Telstar in association with its sister company KeyPlants has developed a pre-engineered modular aseptic facility for manufacturing of small-volume parenterals (SVP). This installation is designed to be adapted to pharmaceutical/biopharmaceutical processes areas requiring to be operated both in aseptic conditions for product protection and/or under contained conditions for operator protection.
The facility, which is designed for either lyophilised powder or solutions, allows handling either vials or pre-filled syringes with a range from two to 20ml. Furthermore, this installation is conceived to be flexible with the ability to add lyophilisation modules and a second line without interruption to existing operations. The line speed is to be from 200 (20ml) to 400 vials (2ml) per minute, with either manual or, if required, automatic loading systems.
The modular concept is an innovative trend in the construction of critical facilities for the pharmaceutical/ biopharmaceutical industry, offering fast track, cost efficient alternatives to conventional design. Furthermore, the modular design provides standardization and repeatability, which further simplifies pre-fabrication and enhances the cost certainty of the project. The modular concept significantly reduces time to market for lifesaving products, such as pandemic vaccines and new cytostatics.
This new modular facility developed by Telstar and KeyPlants will be presented at Interphex 2013, in New York from April 23-25.