REGULATORY COMPLIANCE
Roehm America LLC products comply with USP Class VI, ISO 10993 (Tripartite), and FDA food contact regulations as shown below (only "clear" products tested except CYREX® which was tested in a white medical). The products comply with RoHS and REACH requirements, are free of heavy metals, plasticizers, natural latex, REACH SVHC substances and are BPA free.
Regulatory requirements
| Food contact (1) | USP Class VI (2) | ISO 10993-1 (Tripartite) (3)(4) | |
|---|---|---|---|
| CYROLITE® MD L40 | X | X | X |
| CYROLITE® G-20 | X | X | X |
| CYROLITE® G-20 HIFLO® | X | X | X |
| CYROLITE® GS-90 | X | X | X |
| CYROLITE® CG-97 | X | X | X |
| CYROLITE® Med 2 | X | X | X |
| XT® POLYMER | X | X | X (8RG grade not tested) |
| CYREX® 200-8005 (5) | X | X | X |
Notes:
(1) Products meet FDA food contact requirements of 21 CFR 177.1010 (ACRYLITE® and CYROLITE®) or 21 CFR 177.1580 (CYREX®) under Condition C (no Alcohol) and Condition D @ 8% alcohol.
(2) Class VI United States Pharmacopoeia tests for determining the suitability of a plastic material intended for use in fabricating containers or accessories thereto, for parenteral preparations.
(3) Indicated products have been found to be non-hemolytic, non-cytotoxic, non-pyrogenic, non-sensitizing, and non-mutagenic when tested following the Tripartite and ISO 10993-1 protocols.
(4) In clear and 000, 001, 301 and 3128 tints only. Other colors not tested. In CYREX® 200 8005 color only.
(5) Not BPA free.