Biomedical Engineering Reference
In-Depth Information
helped the case of equipment manufacturers. The suppliers have responded
by providing excellent support to clients by providing data on the leachables
in their products. Equipment manufacturers have also teamed up with CROs
who are willing to conduct full GLP studies for just a few thousands of dollars
to provide fully qualified data. It is anticipated that there would be no way out
of conducting these studies even if parts of the plastic components are replaced
with materials such as Teflon or Gore-Tex that do not leach: there will always be
a component in the line of components that would make the study essential.
Animal Origins
Responding to the risk of bovine spongiform encephalopathy (BSE) and trans-
missible spongiform encephalopathy (TSE), companies have begun avoiding
animal-derived stearates used in polymerization reactions. To comply with
worldwide requirements, the use of animal-derived components in the manu-
facture of plastics will cease.
The Stainless Challenge
Single-use technology has been used in the biotechnology industry for almost a
decade, yet very few manufacturers have switched or retooled their facilities to
solely single-use equipment. Companies with existing conventional infrastruc-
ture in stainless steel, and considering the associated asset depreciation, are
resistant to changing to single-use equipment. There is also a lack of familiarity
with the renovation and the cost of building a new facility. With stainless steel,
the resistance occurs with facilities that already have stainless steel equipment
that is validated: they do not want to implement disposable-type operations.
If there are validated preexisting stainless steel systems within a facility
where some process operations could go completely disposable (e.g., chro-
matography steps, tangential flow filtration, and sterile filtration), there is
more resistance to change to disposables systems.
Standardization
As disposable components found their way from downstream to upstream,
from filters and buffer preparation to bioreactors, equipment suppliers
