Packson specializes in delivering top-notch clean room manufacturing and assembly solutions tailored to meet the needs of medical device companies. Committed to adhering to the ISO 13485 standard, which is the gold standard for quality management systems in the medical device industry, we ensure the highest level of quality and safety for our products.
Based on the specific requirements of the medical device, Packson can achieve ISO Class 7&8 classifications, providing controlled environments with particle counts ranging from 10,000 to 100,000 particles per square foot. Our team is composed of seasoned professionals with extensive experience in navigating the intricacies of the medical industry. From initial prototype design to final product delivery, we offer comprehensive medical device production services, ensuring a seamless journey from concept to market.
Get in touch with Packson and discuss your project requirements! We are dedicated to promptly responding to inquiries, typically within one business day, and are eager to explore how they can support your specific needs and bring your medical device project to fruition.
Our clean room for medical devices typically meets the class 8 criteria. We have 11 sets of high-precision NESSIE injection machines imported from Japan, as well as imported precision finishing technology. To maintain product quality and ensure timely delivery, we update our equipment every few years.
Thanks to clean room injection molding technology, medical device parts and disposables can pass IQ/OQ/PQ certification. There are strict inspection procedures for medical molded products, so you don't need to worry about their quality and sterilization.
With the assistance of mirror spark machines, high-speed CNC, and three-dimensional precision manufacturing and measuring equipment, the dimensions of medical parts are constantly monitored and validated throughout the entire process, from concept to machining, material selection, and manufacturing.
Class I and Class II medical devices are frequently manufactured in our cleanrooms. Clean room injection ensures the hygiene standard for medical devices. Class III devices require more stringent regulatory oversight, and as a result, they are manufactured under the strictest standards.
Our medical injection molding cleanroom adheres to the ISO 13485:2016 quality assurance standard. All plastic materials have biocompatibility reports, and their colors also have medical certification. Finished products undergo a rigorous inspection before delivery.
As a competent cleanroom injection manufacturer, we provide comprehensive services and support to our clients. Like other medical device injection molding factories, in addition to cleanroom molding, we also offer efficient and secure cleanroom packaging services to ensure the sterilization of the products.
As a full-service contract manufacturer of cleanroom injection, our cleanroom is well-suited for assembling particle-sensitive medical device components due to our strict control of the cleanroom environment. This can save our customers time and expense.
Packson's clean room manufacturing and assembly services encompass a comprehensive range of capabilities. These include:
ISO Class 8 Cleanroom Injection
Laser Welding
Bonding (UV and solvent)
Decorating
Flaring
Tipping
Packaging (pouch and tray)
Force testing (pull force, burst, and torque)
IQ/OQ/PQ validations
With our expertise in these areas, Packson is well-equipped to handle diverse medical device projects and deliver high-quality products that meet stringent industry standards.
At Packson, we take great pride in our advanced medical device injection molding cleanroom, meticulously designed to meet the most stringent cleanliness requirements. Our cleanroom provides the ideal environment for producing medical devices of unparalleled quality, combining various materials with precision to cater to our customers' unique demands.
Our Commitment to Efficiency and Excellence: State-of-the-Art Equipment: Equipped with cutting-edge technology, our cleanroom houses the latest injection molding machinery to ensure precise and efficient production processes.
Skilled Engineers: Our team of highly skilled engineers brings their expertise to every project, reducing the risk of errors and streamlining the manufacturing process.
Time and Cost Savings: By leveraging our advanced technology and skilled workforce, we have significantly reduced project lead times and overall costs, translating into greater efficiency for our customers.
Meeting the Demands of the Medical Industry: As a leading medical device injection molding company, we are dedicated to serving the needs of the medical industry. Our cleanroom facilitates the molding and assembly of medical devices, utilizing a wide array of materials, including medical-grade thermoplastics, to meet various healthcare and medical standards.
Focused on Precision and Scale: From small-batch productions to high-volume manufacturing, our cleanroom remains committed to creating precise medical components. Operating within ISO Class 7&8 cleanroom environments, we maintain the highest level of cleanliness and quality assurance.
Value-Added Services for Comprehensive Solutions: To provide a full spectrum of OEM medical device injection molding services, we offer a range of value-added services such as ultrasonic welding, printing, assembling, packaging, and sterilization. This comprehensive approach ensures that our customers receive end-to-end solutions tailored to their requirements.
If you are interested in our cutting-edge medical plastic injection molding cleanroom and wish to learn more, please don't hesitate to contact us today. Our team is ready to address any inquiries and collaborate with you to bring your medical device projects to fruition.
Below are additional value-added services related to medical device injection molding we can offer:
| Packson Value-added Services | |
| Conceptual Part Design | We offer expert assistance in developing the initial concept design for your medical device, ensuring its functionality and manufacturability are taken into account. |
| Design Validation and Implementation | Our team helps validate and implement the finalized design, ensuring it meets all necessary requirements and standards. |
| Design Assessment and Review | We conduct in-depth analyses such as Design for Manufacturability (DFM), mold flow analysis, tolerance analysis, and feasibility studies to optimize the design for efficient production. |
| Prototyping: | We can create prototype molds to produce samples of your medical device, allowing you to verify and refine the design before full-scale production. |
| Medical Device Injection Molding Processing | Our specialized medical device injection molding processes ensure the production of high-quality components that meet stringent medical industry standards. |
| Tool Modification and Maintenance | We offer tool modification services to accommodate design changes and ensure the tools used in the molding process remain in optimal condition. |
| Medical Device Injection Molding Validation | We perform rigorous validation tests to verify that the injection molding process consistently produces medical devices that meet required specifications. |
| Injection Molding Production | Our state-of-the-art injection molding facilities can efficiently produce high volumes of medical devices with precision and reliability. |
| Contract Manufacturing Services | We provide comprehensive contract manufacturing services, assisting you in producing your medical devices from start to finish. |
| Contract Packaging Services | Our packaging services ensure that your medical devices are appropriately packaged, labeled, and prepared for distribution, meeting all regulatory requirements. |
Our medical device injection molding parts are made by injection mold. The first step for making mold is to review the part design. Our medical device injection molding normally can reach 100,000 cycles even more if we use suitable steel material for the mold. Packson offers clean room injection molding service of a lifetime warranty for molds by mold maintaining. Here we have a professional engineering team that is dedicated to your injection molding production.
Process for Clean Room Injection Molding Production:
Quick response for mold and part quote
Analyzing part design and make a personal solution
Create a professional team of project management
Ordering steel material and start mold processing
Weekly schedule for mold processing
Mold Trial and make samples production
Samples checking and make mold modification
Finish final version samples and mold shipment
At Packson, we collaborate with diverse medical industries to provide top-notch medical device injection molding services. As one of the most professional clean room injection molding company in China, we have rich experience in clean room injection molding and medical grade silicone molding . Our expertise allows us to assist customers throughout the entire process, from initial design to the final molding stage. Some of the medical devices we specialize in include:
Class 8 Clean Room
Class 8 cleanroom injection molding is capable of providing you with high-quality, low-pollution plastic products.
Quality Control
Equiping with precision processing and production equipment, and strictly adhere to the quality control processes of ISO9001 and ISO13485 to ensure quality control.
Professional Engineering
Our professional Mold Design Team provides reasonable solutions that help reduce customer development and tool-making costs.
Precise Manufacture
Our world-class production and testing equipment provides a strong guarantee for the precision of your products.
Project Management
Our Bilingual Project Engineers with many experiences ensure smooth project operations and communication.
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