Temperature / Humidity Monitors
Cold Chain Monitor is validated for CFR 21 Part 11 compliance.
Press Release Summary:
To meet data recording needs for pharmaceutical products, TempTRIP® time/temperature monitoring system offers full turnkey solution for cold chain compliance and enables information to be viewed from different locations/companies. Ordering, configuration, viewing, sharing, integration, and data management are possible via Internet browser. Monitoring process involves temperature logging cards with optional LED display and optional RFID reader with or without integrated barcode scanner.
Original Press Release:
TempTRIP® Web-based, Cold Chain System is Validated for CFR 21 Part 11 Compliance
Broomfield, Colo. - TempTRIP®, LLC has upgraded its time/ temperature monitoring system to address stringent data recording needs for pharmaceutical products. The system enables information to be viewed from different locations and companies which makes it ideal for complex pharmaceutical distribution systems where sharing critical product temperature data has traditionally been a challenge.
TempTRIP's easy-to-use, web-based customer interface has been validated for United States Code of Federal Regulations (CFR) 21 Part 11 compliance. Part 11 defines the criteria under which electronic records are considered to be trustworthy, reliable and equivalent to paper records.
The web-based system offers a full turnkey solution for cold chain compliance priced less than many temperature devices alone. It enables ordering, configuring, viewing, sharing, integrating and managing data through an internet browser.
"Although pharmaceutical wholesalers and distributors are not currently required to comply with CFR 21 Part 11, we've upgraded the TempTRIP system to provide those involved in the distribution chain with additional capability," said Phaedra Culjak, chief operations officer, TempTRIP. "Additionally, should their compliance become mandatory, they will already be prepared."
The TempTRIP monitoring process incorporates three basic components-temperature logging cards (optional LED display), optional RFID reader with or without integrated barcode scanner, and the internet. Users set up an on-line profile which includes shipping, storage and receiving-point data plus temperature configurations, and which parties get to see the results.
To start the time and temperature monitoring process an RFID smart card is placed on the pallet or box. Next the RFID reader scans the pallet's bar code and writes it to the smart card's memory. Temperature is recorded continuously, at whatever interval the company specifies.
When the TempTRIP-tagged pallets or boxes arrive at distribution center they are "read" to determine what temperature discrepancies have occurred. A green or red light will indicate the alarm status. Results are sent, via USB or Wi-Fi transmission, to a dedicated page on the internet, with optional email and text alerts sent to the chain partners. (Users also have the option of mailing the smart card back to the TempTRIP Logistics Center, which then posts results online within 48 hours.)
The tags can be read and restarted at any time to record new segments with new starting and ending times. For example, as boxes or pallets are received, tags continue to record time and temperature in the truck, in the air and at delivery. Tags can even receive new "ownership" and new time and temperature parameters as they move from manufacturer to distributor to clinics and hospitals.
"Today's economy mandates that you keep a sharp eye on costs. One way to do that is by utilizing existing systems that can be configured to provide the custom solution your operation requires. TempTRIP gives you a way to integrate data in a custom way without incurring additional configuration costs regardless of the complexity of your distribution system," Culjak said.
About TempTrip
TempTRIP, LLC was established to improve the cold chain temperature monitoring process. The company's "systems approach" goes beyond the basic hardware/software offering for temperature monitoring products by offering customers monitoring and comprehensive cold chain logistics with minimal infrastructure.
TempTRIP is a joint venture between Sealed Air Corporation (NYSE: SEE), a Fortune 500 company and Results Oriented, Inc., a software, hardware and Web development company with expertise in product tracking and radio frequency identification (RFID) dating back to 1989. For more info: www.temptrip.com.
For more information:
Phaedra Culjak
TempTrip
10900 Dover St
Broomfield, CO 80503
(303) 895-3455
phaedra@temptrip.com
