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Temperature Mapping Validation

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  • Temperature Mapping Services for Industrial Regulatory Compliance
    Model: Temperature Mapping Services
    Call For Details

    Temperature Mapping Services

     

    SIERRA delivers optimized validation by custom designing a protocol for each client to ensure the organization complies with the necessary regulatory standards.

     

    Each custom protocol is reviewed and approved before our technicians arrive on-site, allowing for an efficient, consistent process that includes:

     

    > 24-hour loaded, empty, or as-is mapping
     
    > Open-door and power-failure recovery studies
     
    > Calibration of pressure gauges and temperature probes
     
    > Use NABL traceable wireless or standard data acquisition systems in all our studies
     
    > Autoclave Validation
     
     

    Sierra Instrumentation & Controls is serving the Life Science Industry since 20 Years & understand better the risk associated with critical environment. We are India’s leading provider of Validation Services & have a long established reputation for helping clients demonstrate compliance with regulatory authorities, Saving both time and money and preventing the occurrence of embarrassing audit visits.

     

    If you need Temperature / Humidity mapping to be carried out in your factory, then look no further! Whether it is an ultra low temperature mapping on a freezer or an incubator, a cold room, autoclave or an oven, we provide a solution to not only meet your validation requirements, but exceed your expectations.

     

    Validation 

    Using a combination of NABL traceable calibrated equipment and state of art 21 CFR Part11 data acquisition systems, Sierra provides extensive temperature & humidity testing. The data acquisition system used by our validation and calibration engineers provides ability to automatically monitor and record data from all equipment at a time which causes minimum disruption to your process.

     

    The Temperature & Humidity mapping will plainly reveal:

    • Hot & Cold Spots

    • Power Outages

    • Effects of door openings

    • Effects of introducing good

    • Time until recovery of set temperature.

     

    What we validate:

    We bring the experience you need for Temperature / Humidity mapping of:

    • Chambers

    • Freezers

    • Incubators

    • Sterilizers

    • Lyophilizers

    • Stability Chambers

    • Warehouses

    • Water Baths

     

    VALIDATION REPORT

    Using defined standard templates we generate comprehensive validation reports that compliance with FDA requirements. Your company will get a professional report that contains:

    • Calibration Certificates

    • Sensors placement

    • Charts

    • Trends

     

    Experience

    Our qualified staff are experienced, extensively trained and adhere to cGMP guidelines for documentation generation and execution.

     

     

    CPhI India 2019 | P-MEC India 2019

     

    Join us at the India Pharma Week 2019

    26, 27 & 28 November 2019, Timing 10:00 - 18:00

    Venue: India Expo Mart, Greater Noida, Delhi NCR, India

    Booth No : Hall 1A / D08 / API Section

     

     

  • Warm and Cold Storage Temperature Mapping Validation Services
    Model: Warm and Cold Storage Temperature Mapping Services
    Call For Details

    Warm and Cold Storage Temperature Mapping Services

     

    At Sierra, we know accurate and consistent autoclave and cold storage temperature performance is critical to meeting regulatory standards and internal goals for excellence.

     

    Even the smallest deviation in temperature consistency can have a significant impact on your end results.

     

    That's why our highly qualified validation technicians come fully prepared with the latest tools and temperature mapping calibration capabilities to perform temperature mapping validations with industry-leading expertise.

     

    Establishing a regular maintenance and calibration schedule with SIERRA for all of your temperature-dependent equipment ensures that you're getting the best return on your investment and that your equipment is performing to the manufacturers specifications.

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