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In order to ensure the safety of medical devices, USP Class VI testing is required.  Developed by the United States Pharmacopeia, the Class VI test is a specific test conducted on medical devices to assess their biocompatibility.  It is designed to evaluate the potential adverse biological effects of the materials used in a medical device when they come into contact with living tissues or bodily fluids. Performance Plastics is proud to announce we have passed the test – we now offer material and process expertise.

The USP Class VI test is particularly important for medical devices that directly or indirectly interact with the human body, such as implants, surgical instruments, catheters, and tubing. The test helps to ensure that these devices are safe and do not cause harmful reactions or toxicity when used in clinical settings.

 

Here are a few key reasons why the USP Class VI test is conducted on medical devices:

 

Patient Safety: The primary objective of the USP Class VI test is to ensure patient safety. By assessing the biocompatibility of the materials used in medical devices, it helps identify any potential risks or adverse reactions that may occur when the device is used in the human body.

Regulatory Compliance: Compliance with regulatory standards is a crucial aspect of the medical device industry. Many regulatory bodies, including the U.S. Food and Drug Administration (FDA), require medical device manufacturers to demonstrate the biocompatibility of their products. Conducting the USP Class VI test helps meet these regulatory requirements.

Material Selection: The USP Class VI test aids in material selection for medical devices. It helps manufacturers evaluate different materials and determine which ones are the most suitable in terms of biocompatibility. This allows them to make informed decisions about the materials used in their devices, minimizing the risk of adverse reactions.

Product Development and Improvement: The test is also valuable during the product development and improvement stages. By identifying any potential biocompatibility issues early on, manufacturers can modify or optimize their device design or materials to enhance safety and efficacy.

Industry Standard: The USP guidelines are widely recognized and accepted within the medical device industry. Conducting the USP Class VI test demonstrates a commitment to quality and safety, providing confidence to healthcare professionals, regulatory bodies, and end-users.

It’s worth noting that the USP Class VI test is just one of several tests and evaluations conducted to assess the biocompatibility of medical devices. Other tests, such as cytotoxicity, sensitization, and irritation tests, may also be performed depending on the specific device and its intended use.

Foundational function supplemented by modern tech. While grandpa’s hearing aids may share a common purpose with today’s generation of hi-tech devices, modern tech engineering has led to wonderful innovations. From expanded frequency response and battery tech to streaming blue tooth audio and programmability that gives doctors greater reach in addressing individual needs, these micro devices wondrously apply the best of today’s developments.

At ABERY Industries, several recent manufacturing projects have benefited from a number of injection molded material developments, medical molding capability, and innovative processes like metal injection molding. Whereas design engineers have typically been bound to design components by set manufacturing guidelines, expanded injection molded material and process combination have allowed devices to shrink in order to make room for additional capability. For example, battery contacts that were once stamped and were larger than absolutely necessary for structural reasons, may now be miniaturized and then overmolded into housings or combined with other components. Small metal components that were designed to be stamped can now be injection molded as complex MIM parts freeing designers to compress designs even further.

Compounded additives in traditional thermoplastic such as Polycarbonate (PC), Acetal (POM), Polyethylene (PE), and alloys such as PC/ABS, have improved product longevity, the ease with which moving components may be manipulated, impact resistance, and resistance to heat/cold cycles. ABERY looks forward to exploring how modern developments can enhance your next new product line.

 

Injection molds are important tools in industrial production and are used to manufacture various molded products such as electrical enclosures, furniture components, and automotive parts. In the mass production process of injection molds, controlling product quality is a critical issue. Various measures and methods are needed, including setting reasonable injection mold parameters, strictly controlling the selection and use of raw materials, establishing a sound quality inspection system, maintaining and repairing injection molds, and training employees.

 

• Regarding the maintenance and repair of injection molds, the following points should be noted. First, cleaning the mold surface can prevent the influence of oil stains, dust, and other impurities, ensuring the accuracy and service life of the mold. Second, applying rust preventive oil when storing or not using for a long time can prevent oxidation and corrosion of the mold surface. In addition, regularly checking the mold for wear, cracks, deformation, and applying mold release agent and controlling the mold temperature can also help extend the mold’s service life, improve the quality of injection molded products, and reduce production costs.

 

• In summary, maintaining and repairing injection molds is one of the important means to ensure product quality and extend the mold’s service life. Before using injection molds for production, it is necessary to clean and maintain them and perform regular maintenance and repairs to ensure their normal operation and product quality. At the same time, establishing maintenance records for molds can help manage and track their usage, further improving production efficiency and product quality.

 

• In addition to the above methods, it is also important to properly store the injection molds when they are not in use. The molds should be stored in a dry and cool place to prevent them from being affected by moisture and temperature changes. It is also important to avoid stacking the molds on top of each other, as this can cause deformation or damage to the molds.

• Regular training of employees who use injection molds is also important to ensure proper use and maintenance. Employees should be trained on how to use the molds correctly and how to perform routine maintenance and repairs. This can help prevent damage to the molds and ensure their longevity.

 

• Furthermore, it is important to work with a reputable and experienced injection mold manufacturer. A good manufacturer will be able to provide high-quality molds that are durable and easy to maintain. They will also be able to provide guidance and support on how to properly use and maintain the molds.

In conclusion, controlling product quality in the mass production process of injection molds requires a comprehensive approach, including setting reasonable parameters, strict raw material control, establishing a sound quality inspection system, and maintaining and repairing injection molds. Proper maintenance and storage of molds, regular employee training, and working with a reputable manufacturer are also important factors in ensuring product quality and mold longevity.

If you have ever purchased an item that is plastic from a store, that item was likely manufactured using injection molding. There are many advantages of using injection molding. Injection Molding is a manufacturing process used to produce plastic products and components. The process involves injecting molten material into molds that form the product. Injection molding can use many different materials, but thermoplastic and thermosetting polymers are the most common. There are many products made using this process, and some of those are bottle caps, electronic housings, toys, and many more.

There are some substantial advantages of injection molding, and we want to share 5 of these advantages in this article. If searching for a flexible manufacturing process, read more to learn how these advantages can benefit your business.

Products Made from Injection Molding

The injection molding industry has exceeded all projections and shows no signs of slowing down. Current projections show that the market will grow by over 476 billion by 2028. New items are manufactured using the injection molding process daily. Plastic injection molding manufacturers have partnered with many industries, enabling companies within those industries to produce cheaper and more creative product designs.

Household Appliance Industry

Household appliances are in every home in the world. When we think of kitchen appliances, we think of stoves, refrigerators, and dishwashers. Each of these items includes many molded parts. But we often forget things like heater shells, hand warmers, rice cooker shells, handheld fans, humidifier shells, stirring machines, air conditioner shells, hairdryer shells, TV shells, and so many more. It is difficult to identify a product that does not have molded plastic as a part of its design.

Cosmetic Packaging Industry

The cosmetic industry is also a massive user of injection molded products. Specifically, cosmetics need packaging, where injection molding comes into the picture. Historically, glass was used for packaging cosmetics, but other options were sought due to cost, weight, and damage potential. Some typical packaging for cosmetics are tubes, powder boxes, eyebrow pencils, makeup bottles, and most cosmetic product packaging found in stores worldwide.

Toy Industry

It wouldn’t be easy to find a single child without a toy. The makeup of toys has evolved over the years from being made with metal materials to various plastics. The change in toy materials has enabled designers and manufacturers to be more creative, resulting in more advanced and innovative creations. Some toys include cars, trucks, barbie dolls, balls, remote-controlled cars, and small playsets. Plastic injection molding manufacturers and designers have also learned that this innovative process can make smaller components necessary to build a toy. Some smaller parts are wheels, buttons, clips, screws, bolts, nuts, and other small pieces needed to assemble a toy. These examples are a portion of toys and components but give us a taste of the advantages of injection molding.

Medical Industry

The medical industry is a large consumer of products using injection molding. Due to the need for sterilization, many items used by hospitals, doctors, and staff must be thrown away. This would be very costly using metal or cloth products. New possibilities are available now that plastic injection molding manufacturers use this new process. Examples of items used in the medical industry are tubes, syringes, connectors, clips, vials, bottles, containers, housings for small and large equipment, blood pressure cuffs, and so on.

Household

Injection molding has many advantages, and it is easy to see by just looking around your surroundings. We can’t overlook the average home and the products we use daily. I look around the rooms in my house, and there are so many plastic products within reach. Food containers, forks, knives, spoons, bottles, bottle caps, cups, drinkware, plant pots, television housing, computer housings, toothbrush handles, toothpaste tubes, and more.

There are numerous advantages of injection molding, evident in the previous examples. However, some specific advantages of injection molding benefit manufacturers and designers. This article will cover five benefits plastic injection molding manufacturers can leverage to grow their business.

 

5 Advantages of Using Injection Molding

Injection molding has numerous advantages:

1. The Ability to Make Products Consistent within Tolerances

Historically, we could hold two of the same product side by side, and almost always, each item would be somewhat unique. I could always find some variation in size, shape, or weight. Injection molding advancements have revolutionized Plastic injection molding manufacturers’ approach to producing consistent parts. The injection molding process and the machines used can hold tolerances to +/- .125 mm (.005 in). The reason is that steel molds are made to the exact dimensions and shape of the product. If the pieces are small enough, a mold is created that can produce multiple parts with each injection. This results in each piece being 100% exact and uniform. This process thoroughly removes inconsistencies in the manufacturing of parts and components. An inherent advantage of injection molding is that by using molds, there is little to no effort in forming pieces and maintaining tolerances, lowering injection mold costs.

2. Increased Production of Parts

In the past, machines would stamp out metal parts, or humans would manually make components using templates. Not only did consistency suffer, but so did productivity. A machine producing a single piece or a human making a part one by one is labor intensive and, therefore, expensive. A  significant advantage of injection molding is increased productivity with less human work resulting in lower injection mold costs. Plastic injection molding manufacturers’ can mass produce parts and pieces. These components are made with 100% accuracy in one pass by simply injecting material into the molds and allowing the required cooling time. Other processes like CNC machining and 3D printing require more time and expertise. Mass production at lower injection molding costs is a clear advantage.

3. Compatible with Many Materials and Colors

Plastic injection molding manufacturers’ are no longer limited on the materials and colors available to produce products. It is estimated to be over 18,000 different materials available that are compatible with the injection molding process. Further, suppose a part or piece needs to be manufactured using specific additives and compounds. In that case, finding materials that match your need is more accessible. When it comes to colors, almost every color is available. This allows for great flexibility for plastic injection molding manufacturers.

4. Low Labor Costs

Yet another advantage of injection molding is lower labor costs. Plastic injection molding manufacturers use mostly machines to mass produce parts and pieces. The only human labor required is supervision and staff to perform quality checks. This is another clear advantage for plastic injection molding manufacturers as the less staffing, the lower the injection mold costs.

5. Material Recyclability

In current society, people are more conscious of protecting the earth, and recycling is now a part of our everyday routine. One of the main advantages of injection molding is that the material used in the process is 99% recyclable. Plastics can be repurposed many times and make manufacturers and consumers more conscious of the environment.

 

Conclusion

The advantages of injection molding range from lower labor and higher productivity to lower injection mold costs. Plastic injection molding manufacturers can benefit from these advantages and so many more. There are very few products not able to use the injection molding process.

Out of the numerous plastic injection molding manufacturers available, one is set apart from the rest – Abery. Our mission is to keep customers successful on all our critical projects. Exporting to all parts of the world, we are well positioned to be the game-changing strategic partner. Abery has deep experience working within all sectors and industries, and our portfolio is broad.

Abery’s facilities are state-of-the-art, leveraging advanced equipment. Abery incorporates complete quality control into every aspect of its manufacturing process resulting in precise manufactured parts and pieces. Click to Learn More.

 

In recent years, our phenolic molds have been widely used in industries such as electronics, automotive parts, construction materials, and industrial equipment. Our clients have been searching for a material that is high-temperature-resistant, high-strength, and wear-resistant to meet their strict production requirements.

In a recent case, our phenolic molds were used to manufacture a batch of high-strength and high-temperature-resistant electrical enclosures. The challenge of this project was that the client needed to produce a large quantity of high-quality electrical enclosures within a very tight schedule, while ensuring that each enclosure was very precise in size and shape.

Our team took the following measures to meet the client’s requirements:

Optimized mold design: Our engineers used CAD software for mold design, considering the client’s specific requirements and every detail of the production process. We chose high-strength and wear-resistant steel materials to ensure the mold’s lifespan and stability.

Efficient manufacturing: We used advanced CNC machining equipment and processes to ensure the mold’s accuracy and quality. We also used high-temperature heat treatment technology to improve the mold’s hardness and strength, thereby extending the mold’s lifespan.

Strict quality control: We implemented strict quality control measures throughout the production process to ensure that each electrical enclosure met the client’s requirements and standards.

Through these measures, we successfully completed this project, providing the client with high-quality phenolic molds and electrical enclosures. The client was very satisfied with our work and praised our professional ability and efficient service.

This case study demonstrates that our phenolic molds have the characteristics of high strength, wear resistance, and high precision, which can meet the production needs of clients in industries such as electronics, automotive, construction materials, and industrial equipment. Our professional team and advanced equipment can ensure the quality and performance of the mold, providing clients with high-quality products and services.

If you have any needs for phenolic molds or plastic product manufacturing, please feel free to contact us, and we will provide you with the best solution.