Certified Quality Management ISO 13485 : 2012 2008 FDA RegisteredCertified Quality Management
ISO 13485 : 2012
ISO 9001 : 2008
FDA Registered

Tooling Repair & Maintenance of a Disposable Tube Mold

At Marman, we help customers achieve success when other suppliers fail. For this project, a customer in the medical component industry contacted us regarding issues with a mold designed to create tubes used during allergy testing. The tubes are designed to hold media that is used to test patients for allergic reactions. The mold used to make these tubes had hidden damage and was removed from the previous vendor after unsuccessful attempts to resolve the quality issues. Damage to the hot runner system inside of the mold was significantly affecting part quality and rendering molded tubes unusable. Faced with unusable parts and an impending deadline, the customer reached out to our team for assistance.

We were able to repair the tooling and produce the tubes from K-Resin SBC. Having mold design and contract manufacturing capabilities available in house allows us to design, repair, and modify tooling quickly and accurately. Each tube measures 1.772" in height, with an outer diameter of 0.362" and is polished to an SPI A3 finish. After repairing the mold and optimizing the manufacturing process we were able to achieve a far superior cosmetic finish than the customer had been receiving from their previous supplier. The quality of the completed tubes was verified through inspections using functional leak testing methods.

We are ISO 13485:2003 certified and registered with the FDA. Our team has a wealth of experience in navigating the sometimes complex regulatory compliance process. These disposable tubes are a high volume part, with an annual usage of approximately 30 million units. Weekly deliveries are made to our customer in Southern California. For additional details regarding this custom plastic injection molding project, see the table below, or contact us directly.

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Tooling Repair & MaintenanceTooling Repair & Maintenance

Tooling Repair & Maintenance of a Disposable Tube Mold Project Details

Project/Product Name
Disposable Tube Mold
Capabilities Applied/Processes
Primary: Mold evaluation and repair, Injection molding, Contract Manufacturing

Secondary: Validation, Packaging, Design Transfer
Equipment Used to Manufacture Part
Molds and Fixtures: EDM, CNC Milling, Surface Grinders
Parts and Assemblies: Injection Molding Mach Package equipment: 1.5 mil poly bag
Overall Part Dimensions
.362" OD x .298" ID x 1.772" Height
Tightest Tolerances
+/-.003 Plastic, +/-.0002 Steel
Material Used
Phillips K-Resin
Material Finish
In Process Testing/Inspection Performed
AQL sampling, Functional Leak Test
Industry for Use
Medical diagnostics and disposables
Up to 30 million / year
Delivery/Turnaround Time
weekly deliveries/ Kanban
Delivery Location
Southern California
Standards Met
ISO 13485, FDA registration
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