CHINA
TEL : +86-10-6512-9692, FAX : +86-10-6512-0031
TEL : +86-21-6209-0123, FAX : +86-21-6209-6145
TEL : +86-20-3765-7458, FAX : +86-20-3765-7481
TURKEY
TEL : +90-212-284-1601, FAX : +90-212-284-1609
www.hyosungchemical.comwww.topilene.com
Beijing Office
Shanghai Office
Guangzhou Office
Istanbul Office
KOREAOverseas Sales Team
TEL: +82-2-2146-5475 (China)TEL: +82-2-2146-5448 (America)TEL: +82-2-2146-5397 (Europe)TEL: +82-2-2146-5442 (Middle East)TEL: +82-2-2146-5468 (Southeast Asia)
Customer Technical Service
TEL: +82-2-2146-5459
HYOSUNG CHEMICAL PP
MEDICAL APPLICATIONS
All That We Can Do For You
THE OVERALL FLOW FOR ULTRA-HIGH PURITY PP PRODUCTION
Raw Material Production Packaging
The production of Hyosung Chemical PP includes the gas
phase process that involves high randomness of the co-monomers and self-developed multi reactor
polymerization to materialize the optimal PP random copolymer
for medical applications. The PP produced this way has high
transparency and toughness and it is suitable for blow process such
as ISBM and EBM.
The new facility of Hyosung Chemical, the De-Duster,
eliminates dust, angel hair and black spot from the PP for medical applications. Then the
PP is packaged in bags made of specially selected materials to
prevent the inflow of dust and the damage of the products. We have
developed a suitable bag design technique for medical products
with plenty of experience of sales.
Hyosung Chemical PP Topilene® for medical applications has superior purity compared to other normal PP. Hyosung Chemical supplies itself with ultra-high purity over 99.7% propylene from the propane dehydrogenation (DH) process where it has adapted cutting-edge manufacturing technology.
Reliability
Quality
Technology
Resin Properties(ASTM) Method Unit R530A R530 R530C
Melt Flow Index (230℃, 2.16kg) D1238 g/10min 2 7 7
Density D792 g/cm³ 0.90 0.90 0.90
Tensile Strength at Yield D638 kg/cm² 280 280 220
Flexural Modulus D790 kg/cm² 9,500 9,500 7,500
Notched Izod Impact Strength (23℃) D256 kg·cm/cm 8 5 10
Application - - AmpouleEBM Bottle ISBM Bottle I.V. bag
Topilene® for Medical Applications is a specially designed polypropylene that features excellent processability, balanced mechanical properties and good clarity. It is suitable for Medical IV(Intravenous) Bottles, IV Bags, Ampoules and Disposable Syringes.
HYOSUNG CHEMICAL Specialized Ultra-high Purity Polypropylene Ensuring the Best Safety for Medical Applications
PHYSICAL PROPERTIES
For Medical IV Bottles
For Medical Syringes
Resin Properties(ASTM) Method Unit J800S J801
Melt Flow Index (230℃, 2.16kg) D1238 g/10min 20 25
Density D792 g/cm³ 0.90 0.90
Tensile Strength at Yield D638 kg/cm² 400 390
Flexural Modulus D790 kg/cm² 21,500 16,500
Notched Izod Impact Strength (23℃) D256 kg·cm/cm 3 3.5
Syringe Part Used - - Plunger, Hub, Cap Barrel
MEDICAL APPLICATIONS
HISTORY
Started the development
Completed the development design
Mass-production for the first time & acquired USP certificate
Certified KP
Certified Chinese pharmaceutical standards (Resin & Bottle)Certified FDA, DMF submissionCertified European pharmaceutical standards (EP)Renewed USP certificationCertified RoHS compliance
Improved the packaging system, certified REACH compliance
2000 2001 2002
2003
2004~2009
2010~
New
Application PP
Re
sins &
Pro
cess
& Certification
Development
Testing Servi
ce
We offer
We Offer Total Solutions for Medical Applications
Hyosung Chemical provides the perfect solution for various processing machine, and constantly develops new products by co-working with diverse machine makers.
CHINA
TEL : +86-10-6512-9692, FAX : +86-10-6512-0031
TEL : +86-21-6209-0123, FAX : +86-21-6209-6145
TEL : +86-20-3765-7458, FAX : +86-20-3765-7481
TURKEY
TEL : +90-212-284-1601, FAX : +90-212-284-1609
www.hyosungchemical.comwww.topilene.com
Beijing Office
Shanghai Office
Guangzhou Office
Istanbul Office
KOREAOverseas Sales Team
TEL: +82-2-2146-5475 (China)TEL: +82-2-2146-5448 (America)TEL: +82-2-2146-5397 (Europe)TEL: +82-2-2146-5442 (Middle East)TEL: +82-2-2146-5468 (Southeast Asia)
Customer Technical Service
TEL: +82-2-2146-5459
MEDICAL APPLICATIONS
Med
ical Certificates
E.P 3.1.6(Europe) KP(Korea)CFDA(China) USP Class Ⅵ (United States)
Plant C
ertificates
ISO 9001 ISO 14001 GOST(Russia)
CERTIFICATES
CERTIFICATES R530A R530 R530C J800S J801
US Pharmacopoeia (USP Class VI) ● ● ● ●
European Pharmacopoeia (EP 3.1.6) ● ●
Chinese Pharmacopoeia ● ● ●
Korean Pharmacopoeia ● ●
FDA Drug Master File Registration ● ● ● ●
CHINA
TEL : +86-10-6512-9692, FAX : +86-10-6512-0031
TEL : +86-21-6209-0123, FAX : +86-21-6209-6145
TEL : +86-20-3765-7458, FAX : +86-20-3765-7481
TURKEY
TEL : +90-212-284-1601, FAX : +90-212-284-1609
www.hyosungchemical.comwww.topilene.com
Beijing Office
Shanghai Office
Guangzhou Office
Istanbul Office
KOREAOverseas Sales Team
TEL: +82-2-2146-5475 (China)TEL: +82-2-2146-5448 (America)TEL: +82-2-2146-5397 (Europe)TEL: +82-2-2146-5442 (Middle East)TEL: +82-2-2146-5468 (Southeast Asia)
Customer Technical Service
TEL: +82-2-2146-5459
MEDICAL APPLICATIONS