 |
2006-08-26 News Headlines
Ciba Specialty Chemicals:
new antimicrobial test method
Test method from Ciba Specialty Chemicals and Bio-Gate helps optimize
antimicrobial applications for determining adhesion of microbes to surfaces
or components.
Ciba Specialty Chemicals together with its marketing partner Bio-Gate
has provided a comprehensive master file to the US Food and Drug Administration
(FDA), for its new antimicrobial test method called NUMETRIKA*, a recognized
scientific methodology for the evaluation of antimicrobial performance
of surfaces or devices. This master file can now be referenced by developers
and marketers of antimicrobial-containing devices and products in order
to support permissible efficacy claims and in obtaining regulatory approvals.
The FDA master file complements the European accreditation granted in
Germany (ZLG - Zentralstelle der Lander fur Gesundheitsschutz) under EN
ISO/IEC 17025.
Find
Information and Suppliers of antimicrobial testing.
|
The NUMETRIKA* test method
helps optimize antimicrobial applications sensitive to
infection, such as instruments, surgical clothing and
post-operative bandages. Click
Go for High resolution image. photo: Ciba
|
|
. NUMETRIKA method quantitatively evaluates the antibacterial and anti-adhesive
properties of surfaces
. Filing enables medical device marketers to reference the master file
in support of permissible antimicrobial claims
. NUMETRIKA technology, marketed by Ciba’s Expert Services business,
is now available to the US market
The Ciba Expert Services business unit offers a wide range of consulting,
testing and information services in the fields of regulatory affairs,
environmental compliance, powder and process safety testing, high end
material and analytics testing as well as industry and technology driven
consulting, publications and conferences.
The above referenced master file, MAF 1401, was submitted to and received
by the FDA on June 22, 2006 by Ciba Specialty Chemicals’ Washington,
DC legal counsel.
Miles Hutchings, Head of Expert Services NAFTA says, “The method
NUMETRIKA offers a novel, sensitive, and quantitative method for determining
adhesion of microbes to surfaces or components as well as a measure of
the subsequent proliferation of microbes under standardized conditions.
This unique testing method now provides US companies with the opportunity
to quantitatively document the antimicrobial effectiveness of their products
and to substantiate permissible product claims. Customers utilizing this
novel technology to assess antimicrobial properties of surfaces can cross-reference
our extensive data set we have provided to the FDA documenting the procedure,
its application, and validation."
The test method was developed by Bio-Gate
in the mid-1990s and has been adopted by European clients. Global marketing
of the method is now handled by Ciba's Expert Services Business Unit under
the trade name NUMETRIKA*. The highly sensitive procedure has been tested
successfully in clinical applications and is patented in Germany. This
automated method lends itself to the high throughput evaluation of antimicrobial
performance in a fast and cost effective manner. This enables accelerated
R&D compared with traditional antimicrobial test methods that are
manual and rely on labor intensive cell counting. Due to the high throughput
aspect, the described test method can also be used for quality control
during the production of products with antimicrobial features.
Find Information about Ciba Specialty Chemicals.
* NUMETRIKA is a registered trademark of Ciba Specialty Chemicals.
Read a recent press release from Ciba about - 'Ciba Specialty Chemicals
announces global price increases
for its water soluble polymers'
Chemical
Engineering Jobs - Post Employment Opportunity!
Click
here to view more news headlines.
E-mail this page to a friend 
|
|
Maybe
it's time to check your Homeowners
News / Resources
- Ticona polymers
gives scalpel stability for laser eye surgery
- Certification, Training and Courses
from The American Management Association
- Specials this month at
Online Metals
-
Looking for a Study Program?
- All this Months News
- How Well Do You Know Yourself? Select from 22 different
tests and find out!
Copyright
- Unless otherwise
stated all contents of this web site are © 1998/2006 JOBWERX.COM.
|
