MEDICALPLASTICS

Notice: It is strongly recommended that all potential activities for applications related to pharmaceutical, medical device, laboratory and diagnostics area have to be discussed with SCG Performance's technical service department first. It is the responsibility of customers to determine that the product is safe, lawful and technically suitable for the intended use. SCG performance makes no warranties concerning the suitability of SCG Performance's product for using in any given medical application.

Disclaimer: - The applications specified for reference only.- It is customer’s responsibilities to inspect and test the product for suitability of the customer’s own use and purpose. The customer is responsible for appropriate, safe, legal use, processing and handling of the product.- To the best of our knowledge, the information contained herein is accurate and reliable as of the date of publication. We however do not assume any liability whatsoever for the accuracy and completeness of the information contained herein.- We make no warranties which extend beyond the description herein. Nothing herein shall constitute any implied warranty of merchantability or fitness for a particular purpose.- No liability can be accepted in respect for the use of the product in conjunction with other materials. The information contained herein relates exclusively to the product when it is not used in conjunction with any third party’s materials.

Rev. Aug 2017 valid until next revision

01

INTRODUCTION

SCG Chemicals is one of the largest integrated petrochemical companies in Asia and a key industry leader. We manufacture and supply a full range of petrochemical products ranging from upstream monomers to downstream polymer including PE, PP, PVC, PS and MMA

To better serve customers’ requirements, SCG Chemicals assign prime importance to development of new technology and innovation for the creation of high value-added products and services (HVA).

Widely recognized for product quality as well as for excellent management and world-class operation efficiency, SCG Chemicals has joint ventured with a number of the world’s leading chemical companies, including the DOW Chemical Company, Mitsui Chemicals and Mitsubishi Rayon.

Our Production Capacity (As of 2017)

(PE / PP / PVC)

Total Capacity : 2,878 KTA

PolyolefinTotal : 1,912 (KTA)

PVCTotal : 966 (KTA)

HDPE 920

PP 720

LLDPE 120

LDPE 152PVC Resin 850

PVC Compound 80

PVC Paste Resin 36

EL-ProTM Polypropylene medical resin is exclusively designed for various medical, healthcare and pharmaceutical applications. Our products can meet all customers’ requirements with international standards of safety compliances such as European Pharmacopeia, USP Class VI, U.S. FDA21 CFR 177.1520, and Drug Master File (DMF). Additionally, our production process is certified by ISO 13485, a quality management system for medical devices.

PP Medical Resin

03

1. Ethylene Oxide (EtO) EL-ProTM PP Homopolymer and PP Random resin has good processability and can be sterilized by Ethylene Oxide (EtO).

1212

14,50015,000

2934

4720

3.1.63.1.6

USP Class VIUSP Class VI

30046

20

13,000

64

15

3.1.6

USP Class VI

30047N/A

- Application requires high stiffness property- Syringe plunger- Needle hub- Laboratory ware and packaging

- Application requires excellent transparency property- Syringe barrel- Baby bottle- Laboratory ware and packaging

- Application required high transparency and high stiffness properties- Small syringe barrel- Laboratory ware and packaging

MFR @ 23°C, 2.16 kg.(g/10 min)

ASTM D1238

Flexural Modulus(kg/cm2)

ASTM D790

Notched IZOD Impact @ 23°C(J/m)

ASTM D256

Haze(%)

ASTM D1003

European Pharmacopeia

United States Pharmacopeia

DMF No.

RecommendedApplication

Remarks: Typical Value Only

P705JM P755JMP704JMGrade

04

20

10,000

78

11

3.1.6

USP Class VI

30044

- Application requires high transparency- Injection Molding for syringe barrel- Laboratory ware and packaging

MFR @ 23°C, 2.16 kg.(g/10 min)

ASTM D1238

Flexural Modulus(kg/cm2)

ASTM D790

Notched IZOD Impact @ 23°C(J/m)

ASTM D256

Haze(%)

ASTM D1003

European Pharmacopeia

United States Pharmacopeia

DMF No.

RecommendedApplication

Remarks: Typical Value Only

P859JMRGrade

2. Gamma/E-Beam Irradiation EL-ProTM PP Random Copolymer resin offers good flowability with excellent transparency property and high-energy radiation tolerance.

05

7

9,000

69

3.1.6

USP Class VI

25971

- Injection Stretched Blow Molding (ISBM) for pharmaceutical and saline solution packaging

MFR @ 23°C, 2.16 kg.(g/10 min)

ASTM D1238

Flexural Modulus(kg/cm2)

ASTM D790

Notched IZOD Impact @ 23°C(J/m)

ASTM D256

European Pharmacopeia

United States Pharmacopeia

DMF No.

RecommendedApplication

Remarks: Typical Value Only

P655IMGrade

3. Autoclave EL-ProTM PP Random Copolymer resin has good processability with excellent dimensional stability, high transparency, good impact resistance, and autoclavable up to 121oC

PVC Medical Resin

PVC medical resin is exclusively produced by suspension polymerization process, white powder and free-flowing resin, and compounded with other additives by special mixing techniques suitable for medical purpose applications used.

Our products also have good processability and complied with many international standards of safety such as REACH compliance of EU, not contained of specified substances according to RoHS of EU, complies with USP Class IV, and Bis Phenol A Free.

07

57.9 60.6

0.58 0.57

< 0.3 < 0.3

< 2 < 2

> 90 > 90

< 5 < 5

< 1 < 1

< 10 < 10

- Medical rigid & semi rigid sheet- Medical molded devices (connector, wing, cap, chamber, etc.)

- Medical rigid & semi rigid sheet- Medical molded devices (connector, wing, cap, chamber, etc.)

K ValueISO 1628-2

Apparent Bulk Density(g/ml)ISO-60

Volatile Matter(%)

ISO-1269

Sieve Analysis, Retainedon 250 micron

(%)ASTM D1921

Sieve Analysis, Retainedon 75 micron

(%)ASTM D1921

Impurity and Foreign Matter(Specks/100sq)

ISO/R-1265

Residual Vinyl Chloride Monomer

(ppm)ASTM D3749

Fish Eye(Point/150 cm2)Inhouse Method

Elution TestInhouse Method

RecommendedApplication

PVC Medical Resin

Passed Passed

Remarks: Typical Value Only

Rigid Applications

SM58E SM61EGrade

08

65.8 71.3 76.5 84.9

0.53 0.49 0.47 0.48

< 0.3 < 0.3 < 0.3 < 0.3

< 2 < 2 < 2 < 2

> 90 > 90 > 90 > 90

< 5 < 5 < 5 < 5

< 1 < 1 < 1 < 1

< 10 < 10 < 10 < 10

- Medical flexible film & sheet- Flexible devices such as nasal tube, blood tube, and blood bag

- Medical flexible film & sheet- Flexible medical devices such as nasal tube, blood tube, and blood bag

- Medical flexible film & sheet- Flexible medical devices such as nasal tube, blood tube, blood bag, and main tube

- Medical flexible film & sheet- Flexible medical devices such as main tube and pump tube

PVC Medical ResinSoft Applications

Passed Passed Passed Passed

K ValueISO 1628-2

Apparent Bulk Density(g/ml)ISO-60

Volatile Matter(%)

ISO-1269

Sieve Analysis, Retainedon 250 micron

(%)ASTM D1921

Sieve Analysis, Retainedon 75 micron

(%)ASTM D1921

Impurity and Foreign Matter(Specks/100sq)

ISO/R-1265

Residual Vinyl Chloride Monomer

(ppm)ASTM D3749

Fish Eye(Point/150 cm2)Inhouse Method

Elution TestInhouse Method

RecommendedApplication

Remarks: Typical Value Only

SM66E SM71E SM76E SM84EGrade

Shanghai

Guangzhou

Australia

Surabaya

Ho Chi Minh

Myanmar

Hanoi

Thailand

Overseas Offices & Contact Information

Head Office: SCG Performance Chemicals Co., Ltd. 1 Siam Cement Road, Bangsue, Bangkok, Thailand 10800Tel: +662 586 1111 Ext. 4042Fax: +662 586 3676Email: medicalplastics@scg.com

SOUTHEAST ASIA

PT. TPC Indo Plastic and Chemicals (Surabaya Office) Lt.5, unit S 508-509, Kompleks Graha Festival Kav.3 Mayjend Yono Soewoyo, Graha Family, Surabaya 60226Tel. +62 319 900 120 56Fax. +62 319 900 1204

CHINA

SCG Plastics Co., Ltd. (Hanoi Office)SCT Co., Ltd. (Hanoi) Representative Office 196 Truong Chinh, Dong Da dist., Hanoi cityTel. +84 439 744 354Fax. +84 439 744 350

SCG Plastics Co., Ltd. (Ho Chi Minh Office)10th Floor, An Phu Plaza 117-119 Ly Chinh Thang P7, Q3 Ho Chi Minh City, VietnamTel. +84 988 804 672Fax. +84 829 612 76

TPC Vina Plastic and Chemicals Corporation Co., Ltd. (Ho Chi Minh Office)U.901-9th Fl., Harbor View Tower, 35 Nguyen Hue Street District 1, Hochiminh City, VietnamTel. +84 838 234 730Fax. +84 838 234 725

SCG Plastics Co., Ltd.2nd floor N. 136/137, Pyay Road, Saw Bea Gyi Gone, Yangon, MyanmarTel. +95 951 946 41, +95 973 183 332

MYANMAR

VIETNAM

SCG Plastics (China) Co., Ltd. (Shanghai Office)RM 1012 Huarong Building No.1271-1289, South of PudongRoad, Pudong New Area, Shanghai, China, 200122Tel. +86 182 170 743 69Fax. +86 216 888 6092

AUSTRALIA

SCG Trading Australia Pty Ltd.Level 4, No.1 Chandos Street, St. Leonards NSW 2065, AustraliaTel. +61 294 381 225, +61 411 022 231Fax. +61 294 360 195

SCG Plastics (China) Co., Ltd. (Guangzhou Office)Unit 3207, Block B, China Shine Plaza, No.9 Lin He Xi Road, Tianhe, Guangzhou, China 510610Tel. +86 139 030 579 29Fax. +86 203 810 1370

INDONESIA

SCG Performance Chemicals Co., Ltd.1 Siam Cement Road, Bangsue, Bangkok, Thailand 10800

Tel. +662 586 1111 Ext. 4042 Fax. +662 586 3676www.scgchemicals.com