A manufacturing site of a multinational biopharmaceutical company in the USA produces at its site more than 10.000 liters of bulk drug substance per year. In order to diminish storage capacity at their production site, the customer has changed their primary packages of drug substance to single-use bags recently and now uses bags with a filling volume of 12 liters.
The customer figured out that the increase of storage density did not yet become reality, by reason that only two bags could be placed on one pallet for shipping with the initially implemented bag based technology. The problem of inefficient piling of the BDS (bulk drug substance) in single use bags for storage and shipping could not be solved yet.
- Single Use Support has been informed about the situation and has offered their support. The goal was to find a solution to increase storage density for both,
- during international transportation with holding the temperature lower than -50°C after one week (> 168 hours), but also in-plant storage in cooled storage rooms
RoSS (Robust Storage and Shipping) shell has been selected as a robust secondary packaging solution for the single use bags. The combination of both, single use bag and RoSS, makes them a cost-effective solution, as they require little storage space. RoSS shells are available for all sizes and suppliers of single use bags and can be stacked with high flexibility.