fourtec - Fourier Technologies
NEWSLETTER |
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It's Time for Some Cold Chain News Greetings!
In our May issue, we present a new case study outlining the implementation of the DataNet wireless solution in a syringe manufacturing plant. We think this case study provides an interesting example not only of the importance of environmental monitoring medical-related products to ensure its quality and safety products, but also how beneficial it can be to implement a wireless system that is able to seamlessly integrate with existing, onsite systems to provide a robust alarm notification mechanism.
This issue also links to two highly relevant news items for the cold chain industry. The first item focuses on the Good Supply Practice for Pharmaceutical Products (GSP), which will go into effect as of June 1, 2013, published by the Chinese State Food and Drug Administration (SFDA). The second item discusses the FDA Food Safety and Modernization Act (FSMA).
Enjoy the issue,
THE FOURTEC TEAM |
DataNet Solution - Wireless Monitoring Network in Syringe Manufacturing Plant
Application: Environmental monitoring in a medical equipment plant Organization: PROESCA, C.A.
Background:
Monitoring environmental conditions in plants that manufacture medical-related products for the health sector is a crucial element for ensuring the quality, safety and aseptic packaging of products. Environmental monitoring systems enable evaluation and control of all the required conditions by providing online transmission of data and analysis reports, allowing implementation of preventive and corrective measures when needed.
About the Customer:
The "Promotora de Empresas Socialistas" (PROESCA) is a subsidiary of Pequiven, founded in 2008 to promote, support and develop socialist enterprises in the industrial processing of polymers, fertilizers and chemicals, including sustainable community projects in harmony with the environment and its surroundings. The syringe factory is located in the Industrial Field Ana Maria Campos (CIAMCA), in Venezuela. The factory produces syringes for the Venezuelan Institute of Social Security. Its current production capacity is 144 million syringes per year.
Key Customer Challenges:
The PROESCA syringes plant required a monitoring system able to monitor the following parameters:
- Temperature: Between 10 to 40 �C, with an accuracy of �0.5 �C.
- Relative humidity: Between 10-90%, with an accuracy of �5%.
- Differential pressure: Between -60 to 60 Pascal, with an accuracy of �2.5 Pascal.
- Ethylene oxide: Between 0 to 2 ppm, with an accuracy of � 0.1 ppm.
In addition, the system must be able to automatically record all the values of each parameter in a defined interval via a computerized system and produce reports for analysis purposes.
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Market News
Good Distribution Practices in the Pharma Supply Chain - Focus on China
Published: May 2013
Source: Cold Chain IQ
To remain competitive in the global
pharmaceutical industry China is taking steps to improve the quality of its pharmaceutical supply chain. In January this year the Chinese State Food and Drug Administration (SFDA) published a newly revised Good Supply Practice for Pharmaceutical Products (GSP), which will go into effect as of June 1, 2013. The revised guidance sets higher qualification requirements, increases standards for drug distribution and also has higher requirements for quality management.
The revised GSP means that many local pharmaceutical companies will need to raise their game when storing and handling drug products or they risk getting left behind their competitors.
To read more |
Getting Ready for the FDA Food Safety Modernization Act (FSMA)
Building Domestic Capacity to Implement the FDA Food Safety and Modernization Act (FSMA)
Published: May 23 2013
Source: FDA
Michael R. Taylor, FDA Deputy Commissioner for Foods and Veterinary Medicine stated in the report "Building Domestic Capacity to Implement the FDA Food Safety Modernization Act" that the promise of FSMA to modernize the food safety system in the U.S. and to significantly reduce the burden of foodborne illness cannot be realized without additional funding. Rules can be written but they can't be implemented effectively and efficiently with current funding. For example, investments are needed to provide guidance and technical assistance to industry, train federal and state inspectors, modernize and strengthen the inspection program to ensure quality and consistency nationwide, and implement a new import oversight system that ensures the safety of imported food and creates a level playing field for the U.S. food industry.
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2013 - 2014 Global Cold Chain Directory Published by Global Cold Chain Alliance
The Global Cold Chain Alliance (GCCA) has published the 2013-2014 Global Cold Chain Directory, the most comprehensive cold chain industry buyer's guide in the world.
The directory includes 566 pages of listings of cold chain industry providers. These companies are members of the Core Partners of GCCA, which represent all major industries engaged in temperature-controlled logistics.
"The companies listed in this directory represent the highest level of quality and service in the cold chain industry," said GCCA CEO Bill Hudson. "As members of the Global Cold Chain Alliance, these companies are committed to maintaining a strong, unbroken cold chain for their customers and consumers."
Fourtec is a proud member of the Global Cold Chain Alliance and can be found in the 2013-2014 Global Cold Chain Directory.
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Tip of the Month
New Firmware for MicroLite II & MicroLogPRO II
On June 3, a new firmware version for the MicroLite II (v1.03)and MicroLogPRO II (v2.02)data loggers will be released. This release will fix an issue affecting the battery level reading on these devices. For example, when replacing the logger battery with a new one, you may have noticed the battery icon on the LCD change from full to a low or even empty icon. If you have this issue, following firmware update simply disconnect the logger from the USB port to obtain the correct battery reading.
From June 3, to update the logger firmware just go to Help > Check For Updates in your DataSuite main menu and follow the instructions to download the new firmware file (Internet connection required). Or download the firmware directly from the Fourtec Download Center.
If you have any questions regarding this new release, please contact Fourtec's technical support department: support@fourtec.com. |
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