Biomedical Engineering Reference
In-Depth Information
and/or are too short to perform bottom-up filling. Bottom-up filling, where
the filling needle penetrates the container and is drawn out during dosing,
is common with high-speed filling to reduce product splash and foaming.
The plastic needles are also not shaped to fit correctly within needle holders
on common commercial filling systems. Custom fixtures are required to use
them on existing machines.
High-speed filling requires needles made to very tight tolerances, particu-
larly the needle diameter, as this has an influence on dosing accuracy and
precision. Because high-speed needles travel during and after dispensing,
needle drip between doses has to be eliminated. Precise needle opening size
and opening shape is also required. Substituting plastic needles with ones
made from stainless steel can solve most of these issues, but is too expensive
for single-use assemblies.
The PreVAS family of aseptic single-use dosing systems by Bosch repre-
sents a major step in dosing system technology. PreVAS is the first completely
preassembled and presterilized dosing system available for the clinical and
production pharmaceutical and biotech filling market that is supplied with
supporting validation documentation. This allows a risk-free scale-up of fill-
ing operations in a single-use format. PreVAS removes several risk factors
from the filling operation. There are no complicated cleaning procedures
and validation protocols required, and the entire system is quickly installed
and made operational (
Figure 9.4
).
PDC Aseptic Filling Systems
The PDC Aseptic Filling Systems (
www.lpsinc.net/pdc
)
specializes in the
design and manufacture of innovative filling solutions used by major bio-
pharmaceutical companies (
Figure 9.5
). Through years of development,
testing, and validation by major biopharmaceutical companies, PDC's tech-
nology allows for aseptic filling within any cleanroom classification, at a
fraction of fixed stainless steel system cost and manifold filling cost. Further,
through the use of proprietary disposable fill system liners, customers have
a fully disposable option eliminating the risk of cross-contamination and
eliminating much of the cost of cleaning and documentation at all levels of
pharmaceutical production.
PDC manufactures aseptic filling systems featuring a unique disposable
sterile fill line. Aseptic filling systems are available to fill bottles, bags, or
drums from 5 mL up to 1,000 L. PDC's disposable filling lines offer single-
use noncontact aseptic filling that can be custom-designed for a variety of
biopharmaceutical filling applications.
