Construction Standards of Sterile GMP Dust-Free Workshop for Masks
2024.08.07
In the current environment, masks have become an indispensable protective item in our lives. The production of high-quality, sterile masks is inseparable from a strict GMP dust-free workshop. Today, let's take an in-depth look at the construction standards of the sterile GMP dust-free workshop for masks.
Layout and Design of the Workshop
The layout of the sterile GMP dust-free workshop for masks should follow the technological process and avoid cross-contamination. Different functional areas should be divided within the workshop, such as raw material storage area, production processing area, finished product packaging area, inspection area, etc., and there should be clear separation and airflow control between each area.
At the same time, the design of the workshop should consider the flow routes of personnel and materials, minimizing detours and intersections. Personnel passages and material passages should be set separately, and both should be equipped with corresponding purification facilities.
Air Purification System
This is the core part of the dust-free workshop. The air purification system should be able to effectively filter particles, microorganisms and harmful gases in the air to ensure that the air quality in the workshop meets the prescribed standards.
Generally, multi-stage filtration is required, including primary filters, medium filters and high-efficiency filters. At the same time, a positive pressure state should be maintained in the workshop to prevent unpurified air from the outside from entering.
For example, the filtration efficiency of high-efficiency filters should not be lower than 99.97%, which can effectively filter particles above 0.3 microns.
Temperature and Humidity Control
In order to ensure the production quality of masks and the comfort of operators, the temperature and humidity in the workshop need to be strictly controlled.
The temperature is generally controlled between 18-26°C, and the humidity is controlled between 45%-65%. Moreover, corresponding monitoring and adjustment equipment should be available to monitor and automatically adjust the temperature and humidity in real time.
Lighting and Noise
Sufficient and uniform lighting is crucial for production operations. The illuminance in the workshop should comply with relevant standards to avoid shadows and glare.
At the same time, the noise level in the workshop should be controlled to ensure that it does not exceed the prescribed limit, providing a relatively quiet working environment for operators.
Cleaning and Disinfection
Regular cleaning and disinfection are the key to maintaining the sterile environment of the workshop. A detailed cleaning and disinfection plan should be formulated, including the frequency and methods of cleaning and disinfecting the ground, walls, equipment, etc.
The disinfectants used should have a good bactericidal effect and will not cause pollution to the products and the environment.
Personnel Management
Personnel entering the workshop must undergo strict training and changing procedures, and wear sterile work clothes, masks and gloves that meet the requirements.
Moreover, the number of personnel and their range of activities should be limited to avoid unnecessary interference to the workshop environment.
In conclusion, the construction standards of the sterile GMP dust-free workshop for masks are a comprehensive requirement involving multiple aspects. Only by strictly following these standards for construction and management can high-quality, sterile masks be produced and provide a strong guarantee for our health.
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