USP Class 6 O-Rings, Seals and Gaskets Pune India

USP Class VI <88> (in vivo) Approved O-Rings

Twin Seal Tech Pvt. Ltd.
Warehouse Address – Plot No. 8, Warehouse
No-3B, Near Johnson Controls, Indialand Global
Industrial Park, Warehouse No. 3B, Near
Hinjawadi Phase-1, Pune – 411 057 India.
Tel: +91-20-6799 4400
www.fdao-ring.com
email ask@gmors.com

USP Class 6 O-Rings, Seals and Gaskets CFR 21 FDA 177.2600
USP Class VI <88> (in vivo)
European Framework Regulation EC 1935/2004

Rubber components used in medical equipment and devices for surgical application may come into direct contact with human tissue, and bio-compatibility is a requirement as stipulated by USP Class VI. The US Pharmacopeial sets the safety standards for the healthcare, food and medical technologies industries. The series of tests consist of six classes, and Class VI is considered the most thorough and stringent. The purpose of Class VI tests is to determine the absence of harmful chemicals that may migrate out of rubber materials giving rise to adverse health effects.

USP Class VI Chapter 88 refers to in vivo biological reactivity tests with the purpose of ascertaining the biological response effect of elastomeric materials on live animals (in vivo). USP <88> stipulates three testing requirements:

An extract of the material to be tested is prepared with specific extraction fluids like vegetable oil and polyethylene glycol, and injected in vivo into living specimens. Biological reactivity is recorded.

1) Systemic Injection Test

Intravenous injection with the prepared extract is conducted on live specimens (mice or rabbits). The specimens are observed for 72 hours and abnormal response to toxicity recorded.

2) Intracutaneous Test

Intracutaneous injection with the prepared extract is conducted on specimens to determine adverse skin reactions. Observation is for 72 hours and results are recorded.

3) Implantation

The material to be tested is implanted into the specimen, and the live tissue that is in contact with the test material is monitored for abnormal response for a duration of 120 hours.

Approval	Tested by	Specification	Compound Reference	Elastomer Compound	Shore Hardness	Color
FDA 21 CFR	Internal approval	§ 177.2600		NBR	From Shore A 60~90	Customized
FDA 21 CFR	Internal approval	§ 177.2600		EPDM	From Shore A 60~90	Customized
FDA 21 CFR	Internal approval	§ 177.2600		VMQ	From Shore A 60~90	Customized
FDA 21 CFR	Internal approval	§ 177.2600		FKM	From Shore A 60~90	Customized
EC 1935/2004	SGS Taiwan	ResAP(2004)4	E7083AA	EPDM perox.	70 ±5 Shore A	Black
EC 1935/2004	SGS Taiwan	ResAP(2004)4	N7041AA	NBR sulf.	70 ±5 Shore A	Black
EC 1935/2004	SGS Taiwan	ResAP(2004)4	V7502AA	FKM bisphenol	75 ±5 Shore A	Black
USP Class VI – 121 °C	Eurofins	Chapter 88 (in vivo)	V7092AP	FKM bisphenol	70 ±5 Shore A	White
USP Class VI – 121 °C	Eurofins	Chapter 88 (in vivo)	E7003AP	EPDM perox.	70 ±5 Shore A	White