In the plastic fabrication industry, injection molding is presumed to be an economical process to produce parts in bulk volumes. It’s a relatively inexpensive, and affordable technique to manufacture parts from intricate detail components to large volumes by maintaining parts integrity. It’s quick, time efficient, and produces parts of the highest quality standards.
However, injection molded parts are manufactured on a large scale across various sectors from automotive to medical use accessories. These parts may require stringent quality standards like ISO 13485, and, ISO 16949, for medical, and automotive respectively. These quality standards may tend to incur additional costs per injection molded part. In addition, the FDA has also necessitated that parts must meet strict quality standards and must comply with patients’ safety.
This blog post will provide information about the role of injection molding in the medical sector, and highlight the quality standards adopted for injection molded medicare products or components.
Importance of Quality Standards In The Medical Industry
Standards are a critical element in the medical sector, especially in the case of medical equipment that has been made through the injection molding method. They are a certain set of rules that designers and manufacturers must comply with to ensure the safety and quality of the products, thus, reducing risks for the patients who use these products. The injection molders are called to follow strict protocols throughout the production which is to meet these standards and make sure that medical treatments are safe and effective for patients’ health.
Commonly ISO Standards For Medical Injection Molding Devices
Here are some of the common ISO standards for quality control management of injection molding devices for medical use. These include;
ISO 13485: For Quality Inspection of Medical Devices
ISO 13485 is similar to the rulebook that guides the production of quality medical devices. It doesn’t only deal with plastic injection molding but also includes all the methods that can be used to produce medical equipment. The main goal? Consistency and safety of medical goods. These goals will be achieved by following the steps of ISO 13485 which include managing risks, observing rules, and continuing to improve. It’s all about doing everything right, from the beginning to the end, including keeping detailed records, training professionals well, monitoring everything from start to end, planning wisely, making products accurately, and correcting errors when they occur. All parties, from designers down to injection molders, are well aware of their specific roles to run things smoothly.
In the U.S., the FDA has its version which is similar to ISO 13485, that is, the Quality System Regulations (QSR). Therefore, the ISO 13485 standard or the QSR depending on where you are, will be applied to ensure that your medical devices are of high quality.
ISO 10993: Evaluate Biocompatibility of Medical Devices
ISO 10993 primarily ensures the biocompatibility of medical devices by ensuring that medical devices do not affect our bodies’ health. It is about how we are affected by these materials, for instance, the plastics from injection molding, as much as they affect us. The primary aim of ISO 10993? For the safety of the patients. ISO 10993 is a standard that guarantees that materials are not harmful to us, meaning they are non-toxic, immune system-friendly, and do not lead to cancer-causing diseases.
This standard is very comprehensive as it entails 23 parts covering the testing of animals, checking for cancer risks, reproductive issues, cell toxicity, and safe sterilization of these materials. In the US, there is a similar standard known as USP Class VI that is also used to check the biocompatibility of plastics. Designers utilize these standards to make a selection of materials that will not cause any problems when used in medical devices.
ISO 14644: Ensures Cleanliness and Environmental Reliability
ISO 14644 is a standard that helps keep the rooms where medical devices are manufactured in antibacterial, and clean conditions. It separates these cleanrooms into different classes starting from Class 1 (super clean) and ending with Class 9 (not so clean). The clearer the space, the fewer the tiny particles that are floating.
Why does this matter? Firstly, they could get into and damage some of the sensitive equipment used in medicine. ISO 14644 establishes a standard of how cleanrooms are designed, constructed, and kept clean. For example, designers will be seeking a company that has a Class 7 or Class 8 cleanroom to ensure that their devices won’t be contaminated during manufacturing.
What is The Use of Injection Molding In the Medical Field
Injection molding is the most popular technique in the medical field, especially when large volumes of similar devices are acquired quickly and with high quality. It is relatively time-efficient for high-volume production as it maintains consistency and does not require a lot of manual effort. Here are some things commonly made through medical injection molding:
Here are some of the commonly used medical devices made through medical injection molding:
- Device cases
- Lab tools
- Implants
- Pregnancy tests
- Surgical geat
- Orthopedic items
- Syringes
- Oxygen masks
It is a versatile technique that is mandatory for the production of many useful medical equipment and tools in shorter time leads.
Medical Grade Plastics Used In Medical Injection Molding
Some plastics are not made for all purposes. Medicare designers should be aware of the importance of choosing the appropriate materials that would meet the rigorous requirements for medical devices.
Shot molding enables the use of different kinds of plastics, including commodity plastics, specialty plastics, and polymer blends. Here are some commonly used medical-grade plastics and their key features: Here are some commonly used medical-grade plastics and their key features:
1. PEEK (Polyetheretherketone): PEEK possesses a unique ability to withstand chemicals, heat, and radiation.
2. PE (Polyethylene): It is a biocompatible and widely used material in medical applications due to its versatility.
3. Silicone: It provides flexibility, biocompatibility, and molding at lesser pressures than other plastics do.
4. PP (Polypropylene): polypropylene being a pliable, and medical-compatible plastic finds its extensive use steam sterilized components such as disposable syringes, test tubes, and pipettes, and beakers.
5. PC (Polycarbonate): polycarbonate is extremely resistant to high temperatures, heat, and impacts. Because of these peculiar characteristics, its use is common in medical prototype parts including; goggles, surgical face shields, and eyeglasses.
6. PFA (Perfluoroalkoxy): It offers a high thermal and chemical resistance which is suitable for more stringent use applications.
7. FEP (Fluorinated ethylene propylene): fluorinated ethylene propylene is well known for being low friction, and having good impact resistance and flexibility. Further, it is a biocompatible engineered grade plastic widely used in making critical medical components like disposable syringes, and catheters.
FDA Classes of Medical Injection Molding Devices
Medical devices are categorized into groups according to the risk to patients, users, and others. The FDA classes for medical devices include;
Class I devices have the lowest risk and include things like wheelchairs and test tubes that are not designed to support life or cause harm.
Class II devices are of moderate risk and so may need some more controls for safety and effectiveness. The EU MDR further divides Class II into two subcategories: IIa for intermediate-risk devices and IIb for high-risk devices. Such products can be mentioned as contact lenses and syringes.
Class III devices have the highest risk and include implants that are life-supporting or life-sustaining, such as pacemakers and prostheses. Getting these classifications right is essential to make sure that the medical devices are properly regulated and monitored to protect patients’ health.
Conclusion
In summary, adherence to stringent standards is essential in plastic injection molding within the medical industry. The standards are meant to guarantee the safety, reliability, and performance of medical devices, hence, health professionals and patients are the ultimate beneficiaries.
Through the application of strict processes and the use of the best materials, injection molders can make a great contribution to the development of healthcare while maintaining the requirements of regulatory bodies and good manufacturing practices.
FAQs
Q1. What are the main issues that plastic injection molding for medical devices faces?
Injection molding of plastics in the medical field has to deal with the issues of keeping tight tolerances, biocompatibility, and ensuring that sterilization and packaging meet the regulatory requirements.
Q2. How does quality control affect the price of medical device manufacturing?
Although stricter quality control measures may increase the initial manufacturing expenses, they will help to prevent product recalls, warranty claims, and regulatory penalties in the long term, leading to cost savings and thereby to a good brand reputation.
Q3. What is the significance of material selection and testing in the case of medical device injection molding?
Material compatibility is one of the primary steps for desired properties like biocompatibility, chemical resistance, and mechanical strength in medical components. The testing of products, which includes accelerated aging and sterilization validation, confirms the suitability of materials for medical applications.