Contract Research Organizations (CRO) & Contract Development Manufacturing Organizations (CDMO)
Producing small batches to support development of a new products, batches for clinical studies or small scale manufacturing requires the right equipment to mimic the conditions for future batches and scale-up. Small batch manufacturing does not run efficiently on standard, higher-speed production lines. Even where changeovers are possible, they are time-consuming and inefficient. In contrast, every SP Versa-Line component is compact and has a small footprint to ensure the minimal occupation of cleanroom space. This compactness enables quicker, and more straightforward changeovers during fill-finish production.
Every piece of SP equipment required for the fill-finish process has a modular, standardized footprint, and therefore production lines can be customizable based on room design and space. The filling and stoppering module is versatile to accommodate liquid or powder filling into vials or syringes by simply exchanging change parts. This feature expands your site capabilities to work on different projects. Standardization supports less challenging isolator installation and restricted access barrier systems (RABS) adaption, which regulate the environment to meet regulatory requirements and reduce the risk of contamination during aseptic processing. Critically, standardized modules safeguard the establishment of best practice, rapid set-up, reliability, a shorter lead-time, and a shorter time to production.
For an exploratory discussion on your fill-finish manufacturing project, please contact SP and we will connect to our specialist team.