Amedcon Healthcare Manufacturing Ltd.

Injection Molding

Amedcon has been producing injection molded plastic parts and assembly units of the highest quality for use in medical, dental and pharmaceutical industry. We provide a precise and stable molded parts using state-of-the-art injection molding technology, such as insert molding and thin-wall molding using high-speed electric injection molding machines. With the precise and stable molded parts which are able to satisfy the higher demands either for application or accuracy of assembling process. Therefore, a stability that is significant for the high requirements for some of medical devices produced fully automatically in large volumes.

Our molding capabilities include:

Advanced injection machine from 25 tons to 120 tons which includes precision horizontal and vertical machine
ISO Class 8 clean room molding
Fully automatic molding with a robotic system for reaching higher productivity.

Assembly

We provide the optimal assembly solution from low to high volume production with manual or automation. In order to ensure medical device fulfilling higher requirements in quality and functional safety, we would integrate a variety of intelligent camera systems and inspection stations into the assembly process no matter in fully automatic and semi-automatic.

Nevertheless, we would also improve workmen-ship through optimization of the equipment performance to deliver higher outputs with fewer machines, which means cost savings for our customers

Particularly in the case of medical device manufacturing, the higher requirements for quality apply, which is also reflected in the effort required for the environment. We perform all assembly steps in the clean room according to ISO class 8.

Our assembly capabilities include:

Manual, semi-automation and fully automation with integration of camera system in-line inspection.
Ultrasonic welding for various plastics
Dedicated ISO class 8 clean room and white room space During stage of assembling process, it includes the post processing of plastic parts in a variety of ways such as surface decorations as below.
Various decorations such pad printing, screen printing, heat transfer printing
Laser marking

Post-production Process

Our all-rounded service for medical devices encompasses much more than the injection molding at a high level. It includes the post processing of plastic parts in a variety of ways such as sonic welding and surface decoration of all components including pad printing, transfer printing, screen printing and laser marking. The same quality requirements apply for refinement in both mass production and small batch run.

We integrate our camera systems into the decoration systems in order to ensure the printed images are clean and precise. Through this way, we can display customers’ logo design both at a high level of quality and economically.

Product Packaging Options

When it comes to successfully commercializing medical devices, the packaging process plays an incredibly important role. It is to reduce the risk of contamination or damage for the devices during different stage such as transportation and storage.

We provide various packaging solutions as below:

Airtight aluminum pouch (good barrier from moisture)
Transport tray with PETG material
Sterile pouch with Tyvek or equivalent material
Re-usable bag with zip-lock

Sterilization

Every device may present unique requirement to the sterilization process. We can provide the optimal sterilization method for the device and manage the process with a contract sterilization provider. Our services include:

Managing contract sterilization providers (ETO and Gamma)
Performing sterilization validations
Involve writing sterilization protocols
Auditing sterilization suppliers

Quality and Regulations

We have established a comprehensive Quality Management System that allows our company to meet the requirements of ISO 13485 in design and manufacturing of medical device, and the requirement for the clean room according to ISO 14644.

In addition, we comply with the relevant FDA guidelines and normative product requirements (such as the labeling of medical products). This also means that, in addition to the validated production processes, our buildings and clean rooms as well as the warehousing are qualified and validated in accordance with clearly defined quality criteria. For specific products, we meet additional requirements or standards in our various facilities.

Our Quality Statement:

Quality is the responsibility of everyone in our company.
Product safety and customer satisfaction are always our top priorities.
Continuous improvement and training are essential in order to maintain our best quality products and services to our customers.