RXinsider: Environmental Monitoring / Temperature Monitoring

Isensix

Pharmacy Category:
Cleanrooms and refrigeration, environmental monitoring

(Old Manual Way)

(Eliminate Manual Paper Methods)

(View Real-time Status On All Equipment)

(Continuous monitoring and alerts)

WIRELESS TEMPERATURE MONITORING

USP <797> and JCAHO Compliant
Be Prepared For Unannounced Inspections
Isensix is the Vendor of Choice for Top 200 Pharmacies and Medical Centers Nationwide

Currently, staff members are required to manually collect data from refrigerators, freezers, and other types of storage units used to store medication, and chemicals, and either record them on daily log sheets, or collect expired rotary charts. Not only is this practice fraught with numerous inherent problems by relying on human memory and staff already working at their upper limitations, but the ramifications of inaccurate reporting, and the potential negligence of a failing unit, can be extremely costly.

But that was then, this is now, and the future is today! Because by utilizing our patent-pending Advanced Remote Monitoring System (ARMS™) technology, Isensix provides customers with a complete end-to-end enterprise solution. We can monitor a single room or an entire campus. Our 24/7, wireless, real-time solutions eliminate the need for any manual temperature monitoring processes—all without costly changes to facility infrastructure.

Isensix technology provides the following:

Peace-of-mind with the most reliable, highest quality system available
Immediate positive return on investment (ROI) from labor savings and avoidance of loss
Continuous monitoring and alerts for temperature, humidity, air flow, door access & more
User-friendly web-browser
Central data collection record keeping on a secured server with Intranet and Internet remote access
Real-time visual, audio, e-mail, paging, and voice notifications to staff, bio-medical engineering, and staff workstations
Complete training, validation, calibration, documentation to meet JCAHO and USP <797> requirements
Fully compliant with FDA 21CFR Section 11 Electronic Signature
Automated compliance reporting, corrective action logs, and back-up

For more information about our products, please use the links below to contact us or visit our website.

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Coldchain Technology Services

Pharmacy Category:
Environmental Monitoring, temperature monitoring

Excel Based Reporting
Software

Calibrated Ethernet
Connected Sensors

Wired and hospital approved
wireless sensors available for clean room, negitive/positive pressure rooms, and others.

SQL Based Graphs
and Trending

Configurable Alarm Limits

3M TL25 Datalogger

Benefits of Using Coldchain Technology Services

Reduce cost of temperature monitoring and recording.
Eliminate product loss due to compromised storage temperature.
Reduce medical liability from accidentally vaccinating patients with ineffective vaccine or providing medications that are ineffective due to a compromised storage environment.
Helps achieve compliance with USP 797 temperature guidelines, JCAHO MM.2.20 & EC.6.10 standards, CDC standards, and FDA 21 CFR (Part 11, Part 210, Part 211) guidelines.
Document process improvement efforts as part of a QA / QC program.
Provide a comprehensive roadmap to satisfy the audit portion of critical contained environment areas.

Plug-n-Play Monitoring System

Simple desktop software
Excel based reporting software
Easy plug and play installation
Alarm notifications
Calibrated thermocouple probe
Ethernet connected devices

The Plug-n-Play system provides oversight of climate controlled environment/equipment for less cost than traditional monitoring systems. The devices are shipped with informational software that walks you through the installation process. All installation hardware, a calibration certificate from Coldchain Technology Services, a user's guide, and self assessment forms are included.

Custom Monitoring System

Dedicated PC user interface and system
Integrated SQL reporting
Wireless and direct wired installation options
Single site and enterprise solutions available
Visual display of your facility
Validations and other services can be included

The Custom Monitoring System would encompass a 21 CFR part 11 compliant environmental monitoring system as well as an enterprise wide alarm and control package. These systems typically include data storage, system management, and alarm notification via phone or pager. Additional options that could be offered are building layouts, validation, inventory management, web based monitoring and process control. Each of the features are offered to meet your individual requirements.

Some of our sensor options include:

Temperature
Humidity
Light
Pressure
Video
Doors (open closed)

Environmental Assessment

Identify deficiencies and provides recommendations
Detailed assessment of equipment over 14 days
Summary of hourly average temperature of the unit
Min, max, and average temperatures
Dates and times of excursions, time at max/min
Recommendations on how to correct the deficiencies

Coldchain Technology Services recognizes that most facilities/businesses operate on strict budgets while striving to meet industry standards and regulations. CTS offers assessment services to help you decide whether you need to invest in new equipment and whether it's time to institute an electronic monitoring capability. Depending on your needs, we can assess a single refrigerated unit or provide extensive on-site evaluations to include protocols, equipment, SOPs, process improvements, etc.

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