Class 8 Clean Room
Quality Control
Professional Engineering
Precise Manufacture
Project Management
Packson - medical plastic injection moulding cleanroom Expert
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.
ISO Class 8 medical silicone overmold inje
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.
IQ/OQ/PQ Validation
Thanks to medical grade silicone 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.
Product Part Validation
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.
Manufacture Class I/Class II/ Class III Medical Devices
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.
Rigorous Quality Control & Inspection
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.
Medical Cleanroom Packaging
As a competent clean room 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.
Medical Cleanroom Assembly
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.
clean room injection molding Video
Packson Clean Room silicone moulding services
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.
Packson Medical Device Cleanroom Capabilities
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.
Expanded Packson Clean Room Medical Injection Molding Services
Packson Clean Room Injection Molding Process
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
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Custom Clean Room Assembly For Medical Device
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 manufacturer 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:
Syringe Parts
Respiratory Devices
Fluid Management
Multi-component Valves
And more
If you need any kinds of medical injection moulding, please contact us, as a professional injection mold manufacturers china, Packson Mold is willing to offer you high quality products.
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