Complaint
We, Hebei Guorun, offer wide range of high performance calendared rigid thermoforming PVC film for Pharmaceutical Packaging. These PVC film are manufactured from excellent quality pharmaceutical grade raw materials using latest calendaring technology.
These films are produced under the most rigid quality standards in the industry, meeting all national and international regulations like Pharmacopoeia, FDA requirements, BGA recommendations of German Federal Health Authority, EC ( European Community) directives and GMP standards.
Product Features:
Manufactured under controlled environment.
Full production traceability.
Meets all international drug regulations.
Controlled shrinkage, consistent forming and punching.
Superior thermoforming.
Special grades available for deep drawing.
Taste and smell neutral.
Low migration levels.
Low moisture and gas transmission rates.
Excellent dimensional stability and salability.
Guaranteed thickness control for higher yields.
Available in wide range of colours.
Good tight winding for trouble free operations.
Technical Parameters:
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. | |||||||||||
Certificates:
Register in Center for Drug Evaluation NMPA
1)Good and competitive prices
2) 100% New raw materials
3) Delivery guarantee, Prompt
4) We can produce according to customers requirements
5) High quality and stable
6) Rich export experience
7) Free sample inspection
We sincerely hope to cooperate with your esteemed company in the near future.
