The goal of GMP required by biopharmaceutical companies is to ensure the establishment of a scientific and strict sterile drug production environment, process, operation, and management system, to minimize all possible and potential biological activity, dust, and pyrogen contamination, and to produce high-quality, hygienic, and safe drug products. The biopharmaceutical purification engineering GMP cleanroom engineering solution and pollution control technology we refer to are one of the main means to ensure the successful implementation of GMP;

Through in-depth research on the production environment of biopharmaceutical clients and accumulated engineering experience, we have a clear understanding of the key factors in environmental control during the biopharmaceutical production process; Energy conservation is a top priority in our system solution; Our expertise lies in providing customers with environmental solutions that comply with GMP and Fed 209D, ISO14644, IEST, EN1822 international standards, while also utilizing the latest energy-saving technologies; We can provide GMP whole plant planning and design, including human and logistics purification solutions, clean air conditioning systems, and clean decoration systems; Comprehensive installation and supporting services for energy-saving renovation of the entire factory, water and electricity, ultra pure gas pipelines, clean room monitoring, maintenance systems, etc;

Biopharmaceutical Purification Engineering GMP Cleanroom Engineering Solution Description:
1、 Overview
The biological aseptic production workshop of XX company is a three story reinforced concrete structure factory building with a building size of 121x18 meters and a single floor area of 2268 square meters. The first production workshop is located on the west side of the first floor, with a building height of 5 meters and a beam bottom height of 4.2 meters; The injection molding workshop is designed with a ceiling height of 3.0 meters, while other areas have a ceiling height of 2.6 meters; The raw material crushing and batching room is 2.4 meters long. Mainly produces sterile disposable medical equipment. Designed as a 100000 level domain with air conditioning area.

1) Good Manufacturing Practice for Drugs (Revised by the Ministry of Health in 1992);

2) Design Specification for Cleanrooms in the Pharmaceutical Industry (1997)

3) Guidelines for the Implementation of Good Manufacturing Practice for Drugs (1992)

4) Design Specification for Cleanroom (1984)

5) Design Code for Heating, Ventilation and Air Conditioning (GBJ19-87)

6) <Sterile Medical Device Production Management Specification>(YY/T-0033-90)

7) The process layout plan and other relevant technical materials provided by Party A;

3、 The production workshop is divided into general production area, control area, and according to the production process and product quality requirements. Set up personnel shoe changing area, men's and women's first and second changing rooms, hand washing, hand disinfection, laundry room, air shower channel, clean pedestrian corridor, logistics and cargo shower corridor, injection molding room, rubber pad dust blowing, central storage, assembly room, inner packaging room, outer packaging room and machine room, logistics, etc. The computer room is located in the original small room on the third floor and needs to be treated with sound insulation and earthquake resistance; The cooling tower and cooling pump are located on the third floor ceiling; The operating load of the equipment meets the load-bearing requirements of the floor slab.

4、 Personnel flow direction: changing shoes, changing clothes, washing hands, hand disinfection - air shower channel - clean corridor - clean workshop

Install safety doors in the purification workshop and corridors to facilitate personnel evacuation.

Product flow direction: Logistics channel - Cleanroom - Finished product packaging