06 medical plastics 2017 - scg chemicals · email: [email protected] ... yono soewoyo, graha...
TRANSCRIPT
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: [email protected]
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