Ultrasonic Coating Machine for Stent & Balloon Catheter

Customer case: Ultrasonic coating machine for stent and balloon catheter drug coating preparation

Customer Profile

Company Profile: This is an overseas professional enterprise specializing in the research and development, as well as pilot production, of cardiovascular interventional medical devices. Its core product line includes drug-eluting stents and drug-eluting balloon catheters, which are developed for the peripheral vascular and coronary intervention treatment fields. The enterprise strictly follows the coating quality control standards of the medical device industry, and the uniformity of product coatings, drug loading stability, and drug release performance directly determine the safety of clinical use. The enterprise has long-term independent research and development of anti proliferative drug coating formulas, which have extremely high requirements for the precision, cleanliness, and process reproducibility of coating equipment.

Core requirement: Purchase specialized ultrasonic coating machine for drug coating spraying on the surface of vascular stents and balloon catheters; The equipment needs to be adapted to various drug polymer suspensions to achieve an ultra-thin and uniform drug loading layer, without coating bridging, leakage, or detachment issues, while also taking into account the preparation of new product research and development samples and small-scale pilot production.

Pain points of the original process

Before consulting ultrasonic coating equipment, the enterprise used traditional pressure two fluid spraying and immersion coating processes to prepare drug coatings, and multiple process defects hindered product research and mass production

Bracket mesh holes are prone to coating bridging
Traditional high-pressure spraying has a high impact force, and it is easy to form drug film adhesion and bridging between the micro support rods of the stent. After implantation in the human body, coating peeling is prone to occur, which increases the risk of thrombosis and vascular restenosis; Immersion coating can cause significant differences in coating thickness between the inner and outer layers of the stent, leading to uncontrolled drug release curves.

Uneven thickness of balloon surface coating
The balloon catheter is made of curved flexible substrate, with edge drug accumulation and thin intermediate coating during air pressure spraying. The drug loading deviation exceeds the compliance standards of medical devices, and the product consistency between batches is poor. A large number of samples are scrapped.

Serious loss of expensive drug raw materials
The procurement cost of medical drugs such as paclitaxel and rapamycin is high, and the traditional spray coating has a large amount of splashing and overspray. The utilization rate of the coating is less than 30%, and the cost of research and production consumables remains high.

High temperature and high pressure disrupt drug activity
Traditional atomization relies on high-pressure airflow, and local airflow heating can easily lead to degradation of the active ingredients of the drug, directly affecting the clinical treatment effect of the device, with poor repeatability of experimental data.

Process parameters cannot be standardized and retained
Manually adjusting the spray pressure and distance, with no storage function for parameters, makes it difficult to replicate different batches of sample processes and meet the data traceability requirements for overseas medical device registration and third-party testing.

Customer consultation and docking details

The enterprise initiated a special inquiry through the international medical device equipment platform, specifically inquiring about ultrasonic coating equipment suitable for interventional devices, and clarifying the hard technical indicators:
– It is compatible with both metal stents and flexible balloon catheters for drug spraying, and is equipped with a dedicated rotating fixture to achieve 360 ° full coverage and no dead corners coating;
– Low tenderness and atomization, no high-pressure impact throughout the entire process, fully preserving the biological activity of the drug, preventing stent bridging and balloon substrate swelling damage;
– The coating thickness is precisely adjustable at the micrometer level, and the drug loading error is controllable, meeting the quality control standards of medical devices;
– The whole machine is designed with a clean and sealed chamber, suitable for pharmaceutical dust-free workshops, equipped with an English operating interface and complete process parameter storage and export functions;
– We provide overseas remote process debugging and specialized technical training for medical coatings, and can customize spraying process plans based on customer drug formulas.
Our medical coating specialized technical team connects with enterprise R&D engineers, matches medical grade ultrasonic coating systems based on the working conditions of their stent and balloon dual product lines, and synchronously provides mature spraying process plans and testing data for intervention instruments in the same industry, quickly completing the confirmation of the plan.

Customized ultrasonic coating solution

For the dual application scenarios of stent and balloon catheter drug coating, a medical closed high-precision ultrasonic coating machine is configured, with the following core advantages:

Soft ultrasonic atomization, protecting instruments and drugs
Using high-frequency medical ultrasonic nozzles and relying on sound wave vibration to atomize medication, there is no need for high-pressure auxiliary airflow, and the kinetic energy of droplets is low. When spraying the bracket, there will be no bridging of the support rod, and spraying the flexible balloon will not cause deformation or swelling of the substrate; Full process room temperature atomization, with no loss of drug activity.

Dual workpiece specialized rotary spraying fixture
Equipped with a fast switchable bracket and a specialized clamping and rotating mechanism for balloons, the workpiece rotates uniformly 360 °. The bracket mesh and balloon surface are fully covered with spray coating, without any blind spots. The coating is continuous and smooth, without pinholes, bubbles, or clumping defects.

The utilization rate of medication has been significantly improved, saving raw materials
Directional settling atomization can achieve an effective adhesion rate of over 90% for the drug solution, significantly reducing the waste of expensive medical drugs and significantly lowering the cost of research and development and pilot raw materials for enterprises.

Accurate and controllable coating thickness, strong batch consistency
Independently adjust the ultrasonic power, liquid supply flow rate, movement speed, and spraying spacing, and the coating thickness can be precisely adjusted in the range of submicron to tens of microns; All process parameters can be stored, retrieved, and replicated with just one click, with minimal deviation in drug loading between batches, meeting the requirements for medical device registration and testing.

Medical grade clean machine configuration
The sealed negative pressure spraying chamber is equipped with an exhaust gas solvent recovery system, which complies with the usage standards of pharmaceutical dust-free workshops; The all English PLC control system allows for complete export and archiving of operation logs and spraying data. It is equipped with a dedicated process database for medical device coatings and supports stable spraying of various PLGA and PVP drug polymer carrier formulations.

 Implementation effectiveness

After completing cross-border delivery, installation, debugging, and process training of the equipment, it was fully invested in the enterprise’s new product research and development and small-scale pilot production line, with outstanding comprehensive improvement effects:

The coating quality fully meets clinical standards
The stent has no coating bridging, the balloon has uniform coating throughout the entire area, and the drug loading error is controlled within the compliance range; The drug release curve is stable, and the one-time pass rate of the finished product has been significantly improved, successfully passing the third-party medical device coating testing.

The cost of pharmaceutical consumables has significantly decreased
The loss caused by excessive spraying of medication has been significantly reduced, and the usage of drug raw materials has decreased by 60%, effectively reducing the cost of new product development samples and pilot production costs.

R&D and production efficiency improvement
Equipment parameters can be quickly replicated without the need for repeated process debugging; Quickly switch between supports and balloons in tooling, reducing the preparation time of single batch samples by 50% and accelerating the iteration speed of new products.

Meet compliance and traceability requirements
The complete and exportable spraying process data can be directly used for medical device registration and customer review, enhancing the competitiveness of enterprise products in the overseas medical device market.

Customer reviews

We have been looking for precision coating equipment that can simultaneously adapt to drug stents and balloon catheters. Traditional spraying processes have always been unable to solve core problems such as uneven coating, high drug loss, and stent bridging. This ultrasonic coating machine perfectly matches the research and development and small batch production needs of our two types of interventional devices, with soft atomization that does not damage the drug and substrate, and coating stability far exceeding expectations. The English system is easy to operate and remote technical support is responsive in a timely manner. It has become the core equipment for our drug coating preparation. In the future, we will continue to purchase additional supporting equipment for expanding the small batch production line

Summary of Applicable Scenarios

This series of ultrasonic coating equipment is specially designed for drug coating of interventional medical devices, suitable for precision instruments such as drug-eluting coronary/peripheral vascular stents, drug-eluting balloon catheters, and micro interventional guide wires. It can be used for the research and development of new product formulas, sample trial production, and small to medium batch compliant pilot production in enterprises.

About Cheersonic

Cheersonic is the leading developer and manufacturer of ultrasonic coating systems for applying precise, thin film coatings to protect, strengthen or smooth surfaces on parts and components for the microelectronics/electronics, alternative energy, medical and industrial markets, including specialized glass applications in construction and automotive.

Our coating solutions are environmentally-friendly, efficient and highly reliable, and enable dramatic reductions in overspray, savings in raw material, water and energy usage and provide improved process repeatability, transfer efficiency, high uniformity and reduced emissions.

Chinese Website: Cheersonic Provides Professional Coating Solutions