Board and Department of Health Share
Sterile Compounding Lessons Learned
Chief Medical Officer for the Tennessee Department of Health
David Reagan, PhD, MD, and former Acting Director and current
USP Sterile Compounding Investigator Trainer Terry Grinder,
DPh, discussed lessons learned over the last year. Many of these
same topics are covered in the USP 35 Chapter <797> sterile
compounding section. This summary includes:
1. Sterile Process
a. The process to ensure appropriate sterile technique
should be clearly documented, and staff authorized
to perform sterile compounding should be
appropriately trained and observed performing the
standard process routinely as a part of their ongoing
authorization to compound.
b. Protective apparel should be available and used
appropriately to allow maintenance of sterility
during operations; no makeup or jewelry should
be worn.
c. Equipment coming in contact with sterile product
must be sterile. Careful attention to sterile surfaces,
including gloves, hoods, and other equipment, is
essential.
d. Sterile equipment or supplies are usually supplied
in packaging whose outside is nonsterile. Proper
handling of the nonsterile packaging is essential to
maintenance of a sterile field.
e. Manipulation of compounded sterile products
following any sterilization step(s) should be
minimized so as to not to introduce any risk of
contamination. Final product sterilization should be
the last step in the compounding process, or as close
to the last step in product preparation as possible.
f. Careful attention is needed to environmental control
measures and should include ongoing monitoring
and recording of pressure differentials from the
cleanest to clean to dirty rooms as applicable.
2. Labeling, Storage, and BUD
a. Product should be clearly labeled with beyond-use
dates (BUD) and storage specifications, based on
USP Chapter <797> risk levels and the appropriate
storage conditions (room temperature, refrigerated,
or frozen) as well as product testing (unless product
is prepared in batches of 25 or less).
b. Sterile products may not be packaged in a manner
labeled or implied as multi-patient use. The
term “multi-dose vial,” when applied to injectable
medication, is reserved for Food and Drug Administration
(FDA)-approved manufactured products
using FDA-approved labels.
c. Repackaging of manufactured injectable medications
(eg, dividing a manufacturer-supplied singledose
or single-use vial into syringes) requires
clear labeling and packaging to facilitate product
trace-back.
d. Lot numbers should be specific for product, product
formulation, date, and batch.
3. Preservative-Free Medication Formulation Considerations
a. Preservative-free medication should only be used
for a single patient (ie, single package, single-dose
vial)
b. Please refer to USP Chapter <797> to determine
BUDs, but for high-risk preservative-free medication,
the BUD established should not exceed three
days when sterility testing is not performed.
4. Quality Assurance and Equipment Maintenance
a. Thoroughly document successful completion of
sterilization steps, such as use of an autoclave.
b. Autoclaves should have documentation of load
configuration studies, biological indicators, and
parameters (temperature, time, and pressure).
c. For those compounding over 25 doses of medication
in a batch, testing of sterility of product that
been formulated for distribution is needed, with a
clear documentation chain.
d. A clearly documented process should be in place
to guide and monitor equipment cleaning, maintenance,
and use.
e. Quality control information falling outside of
expected values must be immediately assessed
and remedied, including removal of unused
product from all potentially affected lot(s) from
distribution.
f. Media-fill test procedures should be performed
under conditions that closely simulate the most
challenging or stressful conditions encountered
when compounding high-risk products.
g. Procedures for receiving and investigating complaints
must be in place, operating in a timely way,
and well documented.
h. Rejected components or products should be sequestered
from other components.
5. Record Keeping
a. All relevant information regarding the compounded
product should be well documented. Such records
should be easily retrievable (and preferably electronically
maintained) for at least two years from
the last date dispensed.
b. Linkage between lot numbers and distribution
(eg, invoices) and significant process records (eg,
autoclave, sterility testing records, and operator)
must be created, maintained, and easily retrievable.
Pharmacies operating outside FDA registration as manufacturers
are not permitted to supply compounded sterile product
(including repackaged products) to a third party such as a distributor
or sales agent.
quoted from here
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