F
OOD AND
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RUG
A
DMINISTRATION
O
FFICE OF
R
EGULATORY
A
FFAIRS
Office of Regulatory Science
Document Number:
ORA.007
Revision #: 02
Revised:
25 Aug 2020
Title:
Pharmaceutical Microbiology Manual
Page 32 of 92
For the most current and official copy, check QMiS.
The potency of the control standard endotoxin (CSE) with respect to the
reference standard endotoxin (RSE) is determined by the CSE manufacturer.
This information is found in the associated package insert and need not be
repeated.
NOTE: Follow manufacturers’ recommendations for the storage, reconstitution,
and preparation of CSEs, lysates, and other Limulus Amoebocyte Lysate
(LAL) reagents. In case of a dispute, final decision is based on results
obtained with the USP Endotoxin RSE.
The field laboratories are encouraged to mix the reconstituted CSE for at least
5 minutes and for at least 1 minute between dilutions.
2. Negative Controls
Run appropriate negative controls with each sample tested. This assures that
the equipment and solutions used in the test contain no extraneous detectable
endotoxin. This assay requires two negative controls: negative water control
and negative system accessory control. The negative water control (blank)
consists of the pyrogen-free water (Water for BET or LAL Reagent Water)
used in the assay and is tested undiluted. Run a system negative (accessory)
control to test the detectable endotoxin level, if any, of accessories used in the
assay (i.e. beaker full of pyrogen- free test tubes stored for an extended period,
pipette tips, pipettes, sample tubes, syringes, spatulas, etc.). Rinse all
accessories used in the assay with pyrogen-free water and test undiluted prior
to completing all testing for a particular sample. If an alternative diluent is
used, run an alternative diluent control prior to completing all testing for a
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