Aseptic processing line integrated with Isolator is applied to biotech industry, aiming at oncology drugs, novel injections and antibody drugs, etc. From the perspective of improving the level of sterility assurance, reducing the operational risk of personnel and meeting the EHS requirements, more and more biopharma manufacturers favor the use of isolator production line in the critical aseptic processing of lyophilized injectables.
To meet the Biotech growth demand in global market, Tofflon has developed an advanced flexible injectables system integrated with isolator named KUFill and launched it into global market.
KUFill is Cool
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 Tofflon philosophy "Synergy global technology, serve pharma industry".
KUFill stands for the coolest and most advanced lyophilized injectables system, which is not a set of equipment, but an advanced drug manufacturing platform.
Features of KUFill
KUFill System has the following features:
Firstly, as isolator is completely closed barrier systems, the use of isolator can prevent manual errors as much as possible from the physical barrier and avoid cross-contamination.
Secondly, comparing with traditional clean room, the use of isolator can greatly reduce the operating costs, such as air-conditioning, gowning change, environmental monitoring and other costs as the isolator is located in the Grade C or D background environment instead of traditional Grade B+A clean room design.
Thirdly, for the products with high toxicity and high potency, the use of isolator has become a standard approach around the world, i.e. using isolator 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, isolation design needs to be considered for the entire process.
The application of KUFill System can meet the requirement of flexible manufacturing, with one production line compatible with the production of different containers and different products. For example, we recently manufactured a KUFill System, which supports lyo vials, liquid vials and powder vials to be manufactured in the same production line.
In addition, Tofflon KUFill System can also work for bulk lyo vials and RTU (Ready to Use) containers, such as nested vials, nested syringes and nested cartridges in the same production line by quick and simple changeover. Such combo line is specifically suitable for the pilot-scale production of biotech drugs with high value and multiple containers.
To achieve faster time to market, Tofflon adopts modular concept in the equipment design, hardware and software interfaces design between upstream and downstream equipments. As the whole KUFill System is supplied from one source, complicated interfaces can be solved within one project team, which greatly shorten the life cycle of system project.
In summary, KUFill System brings you the following benefits:
• Faster time to market.
• Lower financial investment.
• Flexible and expandable factory.
• A complete line solution through one point contact.
• Strong technical support and service for cGMP compliance.