Texas Register, Volume 37, Number 35, Pages 6819-7008, August 31, 2012 Page: 6,935
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of sterile Soybean--Casein Digest Medium are transferred with the
same sterile 10-milliliter syringe and vented needle combination into
separate sealed, empty, sterile 30-milliliter clear vials (i.e., four 5-mil-
liliter aliquots into each of three 30-milliliter vials). Sterile adhesive
seals are aseptically affixed to the rubber closures on the three filled
vials. The vials are incubated within a range of 20 - 35 degrees Celsius
for 14 days. Failure is indicated by visible turbidity in the medium on
or before 14 days. The media-fill test must include a positive-control
sample.
(ii) Medium risk preparations.
(I) Quality assurance procedures for medium-
risk level compounded sterile preparations include all those for
low-risk level compounded sterile preparations, as well as a more
challenging media-fill test passed annually, or more frequently.
(II) Example of a Media-Fill Test Procedure.
This, or an equivalent test, is performed at least annually under
conditions that closely simulate the most challenging or stressful
conditions encountered during compounding. This test is completed
without interruption within an ISO Class 5 air quality environment.
Six 100-milliliter aliquots of sterile Soybean--Casein Digest Medium
are aseptically transferred by gravity through separate tubing sets
into separate evacuated sterile containers. The six containers are then
arranged as three pairs, and a sterile 10-milliliter syringe and 18-gauge
needle combination is used to exchange two 5-milliliter aliquots of
medium from one container to the other container in the pair. For
example, after a 5-milliliter aliquot from the first container is added
to the second container in the pair, the second container is agitated for
10 seconds, then a 5-milliliter aliquot is removed and returned to the
first container in the pair. The first container is then agitated for 10
seconds, and the next 5-milliliter aliquot is transferred from it back to
the second container in the pair. Following the two 5-milliliter aliquot
exchanges in each pair of containers, a 5-milliliter aliquot of medium
from each container is aseptically injected into a sealed, empty, sterile
10-milliliter clear vial, using a sterile 10-milliliter syringe and vented
needle. Sterile adhesive seals are aseptically affixed to the rubber
closures on the three filled vials. The vials are incubated within a
range of 20 - 35 degrees Celsius for 14 days. Failure is indicated by
visible turbidity in the medium on or before 14 days. The media-fill
test must include a positive-control sample.
(iii) High risk preparations.
(I) Procedures for high-risk level compounded
sterile preparations include all those for low-risk level compounded
sterile preparations. In addition, a media-fill test that represents
high-risk level compounding is performed twice a year by each
person authorized to compound high-risk level compounded sterile
preparations.
(II) Example of a Media-Fill Test Procedure
Compounded Sterile Preparations Sterilized by Filtration. This test,
or an equivalent test, is performed under conditions that closely sim-
ulate the most challenging or stressful conditions encountered when
compounding high-risk level compounded sterile preparations. Note:
Sterility tests for autoclaved compounded sterile preparations are not
required unless they are prepared in batches of more than 25 units.
This test is completed without interruption in the following sequence:
(-a-) Dissolve 3 grams ofnonsterile commer-
cially available Soybean--Casein Digest Medium in 100 milliliters of
non-bacteriostatic water to make a 3% nonsterile solution.
(-b-) Draw 25 milliliters of the medium into
each of three 30-milliliter sterile syringes. Transfer 5 milliliters from
each syringe into separate sterile 10-milliliter vials. These vials are thepositive controls to generate exponential microbial growth, which is
indicated by visible turbidity upon incubation.
(-c-) Under aseptic conditions and using
aseptic techniques, affix a sterile 0.2-micron porosity filter unit and a
20-gauge needle to each syringe. Inject the next 10 milliliters from
each syringe into three separate 10-milliliter sterile vials. Repeat the
process for three more vials. Label all vials, affix sterile adhesive seals
to the closure of the nine vials, and incubate them at 20 to 35 degrees
Celsius. Inspect for microbial growth over 14 days as described in
Chapter 797 Pharmaceutical Compounding--Sterile Preparations, of
the USP/NF.
(B) Finished preparation release checks and tests.
(i) High-risk level compounded sterile preparations.
All high-risk level compounded sterile preparations that are prepared
in groups of more than 25 identical individual single-dose packages
(such as ampuls, bags, syringes, and vials), or in multiple dose vials
for administration to multiple patients, or are exposed longer than 12
hours at 2 - 8 degrees Celsius (36 - 46 degrees Fahrenheit) and longer
than six hours at warmer than 8 degrees Celsius (46 degrees Fahrenheit)
before they are sterilized shall be tested to ensure they are sterile and
do not contain excessive bacterial endotoxins as specified in Chapter
71, Sterility Tests of the USP/NF.
(ii) All compounded sterile preparations that are in-
tended to be solutions must be visually examined for the presence of
particulate matter and not administered or dispensed when such matter
is observed.
(iii) The prescription drug and medication orders,
written compounding procedure, preparation records, and expended
materials used to make compounded sterile preparations at all contam-
ination risk levels shall be inspected for accuracy of correct identities
and amounts of ingredients, aseptic mixing and sterilization, packag-
ing, labeling, and expected physical appearance before they are admin-
istered or dispensed.
(13) Quality control.
(A) Quality control procedures. The pharmacy shall
follow established quality control procedures to monitor the com-
pounding environment and quality of compounded drug preparations
for conformity with the quality indicators established for the prepa-
ration. When developing these procedures, pharmacy personnel
shall consider the provisions of Chapter 797, Pharmaceutical Com-
pounding--Sterile Preparations, Chapter 1075, Good Compounding
Practices, and Chapter 1160, Pharmaceutical Calculations in Prescrip-
tion Compounding of the current USP/NF. Such procedures shall be
documented and be available for inspection.
(B) Verification of compounding accuracy and sterility.
(i) The accuracy of identities, concentrations,
amounts, and purities of ingredients in compounded sterile prepara-
tions shall be confirmed by reviewing labels on packages, observing
and documenting correct measurements with approved and correctly
standardized devices, and reviewing information in labeling and
certificates of analysis provided by suppliers.
(ii) If the correct identify, purity, strength, and steril-
ity of ingredients and components of compounded sterile preparations
cannot be confirmed such ingredients and components shall be dis-
carded immediately.
(iii) If individual ingredients, such as bulk drug sub-
stances, are not labeled with expiration dates, when the drug substances
are stable indefinitely in their commercial packages under labeled stor-
age conditions, such ingredients may gain or lose moisture during stor-ADOPTED RULES August 31, 2012 37 TexReg 6935
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Texas. Secretary of State. Texas Register, Volume 37, Number 35, Pages 6819-7008, August 31, 2012, periodical, August 31, 2012; Austin, Texas. (https://texashistory.unt.edu/ark:/67531/metapth253227/m1/116/: accessed April 30, 2024), University of North Texas Libraries, The Portal to Texas History, https://texashistory.unt.edu; crediting UNT Libraries Government Documents Department.