Innovafit® Port Disc

Innovafit® port discs are made of biopharmaceutical grade polypropylene resin in ISO class 7 clean room. 

Features	Physical properties	Regulations
Polypropylene	Hardness Shore D : 50D	USP Class VI
Non-animal derived and nonhemolytic	Specific gravity : 0.90g/cm3	ISO 10993
Sterilizable by ETO, autoclave, Gamma	Max working temperature : 135C	FDA 21CFR 177.2600
Manufactured in ISO 7 clean room		USP 665, 788, 661

 

Packing quantities are available from standard 25 pcs to 100 pcs upon request.
All custom products are subject to minimum order quantities and lead times.
For other custom options, please contact us at info@innovapure.com .

More ID/OD/Coil length are available upon requests.

Download datasheet for more detailed technical specifications.

Asking for validation guide and regulation information.

ISO 10993-3 Genotoxicity
ISO 10993-4 Hemolysis
ISO 10993-5 Cytotoxicity Tests
ISO 10993-10 Irritation/Intracutaneous Reactivity
ISO 10993-11 System Toxicity
USP Class VI Biological Reactivity Tests
USP 71 Bacteriostasis & Fungistasis
USP 87 Cytotoxicity Tests, In-vitro
USP 85 LAL Gel Clot Endotoxin
USP 643 Total organic carbon
USP 788 Particulate matters
USP 661 Physicochemical Tests
FDA 21CFR Total extractables in rubber articles for repeated uses
Animal Derivative Content Free Tallow/BSE/TSE
Compliance statements
RoHS/REACh