Integrity and assurance of the container chosen for the storage of an API or bulk intermediate is paramount. The negative implication of contamination at this stage can be economically significant. Minimizing the risk of contamination not only falls on the reliability of the components used to transfer the fluid to the container but is dependent on the container itself.
The choice between flexible and rigid solutions for the storage of a valuable drug substance is a challenging consideration. There are a variety of materials, shapes, and sizes in single-use disposable formats on the market today that provide integrity, stability, and assurance in addition to chemical resistance and durability.
Nalgene brand single-use, certified, sterile, rigid, containers are available in well-characterized and validated materials. This portfolio of containers ranges from small-volume options such as vials to large carboys all manufactured from the same materials, enabling stability studies to be performed on a smaller, more economical scale. In addition, these materials are all tested to ensure biological compatibility and compliance to regulatory standards.
The use of flexible bags is ever increasing due to the space-saving features. The conversion to flexible systems, however, is not without its challenges, one being how to store your bag without compromising the contents. This is extremely important under frozen conditions.
While rigid containers offer well documented durability at conditions of -80°C and below, flexible bags are more susceptible to cracks and tears. In addition, multiple bags can be difficult to lift, transport, and store when filled. The new Nalgene Bioprocess Bag Management System addresses all of these issues. Molded of a rigid polymer, the stackable, clamshell-like design provides a durable, protective barrier offering a combination of rigid and flexible systems; it is also designed to mate with commonly available “pillow” bag containers such as the 5 L and 20 L Thermo Scientific Hyclone BioProcess Container™.
The wealth of equipment and consumables available to the bioproduction industry is constantly expanding. The opportunity to source all materials such as instrumentation (shakers, incubators, and rack systems), automation, culture ware, as well as fluid transfer and containment solutions from one source can be quite efficient.