제품소개

Pharma 65 Tubing은 우수한 유연성과 높은 탄력성 그리고 백금경화 실리콘 튜빙입니다. Dow Corning은 U.S. Pharmacopeia (USP) ClassV 와 VI 기준을 충족하며 바이오산업과 제약산업을 위한 의료 식품 등급의 실리콘 제품을 생산할 수 있는 완벽한 라인을 구축하였습니다. 낮은 경도의 Pharma 65 Tubing은 바이오산업,제약산업에 큰 기여를 하고있습니다. Pharma 65 Tubing의 어플리캐이션은 오염 염려가 있는 고순도의 이송, 연구용 이외 식품기기, 식품 용기 제조에 적합하여 이들 분야에서 광범위하게 사용됩니다. 미국에 위치한 의료용 실리콘 생산 공장인 HIMS (Healthcare Industry Material Site )에서 cGMP 기준을 엄격하게 준수하여 다양한 테스트로 인해 의료용 실리콘의 풍부한 데이터를 보유 하고 있습니다. 또한 FDA에 등록하고 승인을 유지 하기 정기적인 검사를 받고 있습니다.

용도

백신개발,약물전송,가스 이송관

규정상태

FDA 21 CFT 177.2600 (Food Grade) | EP | USP

유통기한

36개월

포당단위

50ft/1carton

연실율

775%

경도

65

Liveo™ Pharma 65 Tubing

Silicone Tubing and Assemblies

(Si)

CHARACTERISTICS

• Delivery form
• Parts, Shapes, Tubing
• Special characteristics
• Translucent, Low emissions
• Medical applications
• USP-VI, ISO10993, European Pharmacopeia
• Food contact
• FDA 21 CFR
• PRODUCT TEXT
  Pharmaceutical grade silicone tubing for transferring of ultra-pure liquids, air or steam in pharmaceutical and biotechnological manufacturing processes.

APPLICATIONS

Designed for applications that require the transfer of high purity fluids where contamination is a concern like filling lines.

FEATURES & BENEFITS

• Excellent flexibility
• Greater pressure and kink resistance
• Low extractables
• Contains no peroxide by-products, chlorophenyls or PCBs
• No organic plasticizers, phthalates or latex additives
• Easily sterilized
• Stable over a wide temperature range
• High resiliency
• No impaired taste or odor
• Non-wetting (hydrophobic) surface
• Made from BioMedical Grade elastomer that exceeds United States Pharmacopeia (USP®) Class VI Plastics Test Requirements
• Meets European Pharmacopoeia monograph 3.1.9. “Silicone elastomer for closures and tubing”
• Manufactured to the principles of FDA 21 CFR 210/211 cGMPs for Pharmaceutical products
• Produced in an FDA-registered (CFN 1816403) and inspected healthcare facility
• High purity quality (USP 788 Particulate matter for Injection, USP 85 Bacterial Endotoxins, ISO 11737-1 Bioburden)
• FDA 21 CFR 177.2600 and USP 661 Physico-chemical tests - Plastics
• Reduces risk of contaminating ultra-pure liquids
  • Complete traceability
• Consistent performance
• Rigorous change control
• Dimensions available from small bore (0.28mm x 0.60mm) to large bore (31.8mm x 41.3mm)

COMMON TUBING PRODUCT SIZES (capability exists for these and many other sizes) AND BURST PROPERTIES:

Inside Diameter [mm]	Outside Diameter [mm]	Wall [mm]	Burst Pressure [bar]
3.2	6.4	1.6	8.5
4.8	8.0	1.6	7.8*
4.8	9.5	2.4	10.8
6.4	9.5	1.6	6.3*
6.4	11.1	2.4	8.4*
6.4	12.7	3.2	10.1
8.0	12.7	2.4	7.3*
9.5	12.7	1.6	4*
9.5	14.3	2.4	6.3*
9.5	15.9	3.2	7.7
12.7	17.5	2.4	4.7*
12.7	19.1	3.2	6.2
15.9	22.2	3.2	4.6
19.1	25.4	3.2	4.3

Note: Burst pressure values are typical values not intended for writing specifications. Test method is based on ASTM D380-14.

• Predicted burst pressure : a regression formula was used to calculate burst pressure of these tubing sizes not actually tested for burst strength.

SPECIAL NEEDS

DuPont has the capabilities to customise products to your specifications. Customisation includes sizes, tolerances, cut lengths, bulk packaging and spooling. For easy identification, Liveo™ Pharma Tubing is also available marked with product name and size. Please contact your DuPont representative to discuss your specific requirements.

QUALITY INFORMATION

The FDA registered and ISO 9001:2015 certified Healthcare Industries Materials Site (HIMS site) is responsible for ensuring consistent product quality.

REGULATORY AND BIOCOMPATIBILITY INFORMATION

Product Regulatory Information document as well as Summary of health data are available from our DuPont website or upon request.

REGULATORY

Chemical Equivalency Certificate

MECHANICAL PROPERTIES

property	valule	unit	TEST NORM
Modulus at 200% strain	2.8[1]	MPa	ASTM D 412
Tensile Strength	7.0	MPa	ASTM D 412
Elongation at break	>300	%	ASTM D 412
Shore A hardness	65		ASTM D 2240
Tear strength, die B	46.0	kN/m	ASTM D 624

[1]: tested on tubes with die D
[2]: tested on tubes

ADDITIONAL INFORMATION

Information from “Chemical Resistance Guide For Elastomers IV”, published by Compass Publications, La Jolla, California, can be used as a reference. It is however recommended that the DuPont product be evaluated in the real conditions of use.

LIMITATIONS

This product is neither tested nor approved for any hospital or patient care use such as for temporary insertion or any in vivo procedures. This product is not to be used in human implantation, or human contraceptive, reproductive, obstetrical or gynecological applications. The user shall hold DuPont harmless from any and all damages resulting from use of this product. It is the sole responsibility of the user to determine the safety and efficacy of this product for any specific use. This product is not tested for specific pharmaceutical or medical device use(s). Should you wish to use this product in a specific pharmaceutical or medical device application, please contact DuPont to discuss such potential use. It remains the User’s responsibility to ensure the safety, efficacy and legal and regulatory compliance in each relevant jurisdiction (including targeted geographic regions of manufacture and supply) of these materials for its intended uses. DuPont makes no representation concerning the suitability of these products for any particular medical or pharmaceutical application. Under no circumstances should these materials be considered for implantation into the human body for periods that exceed 30 days in duration.