What standards must a cleanroom for capsule production meet?
Capsule production cleanrooms must strictly comply with pharmaceutical GMP regulations, ISO 14644, GB 50457, and other national standards, with comprehensive control over the environment, personnel, materials, and facilities. The cleanrooms are classified into four cleanliness levels: A, B, C, and D. Key processes such as capsule forming, cutting, joining, and inner packaging are generally carried out in C-level and D-level clean areas; high-risk exposure operations must be performed under an A-level laminar flow environment. Regarding environmental parameters, the pressure difference between different clean areas should not be less than 10 Pa to prevent contamination and cross-contamination; temperature should be controlled between 18–26°C, and humidity between 45%–60%, to prevent capsules from absorbing moisture, deforming, or molding. Air undergoes three-stage filtration through primary, intermediate, and high-efficiency filters to ensure that suspended particles and microorganisms meet standards. The workshop layout requires separation of personnel and material flows, with changing rooms, airlocks, and buffer zones; floors, walls, and ceilings should be smooth, seamless, and easy to clean and disinfect. Personnel must wear proper attire and undergo disinfection according to regulations, and equipment and tools must be regularly cleaned and sterilized. Meanwhile, the cleanroom must meet static and dynamic monitoring requirements, with continuous testing of suspended particles, settled bacteria, and airborne microorganisms, ensuring that the entire process complies with pharmaceutical production cleanliness requirements, thereby ensuring the safety, stability, and quality of capsules from the source.
Feb 25,2026
Capsule production cleanrooms must strictly comply with pharmaceutical GMP regulations, ISO 14644, GB 50457, and other national standards, with comprehensive control over the environment, personnel, materials, and facilities.
The cleanrooms are classified into four cleanliness levels: A, B, C, and D. Key processes such as capsule forming, cutting, joining, and inner packaging are generally carried out in C-level and D-level clean areas; high-risk exposure operations must be performed under an A-level laminar flow environment.
Regarding environmental parameters, the pressure difference between different clean areas should not be less than 10 Pa to prevent contamination and cross-contamination; temperature should be controlled between 18–26°C, and humidity between 45%–60%, to prevent capsules from absorbing moisture, deforming, or molding. Air undergoes three-stage filtration through primary, intermediate, and high-efficiency filters to ensure that suspended particles and microorganisms meet standards.
The workshop layout requires separation of personnel and material flows, with changing rooms, airlocks, and buffer zones; floors, walls, and ceilings should be smooth, seamless, and easy to clean and disinfect. Personnel must wear proper attire and undergo disinfection according to regulations, and equipment and tools must be regularly cleaned and sterilized.
Meanwhile, the cleanroom must meet static and dynamic monitoring requirements, with continuous testing of suspended particles, settled bacteria, and airborne microorganisms, ensuring that the entire process complies with pharmaceutical production cleanliness requirements, thereby ensuring the safety, stability, and quality of capsules from the source.
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