Polystyrene is used in a lot of packing foams. These are frequently used in the packing of fragile goods and appliances. The white foam that comes with your refrigerator, laptop, or new tablet would be noticeable. Structural foam molding is a type of injection molding. Plastics are used in this procedure to create foams. Because it can keep good stiffness in a porous condition, polystyrene is ideal for this. The foam would be overly soft if the material were too flexible. The cushioning effect of such soft foam would be insufficient to protect a product from damage. Polystyrene foam is both hard and soft, allowing it to endure impact while also absorbing stress. Expanded polystyrene in UAE got a drastic increase in usage, so the suppliers are growing in number to manufacture.

Fictiv can produce injection-molded products for a wide range of medical applications. We have the resources, know-how, and manufacturing network to deliver the injection molded parts that you need, far faster than other manufacturers. And, we deliver 95.4% of orders on time and to spec, thanks to our network of highly-vetted partners, on-site quality engineers, and robust quality management system. Create an account and upload your medical device design today! Along with your quote, you’ll receive expert design for manufacturing (DFM) feedback and guidance to ensure you get great outcomes.

Medical devices are classified according to their potential for causing harm to patients, the general public, or to other personnel who use or operate the medical device. This classification determines the degree of required regulatory oversight.

ISO 14644 regulates the use of cleanrooms during medical device manufacturing. It defines the various cleanroom classes from Class 1 to Class 9, where Class 1 has the most stringent cleanliness requirements.

The ISO 10993 standard consists of 23 parts or subsections. This includes processes and procedures for animal welfare requirements, tests for carcinogenicity, reproductive toxicity, in vitro cytotoxicity, and various sterilization techniques. USP (United States Pharmacopeia) Class VI covers similar biocompatibility requirements for plastics and, as such, is sometimes used in place of ISO 10993 or as a supplement. For designers, this standard can play an important role in material selection.

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Injection molding also considers the plastic’s mechanical qualities. This may not seem evident, but mechanical properties have an impact on how things work. When it comes to removing the product from the mold, it becomes crucial. The removal of the product from the mold may impose some stress on the product, depending on the design of the mold. If the product is too fragile or brittle, it may break throughout the procedure. As a result, the design of the ejector pins or manual removal must take this into account.

Medical injection molding can be used for prototyping or low-volume production, but it’s often used in high-volume manufacturing for medical devices. In part, that’s because products can be injection molded at-scale with consistent quality and with minimal human intervention. Here are some common examples of injection-molded medical products:

The medical device industry is tightly controlled to ensure patient safety. Listed below are some of the common standards that affect manufacturing, including plastic injection molding.

Class I medical devices are not intended to support or sustain life and will not present an unreasonable risk of illness or injury to a patient. Examples include wheelchairs, glasses, hospital beds, and test tubes.

Plastic injection molding is used in many different applications within the medical industry. Examples include enclosures for medical equipment, the overmolding of surgical tools, and spinal implants. Designers have a choice of materials, but the selected plastic must meet the application’s requirements. For example, plastics that will be sterilized with steam need to resist high temperatures and moisture, while those that will come into contact with patients must be biocompatible, meaning that they’re not harmful to living tissue.

Thermal and mechanical qualities are crucial in the molding process. Because the procedure involves heating and deforming the plastic, this is the case. The plastic is cooled and solidified after it has formed the required shape. The plastic retains its new shape after cooling. Thermoplastics are the only materials that can be heated and molded in this way.

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ISO 10993 focuses primarily on the biocompatibility requirements for medical devices. It encompasses products that are designed to come into direct or indirect contact with the body. The goal of ISO 10993 is to reduce the risk of adverse effects on patients when exposed to materials that include, but are not limited to, injection molded plastics. ISO 10993 compliant materials are non-toxic, do not affect the immune system, or do not potentially cause cancer.

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For injection molding, thermoplastics are often favored over thermosets. Injection molding thermoset polymers is a time-consuming process. Within the barrel, the process has the issue of preventing cross-linking. Injection molding is possible with thermoplastic polystyrene. In comparison to other common polymers, polystyrene has a high melting point. It begins to soften at roughly 205 ℃ while having a melting point of around 270oC. Polystyrene injection molding takes place at or above its softening temperature. The plastic in the barrel may become fragile enough to melt at this temperature. When compared to plastics like polyethylene, this temperature is extremely high. When compared to plastics like polyethylene, this temperature is extremely high. As a result, polystyrene injection molding necessitates a larger energy input.

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In cleanrooms, the amount and size of airborne particles are carefully controlled to reduce the chances of exposing sensitive medical components to these particles. ISO 14644 also outlines specific requirements for designing, manufacturing, and maintaining cleanrooms for optimal performance. Designers may need an injection molder with a Class 7 or Class 8 cleanroom to limit the potential for contamination during manufacturing.

Industry standards play an important role in the design and manufacture of medical products, especially medical devices. For designers, these standards help ensure that patients, the end-users of injection molded products, are not exposed to excessive risks during medical treatment. So injection molders must implement stringent processes and procedures to control all stages of production and comply with standards.

To achieve these goals, ISO 13485 outlines processes and procedures to manage risk and regulatory compliance while providing mechanisms to continuously improve the QMS whenever a gap or potential for improved performance is noted. The standard defines best practices for documentation, training, traceability, research and design, production, and how to handle non-conformances. For both the part designer and the injection molders, there are well-defined responsibilities.

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Of course, proper product design is also critical for medical devices, so check out our free Injection Molding Design Guide for best practices — it complements the info in this article.  Download Fictiv’s Injection Molding Design Guide

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When it comes to injection molding plastics, shrinkage is another element to consider. When plastics change phases, their volume tends to decrease. This can range between 0.1 and 3%. This may appear to be a minor factor, yet it is significant when evaluating precision. You may have noticed particular plastic objects with the label included in the design. For instance, the recycle number or the company logo. These are occasionally included in the design of the mold. Such precise requirements are measured in millimeters. Even 0.1 percent shrinkage is significant for a product with dimensions in millimeters. The inscription is not transmitted to the product if the plastic shrinks too much. As the product shrinks, the part may flatten out. This is critical for the proper functioning of products like screws. If the groves aren’t just correct, a screw won’t work well.

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EPS (expanded polystyrene) is a type of plastic that is utilized in a variety of applications. Its primary use, however, is as protective packaging for consumer electronics and white goods. It’s suitable for packaging fish and other foods due to its intense heat insulation and mechanical protection capabilities. Seed trays made of EPS are used in horticulture.

Class II encompasses any medical device for which general controls are deemed insufficient to provide reasonable safety and effectiveness. Examples include contact lenses, syringes, and pregnancy tests. The EU MDR adds two subcategories:

Designers also need to select plastics that meet medical industry standards. This article examines the standards that affect the production of injection-molded medical products. By selecting materials that meet these standards, designers do more than meet requirements from independent bodies and regulatory agencies — ultimately, they promote quality, performance, and safety.

The U.S. FDA (Food and Drug Administration), and the EU MDR (Medical Device Regulation) both divide medical devices into three classifications, where Class I refers to the lowest-risk medical devices and Class III refers to the highest-risk. The EU MDR further breaks down Class II devices into two subcategories: IIa and IIb.

Injection molding can be used to make a wide range of items, from mass-produced minor parts to massive equipment or vehicle components. Injection molding is done with thermoplastics, thermosets, metals, and glass. The injection molding of thermoplastics is the subject of this essay. Polystyrene is the subject of special attention. Injection molding thermoplastics must melt at an acceptable temperature. This reduces the energy required to soften the material and make it moldable. The material must also have a high shear resistance. Injection molding uses strong shear to mix and melt the material. In its molten condition, the plastic must flow freely to fill the mold.

Class III medical devices are usually designed to sustain or support life and may present an unreasonable risk of injury or illness. Examples include pacemakers, defibrillators, and implanted prostheses.

Polystyrene is an excellent material for injection molding. It can be injected and molded into solid hard goods as well as foam products. Its manufacturing necessitates a higher level of energy input due to its higher melting point. It makes up for it with low shrinkage, which enables fine pattern detail. Styrene Insulation Industry (SII) is the best polystyrene box manufacturer and supplier in UAE.

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The QSR (Quality System Regulations), also referred to as 21 CFR part 820, as outlined by the FDA, has many parallels with ISO 13485. In the United States, the QSR may be used as a supplement or replacement for the ISO 13485 standard.

Polystyrene, a synthetic polymer commonly used in packaging and industrial components, is one of the most popular plastics used in thermoplastic injection molding. Polystyrene, usually found in foam or plastic, is a non-toxic and odorless material widely utilized in the food packaging and automation industries. Its strength and clarity make it suitable for various applications, including vehicle parts, electronics, toys, and plastic utensils.

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For designers, it’s important to remember that not all polymers are suitable for medical devices. However, injection molding supports the use of many different materials, typically commodity plastics but also specialty plastics and polymer blends. Designers can also choose medical plastics that have specific trade names like ULTEM®, a polyetherimide (PEI) that can withstand repeated cycles in an autoclave. Below are some common injection molding plastics and their salient characteristics:

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ISO 13485 outlines the requirements for a quality management system (QMS) when producing medical-grade products. It is the most common standard used in medical device manufacturing. ISO 13485 is not limited to plastic injection molding but rather covers the general requirements for all manufacturing technologies that are used to produce medical equipment. This standard was developed to ensure that consistent quality is maintained and that medical devices and equipment are produced in a safe and effective manner.

Polystyrene is the most popular material for cases, disposable utensils, and cups. For many of these products, injection molding is the chosen approach. As a result, polystyrene must be well-suited to injection molding. We shall observe some of the characteristics of polystyrene that make it ideal for injection molding in this article. We’ll also look at the features that make it unsuitable for the process. Some injection-molded polystyrene goods are shown in the image below.

When compared to other popular polymers, polystyrene has a very high transition temperature. A benzene ring is a pendant group in polystyrene. This big pendant group limits the polymer chain’s mobility. A less mobile chain demands more energy to keep it moving. Polystyrene must absorb the energy around its melting point to flow. Polystyrene melt flow index (200oC/5kg) ranges from 12.0 to 16.0 g/10min. This is low compared to polyethylene, which has a yield of 180g/10min at 145oC. It tends to transition from a hard solid to a molten state across a narrower temperature range. This is in contrast to plastics that have more movable structures. As a result, the temperature of the polymers must increase quickly enough to allow them to flow, or the space between the screw and the barrel will widen. Handling plastics with varying melt tendencies necessitates a variety of approaches. One method is to use screw designs that only compress the melt near the barrel’s end.

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The excellent shock absorption of expanded polystyrene packaging means that a wide range of products is protected. Furthermore, EPS’s compression resilience makes it suitable for stacking packing. When it comes to safety, EPS shines. It’s utilized to make children’s car seats and cycling helmets, where its protective characteristics, strength, and shock-absorption are crucial.