Biomedical Engineering Reference
In-Depth Information
8. More than 80% of new products utilize disposable systems, and
almost 70% of existing manufacturing processes have been modi-
fied to include disposable systems.
9. The main concerns about the use of disposable systems in the order
of importance are
a. Capital investment
b. Experience in using these systems
c. Validation and environmental concerns
d. Concern about leachables and extractables
e. Integrity of systems
10. European regulatory agencies, as well as European companies, have
greater concerns for leachables and extractables, and while the FDA
allows greater flexibility in adopting newer systems, the EMEA has
drifted away from common acceptance criteria.
11. The most widely used disposable components are bags and biopro-
cess containers, followed by filters (which constitute the main cost
concern), connectors, bioreactors, mixing vessels, chromatography,
and sensors. This trend shows that the simplest of the components,
which require little problems in validation, are the easiest to adopt;
obviously, chromatography and the use of disposable sensors would
present a much high barrier to validation.
12. The unmet needs of the industry in adopting disposable pro-
cesses include
a.
Leachables
b.
GMP compliance of disposable sensors, calibration scale
c.
Robustness of sensors and chromatography equipment
d.
Reliable bioprocessors that are cheaper
e.
Scalability
f.
High volume and flow rates
g.
Lack of single-pressure flow and temp transmitter
h.
Larger scale, greater than 100 L
i.
Standardization
j.
Lab scale, less than 3 L
13. Most companies have allocated less than US$100 K for disposable
products.
14. The main reasons for adopting disposable systems:
a.
Cleaning/sterilization cycle
b.
Convenience
c.
Flexibility
