Pharmaceutical Industry

Cold Chain and Transit Solutions

Cold chain solutions are of utmost importance in the pharma companies because the vaccines and medicines are highly temperature sensitive. Accurate temperature monitoring is a must to maintain the shelf life and efficiency of pharma products. These include a process that extends from their manufacturing to storage and continues even in transit.

EnviLOG – Temperature & Humidity Data Logger For Domestic Transport

enviLOG is a stunningly designed, portable, temperature and humidity data logger for reefer truck temperature monitoring with robust Ip52 enclosure, 1year of battery life. enviLOG boasts a great option for domestic reefer trucks temperature monitoring .
  • Long term stability. Compact & Robust design for Reefer truck application

  • Data transfer to the PC via USB base station at destination or source point

  • Clear LCD with visual alerts

  • User friendly 21CFR part 11 compliant software

  • Blue-tooth compatibility to download data via mobile app

enviroSUDL - Single use Temperature datalogger for Export Transit cold chain.

Enviro's PDF based Temperature Data Logger is specifically designed for the convenience of cold chain industry, widely used in Transit export consignments of critical medicine.
  • Disposable SUDL 518 collects & stores the ambient temperature on the basis of the time setting interval, when logging session is finished, the logger will automatically generate a PDF report.

  • The same can be viewed on computer by putting it in USB slot of computer.

  • Reports & trend graphs can viewed without any need of software

  • IP67 & EN-12380 compliant

The Risks Abound - Time & Temperature Regulation in Pharma Cold ChainPharmaceutical & Medical Packaging News surveyed supply chain experts and arrived at these ƒOndings: Of temperature-sensitive products shipped, 51% were ambient, 31% were refrigerated, 17% were frozen, and 32% should not be allowed to freeze. More types and numbers of drugs are sensitive to temperature or time than ever. That¡¦s because drug research and development are evolving past traditional chemical based, small-molecule therapeutics to more complex and often more effective large -molecule biologics.According to Craig Montgomery, Cargo Sense, temperature excursions cost the pharmaceutical industry over $15 billion on average a year. What¡¦s more, over $35 billion is lost year on year, and that accounts for the outlay spent replacing those products, as well as the associated costs spent on labor, root cause analyses and so forth. $16 Billion, which is the approximate costs incurred by the top ten pharma ƒirms due to temperature excursions, is 20 times the average price to earnings ratio of big pharmaceutical ƒirms. (From Sources)
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Clean Room Solutions

Pharma clean rooms need to be protected from cross contamination by smartDIS - a reliable door interlocking system. The system benefits in diminishing the microbial, particulate contagion and helps in maintaining differential pressure between rooms. Utilized in Pharma Industries, Formulation / API Laboratories / Clean room and sites where pressure difference needs to be retained to a fixed point.

enviroDPMS - Differential Pressure Monitoring System

enviroDPMS powered with clean room monitoring software, together monitors differential pressure, temperature and humidity in multiple clean rooms within Pharma plant with due Data integrity about the logging of these parameters.
  • Real Time monitoring - 24x7- from one single location

  • Logs the data at SET intervals, or events at any time in a tamper proof manner

  • Clean room door open/close duly logged with any changes in Diff. Pressure at such times are correlated for audits

  • Feature rich & tamper proof MIS reports

Clean Room Wireless Monitoring Systems

Wireless enviLOG (PDL) for Clean Rooms while validation frequently come across changing hot spots. enviLOG (PDL) is a battery operated temperature indicator & logger with wireless interface, that can be easily shifted to new hot spots. It sends data on DPMS which finally sends data to software for record & analysis. Wireless Clean Room Solution gives this flexibility of shifting location which fixed wired unit or solution fails to provide. DPMS available with TFT display with multiple variants.
  • Embedded firmware for onsite configuration of door logic

  • Up to 8 door interlocking solutions with master/slave configuration

  • Centralized emergency switch & emergency switch at every door

  • 21CFR Compliant Proprietary Software

  • Industry proven technology

  • Audit Trail report

  • Customized report for Regulatory Requirement

  • Real time trending for all parameter

Door Interlocking Systems & Access Control

Safeguard Pharma clean rooms from cross contamination by smartDIS - a reliable door interlocking system. The system benefits in diminishing the microbial, particulate contagion and helps in maintaining differential pressure between rooms. Utilized in Pharma Industries, Formulation / API Laboratories / Clean room and sites where pressure difference needs to be retained to a fixed point.
  • Embedded firmware for onsite configuration of door logic

  • Up to 8 door interlocking solutions with master/slave configuration

  • Centralized emergency switch & emergency switch at every door

Access Control with GMP Validation

Personnel entering in a Clean Room are normally the highest source of the airborne particulates and / or microbial contamination risk, so proper gowning and limiting the number of staff into a room must be carefully controlled to be within the Clean Room. Enviro Technologies thus offers access control solution with GMP prerequisites which are mandatory to follow, failure of which will lead to no access in designated clean room or its peripheral area.

enviroCLOCK - GPS Synchronized Clocks

Pharma follows a regulatory controlled environment where Real Time Records and data needs to be maintained for regulatory audits, hence it’s imperative to have synchronized Real Time clocks for accurate time stamping across pharma processes & departments. enviroCLOCK - the Master-slave configured GPS synchronized solution thus provides accurate, Universal Date Time Solution
  • Master with GPS clock or with Windows NT server clock.

  • TCP/IP based Master slave configuration providing communication reliability instead of conventional RS485 based configuration.

Clean Room EMS & ELV Monitoring Software

Specialized software is browser-based and accessible from any network location. Reports are customizable and easily exported to PDF for analysis. Trend and historical reports that are easy to generate often becomes an important aspect of their audit process, whether the audit is conducted by a customer or regulatory agency.
  • Real-time Online Monitoring Dashboard

  • Monitors all parameters e.g. Temperature, Humidity, Differential Pressure, etc.

  • Value added MIS Reports and graphs for management analysis

  • Database SQL and GUI (both) supports Audit Trail

  • Critical alerts sent by SMS & Emails

  • Designed as per guidelines of 21 CFR part 11 compliant

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Pharma Warehouse Solutions

Cold Chain Solutions are of utmost importance in the pharma companies because the vaccines and medicines are highly temperature sensitive. Accurate temperature monitoring is a must to maintain the shelf life and efficiency of pharma products. These include a process that extends from their manufacturing to storage and continues even in transit.

enviroSCAN – Hybrid Multichannel Data logger

enviroSCAN - The Multi-channel Scanner powered with Data Logging and the Web based enviroCLOUD multipoint and multi-location Pharma Warehouse Monitoring Software, together ensure proactive monitoring of temperature & humidity of your vital medicines and vaccines stored in the single or multi-location network of your Pharma Warehouses, thus assisting you to comply with Good Storage Practices (GSP). Hybrid Scanner device with wire & wireless sensors connectivity offers flexibility to monitor low ambient temperature large size warehouses along with ultralow temperature storage equipment.
Rich MIS reports and graphs, in US FDA 21 CFR compliant format, such as the Mean Kinetic Temperature (MKT) and Time Temperature Integration (TTI) in PDF Real-time Alerts and Notification Messages for any alarms Unique Even Time logging feature for very convenient data analysis
  • Rich MIS reports and graphs, in US FDA 21 CFR compliant format, such as the Mean Kinetic Temperature (MKT) and Time Temperature Integration (TTI) in PDF.

  • Real-time Alerts and Notification Messages for any alarms.

  • Unique Even Time logging feature for very convenient data analysis.

enviLOG – Temperature & Humidity data logger for Pharma Warehouses

enviLOG is a Stunningly Designed portable Temperature and Humidity data logger for Standalone Pharma warehouse monitoring along with Data storage and transfer. Mapping of a warehouse is required to assure proper conditions are maintained during all hours of operation and seasons.
  • enviLOG uses precision one time calibrated digital temperature and humidity sensors to provide accurate and stable measurement.

  • LCD display with time, date, temp & RH, battery & storage indication.

  • Long battery life up to 1.5 years with 15 min. interval

  • Large storage memory to accommodate 30000 transactions.

  • Feature rich 21 CFR part 11 compliance software with MKT & TTI report.

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software solution

Clean Room EMS & ELV Monitoring Software

Specialized software is browser-based and accessible from any network location. Reports are customizable and easily exported to PDF for analysis. Trend and historical reports that are easy to generate often become an important aspect of their audit process, whether the audit is conducted by a customer or a
regulatory agency.
  • Real-time Online Monitoring Dashboard
  • Monitors all parameters e.g. Temperature, Humidity, Differential Pressure,etc.
  • Value added MIS Reports and Graphs for management analysis
  • Database SQL and GUI (both) supports Audit Trail
  • Critical alerts sent by SMS & Emails
  • Designed as per guidelines of 21 CFR part 11 compliant

Proudly associated with

Alkem
Cipla
Everest
gsk
IPCA
QUEST
Reckitt-Benckiser
Torrent-Pharma
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