Key messages
Outsourcing
compounding activities
offers many advantages
to pharmacists, such as
enabling a focus switch to
important clinical support
activities, reducing
the risk of exposure
to harmful hazardous
drugs for operators, or
limiting drug wastage and
high costs involved with
maintaining one’s own
aseptic units. However,
outsourcing is not
a possible option for
every hospital pharmacy
and that is why this article
presents a common
understanding of what
should be considered in
term of microbiological
aspects for good
compounding practices
in hospital pharmacies.
The constant increase of
quality and regulatory
requirements for all
aspects of pharmacy
sterile compounding, as
well as the technology
developments and
continuous innovations,
are clear trends within
the field of compounding.
These evolutions will
undoubtedly continue
to provide compounding
pharmacists with a
better and safer working
environment, so that they
can ensure the exemplary
quality and the
absolute safety of every
compounded product.
The extensive
compounding competence
of Fresenius Kabi and the
comprehensive range of
diagnostic solutions of
bioMérieux can provide
you with not only
a deep understanding
of your daily needs and
challenges, but also with
selective support and
solutions beyond the
ordinary scope to improve
your compounding
activities.
with USP <797> subject high-risk compounded
sterile preparation, that is, non-sterile active
pharmaceutical ingredient (API) to sterile
preparation, to the USP <71> Sterility Tests. By
conducting sterility tests on low- and medium-risk
preparations they can extend the beyond use dating
improving inventory control and drug availability.
The USP <71> Sterility Tests is harmonised with its
European Pharmacopeia equivalent (Ph. Eur. 2.6.1
Sterility Testing). The quantity of products per unit
and the number of units tested is specified in Tables
2 and 3 of the compendial test. Both pharmacopeia
allow for the use of alternate test method provided
they can be shown as comparable to the compendial
test during method validation.
Bacterial endotoxin testing of sterile
compounded preparations
Another critical quality attribute of sterile
compounded preparation is the bacterial endotoxin
level within the preparation. Sterile buffered saline,
which is a common vehicle, has a bacterial endotoxin
limit of 0.25EU/ml. The limit for a specific CSP is
determined by the route of IV administration, weight
of the patient, the maximum human dosage, the
rate of administration and the volume administered.
The test methods, that is, gel clot, turbidimetric
and colorimetric are described in USP <85> Bacterial
Endotoxin Tests and is harmonised with the European
Pharmacopeia chapter 2.6.14 Bacterial Endotoxins.
Conclusions
Pharmacy sterile compounding makes a significant
and invaluable contribution to the healthcare by
providing customised medications for patient care.
Microbial contamination risks are higher than with
industrial pharmaceutical manufacturing. However,
with proper facilities, well-managed compounding
operations and good aseptic handling techniques,
these risks can be largely mitigated.
About Fresenius Kabi
Fresenius Kabi is a global health care company that specialises in
lifesaving medicines and technologies for infusion, transfusion, and
clinical nutrition.
Fresenius Kabi is committed to being a full-service partner, with not
only its broad expertise but also a full-range and most comprehensive
product portfolio for core therapeutic areas including enteral and
parenteral nutrition products, IV generic drugs, infusion therapies
and standard solutions, as well as automated compounders and the
medical devices for administering these products.
In virtue of its corporate philosophy “caring for life”, Fresenius Kabi
employs more than 37,000 people worldwide committed to putting
essential medicines and technologies in the hands of people who help
patients and finding the best answers to the challenges they face.
Aiming to shape the future of health care in providing products
and services to help and to improve quality of life to chronically and
critically ill patients in hospitals and outpatient care all around the
globe, Fresenius Kabi also offers a comprehensive compounding
competence to those who seek compounding excellence. Its extensive
global experience is backed up by the highest commitment to product
quality and safety: from assistance with facility design, to jointly
funded and managed facilities on a client’s site, or to fully outsourced
compounding services providing patient- specific ready-to-use
medications. Fresenius Kabi compounding centres, designed and
operated to comply with full good manufacturing practice standards
across four continents, provide every year several millions of IV and PN
compounded sterile preparations. Maintaining industry-level standards
in all Fresenius Kabi compounding facilities worldwide requires
obviously high levels of quality, strong expertise of qualified and
experienced personnel, premium facilities and equipment, and stateof-the-art
production processes. Fresenius Kabi holds itself to the
highest standards of responsibility
and competence: to ensure that
compounded preparations are
manufactured or compounded
both safely and accurately first
time, every time.
About bioMérieux
A global leader in in vitro diagnostics for more than 50 years,
bioMérieux has always been driven by a pioneering spirit and
unrelenting commitment to improving public health worldwide.
Today, in more than 150 countries through 43 subsidiaries and a large
network of distributors, bioMérieux provides diagnostic solutions that
improve patient health and consumer safety.
bioMérieux industrial microbiology solutions enable faster,
more precise diagnostic results, designed to optimise customers’
productivity and profitability by streamlining workflows. With expert
consultation and consistent, accurate testing solutions, bioMérieux
helps customers protect their brand reputation among business
partners and end consumers alike.
Speed and quality are paramount in compounding pharmacy.
Knowing your product is free of contamination allows for faster releases
– giving you greater flexibility to respond to changes
in demand and a competitive advantage in the
market. With a comprehensive range of diagnostic
solutions, bioMérieux delivers the rapid, accurate
results that help you protect your consumers,
your brand reputation – and ultimately, your
bottom line.
38 | Issue 91 | 2019 | hospitalpharmacyeurope.com