SPONSORED
Environmental monitoring
programmes suitable for
sterile compounding
This article presents a common understanding of both Fresenius Kabi and bioMérieux for good
compounding practice, and reviews microbiological testing as related to sterile compounding.
Topics discussed include environmental and personnel monitoring, media fills and the release
testing of compounded sterile preparations. Although the topic is approached from a US point-ofview,
the information will be useful for benchmarking by European compounding pharmacists,
and for consideration for improving compounding practice
Tony Cundell PhD
Dr Cundell consults
with a number of
pharmaceutical,
consumer health and
dietary supplement
companies,
microbiology instrument
manufacturers, contract
testing laboratories and
sterile compounding
pharmacies in the
areas of microbial
risk assessment,
regulatory affairs, and
microbiological testing.
Prior to November 2013
he worked for Merck
Research Laboratories
in Summit, New Jersey,
as the Senior Principal
Scientist in early phase
drug development. Earlier
in his career, Dr Cundell
worked at a director level
in Quality Control and
Product Development
organisations at the
New York Blood Center,
Lederle Laboratories,
Wyeth Pharmaceuticals
and Schering-Plough.
He is a member of
the 2015–2020 USP
Microbiology Committee
of Experts where he
takes a leadership role
in the area of modern
microbiology methods,
co-chairing the USP
Expert Panel that
published a stimuli article
in the Sept–Oct 2017
Pharmacopeial Forum
entitled The Development
of Compendial Rapid
Sterility Tests.
Sponsored by the Business Unit Compounding of
Fresenius Kabi (in collaboration with bioMérieux).
Sterile compounding can be defined as the
preparation of an individual drug to meet
a physician’s prescription that is administered
directly to the patient. In the US, compounding is
performed or supervised by a pharmacist licensed
by a state board of pharmacy. A compounded sterile
preparation (CSP) meets the unique needs of an
individual patient when commercially available
drugs do not meet those needs in terms of dosage,
mode of administration and formulation. A patient
might not be able to take the commercially available
drug, or might require a drug that is currently in
short supply or discontinued.
In the Autumn of 2012, a multi-state fungal
outbreak associated with a compounded sterile
preparation manufactured in a large scale for
interstate commerce changed the global
regulatory landscape in both the US and Europe.
On 21 September 2012, the US Federal Center for
Disease Control and Protection (CDC) was notified
by the Tennessee State Department of Health
of a patient with the onset of fungal meningitis
approximately 19 days following epidural steroid
injection at a Tennessee ambulatory surgery
centre. On 28 September, investigators identified
a case outside Tennessee, possibly indicating
contamination of a widely distributed medication.
On 4 October 2012, out of an abundance of
caution, the CDC and FDA recommended that all
health care professionals cease use and remove
from their pharmaceutical inventory any product
produced by the New England Compounding
Center (NECC), located in Framingham, MA.
hospitalpharmacyeurope.com | 2019 | Issue 91 | 35