New rooms for highly potent APIs
Up to date we have worked with substances up to OEB level 3 to 4 in our lab. To expand our support services to HPAPI, as well, we are currently building a new and separate OEB5 laboratory.
Along with a building contractor, we designed this lab completely by ourselves. Unfortunately, the Covid crisis upset our plans and caused delays and supply shortages here and there. However, we are happy to now enter the final implementation phase. We are expecting to go into operation at the beginning of the second quarter of 2021.
Inquire about OEB5 and HPAPI already now.
In our OEB5 lab we will offer services and trials such as:
- • Formulation development
- • Preliminary tests for product transfer and scale-up
- • Pretrials for product optimization
- • Troubleshooting for individual challenges
The design of our OEB5 lab also allows us to install client machines and devices. Of course, for this purpose certain prerequisites have to be fulfilled, such as a protective casing for your machine. We invite you to attend the trials, either by watching through our observation window or even inside the lab wearing a protective suit.
Design and equipment
Since we wanted to fully comprehend the challenges and tailor the new lab individually for our purposes, we decided to plan and design our OEB5 lab by ourselves. This way we were able to implement a top-level safety concept allowing our employees and clients to work in this environment without any concerns or doubts.
We decided to build a whole new room instead of constructing insulating casings for all devices. The room gives us the freedom to use the equipment more flexibly. The OEB5 lab‘s core is a sophisticated ventilation system providing a pressure stage concept and an air exchange rate of up to 30 times per hour. In addition, it is possible to adjust the air humidity within the working area.
For personal protection we use protective suits with external ventilation. To exit the OEB5 area you must pass a double door system and a decontamination shower.
Apart from analytic devices to evaluate tablet and powder characteristics, the OEB5 lab‘s basic equipment includes another single-punch tableting press, the Styl‘One Evo by Medelpharm. If you require different equipment for your trials, please don‘t hesitate to contact us. We designed the room large enough to accommodate a medium-sized tableting press or roller compactor.