Ami Polymer Pvt. Ltd achieves a new
Ami Polymer Pvt. Ltd., have achieved a
new milestone by having Extractable
Study for their Platinum Cured Silicone
Tubing. Their Platinum Cured Silicone
Transparent Tubing is manufactured in
Clean Room of Class 10000 and having
DMF no #26201 from USFDA.
Extractable data are in general required
to find Leachable coming out of any
particular drug and establish compatibility
with that Drug Product which is a must
requirement of USFDA to sell any Drug
product in US Market. They can now
provide tubing with equivalent standards in
terms of Quality and Certification as of Saint
Gobain, Raumedic & Dow Corning and other
International manufacturers.
APPL’s Silicone tubing is biologically inert
and does not inhibit cell culture. It stays
flexible down to -80?C and maintains its
chemical, mechanical and electrical
performance up to +200?C. APPL’s Tubing
has undergone extensive physical, chemical
and biological tests. These tubing are having
excellent peristaltic pump life. APPL’s
Silicone Tubing is not intended for
implantation.
List of Certificates with their Platinum
Cured Silicone Tubing:
1. Certificate Of Conformity
2. Laboratory Test Report
3. Food Grade Certificate
4. USP Class VI Certificate
5. ISO 10993 Certificate
6. TSE / BSE Certificate
7. German BFRXV Certificate
8. France: Arrete Du 25 Certificate
9. Certificate Of ROHS
10.DMF # 26201 From US FDA
|