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The production of cytostatics not only needs to ensure product safety and reliability, but also puts forward high requirements for safe production and labor protection. In contrast, the production requirements for medical parenteral nutrition infusions are relatively loose. In order to be able to complete the production tasks of two different drugs in one production site, the manufacturer decided to adopt a separate clean room.
The production of cytostatics not only needs to ensure product safety and reliability, but also puts forward high requirements for safe production and labor protection. In contrast, the production requirements for medical parenteral nutrition infusions are relatively loose. In order to be able to complete the production tasks of two different drugs in one production site, the manufacturer decided to adopt a separate clean room.
Eurozyto, a medical product manufacturer located in Königstein, Germany, has built production lines for two different products under different clean room conditions in the same plant. These two ultra-clean laboratories are isolated from each other and close together for the production of non-toxic Oral nutrition and cytostatics. After several months of planning, design and building construction, the production line has started production.
The production process of parenteral nutrition solution needs to follow the regulations of Chapter 13 of the German Drug Act, and a Class B ultra-clean laboratory conforming to GMP EU should be built. For the production of toxic cytostatic drugs for cancer treatment, in addition to the absolute quality and safety of drug production, it is also necessary to absolutely ensure that production workers are not harmed by any toxic and harmful substances, and prevent any spillage and leakage of particulate matter, which is harmful to the clean room. Purity and production process monitoring place high demands.
Part 1 Strict Isolation
In order to ensure the highest safety and reliability, Eurozyto has built two ultra-clean laboratories, Class A and Class B. Pharmacist Mr. Uwe-Bernd Rose said: “We want to achieve the highest quality and highest safety and reliability, so there is no compromise or compromise in the technical equipment of the laboratory. Separation of toxic and non-toxic production areas, Eliminate the possibility of cross-contamination. When choosing clean room equipment, we are looking for experts with rich experience in ultra-clean laboratory manufacturing, which ensures the consistent and safe production process of ultra-clean laboratories.”
The final choice of ultra-clean laboratory manufacturer is Schilling Engineering Technology Company. The Clean Stericell clean room system independently developed and produced by Schilling meets the requirements of GMP drug production quality standards and ensures the highest drug safety.
The new ultra-clean laboratory is equipped with access isolation rooms and work preparation rooms of approximately 100 m2 each. Each laboratory has a multi-level personnel and raw material access isolation system to ensure that different production process requirements are met, and safety and reliability are also improved. In the three-level personnel entering and leaving the isolation room and the subsequent work preparation room that are connected in this way, the cleanliness is sequentially improved, the pressure difference at each level is sequentially reduced, and the air exchange rate is sequentially increased, until it meets the requirements of B-level precision in GMP. The cytostatic production workbench is guaranteed to be free of bacteria, ensuring personal safety during the production of anticancer drugs.
The ultra-clean laboratory for the production of infusion liquid for parenteral nutrition is equipped with a laminar flow aseptic workbench. The protective area of laminar flow isolation gas is connected to each other as a whole; the laminar flow gas control device with ULPA high-efficiency filter provides pure isolation air for clean areas and sterile workbenches according to the principle of non-vortex uniform flow air supply. The air circulation system and the air recovery purification and reuse system are integrated in the sandwich wall of the ultra-clean laboratory. The circulating air system developed by Schilling makes the circulating air reach the temperature adjusted by the air conditioner, and has better energy saving performance than similar equipment. The monitoring system conforming to GMP regulations conducts accurate and continuous monitoring of various parameters of the ultra-clean laboratory. One of the major innovations of the clean room system is the connection between the walls: the walls assembled with the silicone-free GMP seal-clip system make the walls of the clean room free from any wear and tear, and can be directly disassembled for expansion or reconstruction of the clean room.
Part 2 Continuous Monitoring
The CR Control control system conforming to GMP requirements ensures the continuous monitoring of the ultra-clean laboratory and the accurate adjustment of indoor working parameters. The functions of the entire ultra-clean laboratory can be centrally controlled and parameter configuration and adjustment when necessary through the touch screen on the control wall. Through the pressure, humidity and temperature sensors connected to the control system, the working parameters of each area of the ultra-clean laboratory can be accurately measured, and the detection data can be sent to the display. The monitoring system also detects the degree of dirt in each filter and displays maintenance information. Functional failures in the ultra-clean laboratory, such as the door not being closed properly, will emit a clear sound prompt. Equipment and functions such as indoor lighting and air conditioning can be controlled individually. The at-a-glance monitoring system provides high reliability in ultra-clean laboratory safety.
Part 3 Completed The Project With A Record
Within 16 weeks, Schilling completed the design, installation, commissioning and delivery of the ultra-clean laboratory. Mr. Uwe-Bernd Rose was impressed by the efficient completion of the project. He said: “The construction of the clean room has set a new record. Schilling’s technicians have done an excellent job. They have a wealth of project experience. I am full of confidence in the products and firmly believe that the current ultra-clean laboratory will help us provide safe and reliable medicines to patients.”