Insertion of the vials into the nest.
FEM simulation of a nest for vials in the ISO formats 2R and 4R. The colors represent the tensions caused by the weight of filled vials.
maceutical manufacturers’ three requirements: that it uses a
nest-and-tub configuration like that for pre-fillable syringes,
that the nest be made using a proven material, and that the
bottoms of the vials be freely accessible to allow for freeze
drying of sensitive pharmaceutical formulations without having to remove the vials from the nest.
The design of adaptiQ™ is based on a nest-and-tub configuration that overcomes the major roadblock that has
prevented a ready-to-fill vial system in the past: Each vial
must be easily and safely removed from the nest for certain
processing steps. Because adaptiQ™ holds each vial by the
neck, vials can be processed without coming into contact
with one another on the filling line, preventing scratches or
breakage that could affect vial integrity.
With the influx of high-priced medicines, such as biotechnological pharmaceuticals, it’s crucial to keep the vial reject
rate low to reduce unnecessary expenses. And by mirroring
the nest-and-tub design used for syringes, adaptiQ™ can be
processed on existing nest filling lines, eliminating the need
for further investments in machinery.
The system will accommodate formats 2R and 4R ISO
initially and then gradually transition to all of the other common ISO formats of 2 to 30 ml.
FINITE ELEMENT METHOD SIMULATIONS DROVE
THE DESIGN FORWARD
In order to ensure the vials and their nest packaging
were prepared for the filling line, SCHOTT ran a number of
finite elements method (FEM) tests to ensure accurate and
efficient filling. Through this process, SCHOTT chose to
form the nest packaging with polypropylene, a well-established material in syringe nests due to its easy development
through injection molding.
To ensure product integrity, the team of developers
used simulations to ensure the nests’ stability during the
freeze-drying and sterilization processes. Furthermore, the
team tested the nests’ ability to bear the weight pressure of
all the vials when filled with fluids (see illustration two).
After developing the nests, SCHOTT worked to ensure a
successful vial-nest connection throughout the filling line.
The vials are secured by their necks within the nest and held
in place by three snap-in hooks. The clips that hold the vials
in place were the main focus of the FEM calculations, since
they are essential to the success of the nest design. The
clips needed to withstand outward bending pressures to ensure the body of the vial could pass through the clips without breaking either component. Also, the clips had to spring
back and securely hold the vial beneath its curled edge if the
vial was inserted to the extent that the clip reaches the vial’s
smaller neck region. SCHOTT also tested the clips to ensure
they held up to the forces and pressures that the filling process would exert on them. The forces calculated proved to
be quite realistic. Robots are able to place the vials into the
nests without difficulty.
REDUCTION IN TOTAL OPERATING COSTS
The increased price for ready-to-use sterile vials compared to conventional vials will be more than compensated.
Total cost of ownership (TCO) considerations have shown
that pharmaceutical companies can reduce their operating
costs by adopting this system solution. There are various
costs that pharmaceutical companies can reduce or avoid by
outsourcing processing steps like depyrogenation, washing,
and sterilization of vials to SCHOTT, leaving pharmaceutical
companies responsible only for filling the vials inside the nest
Pharmaceutical companies can save money on washing
machines, systems for manufacturing water for injection purposes (WFI), sterilization tunnels, and components for filling
systems, such as accumulation sections and rotary discs. By
avoiding sterilization and washing, manufacturers can also
reduce energy and water consumption, shrinking operating costs. In addition, the new
nest-and-tub configuration reduces the
vial reject rate during filling, saving
Although some health care
trends continue to strain
pharmaceutical manufacturers, it is possible to
reduce total operating costs
and find success in the
landscape. With the
implementation of ready-to-use vials, pharmaceutical
companies can take the next
step in providing high-quality
packaging products while reducing overall expenditures. ■
PHARMACEUTICAL PROCESSING | APRIL 2014 15 ■