CASE STUDY
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6. MICROBIOLOGICAL AIR AND
SURFACE MONITORING
6.2.3 Viable air sampling data
evaluation and action levels
Viable airborne particle counts
by ISO classification must not
exceed actionable levels:
ISO 5 > 1 cfu/m3
ISO 7 > 10 cfu/m3
6.3.3 Surface sampling data
evaluation and action levels:
ISO 5 > 1 cfu/media device
ISO 7 > 10 cfu/media device
The decrease in
staff needing to
enter the cleanroom
associated with
remote verification
can also be used as
a control mechanism
to decrease viable
air and surface
contaminants.
11. MASTER FORMULATION AND
COMPOUNDING RECORDS
11.1 Creating Master Formulation
Records (MFR)
An MFR is a detailed record of procedures
that describes how the CSP is to be
prepared. An MFR must be created for all
CSPs prepared from nonsterile ingredient(s)
or CSPs prepared for more than one patient.
11.2 Creating Compounding Records (CR)
CR documents the compounding of
each CSP. A CR must be created for all
Category 1, Category 2, and Category
3 CSPs. A CR must also be created for
immediate-use CSPs prepared for more
than one patient. The CR must be created
to document the compounding process.
A prescription or medication order or
label may serve as the CR. If an ACD,
workflow management system, or other
similar equipment is used, the required
information in the CR may be stored
electronically as long as it is retrievable
and retains the required information.
The following
DoseEdge
functionality can be
used in aggregate to
support most/all the
requirements for the
contents of an MFR
and CR, and help
ensure that the MFRs
and CRs are followed:
• Customizable
Drug Formulary
• Customizable
Product Formulary
• Customizable
Actions
• Customizable
Procedures
• Customizable
Scan Events
• Storage
capabilities
• Customizable
product-specific
information fields
12. RELEASE INSPECTIONS AND TESTING
12.2 Sterility Testing
For Category 2 CSPs assigned a BUD
that requires sterility testing (see
Table 13) and all Category 3 CSPs,
the testing must be performed.
12.3 Bacterial Endotoxins Testing
Category 2 injectable CSPs compounded
from one or more nonsterile component(s)
and assigned a BUD that requires
sterility testing and Category 3 injectable
CSPs compounded from one or more
nonsterile component(s) must be tested
to ensure that they do not contain
excessive bacterial endotoxins.
Customizable Actions
and/or Procedures
can be used to
remind compounders
when sterility and/or
bacterial endotoxin
testing (or other
requirements) needs
to be completed.
14. ESTABLISHING BEYOND-USE DATES
Each CSP label must state the date, or
the hour and date, beyond which the
preparation must not be used and must
be discarded (i.e., the BUD). The BUD is
determined from the date and time that
preparation of the CSP is initiated.
14.2 Parameters to Consider
in Establishing a BUD
When establishing a BUD for a
CSP, compounders must consider
parameters that may affect quality.
The BUDs for CSPs are based primarily
on factors that affect the achievement
and maintenance of sterility, which
include, but are not limited to:
• Conditions of the environment
in which the CSP is prepared
• Aseptic processing and
sterilization method
• Starting components (e.g., sterile
or nonsterile ingredients)
• Whether or not sterility
testing is performed
• Storage conditions (e.g.,
packaging and temperature)
14.3 Establishing a BUD for a CSP
The BUD must not exceed the
shortest remaining expiration
date of any of the commercially
available starting components.
14.5 Multiple-Dose Containers
The use of preservatives must be
appropriate for the CSP formulation
and the route of administration. For
example, the preservative must not be
inactivated by any ingredients in the
CSP, and some preservatives are not
always appropriate for the patient (e.g.,
neonates) or route of administration (e.g.,
intrathecal or ophthalmic injection).
After a multiple-dose CSP container
is initially entered or punctured, the
multiple-dose container must not be
used for longer than the assigned BUD
or 28 days if supported by antimicrobial
effectiveness testing results on
the CSP, whichever is shorter.
BUDs are
automatically
calculated from the
time the compounding
process is initiated.
They can be
customized and
automated to
account for the many
options that are
available between
and within the three
Compounding
Categories
BUDs can be
customized at the
dose level based on:
• Starting
components
used in the dose
• Location of
preparation
(environmental
conditions such
ISO classified
vs SCA/RABS)
• Storage conditions
• Processes used
during preparation
(including
sterility testing)
The BUD of individual
doses are compared
to the BUDs or
expiration dates of the
components used in
dose to ensure they
are appropriate.
With ‘Preservative-
free” and “Route
of Administration”
designations in the
Product Formulary,
inappropriate
component use
can be prevented.
“Work in Progress”
products and labels
can automate BUDs
for components used
during preparation