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ASSEMBLY & PACKAGING
We provide complete assembly and packaging services.
A number of secondary operations can be performed to deliver a
completed medical device. This includes bonding of silicone to
various substrates, metallics, and other silicones. Completed
devices can be packaged in pouches (i.e. Tyvek®) or thermoformed
trays. Following packaging in our certified Class 10,000 clean
rooms, sterilization can be performed utilizing any method you
prefer.
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Assembly
- Component Assembly: Silicone, plastic, PVC or metals and others
- Bonding Assembly: Silicone RTV, Loctite
- Microscopic Assembly: Bonding, trimming, de-flashing
- Sub-assembly: From simple assembly to complex bonding operations
- User-Ready Products: Sterile, non-sterile
- Inspecting & Testing
Packaging
- Labeling: In-house printed labels ensure full control to meet customer specifications and traceability requirements.
- Bar-code Labeling: ISP prints to health industry bar-coding standards.
- Pouch sealing: Tyvek, paper, foil.
- Tray sealing: Rigid trays with Tyvek lid sealing.
Material Procurement
We work with pre-approved sources, customer-specified vendors, or we can qualify a vendor for you. Materials can be received certified ready to use, or ISP can inspect to customer's specifications.
Traceability
We provide complete traceability of all components and materials.
Environmental Controls
We offer ISO Class 7 (Class 10,000) cleanroom environments for assembly and packaging to ensure minimal contamination levels through production and final packaging activities.
Other Services
- Validation: master validation plans, equipment qualifications, test-method validation, process validation, packaging-validation, stability studies, etc.
- Sterilization: Sterilization program sponsorship through approved contract sterilizers and testing laboratories including validations, regular dose audits and sterile product release.
- Fixture Fabrication: In-house and outside sourcing.
- Project-Specific Outsourcing: Services such as die-cutting, plasma treating, printing, etc.
- Microbial Control Monitoring: Product bioburden, pyrogen testing, environmental testing and monitoring, etc.
- Warehousing: Availability to store product until ready for direct third party shipping or for buffer or safety stock.
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