Disposable Assemblies
» Validation Support Services » Manufacturing | » Certification Levels » Custom Assemblies |
Complete, Validated Solutions
We design, develop, and integrate disposable solutions using a combination of components specifically engineered to fit your specifications. From our broad offering of filters, process containers, connectors and tubing, we help you choose the right combination of products for your application. Add to that our validation support services, and you get a complete solution – all from a single source. Backed by the quality, services and support you’ve come to expect, Millipore’s flexible disposable assembly solutions offer superior quality and safety, and help accelerate speed-to-market.Validation Support Services
Take advantage of Millipore’s proven application, validation, and engineering support. Access Services can integrate and validate disposable assemblies into your processes in a manner that will guarantee product quality and assist with regulatory compliance.Support Services include:
- Bacterial retention validation, physical compatibility testing, integrity test ratio, and extractables analysis on the filter
- Extractables analysis for individual assembly components
- Extractables analysis for the full assembly
- Fulfillment of physical compatibility test requirements relevant to your usage requirements
Manufacturing
With multiple manufacturing sites and validated component manufacturers across the globe, you can be confident in the quality and service of our products. Our USP Class VI products are individually assembled and inspected in our Class 10,000 facilities. They are guaranteed 100% for material quality and workmanship, and are provided with complete validation and traceability documentation.Millipore understands the requirements of the pharmaceutical industry, and performs the appropriate validation and quality verification.
View the types of testing performed for product qualification and lot release.
Certification Levels
Assemblies can be configured to meet your sterility and cost requirements. Select the best certificate level for your assays.| Certification | Shelf Life Claim | Sterility Claim | LAL & Particulate | Leak Testing | Class VI USP (88) |
| Gold | 2 years | Sterile, Quarterly Validation | Lot Release | 100% of lot on full assembly & bag* | Post-gamma, component family |
| Silver | 2 years | Sterile, Quarterly Validation | Quarterly review of results | In-process leak testing | Post-gamma, component family |
| Bronze | None | Gamma-irradiated >25 kGy, not validated sterile | No testing performed | No testing performed | Pre-gamma resin only |
| Basic | None | None | No testing performed | No testing performed | Pre-gamma resin only |
| * Complete assembly testing is performed unless prohibited by the design. | |||||
Custom AssembliesWe can design, develop, and integrate custom components specifically engineered to fit your applications and specifications. Contact your Millipore Application Specialist for more information. |
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Product News & Releases
- Millipore Introduces Solvex™ Solvent Filters - New cartridge filters ideal for sterile manufacture of APIs
- Millipore Introduces the Mobius® MIX500 Disposable Mixing System - Increased process speed and reduced risk now in a 500L size
- Millipore Expands Its NovAseptic® Mixer Family - The new GMP30000 mixer is ideal for effective mixing in large volumes
- Millipore Introduces New Service Offer for Evaluating Mixing Solutions
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