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View Dialysis Catheter
Assembly Process
View Bi-Directional Aspiration
and Infustion Catheter
Assembly Process
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ISP provides quality, innovative solutions for our customers' assembly and packaging needs.
Adherence to techincal standards, excellent customer service and flexible, rapid response to
production requirements signify our commitment to quality and performance.
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: Ridgid trays with Tyvek lid sealing.
Material Procurement
ISP works 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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