Certificate of Quality

Steritest™ NEO – STERILITY TESTING DEVICES

Certificate issued for:

Catalog Number: TZHVAB210

Description: STERITEST™ NEO DEVICES FOR ANTIBIOTICS

Low Binding PVDF Membrane 0.45µm

Lot Number: F2JB95581

Expiry Date: 31-JUL-2024

This certificate provides information about the quality characteristics and acceptance criteria which support
the high quality standards and reliability built into our products.

We certify that the product described within meets the criteria listed.

This document has been produced electronically and

is valid without a signature.

Head of Quality Biomonitoring, Molsheim, France

The Life Science business of Merck KGaA, Darmstadt, Germany operates

as MilliporeSigma in the U.S. and Canada.
 Good Manufacturing Practices Lot Analysis
This product was manufactured at Millipore S.A.S., This manufacturing lot was sampled, tested and released
Molsheim, France which adheres to Good Manufacturing by Quality Assurance for compliance with the following
Practices guidelines. characteristics:
Special emphasis has been placed on cleanliness and
environmental control conditions.
Physical Tests
Following tests were performed in-process on samples of
this batch and met the requirements:
ISO® 9001/14001
The product has been manufactured in a Millipore SAS Clean Water Flow Rate: Samples met the requirements
facility whose quality management system is approved for clean water flow rate of 0.3 L/min at 10 psi (0.7 bar)
by an accredited registering body to the appropriate ISO® at 25 °C.
9001 Quality System Standard and ISO® 14001
Environmental Management Standard. Manufacturing Maximum Pressure: Samples exhibited a maximum
processes are audited on a regular basis. canister pressure rating in accordance with
specifications.

High Pressure: Samples confirm the integrity of the seal

Product
This lot of product was 100% tested during
manufacturing and met the requirements for the
canister, membrane and seal integrity.
The canisters withstand a maximal pressure rating of 45
psi (3.15 bar).
A polyvinylidene fluoride (PVDF) membrane with a
maximum pore size of 0.45 micrometers, as verified by
bubble point, is used in this product.
Sterilization Process Controls
Each packaging received an irradiation dose between
20.5 and 40 kGy. 40 kGy is not inhibiting the growth of
Staphylococcus aureus ATCC® 6538, Clostridium
sporogenes ATCC® 19404, Candida albicans ATCC®
10231, Aspergillus brasiliensis (niger) ATCC® 16404,
Pseudomonas aeruginosa ATCC® 9027, Bacillus subtilis
ATCC® 6633, Escherichia coli ATCC® 8739 and
Micrococcus luteus ATCC® 9343. Re-validation of the
irradiation dose is performed on regular basis following
AAMI requirements.
on the Steritest™ canister ensuring the integrity of the
welds between the top and the base, the membrane and
the base, and between the tubing and the canister.
Splitting capability: The volume difference between the
two canisters has been verified to be below 10%.
Biological Tests
Retention Efficiency and Fertility:
Samples demonstrated the required retention and
fertility of the following microorganisms:
• Staphylococcus aureus (ATCC® 6538)
• Clostridium sporogenes (ATCC® 19404)
• Candida albicans (ATCC® 10231)
• Aspergillus brasiliensis (niger) (ATCC® 16404)
• Pseudomonas aeruginosa (ATCC® 9027)
• Bacillus subtilis (ATCC® 6633)
Sterility:
The radio-sterilization process was validated following
AAMI guidelines. Each lot met the acceptance criteria for
the controlled and validated cycle. Samples passed the
sterility tests per the U.S., European and Japanese
Pharmacopeias.

END OF CERTIFICATE

©2018 Merck KGaA, Darmstadt, Germany and/or its affiliates. All rights reserved.
The vibrant M, Steritest, Millipore and Sigma-Aldrich are trademarks of Merck, KGaA, Darmstadt,
Germany or its affiliates. ISO is a registered trademark of the International Organization for Standardization.
ATCC is a registered trademark of the American Type Culture Collection.
The Life Science business of Merck KGaA, Darmstadt, Germany operates
as MilliporeSigma in the U.S. and Canada.
N° ManGo template 20341433 Version: 1.0 / N° Certificate : TZHVAB210NEOCOQ (N° ManGo certificate 20350398 Version 1.0)