Construction Standards for PET Aseptic Refrigerated Clean Workshop
2024.08.08
In today's medical and pharmaceutical fields, the application of PET (Positron Emission Tomography) technology is becoming increasingly widespread. To ensure the quality and safety of PET-related products, it is crucial to build an aseptic refrigerated clean workshop that meets the standards.
1. Cleanliness Requirements
The cleanliness of the PET aseptic refrigerated clean workshop must reach an extremely high level. Pollutants such as particulates and microorganisms in the air must be strictly controlled to prevent contamination of PET products. Usually, the number of particulates greater than or equal to 0.5 microns per cubic meter of air in the workshop is required not to exceed a specific value.
For example, in some high-precision PET drug production, even tiny dust particles can affect the efficacy and safety of the drugs.
2. Temperature and Humidity Control
Due to the aseptic refrigerated environment, the temperature is usually controlled between 2 - 8 degrees Celsius, and the humidity should also be maintained within an appropriate range. Precise temperature and humidity control can extend the shelf life of the products and ensure their stable performance.
For instance, if the temperature is too high, it may cause the PET drugs to lose efficacy; too high humidity may cause condensation, affecting the product quality.
3. Aseptic Assurance Measures
To achieve an aseptic environment, a series of strict measures need to be adopted. This includes air filtration systems, regular space disinfection, and strict sterilization treatment of personnel and materials.
For example, the air filtration system should be able to effectively remove microorganisms such as bacteria and viruses; personnel need to undergo thorough disinfection and changing procedures before entering the workshop.
4. Refrigeration Equipment and Monitoring System
High-quality refrigeration equipment is the key to maintaining a low-temperature environment. At the same time, a complete monitoring system is equipped to monitor parameters such as temperature, humidity, and pressure in real time. Once an anomaly occurs, it can alarm in time and take corresponding measures.
For example, the monitoring system can automatically start the backup refrigeration equipment when the temperature exceeds the set range to ensure that the products are always in a safe environment.
5. Layout and Airflow Organization
The layout of the workshop should be reasonable to avoid cross-contamination. The airflow should flow from the area with higher cleanliness to the lower area, forming an effective airflow organization and reducing the accumulation of pollutants.
For example, buffer zones are set up between different working areas to prevent contamination caused by chaotic airflow.
6. Building Materials and Sealing Performance
Select building materials that meet the cleanliness requirements and ensure the good sealing performance of the workshop to prevent the invasion of external pollutants and the leakage of the internal environment.
For example, use materials that are not prone to bacterial growth, and the sealing of doors and windows should be tight.
In conclusion, the construction standards for PET aseptic refrigerated clean workshops are very strict and complex. Only by constructing and managing strictly in accordance with these standards can reliable guarantees be provided for the production and storage of PET-related products and contribute to the development of the medical industry.
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