Construction of Pharmaceutical GMP Purification Workshop

Design planning

1. Layout design: The layout of pharmaceutical GMP purification workshop should follow the principle of separation of people flow and logistics to reduce cross contamination. According to the production process, reasonable planning of various functional areas, to ensure smooth production process and comply with GMP requirements.
2. Air purification system: The use of high efficiency filtration system, such as HEPA (high efficiency air particle filter), to ensure that the air cleanliness in the workshop reaches the required level (such as D, C, B, A). Design reasonable air flow organization, such as unidirectional flow or turbulence, to maintain the stability of air flow and velocity in the workshop.
3. Temperature and humidity control: According to the requirements of drug production, set an accurate temperature and humidity control system to ensure that the workshop environmental parameters are stable within the specified range to protect products from temperature and humidity fluctuations.
4. Pressure difference control: Through the pressure difference control system, maintain a reasonable pressure difference between different clean levels of areas, prevent the low level of air leakage to the high level of areas, effectively prevent cross-pollution.

Construction

1. Material selection: All building materials must meet the standards of dust-free, corrosion-resistant and easy to clean. Walls, floors and ceilings are made of smooth and seamless materials for easy cleaning and disinfection.
2. Sealing treatment: Doors and windows, pipelinesthrough the wall and other parts prone to leakage should be strictly sealed to ensure the air tightness of the workshop.
3. Clean room decoration: clean room decoration should be simple and smooth, avoid too much decoration and convex surface, in order to reduce dust accumulation.
4. Installation verification: After the installation of the purification system, ventilation system, temperature and humidity control system and other key equipment, strict performance verification should be carried out to ensure that the indicators meet the design requirements.

Suzhou Pharma Machinery Co.,Ltd.

2025/02/17

Mia