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 not applicable to the packaging o medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.
2 Normative 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.
GB/T 19633.1-2024 Packaging for terminally sterilized medical devices - Part 1 : Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019, IDT)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
IEC and ISO maintain terminological databases for use in standardization at the following addresses:
- IEC Electropedia : available at http://www.electropedia.org/
- ISO Online browsing platform : available at http://www.iso.org/obp
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
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, with the example added]
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: 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 (3.13) prior to assembly into a sterile barrier system (3.25).
[Source: ISO 11139: 2018, 3.110, modified, with the note 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: GB/T 42061-2022, 3.8]
3.7
medical device
instrument, 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: 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;
- disinfection substances
- aids for persons with disabilities;
- devices incorporating animal and/or human tissues;
- devices for in vitro fertilization or assisted reproduction technologies.
Medical devices refer to instruments, equipment, appliances, in-vitro diagnostic reagents and calibrations, materials and other similar or related articles directly or indirectly used in human body, including the required computer software; its effectiveness is mainly obtained by physical means, not by pharmacology, immunology or metabolism, or it only plays an auxiliary role although these methods are involved; for the purpose(s) of
1. diagnosis, prevention, monitoring, treatment or alleviation of disease;
2. diagnosis, monitoring, treatment, alleviation of or compensation for an injury;
3. investigation, replacement, modification or support of the anatomy or of a physiological process
4. supporting or sustaining life,
5. control of conception,
6. providing information for medical purposes by means of in vitro examination of specimens derived from the human body;
[Source: GB/T 42061-2022, 3.11, modified]
3.8
microbial barrier
property of a sterile 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: GB/23694-2013, 4.8.2.1, modified, with the note 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 process, under anticipated conditions, consistently produces a product (3.17) which meets all predetermined requirements
[Source: ISO 11139: 2018, 3.220.4]
3.13
preformed sterile barrier system
sterile barrier system (3.25) that is supplied partially assembled for filling and final closure or sealing
Example: Pouches, bags and open reusable containers (3.21).
[Source: ISO 11139: 2018, 3.201, modified, with the example added]
3.14
process parameter
specified value for a process variable
Note: The specification for a process includes the process parameters and their tolerances.
[Source: ISO 11139: 2018, 3.211]
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: For the purposes of this document and ISO 11607-1, products include preformed sterile barrier systems (3.13), sterile barrier systems (3.25) and contents within them.
[Source: ISO 11139: 2018, 3.217, modified, with the note added]
3.18
protective packaging
configuration of materials designed to prevent damage to the sterile barrier system (3.25) and its contents from the time of their assembly until the point of use
[Source: ISO 11139: 2018, 3.219]
