Publicidad
Certificate for
®
Minisart
-RC|SRP|NY
The purpose of this Certificate is to provide information about Sartorius Stedim Biotech
products' compliance with quality standards. Sartorius Stedim Biotech certifies that its
products listed below meet the high quality requirements placed on them.
Product Catalog No.
Minisart
®
RC:
17821; 17822; 17761; 17762; 17764; 17765
®
Minisart
SRP:
17820; 17558; 17559; 17573; 17574; 17575; 17576
Minisart
®
NY:
17845; 17846, 1776 B, 1776 C
I. Good Manufacturing Practice
These products have been manufactured in a Sartorius Stedim Biotech facility in
compliance with the FDA regulations and Good Manufacturing Practice standards.
II. 100% Tested during Manufacture
Each unit is tested for membrane and housing integrity during manufacture.
III. Quality Assurance Lot Release Criteria
Each manufacturing lot has been tested and released according to the following
in-house criteria: Bubble point, housing integrity, flow rate for water or ethanol
IV. HPLC Certification
The membranes used with methanol/water and acetonitrile/water did not show
any artifacts or interference peaks in the range of 200 – 300 nm during HPLC.
V. Sartorius Stedim Biotech has been certified for compliance with ISO 9001.
Dr. Ralf Wawotzny
Director of Quality Filtration Products
Publicidad
