Comprehensive workshop:
Jiangxi Biological Comprehensive Workshop, including antiserum penicillin bottle preparation production line (Line A), antiserum ampoule preparation production line (Line B), antiserum pilot test line (Line C), supporting auxiliary area and storage area, has a total building area of 6850 m2, including penicillin bottle washing, drying, filling and rolling linkage line, aseptic isolator, full-automatic liquid preparation system, full-automatic lamp leak detection machine and other equipment, with an annual output of 80 million bottles of antiserum preparation The pilot line can meet the requirements of pilot research and development of antiserum products with different specifications and dosage forms.
3 production lines
6850 square meters
Annual production of 80 million bottles
Highlights of comprehensive workshop:
Strict quality management system
Standardize production in strict accordance with GMP requirements to ensure the quality and safety of drug production.
Highly automated production system
Build an advanced automatic production line in China to maximize production efficiency and ensure drug quality.
Global advanced production process
Adopt international advanced technological process for production and keep the technological level leading through continuous technological transformation.
Introduction to some production equipment and systems:
Purified water system
The company is equipped with a set of two-stage reverse osmosis purified water treatment unit, with a water production capacity of 4T/h. The purified water is made from raw water filtered by quartz sand and activated carbon, and then by two-stage reverse osmosis. It is mainly used for dilution of horse plasma in the pulp feeding and digestion process, cleaning in the production process, and as the source of water for injection and pure steam.
Water for injection system
The company is equipped with a multi effect distilled water machine, with a water production capacity of 2T/h. The water for injection is made by using purified water as raw water, heating it with industrial steam and multi effect distillation. In actual production, it is used for insulation circulation above 70 ℃, mainly for alum adsorption, semi-finished product preparation, etc.
Clean air conditioning purification
Heating and cooling and computer system
The tetanus antitoxin production line of the company is equipped with three clean areas, namely Grade D, Grade C and Grade A/B. Each clean area is equipped with an independent air conditioning purification system, which is controlled by an automatic control system. By regulating the temperature, air volume and differential pressure of the air conditioning purification system, the clean environment can meet the production requirements. A set of water cooling unit is configured in the workshop machine room to provide refrigerant for the production area.
Product purification, ultrafiltration machine, washing, drying, filling and sealing linkage machine and full-automatic packaging production line
The company has configured one ultrafiltration machine, which uses 50KD ultrafiltration membrane cells. The product can be concentrated and refined through ultrafiltration; The washing, drying, filling and sealing linkage line consists of an ultrasonic bottle washing machine, a sterilization tunnel oven and a filling machine, which can complete the processes of ampoule cleaning, dry heat sterilization and liquid medicine filling; The company has a fully automatic packaging production line with a production capacity of 500 bottles/minute, which can complete such processes as sub palletizing, labeling, placing in palletizing, and cartoning.
Online monitoring system
In order to strengthen the management of the whole process of aseptic production of products, the company has installed an online monitoring system in the key operation area of the antiserum production line, which mainly monitors suspended particles, floating bacteria, wind speed and other indicators. When the monitored indicators exceed the standard, the system will automatically alarm and the production operation will be suspended, Production can be resumed only after the monitoring indicators are normal and evaluated. Through online monitoring, the operation in the core area can be controlled in the whole process and the drug quality can be effectively guaranteed.