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and to supervise each of these functions. Alcon P.R. was solely
responsible for resolving any problem that arose during the
period from the time that it received the corium up until the
time that the finished Avitene was delivered to a carrier for
delivery to MedChem U.S.A. (manufacturing process).
Alcon P.R. generally manufactured Avitene in accordance with
a two-phase process and kept its inventory of finished Avitene in
its warehouse attached to its manufacturing facility. Avitene’s
two-phase manufacturing process was as follows:
Phase I
(1) Frozen corium and component materials were
ordered from the warehouse attached to the Avitene
manufacturing facility and transferred to a preparation
room in the facility, where the corium was thawed and
machine washed.
(2) The corium was machine cut into approximately
4 square inch pieces, manually inspected for
imperfections, and machine cut into smaller pieces of
approximately one square inch in size.
(3) The smaller pieces were acidified, washed with
alcohol, and tested against product specifications.
(4) The resulting product was refrigerated while
the initial steps were repeated for a second lot of
corium; the two lots were mixed together and dried in a
rotary dryer.
(5) The dried corium was machine milled into a
loose, powdery, fibrous substance known as bulk flour.
The bulk flour was placed in quarantined cages awaiting
further processing into its final form as either
finished flour or nonwoven web.
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