Design of GMP Purification Workshop
The GMP purification workshop is to eliminate potential biological activity, dust and pollutants, fundamentally eliminate the impact, and produce high-quality substances. Therefore, the GMP purification workshop must follow the relevant design requirements to ensure that the quality of the products meets the regulatory requirements.
一、Design of purification structure of GMP purification workshop
1、Each production link should be connected to each other, and it should also facilitate the sanitation control during processing to avoid cross-contamination.
2、In terms of layout, it is necessary to follow the processing sequence of the product, so that the product processing transitions from the unclean link to the clean link, and cross and reverse flow are not allowed in the processing process.
3、The GMP purification workshop is equipped with a tool cleaning area, a disinfection room, and a cleaning tank, a disinfection tank and a rinsing tank for public equipment cleaning and disinfection. When necessary, hot and cold water can also be provided, but the temperature of the hot water cannot be lower than 82°C.
4、The purification workshop should have good dust removal ventilation and ensure that the airflow direction should be from the clean area to the non-clean area.
5、GMP purification workshop lamps must be equipped with protective covers.
二、Design of people flow and logistics in GMP purification workshop
1、In order to avoid cross-contamination, operators and materials entering the clean area cannot use the same entrance, and separate purification rooms should be set up or corresponding purification measures should be taken.
2、Only production-related equipment is set up in the clean production area of the GMP purification workshop to avoid food contamination.
3、Ensure that the passage of the clean area directly reaches each production post, intermediate or inner package material storage room, which can effectively prevent cross-contamination of different varieties of food caused by material transportation and operator flow.
4、Under the premise of not affecting the process flow and process operation equipment layout, if the parameters of the air conditioning system are the same, the adjacent clean operation room of the GMP purification workshop can open a door on the partition wall, and use a transfer window or a conveyor belt to transfer materials.
三、Installation and Design of Air Conditioning System in GMP Purification Workshop
The selection of different air supply and return air systems in the GMP purification workshop is a decisive factor in determining the different cleanliness levels of the workshop.
1、Standard combined air-conditioning fan cabinet + air filtration system + clean room ventilation and insulation duct + HEPA effective air outlet + clean room return air duct system. This form can continuously circulate and supplement fresh air into the clean room workshop to achieve the cleanliness required by the production environment.
2、The ceiling of the GMP purification workshop is installed with FFU industrial air purifier to supply air directly to the clean room + return air column return air system + ceiling air conditioner for cooling. This form is generally used in occasions where environmental cleanliness requirements are not very high, and the cost is relatively low.
