• Temperature Mapping

    Temperature is a critical control parameter for the processing, manufacturing, storage and distribution of pharmaceuticals, food and most other products. Increasingly, industries are requiring temperature validation of environmentally sensitive products both in transit and storage.

    No two environments are the same. In order to find the right solution for you, infitrak will map out where excursions, spikes and fluctuations are occurring and break that data down on a granular level. The mapping of warehouses, walk-in coolers/freezers, transport trailers and containers all provide crucial information on the stability of products across your cold chain.

    Over a 7 to 14 day period, once in the summer and again in the winter, we deploy calibrated (N.I.S.T. traceable) temperature data loggers that report your results. Recommendations and thermal imaging are provided upon completion of each study.

    Whether your aim is to minimize product loss, maintain drug potency or address regulatory guidelines, mapping results and documentation are integral components of any quality assurance program.

  • Shipping Studies

    The safe transportation of temperature and humidity sensitive products requires an understanding of the conditions that shipments will be exposed to and the limitations of a packing material’s ability to maintain a stable environment.

    infitrak’s shipping studies are designed to:

    • Assess the external conditions to which your products will be exposed during the shipping process
    • Evaluate the ability of your packing materials to maintain a stable environment
    • Ensure products are being shipped within their stated stability parameters
    • Recommend solutions to address issues identified during the shipping study

  • Validation and Qualification

    infitrak is pleased to offer a comprehensive set of validation and qualification services to ensure that your critical equipment operates within its stated specifications.

    Validation helps to establish that a product has been transported and stored within its regulatory requirements. The qualification of equipment ensures the validity of the reported data.

    infitrak’s team of validation specialists have years of experience analyzing GMP pharmaceutical and medical device product manufacturing. We’ve assisted a wide range of companies from around the globe maintain compliance with Regulatory Guidelines through testing, packaging and distribution (Cold Chain).

    Our Validation and Qualification Services include:

    • Temperature and Humidity NIST Calibration services
    • Refrigerator and Freezer Validation
    • HVAC System Validation
    • Process Validation
    • Computerized systems validation (21 CFR Part 11)

  • Quality Consulting

    infitrak provides a complete range of consulting services to support your cold and supply chain requirements including:

    • Assessing your storage environments
    • Assessing your transportation methods and packing materials
    • Working with you to develop supporting SOPs
    • Working with you to qualify and validate your processes and systems
    • Identifying ways in which your products can be monitored to minimize temperature excursions
    • Set up alerts to ensure corrective action occurs promptly
    • Assess your regulatory and legislative requirements and find the right methods to address them

  • Healthcare Consulting

    Infitrak has been operating as a Canada-wide company for the past ten years. Its products and services include healthcare consulting, technology development and environmental monitoring solutions. Infitrak‘s healthcare services include:

      Consulting

      Infitrak has been undertaking healthcare consulting projects across Canada for the past 10 years. The types of projects in which Infitrak staff have been involved, typically focus on utilization analyses, process improvement, system restructuring and service siting. This type of work has been completed for hospitals, health care systems and Provincial governments in British Columbia, the Northwest Territories, Manitoba, Saskatchewan, Ontario, Prince Edward Island and Nova Scotia. Infitrak staff have also completed a number of research and academic assignments, and published related results.

      Decision Support

      Infitrak has worked extensively in the design and integration of corporate information and business intelligence systems, by virtue of numerous projects across Canada. Using a variety of software tools, Infitrak has assisted hospitals, LHINs, Provincial governments and Regional Planning Authorities in integrating disparate data sets and developing ‘key’ indicators to assist in improved healthcare management. Projects have been undertaken at Halton Healthcare Services in Oakville, the Vancouver Coastal Health Authority in British Columbia, and many others. As well, Infitrak staff designed and developed the service modeling system used by the Ontario Health Services Restructuring Commission in the redesign of the Ontario healthcare system.

      Geographic Information Products and Services

      Infitrak has developed a specific expertise in the use of census and geographic products to:

      • Evaluate health care service demands.
      • Develop recommendations for service siting and sizing based on population characteristics.
      • Evaluate variations in service utilization and need.
      • Assist hospitals in understanding the communities they serve and the population characteristics that may affect the delivery of services, or the demand for them.

    Each of the service areas noted above are supported by a variety of projects conducted across Canada, with references available upon request.