3123111
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Transcript of 3123111
7/17/2019 3123111
http://slidepdf.com/reader/full/3123111 1/1
Page 117
1. What does "prefilled" mean? (Opposite of reconstituted)
2. Classification of containers according to their abilit to protect their contents from e!terna conditions
he USP classifies containers according to their abilit to protect their contents from e!ternal
conditions. he minimall acceptable container is a#ell$closed container% it protects the contents
from e!traneous solids and from loss under ordinar conditions of handling& shipment& storage& and
distribution. ' tight container protects the contents from contamination b e!traneous liuids& solids&
or apors& from loss of the article& and from efflorescence& deliuescence& or eaporation under the
ordinar or customar conditions of handling& shipment& storage& and distribution and is capable of
tight re$closure. ' hermetic container is imperious to air or an other gas under the ordinar or
customar conditions of handling& shipment& storage& and distribution. *terile hermetic
containers generall hold preparations intended for in+ection or parenteral administration. ' light$
resistant container is intended to proide protection from light.
' single$dose container is one that holds a uantit of drug intended as a single dose and #hen
opened cannot be resealed #ith assurance that sterilit has been maintained. hese containers
include fusion$sealed ampules and prefilled sringes and cartridges. ' multiple$dose container is a
hermetic container that permits #ithdra#al of successie portions of the contents #ithout changing
the strength or endangering the ualit or purit of the remaining portion (ials).
Page 1,-
. /numerate different "terms" general emploed in storage labeling #ith their specefic temperature0conditions
to ensure the stabilit of the pharmaceutical preparations for the period of the intended shelf$life
Page 1,
're there an difference bet#een labels for npatient and Outpatient 3abels drug orders?