Biomedical Engineering Reference
In-Depth Information
Category I includes well-established disposables that came a long time
ago, and these include analyzer sample caps, culture containers, flasks, titer
plates, petri dishes, pipette and dispensing tips, protective clothing, gloves,
syringes, test tubes, and vent and liquid filters.
Category II includes line items that were necessitated by the problems
in cleaning validation. These became fully accepted about a decade ago
and included aseptic transfer systems, bags, manifold systems, connectors,
tri-clamps, flexible tubing, liquid containment bags, stoppers, tank liners,
and valves.
Category III includes the most recent trends within the past five years and
includes bioprocess containers (though the first one was introduced in 1996 by
Wave, it became mainstream only after GE Healthcare bought Wave), bioreac-
tors, centrifuges, chromatography systems, depth filters and systems, isola-
tors, membrane adsorbes, diafiltration devices, mixing systems, and pumps.
There are many published surveys of the industry reported in the litera-
ture and, while these statistics can be tainted because the equipment suppli-
ers support most of these, a few general trends that are established include
[please refer to the Bibliography on the sources of these surveys.]:
This is the current state of the use of disposable systems as of 2010
(BioProcess International Survey summary):
1. The use of disposable bioprocessing is growing at the rate of 30%
per year.
2. The biopharmaceutical or biological manufacturing industry con-
sumes almost one-third of all disposable products used, followed by
the biodiagnostic industry.
3. The CROs are least likely to use disposables because of the capital
cost investment and the fact that they are used to the adaptability of
the hard-walled systems.
4. Most of the adaptations of disposable technology are in the United
States, comprising two-thirds of all worldwide use, and with Europe
a distant 50% of the United States.
5. The companies with fewer than 100 employees constitute about one-
third of customers and so are the companies with more than 5,000
employees; the midsize companies are taking longer to evaluate the
merits of disposable systems.
6. Three-fourths of the companies using disposable systems are using
these for manufacturing, with less than 10% of companies involved
in drug discovery using disposable systems.
7. Companies with more than six products account for almost 60% of
all disposables used.
