The single-use assembly consisted of a filter module connected to a 50L header bag, a pump line and needle assembly. For the
isolator extension, a Getinge LaCalhene alpha port was added to the current restricted access barrier to permit the sterile
transfer of fill lines and needles through the connection to the mating single-use Getinge LaCalhene beta bag. The flowpath
was selfcontained and had limited assembly, increasing operator safety and reducing contamination risk. The hard piped filling
module was replaced by a roll-up peristaltic pump skid to add flexibility to the existing line, which can now run fixed setups
with time pressure, as well as single-use assemblies through an alpha beta connection for new products.
The comparisons between the traditional and single-use fill finish processes at this manufacturer are shown in Table 2. Overall, the campaign fill time was reduced from 36 h to 12 h. In the new configuration, the rate-limiting factor in manufacturing
became the preparation of the drug formulation rather than the facility.
Table 2: Comparison between a traditional and a single-use fill–finish process at a pandemic flu vaccine manufacturing facility.
The new process required less than six months to commission, and in the 85 million doses filled to date, there have been zero
contaminations. Equipment utilisation increased from 35% to 82%, and there was a significant drop in energy use due to the
elimination of CIP/SIP.
A growing number of pharmaceutical and biopharmaceutical companies are exploring the potential of single-use systems to deliver
lean process improvements. The main drivers for adoption are rapid facility start-up, flexible operations, and elimination
of the chemical, utility and labour requirements for cleaning.
When incorporated as part of a larger, overall strategy to reduce waste and process time, improve process consistency and
facilitate technology transfer, single-use systems can deliver measureable benefits and impact the bottom line.
Vikas Gupta is Merck Millipore Group Product Manager, Mobius Single-use Products and Services. email@example.com
Tel. +1 781 533 3264
M. Holweg, Journal of Operations Management
25(2), 420–437 (2007).