Standards for Cleanrooms in Multifunctional Raw Material Pharmaceutical Production
2024.08.08
In the modern pharmaceutical field, the development of multifunctional raw material pharmaceuticals is increasingly important. A high-standard cleanroom is the key to ensuring the quality and production safety of drugs.
1. Stringent Control of Air Quality
For the cleanrooms of multifunctional raw material pharmaceutical production, air quality is the primary consideration. Particulates, microorganisms, and harmful chemicals in the air must be strictly controlled to extremely low levels.
There are precise limits on the diameter and quantity of particulates. For example, the number of particulates with a diameter greater than or equal to 0.5 microns per cubic meter should not exceed a specific value. This helps prevent particulate contamination of raw materials and drugs.
The presence of microorganisms also requires strict monitoring. Regular air sampling and testing can promptly detect and address possible microbial contamination.
2. Precise Regulation of Temperature and Humidity
Appropriate temperature and humidity conditions are crucial for the pharmaceutical process. Generally, the temperature should be stable between 20 - 25 degrees Celsius, and the humidity should be maintained at 40% - 60%.
Fluctuations in temperature may affect the chemical properties of raw materials and the stability of drugs. For instance, some raw materials may deteriorate when the temperature is too high.
Improper humidity control may cause raw materials to absorb moisture or dry out, affecting their efficacy and quality.
3. Reasonable Setting of Differential Pressure
Appropriate differential pressure should be maintained between different functional areas to ensure the correct direction of air flow and prevent the spread of contaminants.
For example, between the raw material storage area and the production operation area, a certain positive differential pressure should be maintained to ensure that the air flows from the clean area to the less clean area.
4. Standardized Management of Personnel and Materials
Personnel entering the cleanroom need to undergo a strict purification process, including steps such as changing dedicated work clothes, washing hands, and disinfection.
The entry of materials also requires strict cleaning and disinfection treatment to ensure that no contaminants are brought in.
5. High Frequency and High Standards of Cleaning and Disinfection
The cleaning and disinfection of the workshop must be carried out strictly in accordance with the prescribed frequency and methods.
Cleaning tools should be dedicated and disinfected regularly, and the selection and use of disinfectants should comply with relevant standards.
For example, using ultraviolet disinfection lamps to disinfect the air and using specific disinfectants to wipe the surface of equipment.
In conclusion, the standards for cleanrooms in multifunctional raw material pharmaceutical production are a comprehensive and strict system. Only by strictly following these standards can high-quality, safe, and effective drugs be produced, providing a strong guarantee for the public's health.
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