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Cleanliness analysis of a dental product. (Source: Fraunhofer IPA)

1. Statute meeting of the industrial association

24.11.2015
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R+D & Community of Interest

"Purity validation of medical devices: How clean is clean?"

Purity is of utmost importance in the medical technology industry. For example, if a dental or hip implant is excessively contaminated, it can interfere with the integration with the bone. How clean the products actually need to be has so far often remained unclear. The Fraunhofer IPA, together with…

The industrial consortium CSC is working on establishing a fixed set of rules for the cleanliness specifications of consumables in cleanrooms. (Source: Fraunhofer IPA, Photo: Rainer Bez)

24.11.2015
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R+D & Community of Interest

Industry consortium CSC creates the foundation for a unified cleanliness specification

Label consumables in the cleanroom clearly

Consumables such as special clothing, gloves, cleaning cloths, or packaging films are essential in cleanrooms. However, there are currently no uniform international regulations on how manufacturers test and label their products regarding cleanroom suitability. Led by the Fraunhofer IPA, the industry…

Table 1: Example of test results of Cadmium decontamination on a metallic surface

Figure 2: PPEs and CPEs during decontamination works

Figure 3: Validation methods (X-ray spectrometer, endoscope, UV lamp, wipe test)

23.11.2015

Parole chiave: Contamination-Diagnosis-Studies-HVAC-API-toxic-heavy metals-decontamination

Contamination diagnosis and studies in pharmaceutical industry – an essential stage in decontamination process

The diagnosis is the main point of decontamination works as it allows to focus on the real and effective problem and to target the contamination in every part of the processes. The team MSE*-Techno-One-Jobbing is completing a DIAGNOSIS before doing any works in order to optimize the operations with…

Figure 2: The website www.kalibrierdienst.at provides information about all calibration services offered by E+E Elektronik. (Photo: E+E Elektronik GmbH)

20.11.2015
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Service

Calibration at the Highest Level

Calibration Certificates from E+E Elektronik Carry the CIPM MRA Logo

E+E Elektronik maintains the national standards for humidity and air velocity in Austria as a designated laboratory of the Federal Office for Metrology, BEV (Bundesamt für Eich- und Vermessungswesen). Recently, the International Bureau of Weights and Measures (BIPM) authorized E+E Elektronik to use…

20.11.2015

Gerresheimer at CPhI India 2015

Triveni Polymers adds eye drop bottles to its portfolio

Gerresheimer is back at this year’s CPhI (Convention for Pharmaceutical Ingredients) in India from December 2 to 4, 2015, exhibiting the new and well-proven glass and plastic pharmaceutical packaging products in its portfolio to an expert public. This is the first CPhI at the Bombay Convention and E…

To give the lower parts of arch printing machines in the Würzburg plant a highly fine finish, KBA acquired a DIXI 270 machining center from the Swiss manufacturer DMG Mori in 2015. (Source: Nerling Systemräume GmbH)

In order for the machine to maintain the required accuracy values of ± 10 µm, a temperature of 22 °C ± 0.2 K/h must be maintained in the machine room. To ensure these climatic conditions, KBA commissioned Nerling System Rooms GmbH to set up a precision manufacturing room with a pre-temperature room. (Source: Nerling System Rooms GmbH)

The system room experts already established a Class 2 measurement room at KBA in 2006, which was directly connected to the machine room. (Source: Nerling Systemräume GmbH)

Overall, this resulted in a U-shaped system room setup consisting of the climate room (right in the background), its pre-temperature room (center of the image), the measurement room, and its pre-temperature room (left in the background). (Source: Nerling Systemräume GmbH)

The room system consists of a steel structure that serves as the load-bearing framework for the ceiling and the on-site 12.5-ton crane. (Source: Nerling Systemräume GmbH)

Since March 2015, the two new rooms have been successfully used. In addition, the lower parts of the arch pressing machines are also pre-fabricated outside the pre-tempering room on a DMG machine. (Source: Nerling SystemrÃ¤ume GmbH)

Then they are brought into the pre-temperature room on a lightweight rail system suitable for weights up to 8 tons.
(Source: Nerling System Rooms GmbH)

There they are stored for 24 hours at 22°C until the parts have also reached this temperature. (Source: Nerling Systemräume GmbH)

There they are stored at 22 °C for 24 hours until the parts have also reached this temperature. (Source: Nerling Systemräume GmbH)

According to the First In – First Out principle, the parts are supplied to the DIXI 270 and machined with an accuracy of ± 10 µm. (Source: Nerling Systemräume GmbH)

Finally, the parts are returned to the tempering area and from there to the pre-chamber of the measurement room. (Source: Nerling Systemräume GmbH)

Measuring represents the final processing step.
(Source: Nerling Systemräume GmbH)

18.11.2015
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Buildings & Rooms

New precision manufacturing room enables processing of printing machine components with ± 10 µm accuracy

22 °C with a minimal deviation of ± 0.2 K/h

To give the lower parts of arch printing presses in the Würzburg plant a highly fine finish, Koenig & Bauer AG (KBA) installed a DIXI 270 machining center from the Swiss manufacturer DMG Mori in 2015. For the machine to meet the required accuracy values of ± 10 µm, special conditions must be met…

Cherwell’s SAS Super 180 air sampler and Redipor® prepared microbiological media are well received by Julie Bowden, QA Releasing Officer, at Portsmouth PMU.

18.11.2015

Cherwell publishes case study discussing key considerations when purchasing an active air sampler

Portsmouth PMU selects Cherwell for quality and service in environmental monitoring

Cherwell Laboratories, specialists in cleanroom microbiology solutions for the pharmaceutical and related industries, has been assisting Portsmouth Pharmaceutical Manufacturing Unit (PMU) in their extensive environmental monitoring (EM) programme for over 20 years. Such is PMU’s confidence in Cherwe…

XENON1T in Hall B of LNGS: on the right, the building, a steel structure with glass walls housing the xenon purification system as well as the experiment control and data acquisition, on the left, the large water tank, in the middle of which the detector is installed. (© XENON Collaboration)

Assembly of the XENON1T detector in the cleanroom. (© XENON Collaboration)

17.11.2015

XENON1T eingeweiht

XENON1T: Gearing up to detect dark matter

There is five times more dark matter in the Universe than “normal” matter, the atoms and molecules that make up all we know. Yet, it is still unknown what this dominant dark component actually is. On 11th November 2015, an international collaboration of scientists inaugurated the new XENON1T instrum…

17.11.2015

Flexible differential pressure transmitters for HVAC and building technology

The sensor manufacturer Setra Systems is one of the leading producers of capacitive differential pressure transmitters in the HVAC sector. With the new MRX family, a series of models is now offered that is hardly surpassed in terms of versatility and flexibility.

The models feature up to 8 switchable…

17.11.2015

The servo press for the cleanroom

UFM Precision HD4

PROMESS has developed a new series of presses in hygienic design (HD). The new unit UFM Precision HD4 has been certified according to the particle cleanroom class ISO 4 according to DIN EN ISO 14644. It is ideally suited for assembly processes in cleanrooms and can be easily integrated into existing…

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