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GB/T 19633.2-2015 PDF in English

GB/T 19633.2-2015 (GB/T19633.2-2015, GBT 19633.2-2015, GBT19633.2-2015)
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GB/T 19633.2-2015
Packaging for terminally sterilized medical devices - Part 2. Validation requirements for forming, sealing and assembly processes
ICS 11.080.30
National Standards of People's Republic of China
Partially replace GB/T 19633-2005
Packaging for terminally sterilized medical devices - Part 2.
Requirements forming, sealing and assembly processes confirmation
(ISO 11607-2.2006, IDT)
Issued on. 2015-12-10
2016-09-01 implementation
Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China
Standardization Administration of China released
Table of Contents
Introduction Ⅲ
Introduction Ⅳ
1 Scope 1
2 Normative references 1
3 Terms and definitions
4 3 General requirements
5 confirm the packaging process 4
6 Packaging system assembly 6
7 repetitive use sterile barrier system 6
8 packaging sterile fluid path 7
Appendix A (informative) Process Development 8
Reference 9
GB/T 19633 "Packaging for terminally sterilized medical devices" is divided into two parts.
--- Part 1. requirements for materials, sterile barrier systems and packaging systems;
--- Part 2. forming, sealing and assembly processes requires confirmation.
This section GB/T 19633 Part 2.
This section drafted in accordance with GB/T 1.1-2009 given rules.
This portion replaces GB/T 19633-2005 "terminally sterilized medical device packaging", compared with the GB/T 19633-2005
The main technical changes as follows.
--- Refine the process of identifying the requirements (installation qualification, operational qualification and performance qualification);
--- Increased packaging systems assembly requirements;
--- Increase the repetitive use of the sterile barrier system requirements;
--- Increase the sterile fluid path packaging requirements.
This section uses the translation method identical with the international standard ISO 11607-2.2006 "Packaging for terminally sterilized medical devices - Part 2. Cheng
Shape, sealing and assembly process validation requirements. "
Consistency correspondence between this part of international documents and normative references of our files are as follows.
--- GB/T 19633.1-2015 terminally sterilized medical device packaging - Part 1. materials, sterile barrier systems and packaging systems
Requirements (ISO 11607-1.2006, IDT)
Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents.
This part is proposed by the China Food and Drug Administration.
This part of the National Standardization Technical Committee disinfection technology and equipment (SAC/TC210) centralized.
This section drafted by. State Food and Drug Administration Jinan Medical Device Quality Supervision and Inspection Center.
The main drafters of this section. Wu Ping, Zhang Limei, Liucheng Hu.
This part of the standard replaces the previous editions are.
--- GB/T 19633-2005.
Sterile condition designed to supply medical devices, should ensure that the manufacturing and packaging of sterile medical devices on the market at the time, and in a sterile screen
Barrier system is damaged or opened prior to maintain sterility in the storage and transportation conditions documented. In addition, the supply of sterile medical devices should state
And confirmed with the corresponding method of manufacturing and sterilization.
One of the most critical characteristics of sterile barrier systems and packaging systems is to ensure sterility is maintained. Development and validation of the packaging process for achieving
And to maintain the integrity of the sterile barrier system is essential to verify the user sterile medical devices before opening the package to maintain its integrity.
It should have a documented process validation procedures to verify the efficiency and reproducibility of the sterilization and packaging process. Not only the sterilization process, forming,
Seal or other closure system, the process of cutting and disposal will also have an impact on the sterile barrier system. GB/T 19633 is divided into Part Manufacturing
Assembly and packaging systems used in process development and validation requirements and provides a framework for behavior. GB/T 19633.1 and this part is designed to
Meet the basic requirements of the European Medical Device Directive.
In ISO 11607-2-making process in one of the main obstacles is to coordinate terms. The term "packaging", "eventually packaging" "First package
Loaded "on a global scale have a different meaning. Therefore, the choice of which of these terms is considered to be the completion of a barrier ISO 11607-2
hinder. The results of coordination, the introduction of the "sterile barrier system," a term used to describe medical device packaging need to perform specific functions
The smallest package. Its unique features are. can be sterilized to provide an acceptable microbial barrier, it can be a sterile access. "Protective packaging"
To protect the sterile barrier systems, sterile barrier system and protective packaging constitute the packaging system. "Preformed sterile barrier systems" can pack
Including the completion of any partially assembled sterile barrier system, such as a combination of bags, head bags, hospital packaging sheet and the like.
Sterile barrier system is terminally sterilized medical devices safety basic guarantee. The reason why the Governing Body sterile barrier system as a medical
An accessory or a component of the instrument, it is recognized that an important feature where sterile barrier system. In many parts of the world are sold to doctors
Sterilization treatment means for the organization of preformed sterile barrier system as a medical device.
Packaging for terminally sterilized medical devices - Part 2.
Requirements forming, sealing and assembly processes confirmation
1 Scope
GB/T 19633 provisions of this part of the development and validation requirements for terminally sterilized medical devices packaging process. These processes include
Preformed sterile barrier systems, sterile barrier systems and packaging systems forming, sealing and assembly.
This section applies to industrial, medical institutions, medical device packaging and sterilization.
This section does not include packaging requirements for sterile medical devices manufacturing. For the combination of drugs and devices, there may be other requirements.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
ISO 11607-1 Packaging for terminally sterilized medical devices - Part 1. materials, sterile barrier systems and packaging systems requirements (Packa-
gingforterminalysterilizedmedicaldevices-Part 1. Requirementsformaterials, sterilebarriersys-
3 Terms and Definitions
The following terms and definitions apply to this document.
Expiration date expirydate
With a date at least year and month represented by this date the product can be used.
Installation identification instalationqualification; IQ
Get device has been installed to provide evidence and documents and the formation of its technical specifications.
[ISO /T S11139.2006]
Tag labeling
In writing, printing, electronic or graphic symbols, etc. is fixed on the medical device or its packaging systems, medical equipment or the accompanying documents.
Note. Tags are identification and medical equipment, and technical documentation related to the use, but does not include shipping documents.
Run identification operationalqualification; OQ
Get device after installation by running the program when it is run within the limits of the expected evidence identified and documented process.
[ISO /T S11139.2006]
Packaging systems packagingsystem
Sterile barrier system and protective packaging portfolio.
[ISO /T S11139.2006]
Performance appraisal performancequalification; PQ
After obtaining the installation and run the program to run through the device according to the evidence continued to run predefined parameters and document the process, from
Leaving the production of its products meet the technical specifications.
[ISO /T S11139.2006]
Preformed sterile barrier systems preformedsterilebarriersystem
Completed part of the assembly for loading and final closure or sealing of sterile barrier system.
Example. paper bag, and the bag open with a combination of reusable containers.
[ISO /T S11139.2006]
Process Development processdevelopment
Establish the nominal value and the limits of critical process parameters.
Products product
Outcome of the process.
[GB/T 19000-2008]
NOTE. In the sterilization standard, the product is a tangible entity, as may be the raw materials, intermediates, components and medical products.
[ISO /T S11139.2006]
Protective Packaging protectivepackaging
Which is designed to prevent the front end-use sterile barrier system and its contents items damaged material structure.
[ISO /T S11139.2006]
Repeatability repeatability
How close the successful results obtained under the same measurement conditions for the same specific amount (measured variable) measured between.
[ISO /T S11139.2006]
Note 1. These conditions are called repeatability conditions.
Note 2. Repeatability conditions include.
--- The same measurement procedure;
--- The same observer;
--- Use the same measuring instrument in the same condition;
--- The same place;
--- Short repetition.
Note 3. The repeatability of the results can be used to quantify the precision of the term representation.
Note 4. from "Metrology international basic vocabulary and common terminology," 1993, definition 3.6.
Reproducibility reproducibility
In the case of changing the measurement conditions for the same specific amount (measured variable) the degree of proximity between the results of a measurement.
[ISO /T S11139.2006]
Note 1. The effective expression of the need to change the conditions for the reproduction of technical specifications.
Note 2. The changing conditions may include.
--- Measurement principle;
---Measurement methods;
--- Observer;
---measuring instrument;
--- Reference standard;
---Conditions of Use;
Note 3. The reproducibility of the results can be used to quantify the precision of the term representation.
Note 4. from "Metrology international basic vocabulary and common terminology," 1993, definition 3.7.
Repetitive use of the container reusablecontainer
Rigid sterile barrier system is designed to be used repeatedly.
Sterile barrier systems sterilebarriersystem
Prevent entry of microorganisms and enables the smallest packaging products at the point of use sterile use.
Packaged sterile fluid path sterilefluid-pathpackaging
Designed to ensure that medical equipment is expected to contact with the liquid part of the sterile protective cover import and export, and/or packaging systems.
NOTE. Internal intravenous infusion line is packaged sterile fluid path of an instance.
Confirm validation
(Process) by obtaining, recording and interpreting the results required to prove that a process can continue to produce products that meet predetermined specifications of the product
The formation of the program file.
Note. from ISO /T S11139.2006.
4 General requirements
4.1 Quality System
The activities described in Section 4.1.1 shall be conducted in a formal quality system.
Note. GB/T 19001 and YY/T 0287 gives the requirements of the applicable quality system. Region may specify other requirements.
4.1.2 To meet the requirements of this part, do not have to obtain a third-party quality system certification.
4.1.3 medical institutions can use the country or region where the required quality system.
4.2 Sampling
Sampling plan for selection and testing of packaging systems shall be applicable to the evaluation of the packaging system. Sampling plan should be based on principles of statistics
Note. GB/T 2828.1 or GB/T 450 gives the appropriate sampling plan. Some countries or regions may also provides other sampling programs.
4.3 Test Method
4.3.1 All test methods used to show compliance with this section shall be confirmed and documented.
NOTE. ISO 11607-1.2006 Appendix B contains a list of appropriate test methods.
4.3.2 Test Method Claim shall demonstrate the suitability of the methodology used. It should include the following elements.
--- Packaging system to determine the appropriate test selection principle;
--- Determine acceptance criteria;
Note. The pass/fail criteria are acceptable for one type.
--- Determine the repeatability of the test method;
--- Determine the reproducibility of the test method;
--- Determine the sensitivity of the integrity of the test method.
4.3.3 Unless otherwise specified in the material test method, the test sample should be at (23 ± 1) ℃ and (50 ± 2)% relative humidity state
Adjusting at least 24h.
4.4 documented
4.4.1 demonstrate compliance with the requirements of this section shall be documented.
4.4.2 All documents shall be retained for a prescribed time. Factors retention period should be considered are regulatory requirements, medical equipment sterilization or barrier system
Validity and traceability.
4.4.3 meet the requirements document may include (but are not limited to) Test Method performance data, technical specifications, using a validated test trial
Experimental results and programs, as well as installation qualification, operational qualification and performance appraisal results.
4.4.4 confirm, process control or other electronic recording quality of the decision-making process, electronic signatures and electronic records handwritten signature should be authentic.
5 confirm the packaging process
5.1 General
5.1.1 preformed sterile barrier systems and sterile barrier system manufacturing process should be confirmed.
Examples of these processes include, but are not limited to.
--- Rigid and flexible blister forming;
--- A combination of bags, paper bags or roll forming and sealing;
--- Forming/filling/sealing automatic process;
--- Ensemble and packages;
--- Disc/cover seal;
--- Repetitive use of the container filled and closed;
--- Sterilization paper folding and wrapping.
5.1.2 The process should at least confirm the order including installation qualification, operational qualification and performance qualification.
5.1.3 Process Development was not an official confirmation of the scope of the process, it should be considered an integral part (see Appendix A) forming and sealing.
5.1.4 confirm existing products available in the previous installation and operation of identification data. These data can be used to determine the key parameters of tolerance.
5.1.5 When it is confirmed a similar manufacturing process preformed sterile barrier systems and sterile barrier system, the establishment of similarities and worst-case configuration
The description should be documented so that at least the worst case configuration in this section is confirmed.
NOTE. For example, different specifications of similarity between the preformed sterile barrier system.
5.2 Installation Qualification (IQ)
5.2.1 should be installed identification.
Identification of installation aspects to consider include.
--- Equipment design features;
--- Installation conditions, such as wiring, utility, and other functions;
--- Equipment operating at nominal design parameters;
--- Documents, prints, drawings and manuals that came;
---Parts List;
--- Software validation;
--- Environmental conditions, such as cleanliness, temperature and humidity;
--- Documented operator training;
--- Operating manuals and procedures.
5.2.2 should specify critical process parameters.
5.2.3 critical process parameters should be controlled and monitored.
5.2.4 alarm and warning system should be shut down or subjected to critical process parameters exceed predetermined limits event has been verified.
5.2.5 critical process instrumentation, sensors, monitors, controllers etc. should be calibrated and a calibration schedule. Performance appraisal should be calibrated before and
5.2.6 A written maintenance and cleaning schedules.
5.2.7 application program logic controllers, data acquisition systems, and inspection software system should be confirmed to ensure that its intended function. Should enter
Line functionality tests to verify that the software, hardware, especially the interface has the correct function. After verification of the number should be (such as entering the correct and incorrect system
According to the analog input voltage reduction) to determine the validity of data or records, reliability, identity, accuracy and traceability.
5.3 Identification (OQ)
5.3.1 Process parameters shall be subjected to all the challenges expected production conditions to ensure that they will be produced to meet the requirements of preformed sterile screen
Barrier systems and sterile barrier system.
5.3.2 Production preformed sterile barrier systems and sterile barrier system in the upper limit and lower limit parameters parameters, and should have to meet in advance
Requirements characteristics. Quality should consider the following features.
a) for forming and assembly.
--- Fully formed/assembled sterile barrier system;
--- Products suitable for loading into the sterile barrier system;
--- Meet basic dimensions.
b) For sealing.
--- Provisions complete seal seal width;
--- Channel or opened;
--- Perforation or tear;
--- Delamination or separation.
NOTE. The sample seal width technical specifications see YY/T 0698.5-2009 4.3.2.
c) For other closed systems.
--- Continuous closed;
--- Perforation or tear;
--- Delamination or separation.
5.4 Performance qualification (PQ)
5.4.1 Performance appraisal should confirm that the procedure under specified operating conditions can continue to produce acceptable preformed sterile barrier systems and sterile
Barrier system.
5.4.2 Performance appraisal should include.
--- Real or simulated product;
--- Run Identification determine process parameters;
--- Verify that the product packaging requirements;
--- Guarantee process control and capability;
--- Process repeatability and reproducibility.
5.4.3 Challenges of the process should include the case of the production process is expected to encounter.
Note. These challenges may include, but are not limited to. machine settings and program changes, and restart the program starts, power failures and fluctuations, as well as multi-team (if applicable).
5.4.4 challenge process should include at least three sets of production operations, with a suitable sample to confirm a further operation of the variability and between each run
Reproducibility. Cycle of a production run should be able to explain the process of change.
Note. These variables include, but are not limited to. machine to warm up, downtime and replacement team, between boot and shutdown, as well as the batch material difference.
5.4.5 shall establish molding procedures and technical specifications of the sealing and assembly operations documented and incorporated into the performance appraisal.
5.4.6 should monitor and record the basic process variables.
5.4.7 The process should be controlled and can continue to produce products that meet predetermined requirements.
5.5 formal approval process validation
As a final step 5.5.1 confirmation process, the process should be reviewed and confirmed officially approved and documented.
5.5.2 The document should summarize and reference all protocols and results, and describes the process validation phase conclusions.
5.6 Process control and monitoring
5.6.1 shall establish procedures to ensure that the process is under control and within the parameters established in the course of normal operation.
5.6.2 critical process parameters should be monitored and documented routine.
5.7 Changes and re-confirmation process
5.7.1 documented, reviewed and approved by a change of change control procedures should include changes related to the packaging and sealing process files.
5.7.2 If the equipment, products, packaging materials or packaging changes will affect the original and will have to confirm sterile sterile medical devices
When the impact state, safety or efficacy, coping process of revalidation.
NOTE. The following procedure changes would affect confirmed.
--- Affect the raw material change process parameters;
--- Install a new piece of equipment;
--- Processes and/or equipment is moved from one location to another;
--- Sterilization process changes;
--- Quality or process control showed a downward trend.
5.7.3 respond to the need for re-confirmation evaluated and documented, if not all aspects of the original re-confirmed confirmed
You do not have to be reconfirmed as comprehensive as the first confirmed.
5.7.4 In recognition of the state of many small changes will bring the process of cumulative effects should be considered to confirm or periodic review process.
6 Packaging system assembly
6.1 sterile barrier system should be adapted to fit under ambient conditions, so that the medical devices subject to the risk of contamination is minimized.
6.2 should be identified and controlled machining program packaging system assembly, in order to prevent misidentification.
NOTE. Additional guidance can be found DIN58953-7 and DIN58953-8.
6.3 should be based on the establishment of the confirmation process on the basis of the description (in the provisions for ensuring sterilization sterilization process) packaging system assembly
And filling equipment. These instructions should include the structure and contents of the shelves, the total weight of parcels and absorbent materials.
7 repetitive use of sterile barrier system
In addition to meeting the requirements set forth in Chapter 6, it should also comply with ISO 11607-1.2006 specified in 5.1.10 and 5.1.11 of the (assembly, disassembly dimension
Protection, repair and storage).
NOTE. Additional guidelines repetitive use of the container see YY/T 0698.8, DIN58953-9 and AAMI/ANSIST33. Repetitive use of other means of fabric
South See YY/T 0506.1 and ANSI/AAMIST65.
8 packaging sterile fluid path
Assembly and closed 8.1 sterile fluid path components shall meet the requirements of Chapters 5 and 6 chapters.
8.2 sterile fluid path marked medical device structure and its closed system devices combined should be kept sterile fluid path sterile.
Note 1. ISO 11607-1 provides requirements for the integrity of the microbial barrier properties and sterile barrier system.
Note 2. As the interpretation of this part of the required equipment and other devices together to form a closed sterile barrier system.
Appendix A
Process Development
Process development was not an official confirmation of the scope of the process, it should be considered an integral part of forming and sealing. Process development or process design
Needed to be assessed in order to identify and evaluate the key parameters and operating range, and set tolerances.
Assessment process carried out in order to establish the desired process of normal operating conditions and the desired upper and lower limits. These procedures should be sufficient to limit the loss away
Failure conditions or boundary conditions. Using the following techniques will help you choose the best process parameters window is drawn corresponding to different conditions (such as temperature
Seal strength curve degrees), together with a corresponding seal the result looks kind.
The impact of potential failure modes and effects the maximum level of the process, it should be identified and traced (failure mode and effects analysis,
Cause and Effect Analysis).
Should use effective techniques of statistical significance, such as screening tests and statistical tests designed to make the process can be optimized.
The basic process parameters being evaluated may include, but are not limited to.
--- Pressure/vacuum, including the rate of change;
--- Dead time (line speed);
--- Energy level/frequency (RF/ultrasonic);
--- Lid closure system torque limit.
The selected basic parameters should be chosen to make them under control and to produce products to meet the design specifications established sterile barrier systems and packaging
[1] GB/T 450-2008 paper and cardboard to take samples and specimens to the vertical and horizontal, positive and negative determination (ISO 186.2002,
[2] GB/T 2828.1-2012 Sampling procedures for inspection - Part 1. batch inspection by acceptance quality limit (AQL) retrieval
Sampling plan (ISO 2859-1.1999, IDT)
[3] GB/T 19000-2008 Quality Management System - Fundamentals and vocabulary (ISO 9000.2005, IDT)
[4] GB/T 19001-2008 quality management system requirements (ISO 9001.2008, IDT)
[5] GB/T 19971-2005 Sterilization of health care products Glossary (ISO /T S11139.2001, IDT)
[6] YY/T 0287-2003 medical device quality management system for regulatory requirements (ISO 13485.2003, IDT)
Section [7] YY/T 0506.1-2005 patients, staff and equipment with the surgical drapes, gowns and clean air suits 1. Manufacturing
General requirements for plants, treatment plants and products
[8] YY/T 0698.5 terminally sterilized medical device packaging materials - Part 5. breathable material and plastic film consisting of a sealable group
Close bag and the membrane requirements and test methods
[9] YY/T 0698.6 terminally sterilized medical device packaging materials - Part 6. for low temperature sterilization or radiation sterilization without
Bacteria produce paper barrier system requirements and test methods
[10] YY/T 0698.8 terminally sterilized medical device packaging materials - Part 8. steam sterilizers repetitive use of sterilization capacity
Requirements and test methods
[11] AAMI/ANSIST33.1996 health care institutions ethylene oxide sterilization and steam sterilization of reusable rigid
Use sterile container and Selection Guide
[12] ANSI/AMMIST65.2000 health care institutions reusable cloth during use
[13] DIN58953-7.2003 Sterilization - Sterilization supply - Part 7. sterilization paper, nonwoven wrapping material, paper bags, hot
And self-sealing bags and a combination of the use of the web
[14] DIN58953-8.2003 Sterilization - Sterilization supply - Part 8. sterile medical devices logistical
[15] DIN58953-9.2000 Sterilization - Sterile supply of materials - Part 9. sterile containers using technology
[16] GHTFStudyGroup3, Processvalidationguidanceformedicaldevicemanufactures.
[17] Metrology international basic vocabulary and common terminology (InternationalVocabularyofBasicandGeneral
TermsinMetrology), 1993, BIPM, IEC , IFCC, ISO , IUPAC, IUPAP, OIML.
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.