Harland’s Coating Services Approach
Initialization
To begin we gain a clear understanding of your device surface characteristics and properties.
Validation
We then use statistical methods and design of experiments to identify the process limits for coating your device. After that, a statistically driven operational qualification, followed by a process qualification helps ensure the process produces coated devices that meet your specification.
Incoming Inspection
Following a previously agreed upon inspection plan, Harland receives, documents and warehouses each incoming lot of materials.
Raw Material Sourcing
We offer efficient sourcing of raw materials that conform to your specifications, helping to optimize the efficiency of your critical supply chain.
Warehousing
We provide warehousing solutions for uncoated sub-assemblies or finished products, helping you to manage in-process inventory.
Coating Service
From surface preparation to device fixturing, coating and curing, Harland’s integrated coating services deliver consistency and excellence through all stages of formulation, testing, application and volume production. Our skilled technicians can handle any commercial or in-house coating challenge, and all services are performed in compliance with our ISO13485 certification.
Inspection, Testing & Quality Assurance
Based on the quality and performance criteria for your product, we can inspect and test for a variety of coating parameters, including surface coverage, thickness, lubricity and durability.
Documentation
Harland establishes and implements written procedures to ensure that device history records are maintained in accordance with the Device Master Record (DMR), including information on incoming material acceptance, manufacturing processes, manufacturing dates and quantities, quantities released for distribution and acceptance records.
