Flexible Lyophilized Injectable Manufacturing
It has been widely recognized that the global pharma industry is currently experiencing dynamic change, especially for biotech industry. Withers & Rogers’ study in particular bolsters the paradigm that big pharma is shifting its development focus from small molecule chemicals to large molecule biologics in recent years. And the personalized medicine requires ever more flexible and versatile processing and packaging solutions. Smaller batch sizes shift the emphasis from speed and mass production of standard dosage products to more individualized products packaged in high-quality materials. Short start-up times, easy changeovers and a high degree of automation are key considerations. Meanwhile pharmaceutical manufacturers are now expected to quickly produce a wide variety of products at significantly lower volumes. These changes have placed increased pressure on drug makers to accelerate product development while reducing development costs.
These new drivers are pushing many pharmaceutical companies to look beyond traditional batch manufacturing processes and begin experimenting with a variety of continuous and flexible manufacturing techniques. Flexible Lyophilized Injectable Manufacturing has the following typical features: high value, low volume, automation and isolation, flexible production line for multiple containers and multiple products, ready-to-use technology and disposable technology are widely applied.
At Achema Frankfurt 2015, Tofflon shows its latest developed Combo Filling Line for Flexible Lyophilized Injectable Manufacturing. Its key features are as below:
(1) Flexible manufacturing: syringes, cartridges, liquid vials and lyo vials combined in one line;
(2) RTU Technology;
(3) Single Use Technology;
(4) In-process Control (IPC) Technology;
(5) Isolator Technology;
(6) Expandable Automation Design;
The Combo Filling Line is capable for multiple containers and multiple products with rapid changeovers. It can be flexible for syringes, cartridges, liquid vials and lyo vials in one line. For syringes/cartridges, their processing includes semi-automatic de-bagging, automatic de-lid/de-liner, In-Process-Control (IPC), aseptic filling with peristaltic pump and single-use disposable components, stopper plugging with vacuum insertion. For liquid vials/lyo vials, their processing includes bulk vials washing with rotary washer, sterilization with sterilization tunnel, In-Process-Control (IPC), aseptic filing with the same peristaltic pump and single-use disposable components, half or full stoppering, capping with capper. In case of lyo vials, their processing also includes fixed (Row-by-Row) auto loading and unloading, lyophilization and full stoppering.
Today ready to use (RTU) glass containers are being developed for pharmaceutical use. It has been applied to clean, sterile, depyrogenated and ready to fill vials, cartridges and syringes in a next & tub format. The solution allows pharmaceutical companies to reduce upstream operations linked to containers preparation, sterilization and validation thanks to a lean, modular and smart solution that improves efficiency.
Single Use Technology
The early biopharmaceutical production line is designed to manufacture a single product and all hard piping is with portable or disposable equipments. Tofflon Combo Filling Line widely combines the single use technology during the production .With the shift to smaller batches, the increase of use highly potent substances and highly industry safety regulations, there rises up the use of single-use, pre-validated, pre-assembled and pre-sterilized components including hoses, buffer bag, filling needles and tubing to improve the production efficiency and capacity without the required time-consuming CIP/SIP throughout the process between batches. The single use technology largely minimizes the risk of contamination between batches run.
In-process Control (IPC) Technology
To improve In-Process Control and reduce high-value products loss, In-Process Control (IPC) Technology is applied for both syringes/cartridges and liquid/lyo vials. At the beginning and end of one batch, 100% IPC will be requested. In the middle of production, statistical IPC will be applied.
Current Good Manufacturing Practice (cGMP) Guidelines require dedicated facilities to minimize the risk of contamination. Tofflon Combo Filling Line is designed with integrated barrier systems [Active oRABS, cRABS and Aseptic and (or) Toxic Isolator].
Expandable Automation Design
As part of Flexible Manufacturing Model, Tofflon adopts “Expandable Factory Design Concept” - rapidly add modules as needed. Presently “Just Enough” and In the future “Just-in-time” to add modules as needed. Therefore Tofflon Combo Filling Line offers expandable automation design: At Stage One: Automation based on Local Control. Stage Two: Local Control can be rapidly upgraded to “DCS”. In the future Stage Three it can be further built as part of MES.
Industry, especially in USA, Europe and Japan, is shifting from site stability
to site agility. This shift can be seen as moving from operating in the known
towards dleaing with a higher degree of uncertainlty and complexity. Through
providing Flexibel Lyophilized Injectable Manufacuturing Solution – new
technologies and practices, Tofflon supports our biological customers to be more
flexible in their operations, making it easier to be successful in an uncertain
and dynamic environment. Your success is our value.