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