However, achieving uniform shrinkage is complicated by the presence and interaction of many factors such as the orientations of the polymer molecules, temperature variations in the mould walls, compaction variations in the plastic parts (over-compacted areas and under-compacted areas, due to unbalanced flow paths), etc. Note that areas of higher compaction, such as injection gates, have a lower shrinkage since part of the compaction of the molten polymer compensates for it. In contrast, areas further away from the gate are subject to less compaction and therefore tend to have a higher shrinkage.

Trapped air will result in voids and bubbles within the moulded plastic part, incomplete filling or surface defects such as stains or burn marks.

Utilizing robust silicone and plastic materials, our advanced processes assure the traceability of every implant, mold, and micro-molded part. Our stringent quality control measures ensure that every weld and polymer application aligns with the highest industry standards. Our in-depth assessment procedures are followed by rigorous testing, guaranteeing the quality and safety of our output.

Some of the actions to be taken to improve the surface finish are related to actions to increase the flow rate and temperature of the molten polymer and the mould walls. Therefore, the improvement of the surface quality is achieved by measures such as:

Safety is paramount in our operations. Our Cleanroom Molding and Sterilization Techniques are implemented with a deep understanding of the importance of safety in medical device manufacturing. We also offer rapid turnarounds, without ever compromising quality or safety.

If welding or joining lines cannot be avoided, a good practice is to ensure that they are generated in low visibility or mechanically non-critical areas. This is often done by modifying the plastic injection gate, modifying the flow fronts and the areas where the weld/joint lines occur. Another practice is to try to achieve a good joint between the two fluxes so that the mechanical weakness that occurs is not excessive. To do this, the aim is for the junction of the two flux fronts to take place at the highest possible temperature and pressure, so that they are not far from the inlet port. Translated with www.DeepL.com/Translator (free version)

like Marlee – Texen at the forefront, the future of medical injection molding promises to deliver even greater innovation and quality analysis, optimizing flow and reducing waste. These advancements ensure that patients around the world benefit from safer, more effective medical devices, a testament to the relentless pursuit of excellence in the medical molding sector.

At Marlee – Texen, we excel in high-volume production while maintaining meticulous quality control. We deploy advanced flow analysis to optimize the production process, and our commitment to creating safe, effective disposable medical products is unwavering.

Our approach to Quality Control is exhaustive. From the initial design and injection phase of Medical Injection Molding to the final assembly and packaging of your device, our team ensures every step of the process is controlled, monitored, and optimized. We understand that the end-use of our products is in the critical healthcare sector, making the safety and functionality of each part and medical device we produce a non-negotiable priority.

The burr is a defect that occurs when part of the molten polymer flows through the existing gaps in the injection mould such as parting plane, aeration zones, ejectors, etc. Burring occurs for the following reasons:

At Marlee – Texen, we adhere strictly to both ISO and FDA standards. Every regulation is taken into account, and compliance is guaranteed. Our processes are regularly audited, our tools and assembly procedures are meticulously maintained, and every component we produce is verified for accuracy using advanced equipment and machines.

companies is the use of automation. Leveraging advanced injection molding equipment and scientific molding principles, they ensure consistent production of high-precision medical device injection molding parts, regardless of whether it’s high-volume production or low-volume production.

The dimensional shrinkage of parts is inherent to the injection moulding process. Shrinkage occurs because the density of the polymer varies from processing temperature to ambient temperature (see, for example, the specific volume of a semi-crystalline polymer in Figure 5.46 – PVT curve). During the stages of the injection moulding process, cooling shrinkage produces a series of internal stresses in the part. These residual stresses act on the part with similar effects as possible externally applied stresses. If the residual stresses induced during moulding are high enough, the part after ejection from the mould may warp / twist or warp, resulting in defective parts.

In the intricate world of Medical Device Design, the selection of High-Quality Materials for Medical Injection Molding plays a pivotal role. A critical aspect of this process lies in the Importance of Biocompatible Plastics in Medical Devices, and this is where we position our expertise.

in creating effective medical packaging. Their offerings ensure safety, sterility, and efficient delivery of medical devices, embodying their commitment to overall patient health and safety.

that comprehensively aligns with FDA Regulations and maintains an unwavering commitment to Medical Standards Compliance. We are proud holders of ISO 13485 certification, which underscores our commitment to quality and safety in the production of medical devices. Our Validation Process is thorough and rigorous, ensuring every part and component we produce is safe, effective, and reliable.

As a leading player in the industry, Marlee – Texen continues to embrace these technological advancements, contributing to molding industry trends and setting the bar high in terms of quality and efficiency.

To conclude, automation and technological advancements in medical molding have made a significant impact on the medical device market. These advancements are not just about high-speed delivery and high-volume molding but also about maintaining safety and quality, ensuring each product meets the strictest medical grade standards.

industry is the adoption and mastery of Micro-Molding. This highly specialized mould design has allowed a significant shift in medical molding innovations. Specifically, it has been instrumental in the production of smaller, more intricate medical components, and the high-precision manufacturing of injection molded parts.

Polyethylene or polythene is the resin made from the polymerization of ethene. PE is the most versatile synthetic resin. It has a crystalline structure and can be high density (HDPE) or low density (LDPE). It is used by the medical plastic products.

The customization process involves a collaborative approach of Design for Manufacturing (DFM). This approach ensures every part of the device – be it orthopedic, cardiovascular, or any other field – is meticulously designed and manufactured. This process not only maximizes quality and efficiency but also significantly reduces risk and time-to-market.

Another significant development is the adoption of liquid silicone rubber (LSR) in the medical injection molding process. LSR is ideal for producing implantable and disposable medical devices due to its superior biocompatibility.

The jetting defect occurs when molten polymer is pushed at speed through a small area, such as the injection nozzle or gate, to access a much larger area. The jetting defect results in mechanical weakness in the part, surface imperfections and multiple internal defects.

Weld lines and joint lines can be caused by holes or insertions in the part, the existence of multiple injection gates, or due to areas of varying wall thickness where hesitation or race-tracking occurs.

In terms of design, we deploy state-of-the-art tools and equipment to create intricate components and assemblies. Every machine we use is operated by expert manufacturers, proficient in handling delicate materials like silicone, vital in the creation of a myriad of implants and medical device parts.

A rule of thumb to avoid excessive distortions in the part due to temperature differences after injection, is that the average temperature differences in any part of the part after injection should not be greater than 15-20ºC.

We provide services like pad printing and silk screening to put 2-D designs on 3-D surfaces. These designs can be customized for labeling, branding, etc. We use standard colors and Pantone matching.

Alloys like PC/ABS and TPE/TPU – PC/ABS combines the strength of PC and the flexibility of ABS, making it ideal for use by a medical plastic products manufacturer. TPE and TPU are thermoplastic elastomers. They are used for making lids, sports goods, power tools, medical device parts, etc. They are used in these industries for their abrasion resistance and elasticity.

Traditionally, the joint angle between the two faces is used to differentiate weld lines from joint lines. A joint angle of less than 135º produces a weld line, while a joint angle of more than 135º is defined as a joint line. In general, a weld line mark disappears when the joint angle reaches between 120º and 150º. The weld lines are considered more critical than joint lines in terms of both aesthetics and mechanical properties of the joint. Translated with www.DeepL.com/Translator (free version)

process, has transformed the medical industry. This advancement ensures more efficient operation of the mold flow analysis system, leading to more precise and consistent results. It facilitates the development of medical product components, reducing the margin of error and waste during production.

Medical device injection molding, however, is not merely about the molding process but also involves detailed tooling design, stringent compliance, and rigorous regulation. In fact, Marlee – Texen has built its reputation as one of the

, has paved the way in producing premium quality, high-performance medical device injection molding products. Their focus extends from simple disposable medical devices to more complex implantable medical devices, with a special emphasis on surgical instruments and diagnostic equipment.

Our team’s expertise in medical device design ensures that the selection of these materials is tailored to the specific requirements of each project. We believe that every part of the process, from initial prototype design to final delivery, is integral to the successful operation of a medical device.

, Stringent Quality Control and Regulatory Compliance serve as the bedrock of our operations at Marlee – Texen. We are recognized as one of the leading

– Reduce the injection speed. High plastic injection speeds can cause jetting, which causes trapped air to appear right at the inlet gate. Reducing the injection speed will give the displaced air at the gate enough time to escape through the aeration zones.

A robust system of automation also offers the advantage of improved traceability, a key aspect of regulation and compliance in the medical industry. Furthermore, companies like Marlee – Texen employ overmolding techniques, contributing to their recognition as one of the

, we prioritize Stringent Quality Control and Regulatory Compliance. Our operations underscore the importance of ensuring Patient Safety and delivering high-quality medical products through our state-of-the-art injection molding facilities.

Automation, combined with cutting-edge technologies like rapid prototyping, has enabled precise molding for both plastic and silicone based products. Furthermore, automation ensures enhanced cleanroom standards, paramount for medical parts production, ensuring compliance with ISO and FDA regulations.

Occasionally, the use of high compaction pressures causes acceptable sink marks by reducing volumetric shrinkage although these cannot be completely eliminated. This is because the volumetric change of plastic from melt to solid is about 25% and the compressibility of plastics at typical injection moulding pressure is only 15%, which means that it is impossible to compact the molten plastic sufficiently to compensate for cooling shrinkage.

to meet your needs. Our emphasis on quality assurance and medical component assembly sets us apart in the medical molding industry, making us a trusted partner for healthcare providers across the globe.

The transformative impact of medical injection molding on the healthcare industry is a testament to its versatile applications. With its precision and efficiency, it caters to a multitude of sectors within the industry, enabling manufacturers like Marlee – Texen to produce top-tier medical devices. One of the significant contributions of this process is in the production of

Our Medical Injection Molding services are meticulously carried out in the confines of our advanced Cleanroom Manufacturing facilities. These environments ensure the sterility and safety of every device and medical device part we manufacture. As an industry-leading provider of plastic injection molding, our cleanroom facilities are designed to eliminate contaminants, ensuring the utmost safety for the end-user.

Two crucial developments further highlight the profound influence of micro-molding in the field. One is the refinement of two-shot injection molding that allows for simultaneous injection of two different plastics into a single mold. This technique has significantly boosted the manufacturing efficiency of complex medical device components. The other is the potential of micro-molding to pave the way for polymer-drug conjugates, a novel innovation that could revolutionize the medical injection molding process.

The trapped air defect appears when a certain amount of air cannot escape out of the mould during injection, a small area without material appeared in the injected part. In a correct Injection mould design, at each injection, air is exhausted through mould vents, mould inserts or even ejectors, which also act as vents.

Our precision in molding extends beyond materials like polypropylene and PEEK. We are also a leading producer of micro-molding components, crucial in the development of advanced medical technologies. Our precision welding processes ensure seamless joins between components, maintaining the integrity of the overall device.

As the best medical plastic injection molding company, we use medical molding in the manufacturing of caps, containers, device components, and medical parts. They are needed in high volumes in pristine conditions for patient safety.

Polypropylene(PP) is a thermoplastic resin used for its flexibility and strength. It has a very low density and is suitable for scientific molding. Its flexibility and resistance find much application in plastic medical packaging sensitive material. PP is an “addition” polymer, made from the linking of many polypropylene monomers.

Every material used and every product produced at Marlee – Texen undergoes rigorous quality checks and verifications. Our comprehensive processes are aligned with top design and tool selection strategies to enable the effective assembly of components. Our equipment and machines are optimized for precision, allowing us to cater to diverse requirements, including surgical applications.

Our range of biodegradable plastics and polymer materials are expertly chosen to ensure the highest grade of biocompatibility. Our offerings include:

A poor finish can be caused by the formation of wrinkles or waves at the edges of the part or in the last filling areas during injection moulding.

From Liquid Silicone Rubber (LSR) molding to complex micro-molding processes, we ensure that every enclosure, packaging solution, and component we create meets the highest industry standards.

In the demanding field of Medical Device Design, the choice of High-Quality Materials for Medical Injection Molding is critical. An essential consideration in this sector is the range of materials available, from Polypropylene to PEEK. At Marlee – Texen, we excel in providing a comprehensive array of materials to ensure your project’s success.

Biocompatible plastics, also known as Bio-Compatible Plastics, are essential for ensuring the safety and functionality of a medical device. They are engineered to interact with the human body without causing any adverse reaction. This feature is paramount in the industry, where patient safety and assurance of product functionality are non-negotiable.

The formation of wrinkles or waves is due to the fact that a part of the flow front cools rapidly on the mould walls producing a fold on the flow front itself. Themain factors influencing the formation of these wrinkles are the flow velocity, the temperature of the mould walls, and the temperature of the molten polymer, among others.

In conclusion, these technological advancements in medical device injection molding have redefined the boundaries of what’s possible in the medical industry. From the smallest micro components to the most complex medical parts, these innovations have facilitated the creation of high-quality, disposable, and durable medical devices, elevating the overall standard of healthcare.

Incomplete filling occurs when a one injection moulded part is missing material to correctly generate its geometry. This occurs when the molten polymer cannot fill the entire cavity (or cavities) in the Injection mould, usually the thinner sections where the polymer melt cools before completely filling the mould. Any factor that increases the flow front resistance of the polymer melt can result in incomplete filling. Some of these factors are:

The warping or twisting of an injection-moulded plastic part is therefore due to the existence of a series of residual internal stresses in the part which are in turn generated by the differential shrinkage of the material during cooling. If the shrinkage throughout the part is uniform, the resulting part does not warp or twist, it simply shrinks uniformly and becomes smaller. Thecrystalline polymers, e.g. acetal, nylon, high density polyethylene, polyethylene terephthalate and polypropylenecause the most serious problems with shrinkage from 1 to 4%. Amorphous polymers, e.g. polystyrene, acrylic and polycarbonate are more treatable, with shrinkages of only 0.3 to 0.7%.

At Marlee – Texen, we are stringent about Biocompatibility Testing. Our medical-grade materials undergo rigorous testing to meet the required standards. We are adamant about quality, from the selection of polymer materials to their transformation into a functional part of a medical device.

Our team of expert manufacturers at our company is well-versed in the requirements of the industry, ensuring traceability of all parts and components, including sensitive implants. Our validation processes and quality checks make us an ideal choice for micro molding requirements in the medical industry.

Marlee – Texen is committed to providing superior solutions that cater to the demanding needs of the medical device industry. We guarantee high-quality materials, stringent testing, and dedicated service to ensure we meet and exceed your expectations.

Sinkage marks are depressions in the surface of the plastic injection moulded part caused in the last phase or stage of the plastic injection moulding process, during the cooling process. The thicker sections of the plastic cool at a slower rate than the others, resulting in a higher percentage of shrinkage in that local area. After the material on the outside has cooled and solidified, the material on the inside begins to cool and its shrinkage pulls the surface inwards, causing a surface depression.

Some of the practices we develop in the Moldblade Engineering Department to correct the problem of incomplete filling are:

A weld line (also called a weld mark) is formed when two melt flow fronts travelling in opposite directions meet. In contrast, a bond line occurs if these two fronts flow parallel to each other creating a bond line.

are the backbone of the healthcare industry, and their production hinges on the precision and reliability of injection molding.

such as Marlee – Texen have consistently leveraged technological advancements to deliver high-quality medical injection molding services, providing a seamless blend of quality and efficiency.

To uphold this principle, we invest in state-of-the-art biocompatibility testing protocols. Our robust testing ensures that our plastics are not only safe for patient use but also contribute to the efficient operation of the devices they form. In this way, we assure both the quality and safety of our products.

. This critical facet of medical device production ensures the sterile and safe transport of these crucial devices, reinforcing their commitment to overall healthcare delivery.

Medical injection molding plays a fundamental role in the healthcare industry, touching nearly every sector with its capabilities. Its breadth of application and adaptability have made it an indispensable part of medical manufacturing. For instance,

Every step, from mold design to post-molding operations, including state-of-the-art plastic welding techniques, is conducted under rigorous regulation and compliance with ISO 13485 and FDA standards. With an emphasis on medical device design and medical injection molding process, Marlee – Texen offers tailor-made medical plastic products for a diverse range of applications.

As a reliable supplier in the industry, we abide by the 13485 quality management system. Our thorough risk assessment procedures ensure the highest level of safety and reliability in our products.

in the industry, primarily due to our unwavering commitment to the highest quality standards and adherence to stringent regulations.

Our Material Selection is extensive and industry-leading. Our expertise encompasses everything from robust Plastic Medical Enclosures to flexible Liquid Silicone Rubber (LSR). Our team’s adeptness at High-Temperature Molding ensures we can work with a variety of Polymer Materials to achieve your project’s specific needs.

The following recommendations can be used to reduce the impact of weld lines and parting lines on injection moulded parts.

Additional CNC machining is provided after thermoplastic injection molding. We can also put metal inserts into medical plastic parts by heat pressing.

Whether you require drug delivery devices, enclosures, packaging, or disposable medical components, Marlee – Texen stands as the

Medical device injection molding process is used in bone repair and rearrangement. It is also used for soft tissue reattachment.

Polycarbonate (PC) is quite an efficient material that is amorphous and transparent in nature. It is a type of thermoplastic used in medical plastic packaging, a wide variety of shapes and sizes of plastic. PC injection molding is one of the best choices for manufacturing custom-tailored plastic because of its highly flexible and impact-resistant qualities.

The range of applications for medical device injection molding is extensive, stretching across diverse medical fields. From implantable medical devices and disposable medical devices to drug delivery devices, Marlee – Texen crafts each component with the utmost precision and compliance with ISO 13485 and FDA standards. They utilize cutting-edge techniques for both short-term implants and long-term implants, ensuring optimal biocompatibility and safety.

The locations of the air leakage areas in the moulds are located in the areas that are filled at the end of the injection cycle or phase. A common cause of the trapped air defect is an insufficient size of the mould vents. Another common cause is when racetracking occurs (tendency of the polymer melt to flow preferentially in thicker sections leaving thinner areas with trapped air). Translated with www.DeepL.com/Translator (free version)

The process of injection molding is complex and requires precision at every stage. Every part we create for your medical device is injection molded to exact specifications, guaranteeing performance and safety. Our thorough selection process, extensive product development capabilities, and advanced process management set us apart in the industry.

. These tailor-made solutions not only maintain the sterility of medical products but also offer efficient storage and delivery of devices.