Isolator production line is the future development trend of high-end drug production process, aiming at the products with toxicity or high added value such as anti-tumor drugs, monoclonal antibody biological drugs, etc. From the perspective of improving the degree of sterility protection, reduce the operational risk of personnel and meeting the EHS requirements, more and more pharmaceutical manufacturers favor the use of isolator production line as the production equipment in the core area.
Based on the current demand for the application of isolator production lines, Tofflon has developed an isolator production line named KUFill and launched it in the international market.
KUFill, literally, is composed of two words, i.e. "KU" + "Fill". As the name implies, "KU" stands for "Cool" and "Fill" stands for "Filling". One is Chinese and the other is English, the combination of which represents the Sino-Western cultural exchange, collision and integration, and also verifies the philosophy of "Convergence of global technology, service for pharmaceutical industry" of Tofflon.
KUFill stands for the coolest and most advanced filling production method, which is not just a set of equipment or a production line, but a production model in the broad sense, and the production concept developed around the isolator.
KUFill system has the following characteristics:
The isolation advantages of production line are self-evident.
Firstly, as isolator is a completely closed barrier system, the use of isolators can prevent manual errors as much as possible from the physical means and avoid cross-contamination;
Secondly, although the initial equipment investment of isolator, first certification and other costs are relatively high, the use of isolator can greatly reduce the operating costs in the later stage, such as air-conditioning operation, clothing changing, environmental monitoring and other expenses as the isolator is located in the class C or D background environment;
Thirdly, for the products with high toxicity and high allergenicity, the use of isolators has become a standard approach around the world, i.e. using isolators to protect the operators;
Fourthly, isolator is also the versatile king, which can create a variety of environments to meet the process requirements of different products, such as the products that require low-temperature filling, products that need protection from light in production, and products that require explosion protection, etc.
It is worth noting that when using KUFill system production line, isolation design needs to be considered for the entire process.
The application of KUFill production line can meet the requirement of flexible production, with one production line compatible with the production of different forms and different products. For example, we recently manufactured a KUFill production line for a foreign company, which supports 2 ~ 100ml specification vials, and vial freeze dried, vial water needle and vial powder separately packaged products can be produced in the same production line at the same time.
In addition, the KUFill production line can also realize the production of bulk vials, RTU (Ready To Use) packaging materials, such as vials, pre-infusion needles and card-type bottles in the same production line by quick and simple specification piece replacement. Such production mode is specifically suitable for the pilot scale production of some products with high added value and multiple specifications.
The biggest problem of foreign similar isolator production lines is the long design and manufacturing cycle, and each production line is non-standard custom product. The whole line requires coordinated processing due to the different suppliers involved and thus the complicated hardware and software interfaces. And a lot of time is wasted in the repeated design communication in the early stage. It can easily take 18 to 24 months of production cycle from the initial design to the completion of FAT of such production line, which is a reality hardly acceptable to domestic pharmaceutical manufacturers.
To shorten the manufacturing cycle of KUFill production line, Tofflon makes modular design in the equipment aspects, including the function and appearance of stand-alone equipment, hardware and software interface between equipment. As the entire KUFill production line Provided is provided by one equipment supplier, overall design can be made according to the requirements of customers to solve all the problems internally in the form of joint project team, which can greatly shorten the delivery cycle of KUFill production line.
A Tofflon overseas project took only 24 months signed from the signing of KUFill production line contract, until the overall workshop FDA verification, which also proved the advantage of the shortened delivery time attributing to the modular design of production line.
Photo with isolator is preferred
KUFill production line system adopts a combination of CS and BS architecture, where a master server monitors and controls all the equipment on the entire production line.
Production instructions are issued by the central control center server to each device on the production line, which has changed the previous situation in which each device requires separate opening operation. Through the remote data monitoring system, the working status of KUFill system at as far as overseas sites can be monitored through network here in Tofflon. Remote monitoring and maintenance of the entire system is allowed within the limits of authorization.
KUFill system also provides reserved seamlessly interfaces with the factory MES system. The entire system can be integrated with the MES system for overall coordinated control.
To sum up, KUFill system has the following advantages:
1. Achieve a better level of sterility and regulatory compliance;
2. Save production operation, verification and validation costs
3. Realize multi-product, multi-standard compatibility, multi-use for one production line;
4. Have standardized process docking interface, which can shorten the delivery time of the entire production line
5. Accomplish intelligent production with less manpower.