Single-Use Solutions

At AdvantaPure, we know no two applications are alike. Leveraging decades of experience and deep technical expertise, our team ensures every industry partner receives a precisely engineered single-use assembly tailored to their unique application—every time.

AdvantaPure Advantages

As an EcoVadis Platinum certified manufacturer we fully embrace the role we play in ensuring our products support our industry partner’s sustainability goals. Our products:

Minimizing our carbon footprint across operations and logistics
Driving energy efficiency and renewable energy adoption
Partnering with suppliers and customers to reduce scope 3 emissions
Ensuring long-term sustainability for future generations

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A robust sterility program is essential to protecting product integrity and ensuring reliable bioprocess operations. Aligned with the principles of EU GMP Annex 1, AdvantaPure’s sterility program is built on validated, risk-based controls designed to minimize contamination risk across the product lifecycle. Our extensive, qualified component library enables rapid integration into custom single-use assemblies while supporting a holistic Contamination Control Strategy (CCS). In highly regulated bioprocess environments, programs like ours help strengthen alignment with cGMP expectations and global regulatory standards. The result is increased confidence in process control, enhanced product quality, and a more resilient supply chain.

Validated and based against ISO 11137, utilizing method VDmax25 and a worst-case master device to routinely substantiate a minimum sterilization dosage of 25kGy.
Both gamma and x-ray irradiation are fully qualified as sterility modalities
All custom sterile devices reviewed to ensure Sterility Assurance Level (SAL) of 10^-6
AdvantaPure boasts over 100 immediately available, prequalified and routinely tested additional components, from over 20 plus manufacturers
Guaranteed two year sterile shelf life, based on packaging studies done in accordance with ISO 11607
Technical support is available to help our industry partners qualify any custom or non-prequalified components, ensuring your specific device is achieving a SAL10^-6

An extensive, well-curated component library is the foundation of reliable single-use bioprocessing assemblies. With a broad selection of tubing, connectors, filters, sensors, and custom interfaces, we can configure assemblies that precisely match process requirements without compromising quality, lead time, or performance. This flexibility enables faster design iterations, simplified change management, and scalable solutions from development through commercial production.

Our component library is built on qualified materials of construction. Each component is selected from approved suppliers and supported by comprehensive regulatory documentation, including material certifications and change notification protocols. This documentation readiness streamlines validation, supports risk-based assessments, and aligns with global regulatory expectations, reducing the burden on end users during audits and submissions.

By standardizing around proven, well-documented components, we can deliver single-use assemblies that enhance process integrity, improve supply chain security, and provide confidence that every build is compliant, traceable, and fit for its intended use.

AdvantaPure proudly offers one of the most robust product validation guides for their single-use components in the industry. These guides reflect a focus on validation, compliance, and safety.

Request a Validation Guide

Bioprocessing is complex and success depends on more than just great products. That’s why our customers gain access to a dedicated team of subject matter experts who partner with them at every stage of development, scale-up, and manufacturing.

Applications Specialists
Our applications experts help customers translate theory into practice. They provide guidance on product selection, method optimization, and best practices tailored to specific bioprocess workflows, ensuring solutions perform as intended in real manufacturing environments.

Engineering and Design Experts
Our engineers support system design, integration, and scale-up. Ensuring equipment, technologies, and processes work seamlessly together, meeting performance, facility, and regulatory requirements.

Materials and Chemistry Experts
Our materials specialists bring deep expertise in polymers, membranes, and other critical bioprocess materials. They help customers understand material compatibility, performance, and lifecycle considerations to ensure reliable, compliant operations.

Quality and Regulatory Support
Our quality and regulatory experts help customers navigate documentation, validation, and compliance expectations. Their guidance supports smooth technology adoption and confidence in regulated environments

Supply Chain Managers
Reliable supply chain is critical to maintaining product quality, ensuring regulatory compliance, and keeping production on schedule. Supply chain subject matter experts who understand the unique demands of the bioprocess industry,

A True Partnership Approach – We don’t just provide products, we provide expertise.

For our US industry partners receiving shipments from our US-based manufacturing facilities is a clear advantage. Our easily accessible, close geographic proximity, provides a reduction in carbon footprint due to a closer shipping origin imparting value as a more sustainable choice than receiving deliveries coming from abroad.

Security of Supply is ensured by not only geographic proximity, but also by our fully stocked expansive warehouses poised to meet demand even under the most challenging circumstances. Whether primary supply or a secondary supply source, your product order is supported by a robust logistics network.

For our European and APAC partners, our manufacturing location abroad, in the Netherlands offers the same advantages.

Single-Use Assemblies

AdvantaPure provides custom single-use assemblies designed to meet the needs of each individual industry partners’ unique set of specifications

Eliminate production stoppages for sterilization, reduce the risk of contamination, and increase efficiency by incorporating Single-Use Molded Manifold Tubing Assemblies from AdvantaPure. Single Use Assemblies simplify cleaning validations—use once and discard.

Each system is custom made using AdvantaSil® platinum-cured, Class VI silicone tubing or reinforced hose or AdvantaFlex® Class VI biopharmaceutical grade tubing to meet sealing and welding application requirements. Add fittings, stoppers and container closures, filters, sensors, bottles, labels, tracking options and now as the pump element.

Single use systems are not intended for implantation or continuous steam applications.