Complaint
There are many manufacturers that can produce PVC, but not many of them are registered in the National Medical Products Administration.
We are engaged in manufacturing and supplying of High Quality PVC Film in Hebei, China. These offered High Quality PVC Films are manufactured using supreme grade quality components that is sourced from reliable vendors of the market keeping in mind set industry norms. Tested on various quality parameters, to deliver the quality approved range for our respected customers at nominal market price.
Our Guorun register No. B20200001012
Product Name | Polyvinyl chloride solid pharmaceutical tablets | Certificate Date | 2022.10.21 | |||||||||
| Specification | 0.35*203mm | Lot NO. | Y20225801 | |||||||||
| 0.35*228mm | Y20225802 | |||||||||||
| 0.35*234mm | Y20225803 | |||||||||||
| Color | Transparent | Report Date | 2022.10.27 | |||||||||
Testing Base | YBB00212005-2015 | |||||||||||
| Item | unit | Specification | Result | |||||||||
| Specification | Thickness | mm | 0.20-0.50 | ±0.02 | Conforms | |||||||
| Width | mm | ≥300 | ±2 | Conforms | ||||||||
| <300 | ±1 | Conforms | ||||||||||
Exterior | Character | / | , Uniform and consistent color | Conforms | ||||||||
| Exterior | / | ,, ,, No wrinkles, oil, foreign bodies, perforations, or impurities are allowed. | Conforms | |||||||||
| Crystal point | Pcs/100cm2 | per100cm2, Ø > 1.3mm 0 crystal points | Conforms | |||||||||
| per100cm2,Number of crystal points Ø≤1.3mm ≤3 | Conforms | |||||||||||
Identify | IR | -- | Should be basically the same as IR | Conforms | ||||||||
| Density | g/cm3 | 1.35-1.45 | Conforms | |||||||||
Residue standard | (Vinyl chloride) | (mg/kg) | <1 | Conforms | ||||||||
(Dibutyltin, DBT) | (mg/kg) | <50 | Conforms | |||||||||
[Tricresyl phosphate(tritolyl phosphate)] | (mg/kg) | <1,000 | Conforms | |||||||||
Dissolution standard | (Pb) | mg/L | <1 | Conforms | ||||||||
(Potassium permanganate consumption) | mg/L | <10 | Conforms | |||||||||
(Total elution) | mg/L | <30 | Conforms | |||||||||
| Dissolution standard | (Di-n-butylphthalate, DBP) | mg/L | <0.3 | Conforms | ||||||||
(Benzyl-n-butyl phthalate, BBP) | mg/L | <30 | Conforms | |||||||||
[Di-(2-ethylhexyl) phthalate, DEHP] | mg/L | <1.5 | Conforms | |||||||||
(Di-n-octyl phthalate, DNOP) | mg/L | <5 | Conforms | |||||||||
| (Diisononyl phthalate, DINP) | mg/L | <9 | Conforms | |||||||||
| (Diisodecyl phthalate, DIDP) | Conforms | |||||||||||
[Di-(2-ethylhexyl) adipate, DEHA] | mg/L | <18 | Conforms | |||||||||
Physical properties | (/) Tensile Strength | MPa | ≥44 | Conforms | ||||||||
| (/) Heating expansion ratio | % | ≤±6 | Conforms | |||||||||
Water vapor transmission | g/(m2·24h) | ≤2.5 | Conforms | |||||||||
| (23±2)ºC Oxygen permeability | cm3/(m2·24h·0.1Mpa) | ≤30 | Conforms | |||||||||
Heat sealing strength | N/15mm | ≥7.0 | Conforms | |||||||||
Leachable test | Clarity | / | Should be clarified | Conforms | ||||||||
| (Pb) | mg/Kg | <100 | Conforms | |||||||||
| (Cd) | ||||||||||||
| (Hg) | ||||||||||||
| 6+(Cr6+) | ||||||||||||
| N-heptane | mg/100ml | <150 | Conforms | |||||||||
| Microbiological Tests | Aerobic count | cfu/100cm2 | ≤1000 | Conforms | ||||||||
Total Yeast & Mold | cfu/100cm2 | ≤100 | Conforms | |||||||||
| E.coli | cfu/100cm2 | Not detected | Conforms | |||||||||
Conclusion | ,. The inspected items met the requirements and were judged as qualified products. | |||||||||||
Hebei Guorun Pharmaceutical Packaging Materials Co,. Ltd was founded in year 2014. It is located in No.1 of Guorun Road, South Area of Zhongguancun entrepreneurship base, Zaoqiang, Hengshui City, Hebei Province China, with beautiful surrounding, convenient traffic, and superior geography location. The company has a registered capital of 36 million RMB. It covers an area of 23,000 square meters. We are specialized in research & development, manufacturing PVC medical rigid sheets, PVC blister rigid sheets, the oral liquid straws, medicinal plastic trays, PVC flocking plastic trays, aluminum-plastic composite films and related products.
The factory has an international advanced production line and the complete inspection equipments. The workshops are all Class D clean areas, which are managed strictly in accordance with GMP requirements and it can meet the needs of different customers.
Good faith is gold. Guorun people adhere to the integrity, and run this business philosophy throughout the production process. Based on the principle of "expanding the market with quality and winning customers with reputation", we strengthen ourselves constantly and contribute to the society and customers with reliable technology & products and high-quality service
.
Our company has established good cooperative relations with many well-known pharmaceutical companies, and won unanimous praise from our customers. Our products have been exported to Thailand, Vietnam, India, Pakistan, Bangladesh, the Philippines, Mexico, Russia and other countries. They are very popular due to the stable quality and the internationally competitive price. Hebei Guorun will take "pursuing product quality as its own responsibility, and cultivate in the land of the pharmaceutical industry silently without regrets"!
Certificates:
CLASS 100,000 CLEANROOM
Lab and tests:
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