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| NEWS 11 | October 2007 |
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1. Facility design (top)
The facility has been designed to perform filling and packaging of pre-formulated injectable products. The facility is equipped with the following rooms:
- Reception, dedusting and storage areas for materials
- Room for equipment preparation and cleaning/washing, equipped with a small WFI generation system, a laminar hood for assembly of tubing and an autoclave to sterilize filling needles
- Filling room with a clinical Crystal® C1 filling line (1,500 vials/hour)
- A room for secondary operations to perform visual inspection, labeling and packaging
- 4°C and room temperature storage areas for filled vials
- A QC lab allowing to perform all in-process control tests and quality control tests.
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2. Scope of inspection (top)
During inspection, a particular emphasis was placed on the new technologies introduced by Aseptic Technologies:
- The Crystal®closed vial technology, including the manufacturing process made in Class A / Iso 5 clean room
- The Validation Master Plan with the test results obtained on raw materials, assembled vials and gamma irradiation process
- The Crystal® filling technology with all validation results obtained, including media fill data
- The concept of using a Non Access Barrier System (NABS) in a clean room class Grade C / Iso 8 / 100,000 dynamic has been approved. A NABS is a barrier system with the additional features - compared to the classical Restricted Access Barrier System (RABS) -of preventing any human intervention in the operating environment. Therefore the doors can never be opened during operation once being closed after the sanitization and any intervention must be carried out only through glove ports
- The connector technology (marketed under brand name Gamma-SART by Sartorius) which eases and secures the aseptic transfer of liquid through a separation between two different room classifications.
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3. Objectives of the filling suite (top) |
| The facility has been set up with the major objectives of filling stability batches for clients who wish to investigate the stability of their product inside Crystal® vial. By being approved as GMP manufacturing site, Aseptic Technologies is now in position to fill stability batches after submitting a request file to the authorities. |
| GSK Biologicals has already planned to launch the filling of a series of vaccines during October to get stability data for their products in the Crystal® vial for preparation of approval files. |
| All parties interested to run stability batches are welcome and should contact us at benoit.verjans@aseptictech.com or at +32 81 409 410 |
| For clinical batch, a file designating Aseptic Technologies as filling site, should be submitted by the client to the relevant authorities. Aseptic Technologies will provide all the necessary support regarding the filling technology aspects of such submission. |
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