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The Production Environment Required for Medical Injection Molding

In the medical field, injection-molded products play a pivotal role. From disposable syringes and infusion sets to precise medical device shells, these seemingly ordinary plastic products are closely related to patients' lives, health, and safety. Medical injection molding has extremely stringent requirements for the production environment, leaving no room for negligence in every detail. Only by creating a high-quality production environment that meets the standards can the quality and safety of medical injection-molded products be ensured.

The production environment for medical injection molding must possess a high level of cleanliness. In medical scenarios, even the slightest contamination can lead to severe infection risks. Therefore, the production workshop needs to achieve specific cleanliness levels, usually Class 10,000 or even higher Class 100 cleanroom standards.

To achieve such cleanliness, the workshop must be equipped with an efficient air purification system. This system employs primary, medium, and high-efficiency three-stage filtration to effectively remove pollutants such as dust, microorganisms, and pollen from the air. The primary filter mainly intercepts large-particle dust, the medium-efficiency filter further filters smaller particles, and the high-efficiency filter can capture particles larger than 0.3 microns with an efficiency of over 99.97%. Meanwhile, the workshop should maintain a positive pressure state to prevent the infiltration of contaminated external air. By reasonably designing the ventilation system, the air pressure inside the workshop is slightly higher than the external environment. When doors or windows are opened, the air flows from the workshop outward instead of flowing in the opposite direction, effectively stopping dust and microorganisms from entering.

In addition, production equipment and tools need to be regularly cleaned and disinfected. Parts prone to dust and bacterial accumulation, such as equipment surfaces and molds, should be treated with specialized cleaning and disinfecting agents to ensure that no pollution sources are introduced during the production process.

An appropriate temperature and humidity environment is crucial for medical injection molding production. Fluctuations in temperature and humidity can affect the performance of plastic raw materials, the stability of the injection molding process, and the dimensional accuracy of products.

class 10000 cleanroom

Generally, the temperature in the medical injection molding workshop should be controlled between 20 - 25℃, and the relative humidity should be maintained at 40% - 60%. Excessively high temperatures can cause the plastic raw materials to soften and increase their fluidity, leading to defects such as flash and burrs. Excessively low temperatures can make the raw materials harden and reduce their fluidity, potentially resulting in incomplete injection molding and insufficient product strength. Changes in humidity are equally important. High humidity can cause the plastic raw materials to absorb moisture, generating defects such as bubbles and silver streaks during the injection molding process, affecting the product's appearance and performance. Low humidity can generate static electricity, which attracts dust and increases the risk of product contamination.

To precisely control temperature and humidity, the workshop needs to install an air conditioning system and a dehumidification device. The air conditioning system can automatically adjust the indoor temperature according to the set value, while the dehumidification device can effectively reduce the air humidity. At the same time, temperature and humidity monitoring instruments should be equipped to monitor the changes in the workshop's temperature and humidity in real time, ensuring that they remain within the appropriate range.

Anti-static measures are essential for protecting product quality and safety during the medical injection molding production process. Plastic raw materials are prone to generating static electricity during processing. Static electricity can attract dust and microorganisms, leading to surface contamination of products and affecting their cleanliness and quality. In addition, static electricity may also trigger fires and explosions, especially when handling flammable and explosive plastic raw materials, posing a greater risk.

To prevent the generation and accumulation of static electricity, the workshop needs to take a series of anti-static measures. First, production equipment and tools should be made of anti-static materials, such as anti-static workbenches and anti-static floors. These materials can effectively discharge static electricity and avoid its accumulation. Second, operators should wear anti-static work clothes, shoes, and gloves. These protective gear can release the static electricity generated by the human body to the ground in a timely manner. In addition, ionizers can be installed in the workshop to neutralize the static electricity in the air by releasing positive and negative ions, further reducing the static electricity hazard.

Personnel are an important factor in the production environment of medical injection molding. The behavior and hygiene habits of operators directly affect the quality and safety of products. Therefore, strict management and training must be carried out for personnel entering the workshop.

All personnel entering the workshop must go through procedures such as changing clothes, washing hands, and disinfecting, and wear clean work clothes, hats, masks, and gloves that meet the requirements to ensure that their bodies and clothing do not bring in pollutants. At the same time, operators should receive regular training on hygiene knowledge and operational skills to make them understand the importance of medical injection molding production and relevant regulations, and master correct operation methods and quality control points.

During the production process, operators must strictly comply with the operating procedures and are not allowed to touch the products and equipment surfaces at will to avoid cross-contamination. In addition, a sound personnel health management system should be established, and operators should undergo regular health examinations to ensure that they are in good health and free from infectious diseases.

The logistics and warehousing links of medical injection-molded products also need to be strictly controlled to prevent contamination during transportation and storage. Raw materials and finished products should be transported in dedicated sealed containers to avoid contact with the external environment. In the warehouse, different areas should be designated to store raw materials, semi-finished products, and finished products separately to avoid confusion and cross-contamination.

The warehouse should be kept clean, dry, and well-ventilated, with temperature and humidity meeting the storage requirements of the products. At the same time, the warehouse should be regularly cleaned and disinfected to ensure a safe and hygienic storage environment for the products.

The production environment for medical injection molding is a complex and stringent system involving multiple aspects such as cleanliness, temperature and humidity, anti-static measures, personnel management, and logistics and warehousing. Only by creating a high-quality production environment that meets the standards can the quality and safety of medical injection-molded products be ensured, safeguarding the development of the medical industry and patients' health. In the future, with the continuous progress of medical technology and the increasing requirements for product quality, the production environment of medical injection molding will also be continuously improved and optimized to meet higher standards and demands.

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Add: 62 Jinghai East Road, Chang'an Town, Dongguan City, Guangdong Province

Whatsapp: 13302615729

Tel: 86-133-0261-5729

Email: info@yizemould.com

Copyright © 2024 Dongguan Yize Mold Co., Ltd
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