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:
I Isolation
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.
II Flexibility
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.
III. Modularization
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
IV. Intelligentization
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.