The purification standard of GMP workshop mainly includes the following aspects:
1. Cleanliness level: GMP workshop needs to reach a certain level of cleanliness, usually 100,000 level (Class 100).
2. Air dust content: GMP workshop air dust content needs to be less than or equal to 0.5mg/m?
3. Indoor noise: The indoor noise of GMP workshop needs to be less than or equal to 65dB.
4. Temperature and humidity requirements: The temperature and humidity of GMP workshop needs to be controlled within a certain range, usually 10~30°C, relative humidity 45%~75%.
5. Illumination requirements: GMP workshop illumination needs to reach more than 1200lx.
6. The floor is flat and smooth, without cracked sand and water.
7. The lighting and power supply system meets the specification requirements.
8. Anti-static floor.
9. Safe access.
10. fire fighting equipment.
In addition to these requirements, the purification standards of GMP workshop also need to meet the "Good Manufacturing Practice" (2010 version), "Design Code for Clean Plants in the Pharmaceutical Industry" (GB-93), "Clean Room Construction and Acceptance Specification" (JGJ73-81) and other regulations and norms. At the same time, the air purification equipment in the GMP workshop of the pharmaceutical factory also needs to meet the relevant standards and requirements, such as middle and high efficiency filters.
SICOLAB - a leading supplier of laboratory systems engineering and construction services