What types of medical mould can we make?

We are an experienced team specializing in manufacturing molds and moulds for medical components, medical devices and laboratory products. We have the best technology, equipment and manufacturing process to provide high quality Plastic Medical Mould. Our expertise over the years has helped us meet the requirements of minimum dimensions, minimum tolerances and optimum functionality. The following article shall tell you more.

Here are the main points of the article:

What are the different types of medical mould?

What is the environment requirement for medical mould factories?

What should medical molders be aware of in medical mould manufacturing?

1. What are the different types of medical mould?

With the continuous support of our technical staff, we meet the various needs of our customers by manufacturing, exporting and providing the best quality injection medical moulds. Some types of medical moulds are listed below:

Medical equipment injection mould

Medical cavity mould

Medical plastic injection mould

Syringe medical mould

Cavity preform mould

Disposable safety syringe medical mould

Plastic clip mould

Precision medical mould

For more customized medical mould, you can contact us.

2. What is the environment requirement for medical mould factories?

For example, employees must follow certain procedures when dressing. Dress from top to bottom, first with a hair net/beard net, then coat, trousers and shoe covers. The workbench separates the clean and dirty sides so that employees' shoes don't stain the floor. The jewelry must be completely covered or removed. Hearing protection and safety glasses and gloves are also required. Most injection cleanrooms are ISO 8 certified. The molding cleanrooms are all ISO 8 certified, while its assembly cleanrooms are a more stringent ISO 8 or ISO 7 standard. If the project requires clean room production, the customer's quality specifications will indicate the ISO level. In medical mould manufactoring, it is important to follow written documents and procedures. When medical-device designers are unsure whether a medical mould product needs to be made in a clean room, the food and drug administration's (FDA) device classification may help. For example, category 1 medical devices may not require cleanroom molding because they have the lowest level of risk and must meet a minimum number of regulatory controls. These simple devices include elastic bandages, floss, floss boxes and toothbrushes. Class II medical devices are moderately complex but at higher risk. As a result, they have stricter regulatory controls to ensure that they are safe and effective. Most, but not all, class II medical devices are molded or assembled in ISO 8 clean rooms. Medical components that are molded in the clean room include an asthma inhaler and an auto-injector pen. The second category of equipment that does not require a clean room includes condoms and pregnancy tests. Category III medical devices are the most complex and risky and are therefore subject to the most stringent controls. For example, pacemakers, continuous glucose monitors and other implants are implanted, all of which are typically shaped and assembled in clean rooms to minimize the possibility of particulate air pollution.

3. What should medical molders be aware of in medical mould manufacturing?

Medical mold manufacturers also need statistical process control (SPC) charts and verify critical and process sensitive dimensions. All tooling and assembly automation must be validated and subjected to rigorous installation, operation and performance validation (IQ/OQ/PQ) procedures. Complete documented reports include first piece inspection (FAI) and process capability results that require customer approval of production readiness.

The environment of our medical moulding is strictly according to the restrictions above. And therefore, the medical moulds we produce are of high standard. We can also customize according to your needs if needed. So don’t hesitate about purchasing our medical moulds, Plastic Test Tube Mould，Centrifuge Tube Mould.