| |
 |
| NEWS 11 | June 2008 |
 |
1. Equipment (top)
The new L1 equipment (L standing for Laboratory) development program has been launched to enlarge our range of filling lines by addressing specifically the small lot manufacturing business. Until now, two equipment formats were proposed to the pharmaceutical manufacturers:
- Clinical lines (mainly C2) with a capacity of 3,000 vials/hour designed to produce lots from ~5,000 up to 40,000 vials per day. Typical applications are large clinical batches and commercial lots for products with limited market size (1 to 5 million vials/year)
- Production lines (P6, P12, P18 and P24) ranging from 9,000 up to 36,000 vials/hour designed to produce large commercial batches from 5 up to over 70 million vials/year
The new L1 filling machine, with a typical capacity of ~400 vials per hour, will perfectly meet development needs for research lots in the closed vial or small stability and clinical batches of 500 to 4,000 vial size, but will be also suitable for small production of niche products (e.g., radioactive products, cell therapies,…). This equipment allows Aseptic Technologies to offer from now a complete range of equipment to fill daily lots from few hundreds up to half a million vials. The first lines are planed to be delivered in the first half of 2009.
The major characteristics of the L1 equipment are:
- Classical Crystal® technology, i.e. filling of ready-to-fill closed vials by means of the well-known process of stopper piercing, stopper laser-resealing and snap-fit capping .
- Several containment configurations will be available depending on product requirements (ranging from cleanroom environment up to isolator for very potent products)
- Very limited space required as the central equipment will be limited to a space of approximately 1 m² size
- Use of robotic technology to ensure fast, reliable and accurate process
- Vials are processed in racks placed manually and processed automatically
- Flexible vial entry procedure, according to client needs and processes.
|
 |
The development is conducted with pharma and biotech interested to acquire the technology. If this program is of interest for your company, please contact Benoît Verjans at benoit.verjans@aseptictech.com. The objective is to have the first equipment installed at client site in the first half of 2009. |
2. Lyophilization with Crystal® technology (top)
Initially, the Crystal® technology was only designed for liquid filling of non-lyophilized vials. Nevertheless, as the related key advantages of the Crystal® technology (safer and easier) provide competitive advantage to pharmaceutical drugs, some asked us to benefit from the same advantages for lyophilized products. The outcome of our investigation was a radically innovative solution to perform safer and easier lyophilization. The major steps of the process are:
- The vial is pierced and filled but not laser re-sealed (piercing trace is naturally re-closed thanks to elastomer elasticity)
- A “penetrator” with a funnel shape is placed on top of the closed vial
- Inside the lyophilizator at the start of the cycle, the shelves are lowered to push down the “penetrator” which re-open the piercing trace
- Lyophilization is made across the re-opened trace
- At the end, the shelve is lifted up and the vial will naturally re-close thanks to the elasticity of the stopper
- To ensure complete closure integrity, the vial is then laser re-sealed and capped as for a normal liquid vial.
|
 |
Once the concept being established, various tests have been conducted. The first products were classical solutions such as lactose 5% and 10% followed by more complex ones such as sucrose 5% and 10%, all showing that lyophilization can be performed in the closed vial without changing the lyophilization cycles defined for glass vials.
A new major step has been reached by performing lyophilization of viruses. Three different kinds of viruses have been lyophilized using both glass and Crystal® vials and identical lyophilization cycles. The outcome is:
- The lyophilization cakes presented a very nice visual appearance
- Level of water in cake was around 1% as with glass and no water is released from stopper (not washed)
- The titer of recovered viruses was identical for both technologies
|
3. ISO 9001 certification (top) |
| Aseptic Technologies has obtained its ISO9001-2000 certification in December 2007, illustrating its commitment to serve optimally its clients. |
|
|
|
|
 |
|
|
Back
|
|
|
|
|
|
|
|
|