EZ-PAK® MEMBRANE

Certificate of Quality
We certify that the product described within meets ISO 14001 Environmental Management Membrane Filter Analysis
the following criteria.
This product was manufactured in a Millipore SAS facility Criteria Specifications Results
whose Environmental Management program is approved Maximum pore size of 0.45 µm as verified
Catalogue Number : EZHAWG474 by an accredited registering body to the appropriate the membrane by bubble point
Conform

Lot Number : F7HA83772 ISO 14001 System Standard. Mean membrane

150 µm Conform
thickness
Expiry date : JUN-2019 Quality Assurance Lot Release Criteria Water flow time of the 25 – 50 sec / 500ml
Conform
membrane @47mm
This manufacturing lot was sampled, tested and released Wettability of the 5 s maximum with
by Quality Assurance for compliance with the following Conform
membrane Milli Q water
Product Description characteristics.
Extratable Inorganic :
Each box consists of 600 (4 x 150) white (or green) Na  0.01 mg/filter Conform
gridded cellulose esters membrane filters, 0.45µm pore Statistical Controls
size.The membrane used in the fabrication of this product The manufacturing process has been validated to
 Physicals Tests
has been sampled and tested and conforms to the  Use tests of the filtration device
conform with the following specifications :
specifications. The membrane filter has been
 Conformity of labeling and packaging. Criteria Specifications Results
manufactured for use in the bacteriological analysis of
potable waters in accordance with procedures referenced Extractables Inorganics :
in Standard method (recent edition), and laboratory Sterility Ca  0.01 mg/filter Conform
standards for equipment and materials set forth by the
U.S. Environmental Protection Agency.
This product has been sterilized by Ethylene Oxide (EO). Zn  0.001 mg/filter Conform
Each lot meets the acceptance criteria for the controlled Ag  0.0001 mg/filter Conform
and validated EO sterilization cycle. Pb  0.0001 mg/filter Conform
Good Manufacturing Practices
EO Residues level :  10ppm (Annual audit). NaHg  0.0001 mg/filter Conform
This product was manufactured in a Millipore SAS facility Cu  0.0001 mg/filter Conform
which adheres to Good Manufacturing Practices. Special Fertility / Growth promotion Cr  0.0001 mg/filter Conform
emphasis has been placed on cleanliness and
environmental control conditions. All the samples provided good growth and typical colony Organic (TOC)  1.0 mg/filter Conform
aspect when challenged with solutions of about 100 CFU of P (reported as
the following microorganisms : Phosphate)  0.02 mg/filter Conform
ISO 9001 Quality Standard  Escherichia coli (ATCC 8739) : recovery  90% versus Ammonia (NH3)  0.01 mg/filter Conform
This product was manufactured in a Millipore SAS facility spread plate. Neutrality pH of extract  8.3 Conform
whose Quality Management System is approved by an  Enterobacter aerogenes (ATCC 49701) : recovery  90%
accredited registering body to ISO 9001 Quality System versus spread plate. According to the above results, the product complies with
Standard. Millipore SAS’s acceptance criteria and is released.
Lot Analysis
This product was designed and manufactured to meet the
EZHA-G--4COQ Version 3.0 03/16 following specifications. Performance is confirmed by
EZ-Pak® is a Registered Trademark of Merck KGaA
Milli Q is a Registered Trademark of Merck KGaA
testing on each lot.
ISO is a Registered Trademark of the International Organization for Standardization
ATCC is a Registered Trademark of the American Type Culture Collection
The M Mark is a trademark of Merck KGaA, Darmstadt, Germany.
© 2012 Merck KGaA, Darmstadt, Germany. All rights reserved. Déborah WILD
BioMonitoring Quality Manager

00012888FM 3.0