Telstar, in association with sister company KeyPlants, has developed a pre-engineered modular aseptic facility for the manufacture of small-volume parenterals (SVP).
The Spanish company says the facility can be adapted to pharmaceutical/biopharmaceutical processes areas that must be operated 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 either vials or pre-filled syringes from 2 to 20ml to be handled. Furthermore, its flexibility means that lyophilisation modules and a second line can be added without interruption to existing operations. The line speed is 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, says Telstar. It also provides standardisation and repeatability, which further simplifies pre-fabrication and enhances the cost certainty of a project. In addition, it can significantly reduce time to market for lifesaving products, such as pandemic vaccines and new cytostatics.
