YBB 00342002-2015 PDF in English
YBB 00342002-2015 (YBB00342002-2015) PDF English
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| YBB 00342002-2015 | English | 150 |
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General requirements for multi-layer co-extrusion film and bag for infusion
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Standards related to (historical): YBB 00342002-2015
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YBB 00342002-2015: PDF in English YBB 00342002-2015
YBB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
General Requirement for Multi-Layer
Co-Extrusion Film and Bag for Infusion
General Requirement for Multi-Layer
Co-Extrusion Film and Bag for Infusion
Multi-layer co-extrusion film refers to the film with two or more layers, formed by a co-
extrusion process, without using a binder. Multi-layer co-extrusion bag for infusion
refers to the bag made of multi-layer co-extrusion film by thermal sealing method.
This Standard is applicable to the 50mL and above multi-layer co-extrusion film and
bag for infusion.
[Appearance] Take the appropriate amount of this product; visually examine it in the
bright place of natural light. It shall be transparent, smooth, and free of visible foreign
matters.
[Identification] Take the appropriate amount of this product; determine as per the fifth
method of Test for Infrared Spectrum of Packaging Materials (YBB00262004-2015);
each layer shall be basically consistent with the control atlas.
[Sterilization Adaptability Test] (Bag) Take several samples of this Product; add
water for injection filtered through a 0.45µm pore size filter membrane to the marking
capacity; and seal. After sterilization by damp heat sterilization (standard sterilization
F0 value ≥ 8; for instance, perform damp heat sterilization at 121°C for 15min), then
carry out the following test.
Temperature adaptability Take a few of the above samples; stand for 24h at -25°C ±
2°C; then continuously stand for 24h at 50°C ± 2°C; finally stand for 24h at 23°C ± 2°C;
place the sample between two plates; withstand an internal pressure of 67kPa;
maintain for 10min; no liquid shall leak out.
Anti-drop Take a few of the above samples; stand for 24h at -25°C ± 2°C; then
continuously stand for 24h at 50°C ± 2°C; finally stand for 24h at 23°C ± 2°C; according
to the drop height in Table 1, separately drop the samples onto a rigid and smooth
surface; there shall be no cracks or leaks.
Table 1 -- Drop Height
Transparency Take a few of the above samples; take another empty bag; add the
Grade-4 turbidity of standard solution, which serves as control bag; under the black
Marking capacity (mL) Drop height (m)
to Test for Tensile Properties (YBB00112003-2015); the sample shall be Type-II; the
test speed (no load) is at 100mm/min±10mm/min or 500mm/min±10mm/min; the
average longitudinal and transverse tensile strength shall be no less than 20MPa.
Thermal Sealing Strength (Bag) Take appropriate amount of this product; determine
according to Test for Welding Strength (YBB00122003-2015); it shall be no less than
20N/15mm.
[Light Transmittance] Take the flat part of this product; cut into 5 sections with size
of 0.9cm×4cm; separately place into the absorption cell in the vertical direction of the
incident light; filled with water; take water as a blank; determine the light transmittance
according to UV-Visible Spectrophotometry (Chinese Pharmacopoeia 2015 Edition,
Volume 4, General Rules 0401) at the wavelength of 450nm; it shall be no less than
75%.
[Ignited Residue] Take 5.0g of this product; check according to (Chinese
Pharmacopoeia 2015 Edition, Volume 4, General Rules 0841); the remained residue
shall not exceed 0.05%.
[Metal Element] Take the residue under the ignited residue items; add 5mL of
hydrochloric acid solution (1→2) and dissolve; then evaporate it; add 25mL of 5% nitric
acid solution to residue to dissolve; determine according to Atomic Absorption
Spectrophotometry (Chinese Pharmacopoeia 2015 Edition, Volume 4, General Rules
0406); it shall conform to the following provisions.
Copper Determine at the wavelength of 324.8nm, which shall not exceed three parts
per million.
Cadmium Determine at the wavelength of 228.8nm, which shall not exceed three parts
per million.
Chromium Determine at the wavelength of 357.9nm, which shall not exceed three
parts per million.
Lead Determine at the wavelength of 217.0nm, which shall not exceed three parts per
million.
Tin Determine at the wavelength of 286.3nm, which shall not exceed three parts per
million.
Barium Determine at the wavelength of 553.6nm, which shall not exceed three parts
per million.
[Test on Dissolved-Out Matter] Preparation of the test solution. Take the flat part of
this product with inner surface area of 600cm2; cut into small pieces with size of
5cm×0.5cm; place it into a conical flask; add appropriate amount of water to shake and
dissolve; and dilute to 1000mL), adding 46mL of blank solution and 2mL of alkaline
potassium iodide test solution; it shall be no darker (0.00008%).
Barium Ions Take appropriate amount of test solution, which can be concentrated, if
necessary; determine as per the provisions of corresponding metal element; it shall
not exceed 1 part per million.
Copper Ions Take appropriate amount of test solution, which can be concentrated, if
necessary; determine as per the provisions of corresponding metal element; it shall
not exceed 1 part per million.
Cadmium Ions Take appropriate amount of test solution, which can be concentrated,
if necessary; determine as per the provisions of corresponding metal element; it shall
not exceed 1 part per million.
Lead Ions Take appropriate amount of test solution, which can be concentrated, if
necessary; determine as per the provisions of corresponding metal element; it shall
not exceed 1 part per million.
Tin Ions Take appropriate amount of test solution, which can be concentrated, if
necessary; determine as per the provisions of corresponding metal element; it shall
not exceed 1 part per million.
Chromium Ions Take appropriate amount of test solution, which can be concentrated,
if necessary; determine as per the provisions of corresponding metal element; it shall
not exceed 1 part per million.
Aluminum Ions Take appropriate amount of test solution, which can be concentrated,
if necessary; determine according to the atomic absorption spectrophotometry
(Chinese Pharmacopoeia 2015 Edition, Volume 4, General Rules 0406) at the
wavelength of 309.3nm; it shall not exceed 0.05 part per million.
[Bacterial Endotoxin] Preparation of test solution. Take an empty bag; add marking-
capacity water for sterilization infusion, then seal the bag; extract at 121°C±2°C for
30min; cool off for later-use; serve as test solution; check according to the law (Chinese
Pharmacopoeia 2015 Edition, Volume 4, General Rules 1143); the content of endotoxin
per 1mL of test solution shall not exceed 0.25EU.
[Biological Test] * * Cytotoxicity Take this product; determine according to the first
method in Test for Cytotoxicity (YBB00012003-2015); take the serum-containing
medium as the leaching medium; the ratio between surface area of sample and
leaching medium is 6cm2/ml; which shall meet the requirements.
Skin Sensitization Take this product; determine according to Skin Sensitization Test
(YBB00052003-2015); the sensitization reaction shall not exceed Degree-I.
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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