Raw Material Selection:
The first step is to create a formulation through bench chemistry analysis. The base chemistry of medical-grade foam consists of toluene diisocyanate (TDI) and polyether polyols or polyester polyols. The chemistry is decided based on the desired properties of the final product, including flexibility, softness, chemical, and biocompatibility.
Chemical Formulation:
After choosing the base raw materials, Foamtec utilizes precision pumps and mix heads to pour exact formulations. Chemicals like colorants, stabilizers, and surfactants may be added to achieve the desired foam characteristics, such as hydrophilicity or swell.
Foaming Process:
The foam is produced in a continuous process. In this process, each of the chemical ingredients is mixed.
The chemical formulation reacts and rises to create the main foam structure, while the water & catalysts help control the reaction & produce the correct cellular structure & desired density. Since this is an exothermic reaction, time and distance are necessary to create a product that is stable and can be handled at the end of the continuous production line.
Reticulation:
Once the foaming process is complete, the cells of the foam are only partially opened. Creating an exceptionally clean and stable product, the foam must be thermally reticulated to completely open the cells and remove residual “windows”, which contribute to particulation and limit the foam’s openness.
Buns of foam are placed into a reticulation chamber where the atmosphere is evacuated and replaced with a mixture of hydrogen and oxygen. This new atmosphere is ignited, and a controlled explosion opens the cells, wrapping the windows around the struts of the cellular structure. Reticulation creates a strong structure devoid of particles and a torturous path, enabling open pores to hold liquids or allow for ultra-filtration.
Cutting and Shaping:
Once the foam is complete, it is cut and shaped into the desired form. This may involve skiving sheets, cutting blocks or strips, die-cutting, lamination, and swab forming to create specific shapes and sizes for medical applications.
Quality Control:
Quality control is a critical step in the manufacturing process. Foamtec inspects every step of the process, from initial chemistry through the foaming process and, finally, fabrication. Products are checked to exact specifications from foam properties through contamination control and sterility through dimensional accuracy and final packaging. This ensures that the final product meets our customers’ specifications. Because Foamtec is a vertically integrated company, we control the quality from the foam to the finished product. We guarantee consistency, quality, and traceability.
Packaging:
After passing quality control, the foam products are packaged suitable for medical use with appropriate labels, assuring complete traceability.
Sterilization:
Depending on the application, the final product may undergo gamma irradiation to ensure they are sterile.
Storage and Distribution:
Foamtec stores the finished and sterilized medical devices in a controlled environment and ships them according to our customer’s instructions.
The manufacturing process of medical foams requires strict adherence to quality standards and regulatory guidelines, mitigating risk for our customers. Foamtec maintains a controlled and clean-room production environment to reduce that risk. Additionally, ongoing research and development efforts continue to improve the properties and performance of medical foams for new medical applications.
Foamtec Medical is the custom medical device manufacturing division of Foamtec International, LLC. Since its inception, Foamtec Medical has been on the front line of innovative medical foam manufacturing and fabrication. No other company provides diversity through the integration of both manufacturing and fabricating polyurethane foam for medical devices.
Our expertise in producing medical-grade foam leads us to innovation and creativity when it comes to meeting all the criteria our customers need for their medical devices.
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