Description

USP Class VI Inflatable Seal for Pharmaceutical Equipment

Ensure Superior Containment and Sterility with Our Premium Inflatable Seals

Our USP Class VI inflatable seals provide a superior solution for maintaining the integrity and sterility of your pharmaceutical equipment. Engineered for demanding applications within the pharmaceutical and biopharmaceutical industries, these seals offer exceptional performance, reliability, and compliance with stringent regulatory requirements.

Key Features & Benefits:

• USP Class VI Compliance: Manufactured from materials rigorously tested and certified to meet the stringent biocompatibility requirements of USP Class VI, ensuring minimal risk of leachables and extractables that could compromise product quality or patient safety.
• Superior Containment: Our inflatable seals create a hermetic seal, preventing ingress of contaminants and maintaining the sterility of your equipment and its contents throughout the entire process. This significantly reduces the risk of cross-contamination and product spoilage.
• Versatile Applications: Suitable for a wide range of pharmaceutical equipment, including:
  • Bioreactors
  • Fermenters
  • Mixing vessels
  • Storage tanks
  • Transfer vessels
• Customizable Designs: We offer customizable solutions to meet your specific equipment dimensions and process requirements. Our engineering team can work with you to design a seal that perfectly fits your needs.
• Enhanced Durability and Longevity: Constructed from high-quality, durable materials designed to withstand repeated inflation and deflation cycles, ensuring long-term performance and minimizing the need for frequent replacements.
• Easy Installation and Removal: Designed for ease of use, our inflatable seals are quick and simple to install and remove, minimizing downtime and maximizing efficiency.
• Traceability and Documentation: Comprehensive documentation, including certificates of conformance and material test reports, is provided to ensure full traceability and compliance with regulatory requirements (e.g., FDA 21 CFR Part 11).
• Reduced Maintenance Costs: The robust design and long lifespan of our seals significantly reduce the frequency of replacements, contributing to lower overall maintenance costs.
• Improved Process Reliability: By ensuring a secure and reliable seal, our products contribute to improved process reliability, reducing the risk of product loss, contamination, and production delays.

Material Specifications: (Specific materials will vary based on customization. Contact us for detailed information on available options.)

• Typical materials: [List specific materials used e.g., Silicone, EPDM, etc. Include relevant grades and specifications]
• Sterilization Compatibility: [Specify compatible sterilization methods, e.g., steam, gamma irradiation, ETO]
• Temperature Range: [Specify operational temperature range]
• Pressure Resistance: [Specify maximum operating pressure]

Regulatory Compliance:

• USP Class VI
• [List other relevant regulatory compliance certifications, e.g., ISO 13485, FDA, etc.]

Contact Us Today:

To discuss your specific requirements and obtain a customized quote, please contact our sales team. We are committed to providing you with the highest quality inflatable seals and exceptional customer service. Let us help you maintain the integrity and sterility of your pharmaceutical processes.