From products ranging from simple tubing sets to more complicated cardiovascular products, Cascade Life Solutions offers component sourcing, assembly, testing and packaging capabilities.

We Offer:

• Experience with high volume medical and custom order manufacturing.
• Years of combined experience with the designing, molding, assembly, troubleshooting, and improvement of plastic components.
• Keen understanding of manufacturing processes and process improvement.
• Working knowledge of flexible manufacturing systems including JIT. Ability to respond to fluctuating demand in hours and days versus weeks and months.
• Ability to in-house prototype and fabricate tooling and fixtures.
• ISO 13485:2003.
• Full lot traceability and lot control.
• Ability to resolve complex technical problems with equipment, processes, raw materials, and designs.
• Ability to improve designs and processes.
• Ability to safely operate with minimum inventory for maximum flexibility in design changes.
• Ability to foresee problems with products and processes.
• Ability to design products which are easily manufacturable.
• Absolute commitment to delivering quality parts and assemblies on time.

SERVICES

Front End Design Assistance

• Design for manufacturability analysis
• Plastic part design
• Material selection
• Rapid prototyping
• Prototype injection molds for low cost design verification
• Sterile package design
• Shelf and shipping box design and configuration

Process Development and Validation

• Assembly process definition and design
• Test procedure definition and design
• Tooling and fixture design and fabrication
• Equipment validations including I/Q, O/Q and P/Q
• Design of experiment
• Validation protocol development, testing and reports
• Sterile package seal strength characterization
• Sterilization validation
• Accelerated age studies
• Transit testing

Material Procurement and Control

• Vendor identification
• MRP inventory management
• Component purchasing
• Receiving inspection
• Component and sub-assembly warehousing
• Full lot control

Order Fulfillment

• Warehousing of finished goods
• Multiple times daily order processing

Product Manufacturing

• Full lot control and/or serialization
• In-process and final quality assurance
• Sterile packaging in all standard formats
• Sterilization coordination including QDA's and annual EO revalidations
• Final packaging
• Worldwide shipping

Device History Record/Master Record

• Complete device manufacturing documentation
• Complete work order history
• Full lot control

MANUFACTURING
We are experts in the joining of plastic components. Our knowledge of solvent and UV adhesive bonding is extensive. Assembly

• Plastic part design
• Plastics injection molding
• Plastics assembly including silicone components
• Solvent and bonding
• UV adhesive, epoxy, and polymer adhesive bonding
• Flow and leak testing
• Ultra-sonic welding

PACKAGING
Properly designed packaging will get your product to your customer intact and in optimal presentation without costing a fortune. Improperly selected packaging can be very expensive and potentially severely delay a new product release. We can assist in all aspects of packaging selection and utilize vendors who deliver quality materials, on time and at reasonable prices. All of our packaging equipment is fully validatable and incorporates total process controls. We routinely validate and monitor package seals using constrained burst testing, dye penetration and peel strength methods.

• Chevron peel pouching utilizing Urania continuous band sealers, and SenCorp thermal impulse bar sealers.
• Package testing is done using ARO 2600 burst testers.

STERILIZATION
Cascade Life Solutions coordinates all aspects of sterilization including sterilization validations, quarterly dose audits, annual ETO re-qualifications and routine processing. We use only ISO certified processors and provide a certificate of processing with each shipment. We can help you select materials for your products which will allow you to use a preferred method of sterilization.

FACILITY

• 15,000 square feet
• A class 10,000 clean rooms with class 100,000 gowning and transfer rooms.
• Pre-sterile, quarantine and sterile controlled access areas
• Production areas equipped with a wide variety of standard and specialized assembly and test apparatus
• Receiving inspection
• Metrology department with NIST traceable standards for complete in-house calibration

QUALITY
We are proud of our quality system. Cascade Life Solutions is ISO 13485 certified, and audited semi-annually by Kema.
Our company is committed to quality and has established and adopted the following Quality Policy:

• Our customers expect and deserve to receive from us quality products and services.
• We are each responsible for providing quality products and services.
• We will work continually and systematically to improve the quality of our products and services.
• We are committed to complying with all relevant regulations and standards, specifically, FDA Quality System Regulation: 1997, the ISO 13485:2003 Standard, the Canadian Medical Devices Regulations, and the Medical Device Directive: 93/42/EEC.

CONTACT
Our corporate office and production facility is located at:
3710 Sysco Court SE
Grand Rapids, Michigan 49512
Michael Ford
Business Unit Manager