In the medical field, silicone products are widely used due to their unique properties. From medical devices to implants, high-quality medical silicone is indispensable. And the decoration project of the medical silicone purification workshop behind it is of utmost importance for ensuring the quality of silicone and medical safety.
I. Special Requirements of Medical Silicone and the Significance of the Purification Workshop
Medical silicone directly contacts the human body and is used for auxiliary diagnosis, treatment, and even long-term implantation. Therefore, it has extremely high requirements for its purity, safety, and stability. The purification workshop is designed to minimize the impact of impurities, microorganisms, and other contaminants during the production process. If the workshop environment fails to meet the standards, contaminants such as dust and bacteria may be mixed into the silicone, causing serious consequences such as infections and allergies during medical use, endangering the health of patients.
II. Core Points of the Decoration Project
(I) Space Layout Planning
1. Reasonable Zoning
The medical silicone purification workshop needs to clearly divide different functional areas, including the raw material storage area, production and processing area, finished product inspection area, and packaging area. Reasonable logistics and personnel flow channels should be maintained between each area to avoid cross-contamination. For example, the raw material storage area should be kept dry and clean, away from pollution sources, and have a dedicated material access channel. The production and processing area should arrange equipment according to the production process to ensure the smoothness and efficiency of production.
2. Separation of Clean and Dirty Items
Independent clean channels and dirty channels should be set up. Clean items such as clean raw materials and packaging materials enter the workshop through clean channels, while waste products and unqualified products during the production process are transported out through dirty channels to prevent the spread of contaminants within the workshop.
(II) Design of Walls, Floors, and Ceilings
1. Wall Materials
Smooth, seamless, easy-to-clean, and corrosion-resistant materials should be selected, such as stainless steel plates or high-quality antibacterial coated panels. These materials can not only effectively prevent the attachment of dust and bacteria but also will not produce debris or be damaged during the cleaning process, ensuring the long-term cleanliness of the walls.
2. Floor Treatment
The floor should have the properties of being anti-slip, anti-static, wear-resistant, and easy to clean. Epoxy self-leveling floors are generally used. This kind of floor can form a seamless whole, reducing the gaps where dust accumulates, and can withstand the weight of production equipment and frequent personnel traffic.
3. Ceiling Installation
The ceiling design should take into account the installation of the air circulation and lighting systems. Airtight ceiling materials should be adopted to prevent dust from falling from the top and to facilitate the installation of high-efficiency particulate air (HEPA) filters and lighting equipment to meet the purification and lighting needs of the workshop.
(III) Air Purification System
1. Filter Levels
The medical silicone purification workshop needs to be equipped with a multi-stage air filtration system, including primary, medium, and high-efficiency filters. The primary filter is used to filter large particles of dust and impurities, the medium-efficiency filter further removes medium-sized pollutants, and the high-efficiency filter can intercept tiny dust particles and microorganisms, ensuring that the air in the workshop meets the cleanliness standards for medical use, such as ISO 7 level or higher.
2. Airflow Organization
Reasonable airflow organization is the key to ensuring the air purification effect. Usually, laminar flow or turbulent flow air patterns are adopted. Laminar flow air can make the air flow stably in a parallel manner and is more suitable for areas with extremely high cleanliness requirements, such as the production area of silicone implants. Turbulent flow air is suitable for areas with slightly lower cleanliness requirements, reducing the concentration of pollutants through sufficient air mixing and dilution.
(IV) Temperature, Humidity, and Pressure Control
1. Temperature and Humidity Adjustment
The production of medical silicone has strict requirements for temperature and humidity. Appropriate temperature and humidity can not only ensure the stability of the physical and chemical properties of silicone but also reduce the generation of static electricity. Generally, it is advisable to control the temperature between 20 - 25 °C and the humidity between 45% - 65%. Temperature control systems and humidity adjustment equipment are installed to precisely control the temperature and humidity in the workshop.
2. Pressure Control
To prevent the intrusion of polluted air from the outside, the purification workshop should maintain a positive pressure state inside. Reasonable pressure differences should be set between different areas according to the cleanliness requirements. For example, the pressure in the production and processing area should be higher than that of the adjacent auxiliary areas to ensure that the air flows from the clean area to the polluted area and effectively blocks the entry of contaminants.
III. Project Quality Assurance and Monitoring
(I) Quality Control during the Construction Process
1. Strict Material Inspection
During the decoration project, strict quality inspections should be carried out on each batch of materials entering the construction site. From wall and floor materials to air filter equipment, it is necessary to ensure that they meet the design standards of the medical purification workshop and relevant quality certification requirements.
2. Standardized Construction Techniques
Construction workers must follow strict construction technique specifications. Whether it is pipeline installation, electrical wiring, or panel splicing, the construction quality must be ensured to prevent problems such as gaps and leaks that may affect the purification effect of the workshop. Meanwhile, attention should be paid to keeping the construction site clean during the construction process to avoid dust and garbage generated by the construction from polluting the workshop environment.
(II) Post-operation Monitoring and Maintenance
1. Real-time Monitoring System
Install temperature and humidity sensors, pressure sensors, dust particle counters, and other monitoring devices to monitor the environmental parameters in the workshop in real time. By connecting with the control system, when the parameters exceed the set range, alarms can be triggered in time so that the staff can take corresponding adjustment measures.
2. Regular Maintenance
Establish a complete equipment maintenance plan, regularly maintain key equipment such as the air purification system and air conditioning system, and replace filters and other components. At the same time, conduct regular cleaning and inspection of the walls, floors, and ceilings of the workshop, discover and repair possible damage or pollution problems in time, and ensure the long-term stable operation of the purification workshop.
The decoration project of the medical silicone purification workshop is a complex and crucial task that is related to the quality of medical silicone products and medical safety. Guangzhou Kunling Purification Equipment Co., Ltd., relying on its professional team and rich experience, is committed to creating high-quality purification workshops for the medical industry and safeguarding the health of every patient.