Plastics have very important applications in the medical field, and injection molded products are among the most used. Given the extremely stringent requirements for hygiene and cleanliness of certain medical injection molded products, clean rooms must be used for their injection molding, while the precision, thinning and high productivity requirements of medical injection molded products challenge the production units such as injection molding machines, molds and robots and the interplay between them.

1.What is the medical parts?
2.What is the application of medical parts?
3. What is the material of medical parts?
4. What is the material property of medical parts?
5.What is the common steel for medical molds?
6.What is the key point to design medical molds?
7.What is the key point to produce medical parts?
8.What are the defects issues of medical parts?
9.What is the difference between medical molds with normal molds?
10.What service can Kemal provide for my medical parts?
11.How to improve the short shot problem of medical parts?
12.How to improve medical mold quality?
13.How to choose injection machines for medical molds?
14.How to check the medical molds before putting them on the injection machine?
15.How to maintain the medical molds after production?
16.How do I choose a partner for medical injection molding?
17.How can Kemal ensure the quality of medical injection molding?
18.How can Kemal manage my medical project?
19.Why should I look for a medical mold maker in China?
20.What are the trends in medical injection molding in China?

1.What is the medical parts?

Answer: Adapting to the development of medical technology, the medical plastic parts industry can develop rapidly. At present, there are thousands of plastic parts for medical use all over the world, and the technology of the products is getting higher and higher. Meanwhile, the medical plastic materials are also put forward higher requirements; In general, the plastic parts used for disease diagnosis, treatment, monitoring, health care, and rehabilitation are called medical plastic parts. Nowadays, medical parts are widely used in hospitals, laboratories, research institutes, and so on.

2.What is the application of medical parts?

Medical parts are widely used in hospitals, laboratories, schools, and research institutes.
Common medical plastic products include:
test tubes and other containers
Auto-injectors, Syringe Syringes
Housing for medical and laboratory equipment
Surgical Equipment and Parts
Drug Delivery Equipment and Components
Plastic Implants
Pipetting Instruments
Laboratory Consumables

3.What is the material of medical parts?

(1)PVC, Polyvinylchloride.
Pure PVC is a random, hard, and brittle material that is rarely used. Depending on the application, different additives can be added to give PVC parts different physical and mechanical properties. By adding the right amount of plasticizer to the PVC resin, a wide range of hard, soft, and transparent products can be made.
(2)PE, Polyethylene. PE has a high impact strength, low friction, stress cracking resistance, and good energy absorption properties.
(3)PP, polypropylene
PP is a thermoplastic with excellent performance. It has the advantages of low specific gravity, non-toxic, easy processing, impact resistance, and flexural resistance.
(4)PS, Polystyrene. PS is mainly characterized by lightweight, transparency, and good molding processability.
(5)ABS, Acrylonitrile Butadiene Styrene copolymers
ABS is rigid, hard, impact and chemical resistant, resistant to radiation, and resistant to ethylene oxide sterilization.
(6)PC, Polycarbonate
Typical properties of PC are toughness, strength, rigidity, and heat resistant steam sterilization.
(7)PTFE (Polytetrafluoroethylene)
PTFE has the lowest coefficient of friction of any plastic and is biocompatible.

4. What is the material property of medical parts?

The basic requirement for medical plastics is chemical stability and biosafety, due to contact with drugs or with the human body. the constituents of the plastic material cannot precipitate into the medication or the human body and do not cause toxicity or damage to tissues or organs. Because each material has unique properties that determine how the product will perform in an application, choosing the right plastic material for your medical part is critical.
(1) Have good tensile, flexural, compressive, and impact resistance properties and can be used alone as a structural material.
(2) Chemical and heat resistance. Chemical resistance and heat resistance are two key considerations when selecting medical grade plastic materials, especially if your medical product must be able to withstand autoclaves and sterilization methods.
(3) Strength and corrosion resistance. If the medical product will be exposed to radiation, then the plastic material chosen needs to be able to withstand the operating environment.
(4) Low coefficient of friction and good biocompatibility, especially in the medical insert molding, as well as other plastic products that are intended for use in the human body.
Kemal has rich experience to help and ensure that you are using the right plastic material for your medical product. We will consider the performance of your product and provide you with expert advice to ensure that the final product meets your requirements.

5.What is the common steel for medical molds?

We use high-strength mold materials for medical mold base, including 420H, P20, etc.;
for the main part of medical molds, including cores, cavities, and related inserts, we use high-grade plastic mold steel, including 1.2083, 1.2344, 1.2316, etc. And so on; and let the professional heat treatment company heat treat the main part of the medical mold, the hardness of the material is generally more than HRC48-52.

6.What is the key point to design medical molds?

(1) Choose hot runners for transparent products to reduce traces of merging.
(2) When using a cold runner, soft PVC should be used to shorten the runner size as much as possible.
(3) Due to the small size and large batch size of medical products, automatic unloading, and gating cut should be used to ensure production efficiency and quality.
(4) Transparent tubular parts, in the design should pay attention to the location of the gate feed and the dynamic model Z fixed the way, to avoid the gate position and the core of the incorrect choice of fixed methods, resulting in filling uneven during injection molding, resulting in inelastic deformation of the core, the product will be an uneven and short shot.
(5) Tube shaped products should pay attention to the appropriate venting method to avoid molding difficulties due to air trapping.
(6) Cooling system should adopt multiple separate cooling channels to reasonably control the temperature of the cavity and core to avoid product deformation.

7.What is the key point to produce medical parts?

(1) The injection molding shop should be fully enclosed, with high power air conditioners installed to ensure constant temperature and clean air in the workshop.
(2) The use of mold release agent and rust remover is strictly prohibited during the injection molding to ensure that the medical parts are not contaminated.
(3) The melting temperature should be strictly controlled during the production process to avoid harmful gases due to high material temperature and long stay in the barrel to decompose raw materials.
(4) Clean the screw and barrel immediately when the machine is stopped to avoid any damage to the screw caused by residual raw materials.
(5) Strictly follow the IS0 9000 quality management system to ensure that no problems occur in the production process.

8.What are the defects issues of medical parts?

Cracking, Sink Marks, Surface Ripple, Surface Delamination, Weld Lines, Short Shot, Warping, Burn Marks, Jetting, Flash, Bubbles, Shrinkage, Warpage, Delamination, Peeling, etc.

9.What is the difference between medical molds with normal molds?

(1) The material selection requirement of the medical mold is very strict because the medical mold is in the cleanroom to complete the injection molding work, first of all, the mold material needs to be stainless steel class materials, and need to do matching surface treatment, such as vacuum heat treatment, PVD coating, laser heat treatment, etc…
(2) Plastic materials for medical parts often have medical grade PP, PVC, ABS, PSU, POM, PA, etc., there are high-strength, corrosive, wear-resistance and high transparency, etc., so that the requirements of the injection mold is relatively high, the commonly used mold steel selection of imported S136, 2316, S136H, NAK80 … and so on, to meet the high corrosion resistance, high polishability.
(3) Medical mold structure design also has a lot of difference, many medical products are transparent color, the product as far as possible to choose hot runner, to reduce the dissolution of traces.
(4) The manufacturing precision of medical mold is higher, medical-related injection molding products are definitely absolutely not allowed to have any flash, which requires extremely high processing accuracy of the mold core, part of the core processing accuracy requirements of less than 0.005mm.
(5) The injection molding environment of medical molds is relatively harsh and needs to be carried out in a cleanroom to ensure that the products are not contaminated.
In general, the medical mold is not much different from the normal mold in structure, mainly in the control of processing technology and processing precision.

10.What service can Kemal provide for my medical parts?

Kemal can provide a one-stop service for your medical parts.
which including:
(1)New product development and design;
(2)Design Review (DFM/mold flow analysis, tolerance analysis, feasibility studies);
(3)3D printing or prototype molds;
(4)Molds build;
(5)Cleanroom, full production 24/7 operation;
(6)Product Assembly and Packaging
(7)Mold maintenance.
(8)Technical support and services.

Kemal offers competitive prices and uses state-of-the-art equipment and methods. And we are ISO 9001:2015 certified. If you have any medical parts project, please feel free to contact us and we will take your product from idea to reality.

11.How to improve the short shot problem of medical parts?

(1) Choose a plastic material with lower viscosity and higher flowability;
(2) Increase the barrel and nozzle temperature as well as the mold temperature to increase the flowability;
(3) Increase the feeding volume of the molding machine;
(4) Select an injection machine with a higher injection volume;
(5) The runners and gates are too small, increase the gate size appropriately;
(6) Increase the injection pressure;
(7) Increase the injection speed;
(8) Improve the mold design and add venting properly.

12.How to improve medical mold quality?

(1) First of all, the design of the medical mold should choose the best structural solution, the designer should consider the technical requirements and its structure must comply with the manufacturability and feasibility of the mold.
(2) The choice of material for the medical mold must meet the customer’s requirements for product quality and also take into account the cost of the material and the fact that the mold has sufficient strength and rigidity.
(3) The processing method and machining accuracy in the manufacturing process of the medical mold will also affect the lifespan of the mold. In order to ensure that the mold has good precision, in the manufacturing process, we should first choose a high-precision processing method, followed by the main components of the mold surface to strengthen, improve wear resistance, so as to better improve the mold quality.
(4) Correct use and regular maintenance of medical molds can prevent problems that may occur during production and improve the lifespan of the molds. It is also a major factor in improving mold quality.

13.How to choose injection machines for medical molds?

For medical products without special cleanliness requirements, such as fitness and equipment products, general injection molding machines can be applied. For medical products that need to be produced in a cleanroom environment, injection molding machines, and peripheral equipment that meet cleanroom standards should be used. For example, for the production of injection syringes, because of the high requirements for appearance and size, you should choose a machine with precise control and suitable for multi-cavity thin shell molding; If manufacturing medical electronics, then in addition to the stability of the machine, you should also consider whether the auxiliary equipment can meet the requirements accurately and efficiently;
Kemal has injection molding machines with tonnage from 25T to 220T, and the injection molding environment includes a class 7 cleanroom injection molding workshop, providing excellent conditions for the realization of our customers’ products. The injection molding services we can provide for you are.
-Mold trial.
-Monochrome injection molding
-Miniature product injection molding
Our engineers and technicians use rigorous methods to thoroughly test the scientific injection molding process of the mold to maintain a stable production process.

14.How to check the medical molds before putting them on the injection machine?

(1) Scrub the dust, oil, and rust on the appearance of the medical mold and remove the dirt on its appearance before putting it on the injection molding machine.
(2) Use an air gun or rag, decontaminant, or alcohol (alcohol for mirror medical mold) to clean up the oil and dirt on the medical mold surface.
(3) Check the cooling water channel of the medical mold for foreign objects and make sure the cooling water is smooth.
(4) Check whether the arc in the sprue sleeve of medical mold is damaged and whether there is a residual foreign matter if there is a need to clean up.
(5) Moving parts: such as ejector pin, taut spring, hydraulic cylinder, slider, whether there is rust, bending, fracture, activity necessary whether smooth.


15.How to maintain the medical molds after production?

(1) Test each part of the medical mold for damage.
(2) Tidy up the oil on the parting surface and the debris left in the mold cavity, and spray the anti-rust oil.
(3) Blow-dry the water left on the cooling water channel.
Please noted that:
It is necessary to wear labor protection when maintaining medical molds, and it is necessary to operate with a crane for overweight objects, and it is strictly forbidden to lift medical molds directly by hand to prevent injury to the limbs.
It is necessary to prevent the rust of medical molds, after the maintenance of medical molds, special attention should be paid to the anti-rust action of medical molds, and it is necessary to blow dry the residual water inside the waterway with an air gun.
Adding too much smooth oil does not bring a better smooth effect, the right amount is enough.
When the medical mold is finished, we should pay attention to the number and direction of the inserts and other parts not to be installed in the wrong way, check whether the screws are completely used up, and lock the screws in the diagonal direction when installing them.

16.How do I choose a partner for medical injection molding?

(1)The first must be a suitable cleaning room class.
Class 8 cleanroom capability is usually required, and if there’s a Class 7 cleaning room, that’s a high standard.
Kemal has a Class 7 cleanroom that can meet any of your medical product requirements.
(2)Can mold, assemble, and package your products in a cleanroom environment.
If your medical parts can be molded, assembled, and packaged in a cleanroom environment, there is no doubt that this will ensure the cleanliness of your medical products.
Kemal is equipped with a vacuum bag sealer to address any concerns you may have
(3) Clean-room molding maintains tight part tolerances.
Mold makers who can guarantee tight tolerances for medical products must have the expertise and experience to do so. Kemal has over 20 years of experience making molds for well-known European brands and has the expertise and experience to ensure that every part is of high quality, not just clean.

17.How can Kemal ensure the quality of medical injection molding?

Kemal useful Class 7 clean injection molding room. and every step is scientifically managed. It is as follows.
(1) Class 7 injection molding room uses positive airflow and strictly controls the number of particles to ensure the purity of the air.
(2) In a Class 7 cleanroom, technicians and operators are required to be fully covered when entering the cleanroom, and are not allowed to remove them during the entire operation.
(3) Motorized machines can avoid more particulate matter in the air.
(4) Scientific injection molding and mechanized data to ensure precise product tolerances.
(5) Vacuum bag sealing machine to ensure that the product is free of dust requirements.

18.How can Kemal manage a medical project?

In general, we execute professional steps to manage your medical project as below:
Kick-off after received the official order;
Evaluating your technical parameters and standard requirements;
(1)DFM Analysis;
(2)After getting the approval of DFM, go with mold design;
(3)After getting the approval of mold design, start to order the steel;
(4)Steel machining and mold manufacturing;
(5)Do the T1 mold trial, also with QC checking report;
(6)Ship the T1 samples for your confirmation;
(7)We will improve the medical parts and mold until getting your approval.
(8)Ship the mold until getting your confirmation.
(9)Follow up on mold performance.
(10)Lifetime technical support and service.
As a professional medical mold manufacturer, Kemal has developed a complete set of medical mold design and manufacturing process after years of experience. Every detail of the design is carefully analyzed and certified by our professional designers, your whole medical project will be charged by our rich experienced project manager, we always insist on doing the most professional medical molds and give you the most worry-free service.

19.Why should I look for a medical mold maker in China?

Answer: Finding a mold manufacturer that can guarantee the quality of your medical products while offering competitive prices can help your product gain a market advantage.
China’s medical mold industry structure, no matter the enterprise organization structure, product structure, technical structure, and import and export structure, are developing toward the direction of rationalization, mold products toward the direction of large, precise, complex, economic, rapid development; The technical content of the mold is constantly improved and the mold manufacturing cycle is constantly shortened. Mold production is developing towards informationization, refinement, and automation. Chinese medical mold production level compared to the previous has made a qualitative leap, and at the same time, cheaper production and labor costs, China has become the world’s factory.

20.What are the trends in medical injection molding in China?

In China, the application of medical products, especially the development and application of high-end medical products, is still just the beginning, which is a promising sunrise industry. The growth of medical products is not troubled by the financial crisis. At present, there is still a considerable gap between the technical level and consumption level of medical plastic products in China and the developed countries. Therefore, to improve the technical level and consumption level of medical products in China is both an opportunity and a challenge for the development of China’s medical injection molding products industry. The only way to achieve leapfrog development is to adhere to the scientific concept of development, take the road of independent innovation, and strive to develop high-end medical parts.