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.
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:
• Stability Chambers
• Water Baths
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
Our qualified staff are experienced, extensively trained and adhere to cGMP guidelines for documentation generation and execution.