YY/T 0681.17-2019 (YY/T0681.17-2019, YYT 0681.17-2019, YYT0681.17-2019) & related versions
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Test methods for sterile medical device package -- Part 17: Testing the microbial barrier performance of porous package materials using aerosol filtration method
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YY/T 0681.17-2019
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YYT 0681.17-2019
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YY/T 0681.17-2019: PDF in English (YYT 0681.17-2019)
YY/T 0681.17-2019
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.080.040
C 31
Test Methods for Sterile Medical Device Package - Part 17:
Testing the Microbial Barrier Performance of Porous
Package Materials Using Aerosol Filtration Method
ISSUED ON: OCTOBER 23, 2019
IMPLEMENTED ON: OCTOBER 1, 2020
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 3
Introduction ... 5
1 Scope ... 6
2 Normative References ... 6
3 Terms and Definitions ... 6
4 Symbols ... 7
5 Overview of Test Methods ... 7
6 Significance and Application ... 8
7 Instruments ... 9
8 Materials ... 11
9 Instrument Preparation ... 11
10 Sample Preparation ... 13
11 Test Procedures ... 13
12 Data Analysis ... 15
13 Report ... 16
14 Precision and Bias ... 16
Appendix A (informative) Precision and Bias ... 17
Test Methods for Sterile Medical Device Package - Part 17:
Testing the Microbial Barrier Performance of Porous
Package Materials Using Aerosol Filtration Method
1 Scope
This Part of YY/T 0681 specifies the determination of the aerosol filtration performance using
aerosol that generates particles with a diameter of 1.0 m, and the evaluation of the filtration
efficiency of the material using two particle counters.
This Part of YY/T 0681 is applicable to air permeable materials used for the packaging of
terminally sterilized medical devices.
This Part of YY/T 0681 does not apply to materials with Bendtsen air permeability1) over 4,000
mL/min.
2 Normative References
The following documents are indispensable to the application of this document. In terms of
references with a specified date, only versions with a specified date are applicable to this
document. In terms of references without a specified date, the latest version (including all the
modifications) is applicable to this document.
GB/T 19633.1-2015 Packaging for Terminally Sterilized Medical Devices - Part 1:
Requirements for Materials, Sterile Barrier Systems and Packaging Systems (ISO 11607-
1:2006, IDT)
3 Terms and Definitions
The following terms and definitions are applicable to this document.
3.1 Challenge Aerosol
Challenge aerosol refers to a sufficient number of aerosolized 1.0 m particles that enables
effective particle counting of filtrate aerosols.
3.2 Filtrate Aerosol
1) GB/T 458-2008 Paper and Board - Determination of Air Permeance provides test methods and information on
Bendtsen air permeability.
Filtrate aerosol refers to aerosolized particles after passing through the test sample.
3.3 Maximum Penetration
Maximum penetration refers to the maximum percentage of filtrate aerosol particle
concentration when the specimen is tested under a certain pressure difference or within an air
flow range.
4 Symbols
The following symbols are applicable to this document.
CF: the average particle count of filtrate aerosols.
CC: the average particle count of challenge aerosols.
R: the percentage of the number of filtrate aerosol particles in the number of challenge aerosol
particles.
RM: the maximum calculated value of R.
P1: the pressure difference generated before and after the specimen by the calibrated air flow
through the specimen required by the particle counter.
P: the pressure difference before and after the specimen.
F: the air flow passing through the specimen.
F1: the calibrated air flow through the specimen required by the particle counter when
measuring the filtrate aerosol.
FM: the air flow, at which the maximum penetration occurs.
5 Overview of Test Methods
5.1 Place the air permeable packaging material specimen in the sample holder, so that a filter is
formed between the challenge aerosol and the filtrate aerosol. On the challenge side of the
sample holder, the particle aerosol is on the surface of the specimen. Let the air flow pass
through the specimen. Use a laser particle counter to monitor the particle concentrations of the
challenge aerosol and the filtrate aerosol. Within a certain flow range, measure the particle
concentration, so as to determine the penetration percentage within the flow range. After data
processing, obtain the maximum penetration point.
5.2 This test uses polystyrene latex (PSL) particle aerosol with a geometric mean particle size
of 1.0 m and a standard deviation of less than 0.05 m. Use two particle counters to
simultaneously, respectively and continuously count the challenge aerosols and the filtrate
hPa ~ 5 hPa and an accuracy of 0.005 hPa, which is used to monitor the pressure difference on
both sides of the sample.
7.6 Pressure regulator: a precision pressure regulator that can provide 1.0 standard liter of gas
per minute when the pressure reaches 0.3 MPa.
7.7 Ultra-efficient air filter: used to remove particles in the ambient air.
7.8 O-shaped ring: nitrile rubber, which forms a seal between the test challenge side and the
filtration side.
8 Materials
8.1 Particle-free dry compressed air.
8.2 Tween 20 or sodium dodecyl sulfate (SDS).
8.3 Concentrated suspension of 1 m PSL particles (such as: Duke Scientific 3K1000, 5100A
and G0100).
8.4 Distilled water.
8.5 Air permeable packaging materials to be tested.
9 Instrument Preparation
9.1 Instrument
The assembly of the instrument is shown in Figure 3.
9.2 Material Preparation
9.2.1 Surfactant solution
9.2.1.1 Use distilled water to prepare a 0.02% (volume fraction) surfactant solution (Tween 20,
SDS or equivalent); prepare it the same day.
9.2.1.2 Aerosolize the surfactant solution; through the method of measuring the challenge
aerosol, determine the particle size distribution of the solution; particles with a diameter greater
than 0.7 m should not be detected. The goal is that the number of particles with a diameter
greater than 0.7 m detected within any period of 6 s does not exceed 2. Conduct monitoring
for 1 min on the aerosolized surfactant solution.
9.2.1.3 Table 1 illustrates the particle size distribution of suitable surfactant solutions, with each
row counting for 6 s.
11.2 Set up the particle counter to continuously record the particle count and pressure data using
the 0.7 m and 1.0 m channel data.
11.3 Test the distilled water / surfactant to ensure that its cleanliness complies with 9.2.1.
11.4 Prepare a PSL suspension with a suitable concentration and verify that the difference in
particle counts is within 3% as described in 9.2.2.3.
11.5 Cut the sample and put the sample into the sample holder as described in 10.
11.6 Select a high flow range.
11.7 Turn on the aerosol flow and allow the challenge count to stabilize.
11.8 Close the Venturi needle valve to make the inlet pressure reach 0.3 MPa. Open the Venturi
needle valve, until the pressure difference across both sides of the sample reaches 2 hPa,
stabilize for 1 min; when 50 filtrate particles are detected (or at least 45 s), start counting the
challenge particles and the filtrate particles, and record the pressure difference, the number of
challenge particles and the number of filtrate particles.
11.9 Adjust the Venturi needle valve (or reduce the Venturi tube / purge pressure to zero) to
reduce the pressure difference on both sides of the sample by 1/2; stabilize for 2 min; wait until
50 filtrate particles are detected (or at least 45 s), start counting the challenge particles and the
filtrate particles; record the pressure difference, the number of challenge particles and the
number of filtrate particles. Continue to reduce the pressure difference on both sides of the
sample by 1/2, until the maximum penetration is detected (or the needle valve is closed, or the
Venturi tube / purge pressure is zero). If the maximum penetration value has not been reached,
record the pressure difference (P1), at which, the needle valve is closed (or the Venturi tube /
purge pressure is zero) before switching to the low flow range.
11.10 If needed, set the Venturi tube / purge pressure to zero and select the low flow range.
11.11 Increase the pressure of the Venturi tube / purging air flow, until the pressure difference
on both sides of the sample reaches the next test point; stabilize for 2 min; when 50 filtrate
particles are detected (or at least 45 s), start counting the challenge particles and the filtrate
particles; record the pressure difference, the number of challenge particles and the number of
filtrate particles. Continue to reduce the pressure difference by 1/2, and collect data, until the
average count result within 60 s is less than 25, or the pressure difference is no longer stable.
11.12 Use the challenge counts accumulated over the time period up to 100 filtrate counts for
data analysis; correct the test results of the low flow range.
11.13 The penetration rate at a given pressure difference is equal to the average number of
filtrate particles divided by the corresponding average number of challenge particles.
......
| Standard ID | YY/T 0681.17-2019 (YY/T0681.17-2019) | | Description (Translated English) | Test methods for sterile medical device package -- Part 17: Testing the microbial barrier performance of porous package materials using aerosol filtration method | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C31 | | Classification of International Standard | 11.080.40 | | Word Count Estimation | 12,155 | | Date of Issue | 2019 | | Date of Implementation | 2020-10-01 | | Summary | This standard specifies the determination of the aerosol filtration performance of breathable packaging materials by generating aerosols of particles with a diameter of 1.0 ��m, and the use of two particle counters to evaluate the filtration efficiency of the material. This standard applies to breathable materials for terminally sterilized medical device packaging. This standard does not apply to materials with a Bentsen air permeability exceeding 4000 mL/min. |
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