Adapt to the industry:Suggested grade for health products: Grade 100 to 100000

Environmental requirements for GMP purification workshop of health products:

An air purification system should be configured based on the variety of health food, production operation requirements, and external environmental conditions to effectively ventilate the production area, with temperature control and necessary humidity

Control and air purification filtration to ensure the production environment of health food. Tablets, capsules, soft capsules, oral liquids, pills, granules, powders, teas, pastes and other health supplements

The exposure process area for food exposure workwear and packaging materials that come into direct contact with health food should be set up in accordance with the requirements of the D-level clean area in Appendix A. Enterprises may

Take appropriate microbiological monitoring measures for the area based on the standards and characteristics of the product.

Purification workshop supporting (auxiliary) equipment:

The weighing room and material preparation room set up in the clean room (area) should have an air cleanliness level consistent with production requirements and facilities for dust capture and prevention of cross contamination. The production workshop should

Set up tool container cleaning and storage rooms for the cleaning and storage of production tool containers; Sanitary ware rooms and storage rooms should be set up for cleaning and storing cleaning tools.

Factory buildings should have dust prevention and capture facilities when necessary. In areas with the same level of air cleanliness, operating rooms with high dust production should maintain relative negative pressure. Clean rooms with high dust production

If cross contamination cannot be avoided through dust capture treatment, the air purification system shall not use return air

Pressure, temperature and humidity process:

The static pressure difference between the clean room (area) and the outdoor atmosphere should be greater than 10 Pa, and there should be a device for indicating the pressure difference. The air cleanliness requirement is to maintain relative negative pressure between adjacent rooms (areas)

The static pressure difference should comply with regulations, there should be a device to indicate the pressure difference, and the pressure difference should be recorded.

The temperature and relative humidity of the clean room (area) should be suitable for the production process requirements. If there are no special requirements, the temperature should be controlled at 18C-26% C and the relative humidity should be controlled at 45% -65%.