Reduce Risk, Accelerate Qualification: Trusted Single-Use Validation from HPNE
Helping biopharmaceutical manufacturers streamline qualification, ensure compliance, and build confidence in their single-use processes
At HPNE, a Getinge company, we believe that being a trusted partner in bioprocessing means delivering more than innovative single-use technologies. Success in biopharmaceutical manufacturing depends on confidence in every component, process, and validation step.
That is why we provide comprehensive in-house testing & validation support services designed to help customers efficiently qualify their systems, meet regulatory expectations, and reduce risk throughout the product lifecycle.
Through these services, our goal is to simplify the validation process by giving customers access to the expertise, resources, and testing capabilities needed to support their specific applications. Our team works closely with customers to generate reliable data that supports informed decision-making.
Validation Support You Can Trust
Testing is performed by our experienced Manufacturing Science & Technology (MSAT) team, leveraging extensive expertise in single-use systems, sterilization methods, and bioprocess applications. When specialized testing is required, we coordinate with trusted external laboratory partners to ensure comprehensive support.
To make the validation process as efficient as possible, HPNE consolidates all completed testing results into a single, comprehensive report package.
Comprehensive Testing Capabilities
Our validation and testing services support a wide range of customer requirements, including sterilization validation, product integrity, packaging performance, stability studies, and material characterization.
Sterilization and Bioburden Validation
These studies help verify the effectiveness of sterilization processes and support regulatory compliance for critical bioprocess components.
- Gamma 10-6 sterility assurance level testing (ISO 11137-2), including bioburden and sterility testing
- Autoclave 10-6 sterility assurance level testing (ISO 17665), including biological indicator testing
- Max dose establishment (ISO 11137-1)
Product Quality and Material Characterization
These analyses help assess product safety, material compatibility, and potential impacts on process performance and product quality.
- Endotoxin testing (USP <85>)
- Sub-visible particulate testing (USP <788>)
- Extractables testing (USP <655>)
Packaging and Transportation Validation
These evaluations help ensure that products maintain sterility, integrity, and functionality throughout shipping, storage, and handling.
- Shipping and transit testing (ISTA)
- Sterile barrier packaging seal strength testing (ASTM F88)
- Pressure decay integrity and leak testing (ASTM F2095, F2096)
- Microbial ingress testing (ASTM E3251)
Stability and Performance Testing
These studies provide critical data to support product qualification, expiration dating, and ongoing process confidence.
- Accelerated and real-time stability testing, including shelf life and gamma compatibility testing (ASTM F1980)
- Bacterial retention filter challenge testing (F838-20)
A Collaborative Approach to Validation
With decades of experience in bioprocessing, we understand that every process presents unique challenges and requirements. In addition to our extensive in-house testing capabilities, HPNE may be able to support custom validation projects and specialized testing requests tailored to customer needs.
Contact our team at info@hp-ne.com to learn how we can support your validation needs.
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About HPNE
As the industry needs grow, High Purity New England, Inc. continues to supply the biopharmaceutical industry with a range of innovative products, from drug discovery and development to fill-finish, including their flagship product, custom single-use assemblies, as well as pumps, sensors, bioreactor systems, storage and handling solutions and other single-use solutions. Along with their own manufactured products for the global market, they are also a distributor for more than 18 brands in North America.
