Different Containment Levels
With Glatt’s Lab Containment Technology, Corden Pharma Plankstadt is now able to perform all necessary steps in the tableting process in five containment stations. The flexibility of these solutions makes it possible to carry out different lab processes consecutively by transferring the intermediate material from one barrier to the next under full containment, resulting in customized and highly efficient operations. The ergonomic design has simplified operations such as the docking and undocking of the process tables. The RTP port allows the safe and contamination- free filling and discharging of the raw materials and components at all times. The design of the process equipment makes handling easy, even with the use of gloves in isolator mode.
The lab containment technology is available with three different OEL working range levels, enabling maximum flexibility for each requirement:
- The first option allows working with an open pane down to the OEL “>10 μg/m³”. This OCS (Open Containment System) is based on clean air technology which prevents contamination and allows safe operation.
- The second option, known as OCS Plus, is an open containment system which includes a sliding glass pane.
- The third option, a CCS (Closed Containment System) is equipped with a closed front window and allows operations at OEL levels below 1 μg/m³. During the entire production process, the highly potent product is surrounded by a defined airflow which reliably keeps particles away from the personnel and contained in the barrier system, avoiding contamination of the surrounding area and maintaining product integrity.
Each of the containment stations mentioned are equipped with an inflatable seal which automatically secures the process table in place in the containment station’s clean room area. The containment stations can be connected through the RTP port. The product and components can be transferred in and out of the individual barriers by an RTP container.
Whatever containment requirements one may have, Glatt offers solutions where various lab-scale processes can be operated in parallel, such as weighing, granulating, drying, blending, coating, and even a full wet granulation line, each in different Containment Stations/Barriers separated from each other while still fully contained.
Glatt’s containment expert Michael Maintok states: “At Glatt, we focus on keeping lab processes safe at all times. We formed an excellent partnership and, by pooling our know-how to achieve the very best results, we developed an innovative technology which was implemented in cooperation with the barrier manufacturer Weiss Pharmatechnik.”
Corden Pharma’s expertise in the production of highly potent APIs and Drug Products is derived from decades of experience, the systematic application of new technologies and scientific learning, a risk-based approach as part of their Quality by Design (QbD)-driven development strategy, and their Glatt Lab Containment Technology.
* * The author is Head of Marketing at Glatt GmbH in Binzen/Germany, Contact: Phone +49-7621-664-145