:BRAZIL
MEETING ANVISA STANDARDS
PENSALAB, SERVOMEX’S EXCLUSIVE DISTRIBUTION PARTNER IN BRAZIL, LOOKS AT THE
DEVELOPING REGULATIONS FOR THE MEDICAL GAS MARKET IN THE COUNTRY.
In Brazil, the production of medical gases
is regulated by the National Agency for
Sanitary Vigilance (ANVISA).
Motivated to follow the international
trends of classifying these products as
medicines, ANVISA published the
Resolutions, RDC number 69 and RDC
number 70, on October 1, 2008.
RDC 69/2008 establishes Good
Manufacturing Practices for medical
gases, while RDC 70/2008 sets out the list
of medical gases subject to notification
as well as procedures for notification. It
is through notification that companies
communicate the manufacture of medical
gases to ANVISA.
However, because the companies that
manufacture medical gases are in the
process of being adequate for the
notification and registration of the
Considering the regulatory impact on
the market for medical gases, ANVISA has
not yet established the requirements with
the concession of AFE for the companies
responsible for the distribution, storage
and transportation of medical gases and,
therefore, these companies do not need
AFE for its operation. Among the requests to meet current
Resolutions, calibration services and
specification of solutions for medical
oxygen are the most frequent. Prior to
the most current publications of the
Resolutions, only oxygen purity had to
be measured, quite similar to the
American Pharmacopeia.
Pensalab is the exclusive representative
of Servomex in Brazil and for this reason
remains involved in sales and services
related to this market. Currently, it is mandatory to measure
the impurities present in this gas as well,
making the Resolution more like the model
applied by the European Pharmacopeia,
product, currently RDC 70/08 is suspended.
Although the Notification of Medicinal
Gases is suspended, all companies that
manufacture or package medical gases
must have the Operating Authorization
(AFE), issued by ANVISA, and comply with
the requirements of Good Manufacturing
Practices established by RDC N. 69/2008,
as amended by RDC 9 of March 4, 2010.
a tendency that ANVISA is demonstrating
to follow for the upcoming Nitrogen Purity
Resolution and, most likely, more to come.
Medicinal nitrogen will also meet the new
requirements of ANVISA. A new regulation,
specific to the purity and impurities of
this product, is expected to be published
soon following the same standards already
adopted for medicinal oxygen.
For more information about the medical gas market in Brazil and Servomex’s specialist
analyzer solutions, contact: [email protected] or call +55 (11) 5180-8300
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THE TOLERANCE LIMITS OF PURITY AND IMPURITIES PRESENT IN OXYGEN AND THE
TECHNOLOGY REQUIRED FOR POST-PACKAGE ANALYSIS.
MEDICINAL OXYGEN
Measured gas Concentration Technology
O 2 >99.5% Paramagnetic
CO 2 <300ppm Infrared
CO <5ppm Infrared
H 2 O <67ppm Electrochemical (P 2 O 5 )
RECOMMENDED SERVOMEX ANALYZERS
SERVOFLEX MiniMP 5200 SERVOPRO MultiExact 4100 SERVOPRO Chroma
servomex.expert/minimp5200 servomex.expert/multiexact4100 servomex.expert/chroma
NEW RSM JOINS
LATIN AMERICA TEAM
Servomex has enhanced its customer
support for the Latin America region by
appointing Virginia Rodrigues as Regional
Sales Manager.
Based in Sao Paulo, Brazil, Virginia will
cover the area from Mexico through to
South America. She previously spent 17
years in sales and marketing at Servomex’s
Brazilian distribution partner, Pensalab.
Servomex’s Director and VP, Global Sales,
Luca Marinelli, said: “I’m delighted to
welcome Virginia to the team.
Her role with Pensalab means she is
highly experienced in our markets and
with our analyzers.
“This expertise will be a great asset to
our customers in the region as she helps
them to determine the right solution for
their process.”
[email protected]
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