Oral Capsule Pharmaceutical Cleanroom Construction Standards
2024.08.08
In the field of oral capsule pharmaceuticals, ensuring the quality and safety of products is of utmost importance. Among them, the construction of a cleanroom that meets the standards is one of the key links. Today, let's take an in-depth look at the construction standards for oral capsule pharmaceutical cleanrooms.
1. Air Quality Requirements
The air quality in the cleanroom must reach an extremely high standard. The content of particulates, microorganisms, and harmful gases in the air must be strictly controlled. For example, for particulates with a particle size greater than or equal to 0.5 microns, the number per cubic meter should be limited within a specific value.
To achieve this requirement, an efficient air filtration system, such as HEPA filters, is usually required, which can effectively remove tiny particles in the air. At the same time, regular air quality monitoring is also essential to ensure that the air quality always meets the standards.
2. Temperature and Humidity Control
Appropriate temperature and humidity are crucial for the production of oral capsules. Generally, the temperature should be maintained between 18 - 26 degrees Celsius, and the humidity should be controlled at around 45% - 65%.
Too high or too low temperature may affect the physical properties of the capsules and the stability of the drugs. Improper humidity may cause the capsules to absorb moisture too quickly or dry out too quickly, affecting their quality.
For example, in hot summers, if the temperature in the workshop is too high, the capsules may become soft and deformed; in dry winters, too low humidity may make the capsules brittle.
3. Differential Pressure Control
Appropriate differential pressure should be maintained between different areas to prevent the spread of contamination. Generally, the clean area should maintain a positive pressure relative to the non-clean area.
For example, between the capsule filling area and the external corridor, there should be a certain differential pressure to ensure that the air flows from the area with higher cleanliness to the area with lower cleanliness.
4. Purification Processes for Personnel and Materials
Personnel entering the cleanroom need to undergo strict purification procedures, including changing clean clothes, washing hands, and disinfection. Materials also need to undergo cleaning and disinfection treatment before entering the workshop.
For instance, workers must wear specialized cleanroom clothing and shoe covers and pass through an air shower to remove dust and particulates from their bodies.
5. Cleaning and Disinfection System
Regular cleaning and disinfection are important measures to maintain the cleanliness of the cleanroom. Surfaces such as floors, walls, and equipment need to be cleaned and disinfected according to the prescribed frequency and methods.
Disinfectants can be used to wipe equipment and wet-clean the floors to kill microorganisms and remove contaminants.
In conclusion, the construction standards for oral capsule pharmaceutical cleanrooms are a complex and strict system that requires comprehensive consideration and implementation from multiple aspects. Only by strictly following these standards can high-quality, safe, and effective oral capsule products be produced to safeguard the health of patients.
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