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What to Pay Attention to When Using Injection Molds to Produce Medical Products?  

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In the medicare prototype fabrication sectors, medical injection has become a renowned technique to form end-use medical prototypes for testing, and components functional testings. It’s renowned for manufacturing products as per desired specification shapes, and exact dimensions. Generally, molds used in operation are made of steel and are composed of front and back dies. The quality of these molds determines whether the production process is smooth or not and the quality of end-use or after-market products. Early engagement with experienced engineers reduces risks and eliminates costly design problems, thus achieving the best performance of critical medical components. This article focuses on critical aspects to count on while fabricating medical products through the medical injection process.

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Here are some key points to consider:

1. Regular Inspection of Injection Mold Usage:  

During the medical injection mold process, any abnormal sounds or products not meeting the standard with a significant difference should be fixed immediately. Discontinue the use of the mold and promptly inspect it throughout to determine whether there are any problems or damages.

2. Timely Cleaning of Injection Mold:

Medical Injection molds as soon as possible should be cleaned to avoid deformation because of oxidation. The mold should be operated under stable conditions in which the temperature is well-controlled.  

3. Regular Examination of Engineering Plastic Particles

Before processing engineering plastics to medical injection molded parts through the mold, a thorough examination of engineering plastics is a matter of necessity. The problems in the engineering plastics can cause the injection mold and the final product to have quality issues. Collaborating with an injection molder that utilizes Design for Manufacturability (DfM) is the key to reducing defects. Through the incorporation of the moldflow analysis in its entirety and the utilization of the plastics engineering experience during the design phase, the early identification of problems is possible, which results in the creation of a refined production strategy.

4. Analyze Process & Working Together

The implementation of moldflow simulation and analysis in the designing phase provides several benefits such as improved part quality, reduced cycle time, and fewer tooling trials. This process is based on the use of the most advanced computer programs which are designed to analyze and predict the flow and cooling of plastic during the medical injection process. The basic moldflow analysis usually includes the simulation of the fill and pack phases to get the best gate location, gate sizes, runner balance, and process parameters. The more advanced simulations can be as detailed as comparing runner systems, evaluating mold temperature, and forecasting fiber orientation. These insights are very important in predicting the outcomes of intricate components and processes.

Molders who are experts in critical-use applications, especially in the medical field, are of great importance because they make sure that the device performance is in line with the design expectations. The involvement of a molder who is experienced in DfM techniques brings an extra level of confidence in the achievement of the desired results.

An experienced complex injection molder will be able to foresee the problems that may arise during the molding process.

5. Identifying & Correcting Molding Defects During Medical Injection Process

The five key areas of emphasis for preventing or correcting defects are residual stress, warping, sink marks, short shots, and flash.

Internal stresses are caused by internal forces during part cooling. It can be subject to variations, such as tooling or machine changes, which can affect part performance. The scientific molding process makes it possible to achieve high precision, which is essential for the production of complex medical parts. It employs sensors and software to control and adjust the variables such as temperature and flow rate in real-time, thus maintaining the desired quality.

Warping, usually a distortion of a part, can be prevented by monitoring and maintaining the resin temperatures before and during injection to avoid overheating or inefficient cooling. Also, the time required to release the part from a mold should be precise to prevent warping. If the part is ejected too early, the stress is not properly restrained and the plastic is not solidified completely so it returns to its natural state and warpage occurs.

Sink Marks: Sink marks typically refer to dimples or measurable pits that appear on the part surface. Sink marks are not only visually unattractive, but they can also be harmful to part functionality and multi-part assembly.

Sink mark formation can be prevented from simple fixes, and complete internal cleaning of a dirty mold. The following parts must ensured to be deeply clean; such as proper gate location, and wall thickness in moldflow analysis. Another possible cause is machine pressure being set incorrectly. The machine may be checked and calibrated to solve the sink mark problems, but this may also mean deviating from the scientific molding process, thus necessitating re-qualification.

Short Shots, happen when the mold is filled with less plastic than required. Short shots are single pieces or parts that are not properly formed or are out of spec. The pressure rate can be adjusted so that this would not occur. Mold flow analysis is valuable in that it aids in the design of a part and its gating for better outcomes.

Flashes typically occur outside of a part surface. Usually, it’s squeezed out from a mold parting line and then solidified. Flashes have relatively sharp edges, so it’s unsafe for general handling. It can also do a lot of damage to the packaging or cut through O-rings and seals. Tooling problems and flash problems are interconnected. In this regard, the right tool design is a key issue and is largely dependent on the molder’s engineering skills and experience. Furthermore, it’s typically important for a sophisticated injection molder to accurately calculate the actual tonnage to use the right size medical injection machine so that flash formations can be eliminated.

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6. The Wall Thickness and Consistency

The wall thickness of medical injection molded parts should be uniform to achieve the structural strength and overall quality of the parts.

Predominantly, the variation in wall thickness may cause problems, for instance, warping, sink marks, and uneven cooling. These may cause defects in the final-use medical products.

Part Complexity  

Medical injection of complex part geometries can be a source of difficulties. To eliminate these complexities around the intended part geometry must be kept simple or include support ribs to solve these issues.

7. Mold Design and Parting Lines

The mold is a crucial element in the manufacture of plastic parts with excellent quality. The parting lines are of great significance as they can have a great influence on the appearance and performance of the end product. Well-designed parting lines can reduce the visible seams, and drag marks, and also ensure a clean release from the mold.

8. Mold Cavity and Surface Quality

The mold cavity design and quality significantly impact the finish and functionality of the product. The surface roughness, aesthetic appearance, and mold release requirements are the key issues to be addressed in the design of this component. The resulting smooth mold surfaces help plastic flow smoothly, decrease the risk of defects, and simplify part ejection. While planar surfaces may be smooth and therefore offer a uniform aesthetic, textured surfaces can produce specific effects, or improve the grip of the users on the final part.

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Key Takeaways

Designing medical injection mold optimally is an essential factor for making high-quality and low-cost parts. The factors of material selection, wall thickness, gate design, and cooling process are the most important elements that can help to improve efficiency and reduce expenses. Some examples of how to do this are reducing the wall thickness and moving the gate location, as well as involving the engineers and the operators in the process to achieve higher part quality and less waste. Constant evolutions in medical injection procedures guarantee that the parts are manufactured with a high level of quality and that production is efficient enough to meet customers’ demands.

FAQ’s

Q1: Why is the quality of injection molds important in producing medical products?  

The mold quality plays a key role in the precision of shaping, the correctness of specifications, and the cleanliness of surfaces, which are of great importance for medical products’ safety and performance.

Q2: When should skilled injection mold engineers be involved in the production process?  

The role of experienced engineers should be considered from the beginning of the design process to identify any potential problems and to optimize the design for efficient and high-quality production. 

Q3: How does early collaboration between mold engineers and design teams benefit medical product manufacturing?

The early collaboration is a risk minimizer, cost reducer, and a guarantee that the final product will meet the highest medical standards and regulatory requirements.

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