eTimestrip

eTimeStrip TC472 2-8C

The eTimestrip TIR temperature recorders offer continuous cold chain monitoring with visual alerts and documentation of temperature with PDF and Excel downloads.

The eTimestrip TIR temperature recorders continuously monitor temperature and calculating remaining stability budget of pharmaceutical products or clinical studies along the entire supply chain.
They are thin and small enough to go on clinical kits and sales units and durable enough to stay on the pharmaceuticals throughout the monitoring time.

There are four eTimestrip TIR devices available. Use TC471 Freeze 0ºC Descending and TC472 2º-8ºC to manage deviations up to 6 alarm zones. The alarm status is always visible and can be extracted via compatible Android app. It is durable enough to stay on the product during its entire shelf life of up to 2 years. Use TC489 for 2º-8ºC shipments where a visual alarm status along with a downloadable PDF or Excel report via compatible Android app is required. Use TC490 for or 2º-8ºC shipments where a visual alarm status only is required.

The electronic indicators monitor temperature exposure and not the product quality. Its purpose is to indicate if product quality evaluation/ testing is required.
Complies with the ISO standard 19005-1 Document Management for the long-term preservation of electronic documents (PDF/A).

Activation tab
Timestrip TIR comes preconfigured as either a 0°C (do not freeze) or 2°C-8°C recorders. Once your product is ready to be shipped, tear off the tab to activate. Temperature monitoring will then begin after a start delay period of 30 mins.

Long Shelf Life
Durable enough to stay on the product during the entire shelf life of 2 years.

Features

Thin, small, durable, smart and cost-effective
Quick implementation
Can be used by 3rd parties
100% calibrated and observes conformity to regulatory guidelines
Stable monitoring along the entire supply chain
Fully FDA GxP / 21 CFR Part 11 compliant
LED indication, PDF download and mobile app versions

PRODUCTS AVAILABLE

Timestrip TC471 0°C
for frozen transports
LED indicator
PDF reporting via app
Measuring range -30°C to 70°C

eTimeStrip TC471 0°C

Timestrip TC472 2-8°C
For pharmacutical shipments
LED indicator
PDF reporting via app
Measuring range -30 °C to 70 °C

eTimeStrip TC472 2-8C

eTimestrip TC489 2-8°C
for 2°C-8°C shipments
LED indicator
NFC indicator with app reporting
Measuring range -30°C to 60°C

eTimestrip TC489 2-8°C

eTimestrip TC490 2-8°C
for 2°C-8°C shipments
LED indicator
Operating range -10°C to 50°C

eTimestrip TC490 2°-8°C

ELECTRONIC TEMPERATURE INDICATOR AND REPORTS

TIMESTRIP TC471 0 °C and TC472 2-8°C

Digital Capture with PDF Data

Visual Alert
The Timestrip TIR TC471 and TC472 themselves can be read by the LED lights. You can also use an app to scan the LED lights on the unit to monitor the status.

PDF Data
PDF files are generated automatically using the ELPRO smartphone app.
The report shows statistics (min/max, alarm) and detailed indicator information (ID, configuration, etc.)

eTimestrip TIR Mobile App

TIMESTRIP TC489 2-8°C

Digital Capture with PDF Data

Visual Alert
Electronic Timestrip Complete TC489 can be read by the LED lights to see if it is activated, OK or Alarm Status.

Digital Data
Scanning the TC489 with an NFC enabled smartphone allows you to access data with our compatible app. A PDF report is also available.

TIMESTRIP TC490 2-8°C

Digital Capture with LED Lights

Visual Alert
Electronic Timestrip Complete TC490 can be read by the LED lights to see if it is activated, OK or Alarm Status.

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Specifications

FAQ'S

How did we verify the performance of produced Timestrip TIR?

A 100% temperature calibration of all sensors was performed during manufacturing. A 100% functional test is performed during assembling. Calibration standards are calibrated by an ISO/IEC 17025 accredited laboratory and are traceable to ISO/IEC 17025, and/or national/international standards (equivalent to NIST, UKAS, DKD).

How did we validate the performance of Timestrip TIR?

Timestrip TIR is developed and fully validated following the guideline “GAMP5 A Risk-Based Approach to Compliant GxP Computerized Systems”. By following the GAMP5 guidelines, the development and validation process is transparent and conforms to the international standard.

What battery is used in Timestrip TIR?

They use a button cell battery type. This avoids customs delays and dangerous goods label requirements per IATA’s 2017 Dangerous Goods Regulations’ 58th Edition.

Would we be able to re-assess reports with a new stability budget?

Yes, a re-assessment with the same alarm limits but different times per zone is possible in the App cloud database.

What technology is used to download the data from the Timestrip TIR to the Smartphone App?

We use photonics (optical communication) to transmit the data. The Timestrip TIR communicates via LED flicker. The Smartphone App uses the camera to film the LED flicker and translates into clear text (alarm status, statistics and events).

Can I add specific information to the Timestrip TIR after readout?

Yes. After read-out, shipping or product specific information can be added in the Smartphone App.

Does Timestrip TIR provide additional statistics and information?

Yes. they provide alarm status and statistics for each zone – Allowed Time, Total Time, Number of Excursion, Longest Excursion, Alarm Status as well as configuration details such as – Profile ID, Logging interval and logging results – Highest and lowest temperature including timestamp, time of the first alarm, Start and Stop Time as well as readout time.

Can Timestrip TIR record a measurement row?

No, Digital TTIs are no data logger but an indicator. Means: it is not storing the measurement row but just the statistics, events and status.

Can Timestrip TIR be stopped?

Yes. There is a configuration option available with a stop button feature.

Can I reuse or reconfigure Timestrip TIR?

No. Timestrip TIRs are a convenient, cost-effective, single-use electronic monitoring devices, programmed with a customer specific profile during the manufacturing process. The devices are designed for limited operation life and are not reprogrammable.

Can a Timestrip TIR be read out more than once?

Yes. Timestrip TIRs can be read out multiple times during operation. Thanks to the documentation capability, they are the ideal device for continuous temperature monitoring and calculating the remaining stability budget along the entire supply chain.

What is the cost for the Smartphone App and where is it available?

A basic version of the Smartphone App is available for free in the App Store (iOS) and the Google Play Store (Android).

How can I read and document Timestrip TIR?

The status (OK or ALARM) can be read visually by pressing the button at any time. In order to document the status, one needs a smartphone and the app installed.

What are the stability budget configurations?

Timestrip TIRs offer some standard configuration options. In addition, the temperature thresholds or alarm delay times and alarm types can be defined by the customer when placing an order.

How long can Timestrip TIR run?

Timestrip TIR is designed to monitor pharmaceuticals over its complete lifetime of up to 5 years.

What are the technical specifications of Timestrip TIR?

The technical specifications are available from us on request.

What is innovative about Timestrip TIR?

Timestrip TIRs are a unique box level readable electronic temperature indicator and report. We combine knowledge on customer needs with state-of-the-art photonics to build our Timestrip TIR.

Documents

Adobe_PDF_file_icon_32x32 eTimestrip TIR Range Sales Sheet
Adobe_PDF_file_icon_32x32 eTimestrip TC471 and TC472 Sales Sheet
 Adobe_PDF_file_icon_32x32 eTimestrip TC489 Sales Sheet
Adobe_PDF_file_icon_32x32 eTimestrip TC490 Sales Sheet