Biomedical Engineering Reference
In-Depth Information
TABLE 11.1
Unitary Comparative Cost of Manufacturing of a
Biological API Using Stainless Steel and
Disposable Systems
Category Stainless Steel Disposable
Capital charge 37 10
Materials 14 11
Media 3 3
Buffer 1 1
CIP 1 1
QC tests 9 6
Consumables 11 14
Resins/MA 4 4
Bags, disposables 0 3
Filters 7 7
Labor 29 17
Process 11 10
Quality 14 5
Indirect 4 2
Other 10 5
Insurance and other 2 2
Maintenance 2 1
Utilities 6 2
TOTAL 100 57
Note: The capital cost is the amortization assuming the
facility is built in Europe or the United States.
Source: Data for stainless steel from Sinclair, A., How
geography affects the cost of biomanufacturing,
BioProcess International , June 2010, 516-519.
of Medical Instrumentation (AAMI), the International Organization for
Standardization (ISO), and ASTM International (formerly the American
Society for Testing and Materials). Validating the sterility of an irradiated
bag can be a difficult and expensive process.
Gamma irradiation is the application of electromagnetic radiation (gamma
rays) emitted from radionuclides such as Cobalt 60 (60 Co) and Cesium 137
(137 Cs) isotopes. Gamma rays are not retarded by most materials and can
penetrate through most disposable bioprocess system components. Living
organisms are inactivated by damage to their nucleic acids resulting from
this ionizing irradiation. Gamma rays are also not retained by material and
leave no residual radioactivity.
Gamma irradiation dosage is measured in kilogray (kGy) units, which
quantify the absorbed energy of radiation. One gray is the absorption of 1 J of
radiation energy by 1 kg of matter (1 kGy = 1 J/gm). Dosages ≥8 kGy are gen-
erally adequate to eliminate low bioburden level. In cases where bioburden
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