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Specific Applications Support Services

SASS is a global organization of market focused scientists and engineers who collaborate with our customers and CUNO R&D teams. Members of the Global SASS group are skilled in performing on-site bench-scale tests and relating the results to full scale manufacturing operations. When unique processing problems are encountered, SASS is fully equipped to identify filter solutions using either CUNO’s wide range of existing filter products or working with CUNO R&D to design a custom solution.

Core Services

Integrity Testing
Water-wet integrity test values are supplied with all liquid sterilising grade CUNO membrane filters. However, many filtration applications are in solutions other than water. The properties of these solutions (surface tension, viscosity, etc.) may affect the integrity test characteristics of the filter under consideration. CUNO has the experitise to execute the required tests to provide product-specific integrity test parameters to address these critical issues.

Bacterial Retention
This evaluation supports the ability of a particular filter to retain a test organism under "worst case" conditions. The appropriate test organism is typically suspended in the drug product or solvent of choice, at a concentration that will provide an effective “challenge” to all the membrane surface area.

Chemical Compatibility
Evidence is provided to confirm that the CUNO filter selected for a particular application is chemically and physically compatible with the fluids and the operating conditions used in the application.

Extractables
This evaluation provides information regarding the quantity and identity of material extracted from a filter when exposed to a particular solvent system. Combined with appropriate flushing protocols, this information can be used to minimise extractables. Biological Safety Tests (USP Class VI Plastics) provide complementary data on the toxicity of extractable materials. Additionally, CUNO can recommend filter combinations that reduce the number of extractable components present, minimising regulatory complexity. For instance, selecting prefilters and final filters composed of the same support and membrane materials reduces the number of materials exposed in a process, simplifying validation issues.

Additional Services

Sterilising Grade Filter Validation Guides
CUNO provides extensive regulatory information in our Validation Guides for sterilising grade filters including the Zetapor®, SterASSURE™, and Microfluor® filter families.

Prefilter Regulatory Support Files
CUNO leads the industry in supplying validation support for upstream filter products. Our Regulatory Support Files cover upstream filters such as LifeASSURE® PB, PolyNet™ PB, PolyPro® XL, Zeta Plus® and ZetaCarbon® filters.

USP Biological Reactivity - Class VI Plastics Test Results
Third-party testing reports are available for CUNO filters documenting that their component materials meet the requirements of the USP Class VI Biological Safety Test for Plastics.

Onsite Filtration Audits
CUNO SASS specialists are skilled in conducting on-site audits of filtration processes and recommending ways to improve filtration performance, reduce filter costs and minimise process downtime.

MicroCheck™ 2 Automated Integrity Test Machine
CUNO supplies on-site validation of automated integrity test devices, such as the MicroCheck™ 2, tailored to meet the specific needs of the customer. IQ/OQ documentation is also available to speed regulatory compliance. CUNO SASS can also assist in your PQ validation.

SOP & Test Protocol Development
CUNO is skilled in helping customers develop standard operating procedures and test protocols for a variety of filter applications.

Pre-inspection Audit Support
CUNO SASS specialists can provide assistance in preparing customers for internal and external audits of filtration processes. Operator training courses, report consultation and compliance trouble-shooting are just some of the services CUNO Validation Support Services can provide.

Regulatory Document Preparation Assistance
CUNO specialists bring their familiarity with regulatory documentation to assist customers in preparation of the necessary materials required by regulatory authorities.

Audits of CUNO Manufacturing Sites
CUNO welcomes audits of our manufacturing facilities and has assembled a team of specialists to provide this service to our customers.

Contaminant Analysis
CUNO laboratories have decades of experience in the analysis of contaminants and can supply technical advice on improved filter selection and usage based on the findings. This service often results in significant cost savings in optimized filtration.

 
The ripples we create impact block-buster drug manufacturing process in a big way.
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