Biomedical Engineering Reference
In-Depth Information
Are there established
standards or guides for
SUSs?
While there are no industry standards specifically for
single-use process systems, there are several standards and
technical guides that can be applied. Some specific
examples are the ASTM International Standard F838-05 on
Sterilizing Filtration, the American National Standards
Institute (ANSI)/American Association for the
Advancement of Medical Instrumentation (AAMI)/
International Organization for Standards (ISO) Standard
11137 on Sterilization of Healthcare Products—Radiation
and the ANSI/AAMI/ISO Standard 13408 on Aseptic
Processing of Healthcare Products.
These and other industry standards and technical, as well as
government regulations and regulatory agency guidelines,
which can be applied to SUSs are further described in the
BPSA Component Quality Reference Matrix. BPSA is also a
leader in developing new best practice guides for SUSs
that are simulating the development of standards or guides
by other organizations (e.g., ASTN Bioprocessing
Equipment Standard (ASTM-BPE), Parenteral Drug
Association (PDA), International Society for
Pharmaceutical Engineering (ISPE). BPSA guides also
cover irradiation and sterilization validation,
determination of extractables and leachables, and disposal
of SUSs. See these at
www.bpsalliance.org
.
Is there information available
on irradiation and
sterilization/validation?
The American National Standards Institute (ANSI),
American Association of Medical Instrumentation (AAMI,)
and the International Organization for Standardization
(ISO) have jointly issued a standard on Sterilization of
Healthcare Products (ANSI/AMI/ISO 11137) that is
recognized by regulative authorities around the globe. To
help biopharmaceutical manufacturers and single-use
equipment suppliers better understand the application of
this standard and its various options to SUSs, BPSA has
published a
Guide to Irradiation and Sterilization of Single-
Use Systems
. This BPSA guide explains the basic principles
of sterilization validation under ANSI/AAMI/ISO 11137,
discusses considerations in choosing among alternate
approach options, and suggests where microbial control by
irradiation without validation may be applicable and
beneficial in terms of development time and cost without
compromising safety or quality. See the references at
www.
