancement in technology, we have a global infrastructure that includes strategically placed manufacturing sites, R&D facilities, and customer support centers. We make infrastructure investments that put us closer to our customers in all global regions. Our highly skilled team members, facilities and resources are right where you need them in order to help you solve your most advanced technology challenges.
PRODUCTS AND SOLUTIONS INCLUDE:
- Filtration products that purify gases, fluids, and the ambient fab environment
- Liquid systems and components that dispense, control, analyze, or transport process fluids
- Gas delivery systems that safely store and deliver toxic gases
- Specialty chemistries for deposition and cleaning at advanced nodes
- Wafer carriers and shippers that protect semiconductor wafers from contamination and breakage
- Specialty coatings that provide high-purity surfaces for wear-resistance, corrosion protection, and smoothness
- Premium graphite and silicon carbide for high-performance applications
- Shippers and trays for protecting and transporting disk drive components
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