Biomedical Engineering Reference
In-Depth Information
Figure 1. Schematic of the fluxes of materials/operations/personnel through controlled contamination
areas. Continuous lines represent means of physical separation (exterior walls, interior walls, transfer com-
partments) or of contamination containment (laminar flux protected areas). Dashed lines borders the
cleanest area. The different areas are monitored for the same parameters (boxed letters, A, B, C) which have
to meet the specifications required for each area (A 0 , A 1 , A 2 , A 3 ,...A N ). Fluxes of materials and operations
are depicted as white arrows, whereas black arrows identify personnel'ins and outs. Access and exit are
allowed through confinement rooms, from the dirtiest (dotted) to the cleanest zone (white), and viceversa.
Note that separate entrance and exit are recommended whenever possible.
Product and/or Process Quality Assessment
In a final rule issued in 1996 15 the FDA has amended the definition of “manufacturer” to
include an applicant for a license. The definition broadly encompasses academic laboratories
and clinics which would assume responsibility for the safety, purity and potency of the final
tissue engineering products even if not directly involved in significant manufacturing steps. By
converse, “manufacturing” becomes broadened to include the more-than-minimal manipula-
tions occurring in autologous cell culturing, as already described.
Whether it comes from the academic or the private enterprise world, the proper docu-
mentation must be submitted to the relevant authorities for the peer review and approval
 
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