| |
 |
| NEWS 13 | February 2009 |
 |
1. Facility of the Year category winner (top)
Aseptic Technologies has built a filling facility equipped with a Closed Vial Filling Line, clinical format. This line, with a capacity of 1,500 vials/hour, has been set up to fill stability and clinical batches for the pharmaceutical and biotech companies willing to investigate the compatibility of their product with the Crystal® technology prior taking the major decision to install this technology in their own facility.
In order to fill clinical batches and stability batches supporting product approval, the facility has been approved by the Belgian authorities representing the European Medicines Agency (EMEA). In addition, two drug master files (DMF) have been filed at the American Food and Drug Agency (FDA).
The decision to install the building has been taken in March 2005 and the first inspection by the Belgian authorities took place in June 2006, i.e., only 18 months after initiating the whole project. The complete file has been submitted in January 2007 and the approval by the Belgian authorities has been granted in July 2007.
The facility, representing 400 m² of clean room, includes a washing room equipped with a double door autoclave, the filling suite with the Closed Vial Filling Line, a downstream processing room, a cold room for storage of bulk containers and filled vials of thermo-sensitive products and a QC lab.
As theCrystal® technology is a real innovation in aseptic filling (by providing better quality for the patient thanks to a permanently closed and unbreakable vial and by simplifying all operations), Aseptic Technologies has taken the decision to submit the facility for the “Facility of the Year” awards. The innovative aspects have been recognized by the jury as a real progress to improve the quality of aseptic filling operations.
|
 |
| Closed vial filling line in Aseptic Technologies pharmaceutical facility |
If you want to use our facility to fill stability batches, please contact us at benoit.verjans@aseptictech.com or at +32 81 409 410 |
2. Laboratory L1 line (top)
To address the market of very small batches (from few hundreds up to 5,000 vials/batch), Aseptic Technologies has decided to launch the development of very small and inexpensive filling line. Its key characteristics are:
- Capacity: ~600 vials/hour
- Filling, laser re-sealing and capping performed by a robot with a multi-function head.
- Vials of different sizes are delivered in sterile racks which are placed and secured manually by the operator. Once rack in place, the operator can start the robot which performs the three operations in a row.
- The standard equipment is equipped with a peristaltic pump and a cap dispensing vibrating bowl. Other type of pumps suitable for the Crystal® technology can be used as well.
- The line has been optimized for the Crystal® technology but is also able to easily perform filling and stoppering of glass vials.
- The line can be surrounded with multiple format of barrier. The various options are no barrier (subunit to be installed in an existing barrier), separation barrier to be installed in clean room, Closed Vial Filling System (CVFS), isolator, isolator for potent product or bio-hazard isolator.
|
 |
| The Laboratory L1 line in Aseptic technologies workshop |
The Crystal® L1 Laboratory has been successfully tested and will be presented at Interphex (New York, March 17-19, booth 873) and Achema (Frankfurt, May 11-15, booth 3.1 O1). You are welcome to visit us and discover the Crystal® technology through live demonstrations.
|
|
|
 |
|
|
Back
|
|
|
|
|
|
|
|
|