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YBB 00242002-2015

Chinese Standard: 'YBB 00242002-2015'
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YBB 00242002-2015English110 Add to Cart 0--15 minutes. Auto immediate delivery. PA/AL/PVC cold-formed foil for solid preparation Valid YBB 00242002-2015
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Detail Information of YBB 00242002-2015; YBB00242002-2015
Description (Translated English): (Polyamide/aluminum/PVC cold forming solid medicinal compound rigid sheet)
Sector / Industry: Medical & Pharmaceutical Packaging Industry Standard
Classification of Chinese Standard: C08
Word Count Estimation: 2,227
Date of Issue: 2015-08-11
Date of Implementation: 2015-12-01
Older Standard (superseded by this standard): YBB 0024-2002
Regulation (derived from): China Food & Drug Administration Announcement 2015 No.164

YBB 00242002-2015
YY / YBB
PETROCHEMICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
PA/AL/PVC cold-formed foil for solid preparation
聚酰胺/铝/聚氯乙烯冷冲压成型固体药用复合硬片
ISSUED ON. AUGUST 11, 2015
IMPLEMENTED ON. DECEMBER 01, 2015
Issued by. China Food and Drug Administration of PRC
PA/AL/PVC cold-formed foil for solid preparation
This standard applies to the composite film using the polyvinyl chloride (PVC),
aluminum foil (Al), and polyamide (PA) by the adhesive through compositing
operation. It is applicable to the cold stamping molding blister packaging for
solid pharmaceutical (tablets, capsules, etc.).
[Appearance] TAKE appropriate amount of this product; CONDUCT visual
inspection against it in bright natural light. It shall be free from perforations,
foreign body, odor, adhesion, composite layer separation and significant
damage, bubbles, wrinkles, dirt or other defects.
[Identification] Infrared spectrum. TAKE appropriate amount of this product;
FOLLOW the method 4 of the packaging material infrared spectrum
determination method (YBB00262004-2015) to determine it; AND the PA layer
and the PVC layer shall be basically in consistent with the control map.
[Physical performance] Water vapor permeation amount. TAKE
appropriate amount of this product. FOLLOW the method 1 test condition B
OR the method 2 test condition B OR the method 4 test condition 2 of the
water vapor permeation determination method (YBB00092003-2015) to
determine it. During the test, LET the PVC face to the low humidity side, which
shall not exceed 0.5 g/(m2 • 24h).
Oxygen permeation amount. TAKE appropriate amount of this product.
FOLLOW the method 1 OR the method 2 of the air permeation determination
method (YBB00082003-2015) to determine it. During the test, LET the PVC
face to the oxygen low pressure side, which shall not exceed 0.5 cm3/(m2 • 24h
• 0.1 MPa).
Peel strength. TAKE appropriate amount of this product; MAKE determination
in accordance with the peel strength determination method
(YBB001020003-2015). The peel strength between the PA layer and the Al
layer shall be not less than 8.0 N/15 mm; AND the peel strength between the
Al layer and the PVC layer shall be not less than 7.0 N/15 mm. (If the
composite layer cannot be peeled off OR otherwise if the composite layer
breaks, the peel strength is qualified).
Heat sealing strength. TAKE appropriate amount of this product; CUT 2 small
pieces of 100 mm x 100 mm; OVERLAP the PVC side with the same size
aluminum foil for medical use (YBB00152002-2015); MAKE it subjected to
heat sealing on the heat sealing instrument, at the heat sealing temperature of
155 °C ± 5 °C and the pressure of 0.2 MPa, for 1 second. CUT a 15 mm width
sample from the heat sealing part; TAKE the middle 3 strips for test. FOLLOW
the heat sealing strength determination method (YBB00122003-2015) to
determine it, AND the mean value of the heat sealing strength of the 6 samples
shall be not less than 6.0 N/15 mm.

YB B00242002-2015
(Polyamide/aluminum/PVC cold forming solid medicinal compound sheet)
Polyurethane/aluminum/polyvinyl chloride cold stamping solid composite hard film
Juxianan/Lü/Julüyixi Lengchongγachengxing Guti Yaoyong Fuhe Yingpian
PA/AI/PVC Cold-formed Foil for Solid Preparation
This standard applies to the combination of polyvinyl chloride (PVC), aluminum foil (Al), polyamide (PA) through the adhesive, the composite
sheet. Applicable to solid drugs (tablets, capsules, etc.) with cold stamping molding blister packaging.
[Appearance] take this product amount, in the natural light bright place, facing visual inspection. No perforation, foreign body, odor, adhesion,
Composite layer separation and obvious damage, bubbles, wrinkles, dirt and other defects.
【Identification】 infrared spectrum to take this product amount, according to packaging materials, infrared spectroscopy (YB B00262004-2015) fourth
Method, PA and PVC layer should be consistent with the control map.
【Physical properties】 The amount of water vapor through this amount, according to the water vapor permeability measurement method (YB B00092003-2015)
The first method test condition B or the second method test condition B or the fourth method test condition 2 determination, the test when the PVC for low humidity
Side, not over 0.5 g/(m2 • 24 h).
Oxygen through the amount of the amount of this product, according to the gas permeability measurement method (YB B00082003-2015) first or second method
It is not allowed to pass 0.5cm3/(m2 • 24h • 0.1MPa) for PVC low side.
Peel strength to take this product amount, according to peel strength determination (YB B00102003-2015) determination. PA and Al interlayer peeling
Strength shall not be less than 8.0 N/15 mm; Al and PVC layer peel strength shall not be less than 7.0 N/15 mm. (If the composite layer can not
Peel or composite layer fracture, the peel strength is qualified).
Heat sealing strength to take this product amount, cut 100 mm × 100mm small pieces of 2, the PVC surface with the same size of the drug
(YB B00152002-2015), heat sealing, heat sealing temperature of 155 ℃ ± 5 ℃, pressure 0.2MPa,
Time 1 second. From the heat of the site cut 15mm wide sample, take the middle of the three test. Determination of heat intensity
(YB B00122003-2015), the average heat sealing strength of 6 specimens shall not be less than 6.0 N/15 mm.
【Vinyl chloride monomer】 take this product amount, according to the determination of vinyl chloride monomer (YB B00142003-2015) determination, not over one hundred
One ten thousandth.
[Dissolution test] Preparation of the test solution. take this product amount, respectively, take the inner surface area of 300 cm2 (divided into 3 cm long,
(70 ° C ± 2 ° C), 65% ethanol (70 ° C ± 2 ° C), n-hexane (58 ° C)
± 2 ℃).200 ml each soak for 2 hours after the removal, let cool to room temperature, with the same batch of test solvent added to the original volume as a supply
Test solution, with the same batch of water, 65% ethanol, positive kang as blank liquid, the following test.
Easy to extract the amount of water for the test solution 20 ml, potassium permanganate titration solution (0.002 mol/L) 20 ml and dilute sulfuric acid 1 ml,
Boil for 3 minutes, quickly cool, add iodine charge 0.1 g, place in the dark for 5 minutes, with sodium thiosulfate titration solution (0.01
Mol/L) titration, titration to near the end, add starch indicator 5 drops, continue to titration to colorless, and the other water white liquid with the law
Operation, the two consumption of sodium thiosulfate titration solution (0.01 mol/L) the difference was not over 1.5 ml.
Non-volatiles were carefully taken water, 65% ethanol, n-hexane test solution and blank liquid 100 ml, placed in constant weight
In a steam pan, dried in a water bath, dried at 105 ° C for 2 hours, precisely after cooling, and the water for the test solution is not volatile.
The difference between the blank liquid residue shall not be over 30.0mg; 65% ethanol for the test solution is not volatile residue and its blank liquid residue difference
30.0mg; n-hexane test solution non-volatile residue and its blank liquid residue difference of not more than 30.0 mg.
Heavy metal precise amount of water for the test solution 20ml, add acetate buffer (pH 3.5) 2ml, according to the law ("Chinese Pharmacopoeia"
2015 edition of the four general rules 0821 first law), containing heavy metals shall not be one millionth.
[Microbial limit] to take this product, with an open area of 20 cm2 sterile metal template pressure on the inner surface, the sterile
Cotton swab with sodium chloride injection slightly dipped in the plate hole within the wipe 5 times, for a cotton swab and then wipe 5 times, each position with
2 cotton swabs wiped 10 times, wiping 5 positions 100cm2. Every cotton swab wiping immediately after the cut (or blow), vote
Into a 30 ml uranium oxide injection bottle (or large test tube). All wiped cotton swab into the bottle, the bottle quickly shake
Akira for 1 minute, that is, for the test solution. For the test solution for film filtration, according to the law ("Chinese Pharmacopoeia".2015
Version of the four general rules 1105,1106). Shall comply with the provisions of Table 1.
Table 1 Microbiological limits
Project oral solid composite hard film external hard complex
Number of bacteria (cfu/100cm2) ≤1000 ≤100
Mold and yeast number (cfu/100cm2) ≤100 ≤10
Escherichia coli -
Staphylococcus aureus -
Pseudomonas aeruginosa -
Note. "-" for every 100 cm2 can not be detected.
【Abnormal toxicity】 * Take this product 500 cm2 (within the surface area), cut into 3cm long, 0.3cm wide small pieces, adding chlorine
Sodium sodium injection 50 ml, set high pressure steam sterilizer, 110 ℃ for 30 minutes to remove, cooling standby, intravenous injection,
According to the law ("Chinese Pharmacopoeia".2015 edition of the four general rules 1141), should meet the requirements.
【Storage】 inner packaging with low-density polyethylene bags sealed, ke......
Related standard:   YBB 00242003-2015  YBB 00242004-2015
   
 
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