06. May 2010
Validation - status, trend and view
Author: Michael trained of: 28.04.2010Die still current FDA Guideline on
general Principles OF Process Validation is now over 20 years old. The
document from May 1987 stands for Industry from November 2008 before
substantial contentwise changes and/or Neuentwicklungen.Die effects on
the topic of the validation from the new Guidance for, stood in the
focus of the PTS training service meeting on 14 April 2010 in Fulda.
The adviser - Mr. Wolfgang H�hnel of the company Gempex GmbH -
presented the fundamental changes and future possible developments in
his lecture. Beginning with the representation of the current
conditions in Germany, Europe and the USA, the adviser presented the
planned and angedachten changes ...
04. May 2010
Pure space gate - certified protection for pure areas tested of the Frauenhofer Institut
Particularly for the employment in medical ranges, fan mA, research,
electronics, semiconductor production, space and other industries, in
which the manufacturing is in pure areas standard, Albany Door of
system developed the new high-speed run roll gate RapidRoll� Clean.
It is first of the Fraunhofer Institut certified Reinraumtor.Das
RapidRoll� Clean fulfills the international standards and guidelines
in pure space's applications according to DIN EN ISO 14644-1 and GMP.
The ISO class 5 as well as the GMP class C was reached and certified.
The gate construction was adapted optimally on the needs of the users
within the range pure area and is characterised in its whole by a
smooth, high-grade steel ...
04. May 2010
Energy efficiency is central topic
�Visit of Ernst Pfister at the conditions of SCHMIDT Technology on
Hannover-MesseAuch the discussions of the minister of economics and
the deputy Prime Minister of Baden-Wuerttemberg, Ernst Pfister, at the
exhibition booth of SCHMIDT Technology, turned around the controlling
topic energy efficiency. Accompanied by Christoph M�nzer, the
managing director of the trade association WVIB, he could convince
himself among other things of how with the help of accurate flow
measurement, substantial energy quantities with the enterprise of pure
areas to be saved to be able. In order to realize printing increased
heights in pure areas, usually quite high flow rates are necessary
over the spatial air-technical plant. ...
30. April 2010
Certified propulsion technology for applications in the pure area
The drive specialist SEW EURODRIVE ONE manufactures a broad portfolio of
drive solutions for a multiplicity of applications in the industrial
surrounding field, among them also for particularly clean environments
or pure spacefor special applications in different industries like
chemistry, far mA and Kosmetikindustrie, the biotechnology, foodstuffs
industry and medical technology as well as the semiconductor industry
and solar panel production high requirements to the air quality and
the associated number and size of the particles is placed. The
mechatronische drive system MOVIGEAR� becomes these requirements
fills fairly: it has a small particle emission and can easily be
cleaned. Besides it exhibits ...
28. April 2010
Dust connection ground mats, also antibacterially
Flusen, lints, hair, Hautschuppen, airborne dust particle can have
substantial influence on the product quality. In particular in
Breichen, where lacquers, colors and other surface coatings are
applied or multi-position products are joined as e.g. in the
printed-circuit practice, such particles can Produktionsausschuss
cause or at least to optical lack lead, which lead then in the most
favorable case only to margin losses. So that by coworkers and
visitors additional dirt is not brought into manufacturing areas,
usually so-called dust connection mats (also ground mats, sticking
mats, Tacky Mats mentioned) lie .ASMETEC supply such dust connection
mats in different formats, also in cuts for the individual ...
27. April 2010
New high-quality sterile alcohol cloth helps to work after GMP
After the newest GMP annex 1 guidelines class A and B of ranges should
be supervised during the entire duration of critical manufacturing.
For this particle counters uses by alcohol particles in air to be
released to be able. The Aerosolbildung is prevented by the use of a
cloth soaked with alcohol likewise by alcohol and an inhalation risk
is reduced. The new sterile and particle-poor Klerwipe 70/30 WFI of
wiping cloths consists sealed edges of 100% before-washed polyester
(138 g/m2) with ultrasonic and is soaked with 70 VOL. - %igem IPA and
water for injection purposes. Endotoxinlevel are guaranteed by the
washing process and the use of WFI of less than 1 European Union per
cloth. The alcohol evaporated ...
26. April 2010
Improved stability with long-term moisture tests
Environments with strict regulations and high requirements in the Life
Science industry and in laboratories require accurate and reliable
moistening and temperature measurements. Processing, packing and
storage presuppose stable site conditions with the equipment
manufacturers for pharmacy, biotechnology and medicine, so that
highest productivity and quality can be ensured. The new high speed
dampness and thermometric bulb, Vaisala HUMICAP� HMP110, are ideally
suitable for these environments owing to their improved long-term
stability. The Vaisala HUMICAP� moistening and thermometric bulb
HMP110 is small and compact to integrate simply very uncomplicated to
maintain and problem-free exchangeably. Their ...
26. April 2010
Free video for professional cleaning and disinfection of safety work benches
Safety work benches are used in laboratories as protective system e.g.
with the production of cytostatic drugs or also while handling
biological working materials. The systems protect thereby on the one
hand the persons against dangerous aerosols and materials and on the
other hand the products against impurities in the context of the GMP
(Good Manufacturing Practice) - fair production. With the daily
cleaning and disinfection of the safety work benches the users however
always push the same problems. The cleaning and disinfection guidances
of the offerers of safety work benches and those the manufacturer of
cleaning and disinfectants differ according to procedures and impact
times frequently seriously. But ...
26. April 2010
New line CLEANLINE for clean-spacefair assembly
�WHITE starts highest reliability, captivating accuracy into that
pure-spacemaximum output. With these nuclear values of own product
philosophy WHITE wants to be opened new Marktpotenziale in the future
also within the pure space range. Under the name CLEANLINE brings the
manufacturer of components for the automation industry a new product
family for the clean-spacefair assembly on the market. All components
the CLEANLINE are adapted matured high speed modules � to the
requirements of clean-spacefair assembly processes in the ranges
medical technology, Health Care, micro-systems or semiconductor
technology. Each particular has the certificate for the ISO air
category of purity 6 or better. The CLEANLINE ...
26. April 2010
Gerresheimer Regensburg develops new generation of Stechhilfen
On behalf a prominent diagnostics company Gerresheimer Regensburg
developed the Stechhilfe for a blood sugar measuring system, which
contains a volume with test fields for 50 tests in place of individual
Teststreifen. The new Stechhilfe of the 5th generation can be
angedockt to the measuring instrument, so that stinging and measuring
are combined patient-friendly in a unit. At the end of the development
stands a Stechhilfe, as well as which is smaller, faster, quieter and
more robust an one-hand operation without embracing made possible.
With the development of the Stechhilfe the Gerresheimer Regensburg
GmbH had to master fastidious challenges. In the comparison to the
predecessor model the equipment should ...
