Industry Progress Improves
Technological advancements lead to higher quality products.
Kimberley Schmitt, Associate Editor
As the freeze drying/lyophilization process has progressed over the past few years, the industry has encountered advancements in technology that can improve the process. Whether it is
exploring alternatives to glass vials or utilizing the latest
control systems ensuring quality and reducing waste, the
freeze drying/lyophilization process offers users technological advancements to produce quality products.
Processors can see advancement in the use of isolators
and barrier equipment. With the ever increasing regulatory requirements, processors are encountering the use of
isolators or barrier equipment to reduce contamination.
“LSNE performs a risk assessment and acquires a toxicology review of all incoming compounds so we can be sure
that we are using the proper level of containment to minimize personnel exposure and cross-contamination,” says
Christine Palus, vice president of sales and marketing for
Lyophilization Services of New England.
Additional safe handling efforts are required as the need
for smaller and more sophisticated freeze dryers continues
to grow. “As technology progresses, drug potency increases
and the amount of product in the vial is reduced,” says T.N.
Thompson, president of Millrock Technology, Inc. “Smaller
vials are being used and the value of the product is increas-
ing…The higher potency drugs also drive the need for safer
handling and the need for isolators and sterilization.”
In order to optimize lyophilization cycles while minimiz-
ing risks, DSM Pharmaceuticals, Inc. looked toward freeze
dryers with oversized condenser capacity and liquid ni-
trogen cooling where isolators and barriers minimize risks
from operator intervention or contamination.
AVAILABLE OPTIONS FOR VIALS
While traditional glass vials have remained a mainstay in
the lyophilization process, some people in the industry note
the potential use for other materials. Utilizing other materials would offer several benefits. Lars Waldmann, process development manager at Pharmalucence, Inc., recognizes that
one benefit to a glass vial alternative is the possibility to
reduce the number of broken vials. However, he also notes
the concern about the age and viscosity of plastics.
According to Jeremy Griffin, with Grand River Aseptic
Manufacturing, glass vial alternatives include container systems manufactured from plastic or with a special coating.
“The technology looks pretty promising, but it is still waiting to be scrutinized by regulatory agencies,” he says.
Palus has seen some movement away from traditional
glass vials, specifically towards the Crystal Zenith resin vials. “They are a good alternative since their dimensions are
similar to the standard glass vials, and they can be filled on
LSNE (above) utilizes the proper level of containment to minimize personnel exposure and cross-contamination. DSM Pharmaceuticals, Inc. (left)