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INTERNATIONAL
STANDARD
ISO
11607-2
Second edition
2019-02
Packaging for terminally sterilized
medical devices 一
Part 2:
Validation requirements for forming,
sealing and assembly processes
Emballages des dispositifs m扯icaux sterili戏s au stade terminal -
Partie 2: Exigences de validation pour Jes procedes de Jormage,
scel/age et assemblage
巨Reference number
ISO 11607-2:2019(E)
© ISO 2019
ISO 11607-2:2019(E)
心\ COPYRIGHT PROTECTED DOCUMENT
© ISO 2019
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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below or ISO's member body in the country of the requester.
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Published in Switzerland
.1.1 ©ISO 2019 - All rights reserved
ISO 11607-2:2019(E)
Contents Page
Foreword.. ...................................................................................................................................................................................................................................... IV
lntroduction .................................................................................................................................................................................................................................. v
1 Scope ................................................................................................................................................................................................................................. 1
2 Normative references .................................................................................................................................... …............................................... 1
3 Terms and definitions ..................................................................................................................................................................................... 1
4 General requirements ................................ ….............................................................................. ….......... …....................................... ….......... 5
4.1 Quality systems ....................................................................................................................................................................................... 5
4.2 Risk management ...................................................................... ….......... …........................................................................................... 6
4.3 Sampling ....................................................................................................................................................................................................... 6
4.4 Test methods ............................................................................................................................................................................................. 6
4.5 Documentation .............................................................................. …........................................ …........................................................... 6
5 Validation of packaging processes ..................................................................................................................................................... 7
5.1 General ........................................................................................................................................................................................................... 7
5.2 Installation qualification ..................................................... …........................................................................................................ 7
5.3 Operational qualification ...................................................... …........ …....................... 擘......................................................….......... 8
5.4 Performance qualification ............................................................................................................................................................. 9
5.5 Formal approval of the process validation. 参.................................................................................................................... 9
5.6 Process control and monitoring 10
5.7 Process changes and revalidati;~·::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::: 10
6 Assembly .................................................................................................................................................................................................................... 10
7 Use of reusable sterile barrier systems .. …......... ……………......... ……......... …............ …....... …….... ………... ……….. ………….. 11
8 Sterile fluid-path packaging .................................................................................................................................................................. 11
Annex A (informative) Process development…......... ….... 啊............…….......... ….......... ……...... ………....... ……………....................... …...... 12
Bibliography ............................................................................................................................................................................................................................. 13
© ISO 2019 - All rights reserved .1.1.1
ISO 11607-2:2019(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (!EC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.i:rn.org/p;:itent~).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following
URL: www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 198, Sterilization of health care products.
This second edition cancels and replaces the first edition (ISO 11607-2:2006), which has been technically
revised. It also incorporates the amendment ISO 11607-2:2006/Amd.1:2014.
The main changes compared to the previous edition are as follows:
terms and definitions for "process variable", "process parameter" and "monitoring of processes"
have been added;
various definitions have been aligned with the latest version of ISO 11139;
the terminology of "critical" process parameters has been discontinued and the concept of a process
specification has been introduced to include all elements required to manufacture a product that
consistently meets specifications.
A list of all parts in the ISO 11607 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user's national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
iv ©ISO 2019 - All rights reserved
ISO 11607-2:2019(E)
Introduction
Packaging for terminally sterilized medical devices should be designed and manufactured to ensure
that the medical device can be sterilized and remain sterile under documented storage and transport
conditions until the sterile barrier system is damaged or opened.
One of the most critical characteristics of a sterile barrier system and packaging system for sterile
medical devices is the assurance of sterility maintenance. Medical devices delivered in a sterile
state should have been manufactured, packed and sterilized by appropriate, validated methods. The
development and validation of packaging processes are crucial to ensure that sterile barrier system
integrity is attained and will remain so until opened by the users of sterile medical devices.
There should be a documented process validation programme demonstrating the efficacy and
reproducibility of all packaging and sterilization processes. Along with the sterilization process, some
of the packaging operations that can affect sterile barrier system integrity are sealing, capping or other
closure systems, cutting, form/fill/seal, assemb_ly processes and subsequent handling. This document
provides the framework of activities and requirements to develop and validate the process used to
make and assemble the packaging system. Guidance for ISO 11607 series can be found in ISO/TS 16775.
The term "sterile barrier system" was introduced in 2006 to describe the minimum packaging required
to perform the unique functions required of medical packaging: to allow sterilization, to provide an
acceptable microbial barrier, and to allow for aseptic presentation. "Protective packaging" protects
the sterile barrier system, and together they form the packaging system. "Preformed sterile barrier
systems" would include any partially assembled sterile barrier systems such as pouches, header bags
or hospital packaging reels.
The sterile barrier system is essential to ensure the safety of terminally sterilized medical devices.
Regulatory authorities recognize the critical nature of sterile barrier systems by considering them as
an accessory or a component of a medical device. Preformed sterile barrier systems sold to health care
facilities for use in internal sterilization are considered medical devices in many parts of the world.
© ISO 2019 - All rights reserved V
INTERNATIONAL STANDARD ISO 11607-2:2019(E)
Packaging for terminally sterilized medical devices—
Part 2:
Validation requirements for forming, sealing and assembly
processes
1 Scope
This document specifies requirements for the development and validation of processes for packaging
medical devices that are terminally sterilized. These processes include forming, sealing and assembly
of preformed sterile barrier systems, sterile barrier systems and packaging systems.
It is applicable to industry, to health care facilities, and to wherever medical devices are packaged and
sterilized.
It does not cover all requirements for packaging medical devices that are manufactured aseptically.
Add 止ional requirements can be necessary for drug/device combinations.
2 N ormat1ve references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 11607-1:2018, Packaging for terminally sterilized medical devices —Part 1: Requirements for
materials, sterile barrier systems and packaging systems
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and !EC maintain terminological databases for use in standardization at the following addresses:
ISO Online browsing platform: available at http://www.iso.org/obp
!EC Electropedia: available at http://www.electropedia.org/
3.1
aseptic presentation
transfer of sterile contents from its sterile barrier system using conditions and procedures that
minimize the risk of microbial contamination
(SOURCE: ISO 11139:2018, 3.13)
3.2
closure
<packaging> means used to complete a sterile barrier system where no seal is formed
EXAMPLE By a reusable container gasket or sequential folding to construct a tortuous path.
(SOURCE: ISO 11139:2018, 3.51, modified—The example has been added.]
© ISO 2019 - All rights reserved
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ISO 11607-2:2019(E)
3.3
control
regulation of variables within specified limits
[SOURCE: ISO 11139:2018, 3.63]
3.4
expiry date
date by which product should be used
Note 1 to entry: For the purpose of this document and ISO 11607-1, expiry date refers to the medical device
in a sterile barrier system. The term "use by date" is used to describe the shelf life of packaging materials and
preformed sterile barrier systems (.3卫） prior to assembly into a sterile barrier system CL罕）．
[SOURCE: ISO 11139:2018, 3.110, modified—The Note 1 to entry has been added.]
3.5
installation qualification
IQ
process of establishing by objective evidence that all key aspects of the process equipment and ancillary
system installation comply with the approved specification
[SOURCE: ISO 11139:2018, 3.220.2]
3.6
labelling
label, instructions for use and any other information that is related to identification, technical
description, intended purpose and proper use of the health care product but excluding shipping
documents
[SOURCE: ISO 13485:2016, 3.8, modified - The term "medical device" has been replaced by "health
care product".]
3.7
medical device
mstrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software,
material or other similar or related article, intended by the manufacturer to be used, alone or in
combination, for human beings, for one or more of the specific medical purpose(s) of:
diagnosis, prevention, monitoring, treatment or alleviation of disease;
diagnosis, monitoring, treatment, alleviation of or compensation for an injury;
investigation, replacement, modification, or support of the anatomy or of a physiological process;
supporting or sustaining life;
control of conception;
disinfection of medical devices;
providing information by means of in vitro examination of specimens derived from the human body;
and does not achieve its primary intended action by pharmacological, immunological or metabolic
means, in or on the human body, but which may be assisted in its intended function by such means
Note 1 to entry: Products which may be considered to be medical devices in some jurisdictions but not in others
include:
items specifically intended for cleaning or sterilization of medical devices;
pouches, reel goods, sterilization wrap and reusable containers for packaging of medical devices for
sterilization;
2
©ISO 2019 - All rights reserved
ISO 11607-2:2019(E)
disinfection substances;
aids for persons with disabilities;
devices incorporating animal and/or human tissues;
devices for in vitro fertilization or assisted reproduction technologies.
[SOURCE: ISO 13485:2016, 3.11, modified - The first two list items in Note 1 to entry have been added.]
3.8
microbial barrier
property of a stenle barrier system to minimize the risk of ingress of microorganisms
(SOURCE: ISO 11139:2018, 3.169]
3.9
monitoring
continual checking, supervising, critically observing or determining the status in order to identify
change from the performance level required or expected
[SOURCE: ISO Guide 73:2009, 3.8.2.1, modified—The note has been deleted.)
3.10
operational qualification
OQ
process of obtaining and documenting evidence that installed equipment operates within predetermined
limits when used in accordance with its operational procedures
(SOURCE: ISO 11139:2018, 3.220.3)
3.11
packaging system
combination of a sterile barrier system (3.25) and protective packaging (3.18)
[SOURCE: ISO 11139:2018, 3.192)
3.12
performance qualification
PQ
process of establishing by objective evidence that the~rocess, under anticipated conditions, consistently
produces a product (.3立） which meets all predetermined requirements
[SOURCE: ISO 11139:2018, 3.220.4]
3.13
preformed sterile barrier system
sterile barrier system (.3王） that is supplied partially assembled for filling and final closure or sealing
EXAMPLE Pouches, bags and open reusable containers (立2JJ
(SOURCE: ISO 11139:2018, 3.201, modified - The example has been added.]
3.14
process parameter
specified value for a process variable (3.16)
Note 1 to entry: The specification for a process includes the process parameters and their tolerances.
[SOURCE: ISO 11139:2018, 3.211]
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ISO 11607-2:2019(E)
3.15
process specification
documented procedure that includes all equipment, process parameters, monitors and materials
required to manufacture a product that consistently meets requirements
3.16
process variable
chemical or physical attribute within a cleaning, disinfection, packaging or sterilization process,
changes in which can alter its effectiveness
EXAMPLE Time, temperature, pressure, concentration, humidity, wavelength.
[SOURCE: ISO 11139:2018, 3.213]
3.17
product
tangible result of a process
EXAMPLE Raw material(s), intermediate(s), sub-assembly(ies), healthcare product(s).
Note 1 to entry: For the purposes of this document and ISO 11607-1, products include preformed sterile barrier
systems (.3. 拉）， sterile barrier systems (二） and contents within them.
[SOURCE: ISO 11139:2018, 3.217, modified—Note 1 to entry has been added.]
3.18
protective packaging
configuration of materials designed to prevent damage to the sterile barrier system (.3益） and its
contents from the time of their assembly until the point of use
[SOURCE: ISO 11139:2018, 3.219]
3.19
repeatability
condition of measurement, out of a set of conditions that includes the same measurement procedure,
same operators, same measuring system, same operating conditions and same location, and replicate
measurements on the same or similar objects over a short period of time
[SOURCE: ISO/IEC Guide 99:2007, 2.20, modified—The term name has been simplified and the notes
omitted.]
3.20
reproducibility
condition of measurement, out of a set of conditions that includes different locations, processors,
measuring systems, and replicate measurements on the same or similar objects
Note 1 to entry: The different measuring systems may use different measurement procedures.
Note 2 to entry: A specification should give the conditions changed and unchanged to the extent practical
[SOURCE: ISO/IEC Guide 99:2007, 2.24, modified—The term has been simplified.]
3.21
reusable container
rigid sterile barrier system (3这） designed to be used repeatedly
[SOURCE: ISO 11139:2018, 3.235]
3.22
seal
<packaging> result of joining surfaces together by fusion to form a microbial barrier
Note 1 to entry: Surfaces can be joined together by, for example, adhesives or thermal fusion.
4
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ISO 11607-2:2019(E)
(SOURCE: ISO 11139:2018, 3.244 modified - The Note 1 to entry has been added.)
3 .23
seal strength
mechanical capacity of the seal to withstand force
(SOURCE: ISO 11139:2018, 3.246)
3.24
sterile
free from viable microorganisms
[SOURCE: ISO 11139:2018, 3.271]
3.25
sterile barrier system
SBS
minimum package that minimizes the risk of ingress of microorganisms and allows aseptic presentation
of the sterile contents at the point of use
[SOURCE: ISO 11139:2018, 3.272]
3.26
sterile fluid-path packaging
system of protective port covers and/or packaging designed to ensure sterility of the portion of the
medical device intended for contact with fluids
EXAMPLE The interior of the tubing for administration of an intravenous fluid.
[SOURCE: ISO 11139:2018, 3.273]
3.27
terminally sterilized
condition of a product that has been exposed to a sterilization process in its sterile barrier system
[SOURCE: ISO 11139:2018, 3.296]
3 .28
validation
confirmation process, through the provision of objective evidence, that the requirements for a specific
intended use or application have been fulfilled
Note 1 to entry: The objective evidence needed for a validation is the result of a test or other form of determination
such as performing alternative calculations or reviewing documents.
Note 2 to entry: The word "validated" is used to designate the corresponding status.
Note 3 to entry: The use conditions for validation can be real or simulated.
[SOURCE: ISO 9000:2015, 3.8.13, modified - "process" has been added to the definition.]
4 G eneral reqmrements
4.1 Quality systems
The activities described within this document shall be carried out within a formal quality system.
NOTE ISO 9001, ISO 13485, and ANSI/AAMI ST90 contain requirements for suitable quality systems.
Additional requirements can be specified by a country or region.
© ISO 2019 - All rights reserved
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ISO 11607-2:2019(E)
4.2 Risk management
The activities described within this document shall consider risk management to medical devices.
NOTE ISO 14971 contains requirements for risk management to medical devices. Addit ional requirements
can be specified by a country or region.
4.3 Sampling
The sampling plans used for testing of materials, sterile barrier systems or packaging systems shall be
applicable to materials, sterile barrier systems or packaging systems being evaluated. Sampling plans
shall be based upon statistically valid rationale.
NOTE Common statistically based sampling plans as given, for example, in ISO 2859-1 or ISO 186 (with
appropriate modifications if necessary) can be applied to materials, sterile barrier systems or packaging systems.
Additional sampling plans can be specified by countries or regions. For further guidance, see ISO/TS 16775.
4.4 Test methods
4.4.1 A rationale for the selection of appropriate tests for the packaging system shall be established
and recorded.
4.4.2 A rationale for acceptance criteria shall be established and recorded.
NOTE Pass/fail is a type of acceptance criterion
4.4.3 All test methods used to show conformity to this document shall be validated and documented
by the laboratory performing the test.
NOTE Annex B of ISO 11607-1 contains a list oftest methods. Publication of a method by a standards body
does not make it validated in any laboratory.
4.4.4 The test method validation shall demonstrate the suitability of the method as used. The following
elements shall be included:
determination of test method repeatability;
determinat ion of test method reproducibility;
establishment of test method sensitivity for integrity tests.
4.5 Documentation
4.5.1 Demonstration of conformity with the requirements of this document shall be recorded.
4.5.2 All records shall be retained for a specified period of time. The retention period shall consider
factors such as applicable requirements, expiry date and traceability of the medical device or sterile
barrier system.
4.5.3 Records of conformity with the requirements shall include, but is not limited to, performance
data, specifications and test results from validated test methods as well as validation protocols,
conclusions and any necessary actions.
4.5.4 Electronic records, electronic signatures and handwritten signatures executed to electronic
records that contribute to validation, process control or other quality decision-making processes shall
remain legible, readily identifiable and retrievable.
6
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ISO 11607-2:2019(E)
5 Validation of packaging processes
5.1 General
5.1.1 Preformed sterile barrier systems and sterile barrier system manufacturing processes shall be
validated.
NOTE Examples of these processes include, but are not limited to, the following:
pouch, reel, or bag forming and sealing;
form/fill/seal automated processes;
kit assembly and wrapping, including application of tape;
assembly of sterile fluid-path products;
tray/lid sealing;
filling and closing ofreusable containers;
sterilization sheets folding and wrapping, including application of tape.
5.1.2 Process validation shall include, at a minimum, an installation qualification (IQ), an operational
qualification (OQ), and a performance qualification (PQ), in this order.
5.1.3 A process specification shall be established for forming, assembly and sealing processes,
including, but not limited to, the following elements:
the required process output;
the process variables and process (and/or product) attributes to be monitored in order to maintain
the process in a state of control and capability;
the process parameters for control to produce the specified process output.
NOTE 1 Process development, while not formally part of process validation, is considered an integral part of
forming and sealing (see Annex A).
NOTE 2 Validation of existing products can rely on data from previous validations of existing products. That
data can be used for determining the tolerances for process parameters.
5.1.4 When similar preformed sterile barrier systems and sterile barrier system manufacturing
processes are validated, a rationale for establishing similarities and identifying the worst case
configuration shall be documented. As a minimum, the worst case configuration shall be validated to
determine conformity with this document.
NOTE For example, similarity can be established by different sizes of preformed sterile barrier systems
made of the same or comparable raw materials.
5.2 Installation qualification
5.2.1 The IQ shall be performed including, as minimum, all elements to be listed in the process
specification.
The following shall be considered:
equipment design features;
installation conditions, such as wiring, utilities, functionality, etc.;
©ISO 2019 - All rights reserved
7
ISO 11607-2:2019(E)
safety features;
equipment operating within the stated design parameters;
supplier documentation, prints, drawings and manuals;
spare-parts lists;
software and/or firmware validation;
environmental conditions such as cleanliness, temperature, humidity, lighting;
documented operator training;
operating manual or procedure.
5.2.2 Tests shall be performed to confirm that process variables can be controlled as specified.
NOTE For further guidance, see Annex A.
5.2.3 Functions that allow process variable monitoring shall be checked or certified in place.
5.2.4 Alarms, warning systems or machine stops shall be challenged in the event that process variables
exceed predetermined limits.
5.2.5 Specified instruments, sensors, displays, controllers, etc., shall be calibrated and have written
calibration schedules.
5.2.6 There shall be written preventive maintenance and cleaning schedules.
5.2. 7 The application of software systems shall be validated.
NOTE For software validation, see also ISO 13485:2016, 7.5.6 and Reference [且］ ．
5.3 Operational qualification
5.3.1 Process variables shall be challenged to determine the upper and lower parameter limits that
produce preformed sterile barrier systems and/or sterile barrier systems that meet all predetermined
specifications.
NOTE See Annex A.
5.3.2 As a minimum, preformed sterile barrier systems and sterile barrier systems shall be produced
at both the upper and lower process limits (see 5.3.1) and exhibit the properties that meet predefined
specifications.
The following quality properties shall be considered.
a) For forming/assembly:
sterile barrier system completely formed/ assembled;
product fits into the sterile barrier system;
essential dimensions are met.
b) For sealing:
seal strength;
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ISO 11607-2:2019(E)
intact seal for a specified seal width;
absence of channels or open seals;
absence of punctures or tears;
absence of material delamination for seals designed to be opened.
c) For other closure systems:
continuous closure;
absence of punctures or tears;
absence of material delamination or separation.
5.4 Performance qualification
5.4.1 The PQ shall demonstrate that the process will consistently produce preformed sterile barrier
systems and sterile barrier systems that meet predetermined requirements under anticipated operating
conditions.
5.4.2 The PQ shall include the following:
the actual or simulated contents, unless a rationale can be established that the contents are not
required for process validation activities;
nominal process parameters established in the OQ;
verification of product/package requirements;
assurance of process control and capability;
process repeatability and reproducibility.
5.4.3 Challenges to the process shall include conditions anticipated to be encountered during
manufacture.
NOTE These challenges can include, but are not limited to, machine set-up and change-over procedures;
process start-up and restart procedures; power failure and variations; and multiple shifts, if applicable
5.4.4 The PQ of the process shall include at least three production runs to assess variability within a
run and reproducibility between different runs.
NOTE These process variations include, but are not limited to, machine warm up until equilibrium is
reached, breaks and shift changes, normal starts and stops, and material lot-to-lot di fferences.
5.4.5 Documented procedures and/or process specifications for the forming, assembly, sealing or
closing operations shall be established and incorporated into the PQ.
5.4.6 Specified process variables shall be monitored and recorded.
5.4. 7 The process shall be under control and capable of consistently producing products according to
predetermined requirements.
5.5 Formal approval of the process validation
5.5.1 Review and formal approval of the process validation shall be carried out and documented as a
final step in the validation program.
©ISO 2019 - All rights reserved
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ISO 11607-2:2019(E)
5.5.2 The documentation shall summarize and reference all protocols and results, and state conclusions
regarding the validation status of the process.
5.6 Process control and monitoring
5.6.1 Procedures shall be established, implemented and maintained to ensure that the packaging
process is under control and within the established parameters during routine operation and consistently
producing the specified process output.
5.6.2 Specified process variables shall be routinely monitored and records shall be maintained.
5. 7 Process changes and revalidation
5.7.1 Processes concerning forming, assembly, sealing or closing shall be covered by a change-control
procedure for documenting, verifying and authorizing change.
NOTE The change control procedure can include a check for the need to revalidate.
5. 7.2 Processes shall be revalidated if changes are made to the equipment, contents, packaging
materials or packa伊ng process that compromise the original validation.
NOTE 1 The following list gives examples of changes that usually affect the status of a validated process:
raw material changes that can impact the process variables;
changes or exchanges to a main part of the equipment which can affect one or more of the established
parameters;
modification or refurbishment of equipment;
transfer of processes and/or equipment from one facility or location to another, or relocation within the same
facility;
negative trends in quality or process control indicators.
NOTE 2 Installation of a new piece of equipment is not included in changes requiring revalidation but rather
new process validation.
5. 7.3 The need for revalidation shall be evaluated and documented. If the situation does not require
that all aspects of the original validation be repeated, this revalidation does not have to be as extensive as
the initial validation.
NOTE It is acceptable practice to keep design validation separate from process validation to allow for
targeted root cause analysis in case of issues and to limit the effort of revalidation to only those aspects that are
really affected.
5. 7 .4 Minor process changes shall be documented and can require review of the validation status.
NOTE Multiple minor changes are considered to be able to cumulatively affect the validation status of the
packaging system.
6 Assembly
6.1 The sterile barrier system shall be assembled under appropriate environmental conditions to
minimize the risk posed by contaminants to the medical device.
6.2 The packaging system assembly process shall follow controlled labelling and processing procedures
to prevent mislabelling.
10 © ISO 2019 - All rights reserved
ISO 1 1607-2:201 9(E)
NOTE Additional guidance can be found in ISO/TS 16775, DIN 58953-7 and DIN 58953-8.
6 .3 Packaging systems shall be assembled and filled according to the instructions based on a validated
process that enables sterilization in a defined sterilization process. These instructions should include
configuration of contents and organizing inserts, total weight, inner wrapping and absorbent materials.
7 Use of reusable sterile barrier systems
In addition to the requir ements listed in Clause 6, instructions and restrictions for use as specified in
ISO 11607-1:2018, 5.1.10 and 5.1.11 shall be fo llowed (e.g. assembly, disassembly, maintenance, repa兀
storage).
NOTE For additional guidance on reusable containers, see EN 868-8, DIN 58953-9 and ANSI/AAMI ST77. For
additional guidance on reusable fabrics, see EN 13795-1 and ANSI/AAMI ST65.
8 Sterile fluid-path packaging
Assembly of sterile fluid-path components and closures shall meet the requirements of f. lau:'ie:'i S and 丘
© ISO 2019 - All rights reserved 11
ISO 11607-2:2019(E)
Annex A
(informative)
Process development
Process development, while not a formal part of process validation, should be considered as an integral
part of forming and sealing. Process development or process design requires an assessment to identify
and evaluate
the required process elements (e.g. sealers, conveyers, forming equipment, assembly tools, etc.),
process variables and attributes to be monitored along with their thresholds, deviations or states
that require action for producing the desired process output, and
process variables to be controlled to meet established parameters (i.e. the operating ranges, settings
and tolerances).
A process assessment is conducted to establish appropriate and necessary upper and lower processing
limits, as well as the expected normal operating conditions to achieve a robust process capable of
consistently producing the desired process output. These process limits should be sufficiently removed
from failure or marginal conditions. One technique is the creation of seal-strength curves with
accompanying visual examples of seal results that can aid in the selection of an optimal process window.
Potential failure modes and action levels having the greatest impact on the process should be identified
and addressed (failure mode and effects analysis, cause and effect analysis).
Statistically valid techniques, such as screening experiments and statistically designed experiments to
optimize the process, should be used.
Process variables that are evaluated can include, but are not limited to, the following:
temperature;
contact pressure;
dwell time (line speed);
vacuum;
energy levels/frequency (radio frequency/ultrasonic);
torque limits for lid/cap closure systems.
The specified process variables will be selected such that they will produce a process that is in control,
and capable of yielding sterile barrier systems and packaging systems that meet predetermined design
specifications.
12 ©ISO 2019 - All rights reserved
ISO 11607-2:2019(E)
Bibliography
[1] ISO 186, Paper and board—Sampling to determine average quality
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[3] ISO 9001, Quality management systems - Requirements
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[6] ISO/TS 16775, Packaging for terminally sterilized medical devices - Guidance on the application of
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(10] ANSI/AAMI ST77, Containment devices for reusable medical device sterilization
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[12] DIN 58953-8, Sterilization -Sterile supply- Part 8: Log的cs of sterile medical devices
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[14] GAMP 5, Good Automated Manufacturing Practice: A Risk-Based Approach to Compliant GxP
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© ISO 2019 - All rights reserved 13
ISO 11607-2:2019(E)
ICS 11.080.30
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© ISO 2019 - All rights reserved
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