Automated coating application systems are the optimal way to apply coatings to medical devices. There are many benefits of automated coating equipment vs a manual coating process. They deliver the highest output, efficiency, and finish quality.
Coatings are critical for the safe and reliable use of invasive medical devices within the biological environment. In turn, most medical devices need to be coated correctly. In addition, the coating must be applied correctly. As a result, medical device manufacturers must select and apply coatings based on the devices’ materials and intended use. This application can be done by outsourcing to a contract coating service or via installing dedicated coating systems in-house.
Today, most major device manufacturers are transitioning to automated coating systems. However, how do you know which system is right for your operation? What are the key considerations when sourcing and installing such equipment?
That is exactly what we touch on below. In this article we outline the key factors to consider when selecting an automated medical coating system. If you are a Plant or Operations Manager, Engineering Manager, Facilities Manager, COO, or individual involved in medical device coatings this article should be a helpful resource.
Also, make sure to read our in-depth guide covering Fully Automated Coating: Performance, Compatibility, and Benefits
Key Considerations while Choosing an Automated Coating System for Medical Devices
1. What Automation Level is Right For Your Operation
Automated coating systems are classified into two categories based on the level of automation they offer:
- Semi-Automated Coating Systems: A semi-automated system utilizes both mechanized processes and manual operations to apply coatings to medical devices. For example, humans are necessary to load and unload devices. The remaining tasks, such as coating application and curing, are performed by machines.
- Fully-Automated Coating Systems: These systems use machines to perform all tasks, delivering greater efficiency and performance than manual or semi-automated alternatives.
Automation levels can be tailored to specific needs. Manufacturers can select which processes to automate, and some suppliers offer flexible solutions to match budget and application requirements.
Some providers, such as Hydromer®, Inc., offer scalable systems that allow clients to add automation modules as production needs grow. These solutions are well-suited for startups and companies establishing new coating operations. They allow the systems to scale with your product stage and demand.
Learn more about Hydromer® Coating Equipment.
2. Production Capacity
Production capacity depends on several factors. Fully automated systems can process thousands of units per hour, though output varies with automation level and production setup.
Below are the two standard production line configurations:
- Batch: This setup processes groups of parts per cycle, with multiple items mounted on racks or trays and moved through each coating stage. Batch configurations offer lower throughput and are best for low-to-medium volume production.
- Inline: This configuration uses a conveyor or transport system to coat parts continuously, making it ideal for large-scale production.
The coating type and application method can also impact production speed. For instance, spray coating is typically faster than dip coating.
3. Medical Device Complexity
Medical device size, structure, and geometry vary drastically. For example, stents, multi-lumen catheters, and implants, such as the neurovascular meshes are some of the most challenging to coat.
The automated medical coating systems need to be configured properly based on the geometry and type of coating. That is because these factors can affect coating uniformity, coverage, and adhesion.
For instance, when using dip or meniscus coating modules, precise control of withdrawal and immersion speeds is essential. This is especially true for devices with long, narrow geometries.
4. Coating Chemistry Compatibility
Medical coating formulations vary widely based on the required performance and safety requirements of the underlying medical devices.
Some automated systems are incompatible with certain chemistries and solvents used in coatings. Advanced coatings, such as hydrophilic coatings for medical devices may contain polymers, solvents, additives, and reactive agents. Inadequate handling of these formulations can cause issues or system shutdowns.
Make sure your selected coating system is equipped with tanks, pumps, tubing, and seals that are compatible with the various chemicals present in coating solutions. Additionally, the automated coating system must maintain conditions that preserve coating properties, such as the viscosity, temperature, and humidity.
5. Surface Preparation Capabilities
Coating surface preparation is a critical step in a medical coating application process. It is used to activate the device surface by removing contaminants, dust, grease, and more. Without surface preparation, the coating adheres poorly and does not cover the entire medical device surface.
Different modules are used in an automated coating system to prepare and clean the medical device surface. The right choice depends upon the device material and coating type.
Below are the most common surface preparation modules:
- Cleaning and Degreasing
- Plasma Treatment
- Corona Treatment
Modern automated systems have integrated surface preparation modules. This ensures devices enter the coating application stage with consistent surface conditions. Preparation is critical for coating adhesion and uniformity.
6. Supported Coating Application Methods
Modern automated systems have numerous components and modules. Among them include specific modules to apply coatings to devices. There are several options available:
- Dip Coating Module
- Spray Coating Module
- Spin Coating Module
- Flow Coating Module
- Meniscus Coating Module
All of them are compatible with the most automated coating systems. However, an advanced coating system should be able to support multiple coating application modules. Such a provision is critical to apply coatings to complex geometries.
If you are interested in this topic, read more about Compatible Coating Methods for Automated Coating Systems.
7. Ensure the Curing Modules Match Your Coating Type
Curing modules convert liquid or semi-solid coatings into solid films.
Automated systems typically offer three types of curing modules:
- Thermal Curing Module: This is the most popular curing method used across many automated medical coating systems. It leverages heat to evaporate solvents and initiate polymer crosslinking. An oven or heated chamber generates the heat, and the temperature is precisely maintained within a defined range.
- UV Curing Module: This module is an ideal choice for large-scale or high-throughput medical coating systems. It uses UV (ultraviolet) light to polymerize coatings such as UV-Curable Hydrophilic Coatings containing photoinitiators rapidly. Such modules are equipped with lamps or LEDs to generate UV light.
- IR Curing Module: The IR curing module uses infrared radiation to heat the coatings and trigger faster solvent evaporation. They use infrared emitters.
The type of module included in an automated coating system depends upon chemistry and production requirements. For example, the standard Hydromer®, Inc. automated coating systems come with the UV curing modules for high-volume applications. Manufacturers choose between thermal and UV curing modules based on their requirements.
8. Quality Control System
Modern automated systems feature inspection tools and sensors to verify coating thickness, adhesion, and uniformity at each stage. This ensures performance specifications are met.
Many of them include a statistical process control system to maintain thickness uniformity. They detect and remove faulty parts or those that are not coated as per the specification.
Advanced sensors track all process parameters, with data accessible through production logs and traceability records.
9. Safety Controls
Automated coating lines must safely handle the coating materials, VOCs, and solvent vapors during application and curing. They must also maintain stable environmental conditions and ensure operator safety for process reliability and compliance. Important components of the coating system include:
- Proper ventilation and exhaust
- Solvent recovery or filtration
- Explosion-proof components (if required)
- Cleanroom compatibility (ISO standards)
Safety encompasses everything from chemical storage and handling systems to temperature and humidity control. Everything plays an important role in coating performance and curing behavior as well as personnel safety.
10. Regulatory Compliance
An automated medical coating system must flawlessly meet strict quality, safety, and documentation requirements. These requirements are outlined by the worldwide regulatory authorities. They are non-negotiable.
Medical coatings play a critical functional role within the biological environment. Any failure in the coating performance can lead to patient discomfort and even life-threatening situations. That’s the reason the regulatory organizations have defined strict rules to fully control, validate, and trace coating processes and performance.
Compliance guidelines differ by region. Consult your supplier to ensure the system meets regulatory requirements for your target market.
11. Maintenance Cost
It is critical to ensure that your automated coating system operates reliably, safely, and within the specified performance parameters. Manufacturers should invest time and money in routing servicing, component replacement, calibration, cleaning, and occasional repairs.
An automated coating system has complex and costly components. The cost of the replacement components and routine servicing must be discussed with the supplier before purchase. It directly affects system uptime and operational efficiency. It also affects the total cost of ownership in the long term. In turn, understanding these costs in advance is important.
12. Supplier Expertise and Customer Support
Many device manufacturers outsource coating applications, while a few invest in dedicated in-house systems for future demand and cost savings. As a result, reliable and responsive coating system producers are limited.
Review supplier websites and documentation to assess products, services, and customer feedback. At Hydromer®, we bring 40+ years of experience and assign a dedicated support executive to each client, ensuring prompt responses to your inquiries.
Hydromer®: Hydrophilic Medical Coating Manufacturer and Coating Systems Supplier
Hydromer®, Inc. is a leading manufacturer and supplier of advanced hydrophilic coatings with over 40 years of experience. Our coating equipment line includes high-performance semi- and fully-automated coating systems as well as friction testing machines and custom built equipment.
We have served startups, OEMs, and CMOs for decades. Our automated systems integrate with various coating application methods and curing processes. This includes Hydromer®’s proprietary UV curing technology, HydrUV™.
Our goal is to enable efficient, high-volume device production for our partners. Hydromer® collaborates closely with clients, providing support throughout the entire product lifecycle. We can also assist you with contract R&D, coating formulation, analytical testing, and many other coating services.
Automated Medical Coatings Systems Available From Hydromer®, Inc
Our two most popular automated coating line solutions are:
- Hydrophilic Coating System: This automated system features integrated UV curing and is designed for applying hydrophilic coatings to medical devices. It requires only one or two operators and supports an annual capacity of 200,000 to 300,000 units.
- Fully Automated Coating System: This end-to-end solution is suitable for industrial applications and compatible with various medical-grade coatings. It requires a single operator and is ideal for large-scale production of complex devices such as catheters and guidewires.
To learn more about Hydromer automated coating systems, please get in touch with us.
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