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Temperature Mapping Services for Industrial Regulatory Compliance Temperature Mapping Services

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Warranty : 6 months manufacturer warranty

Description

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.

 

 

How WE VALIDATE

 

WAREHOUSE

We use accurate & reliable data acquisition system to perform temperature & humidity mapping in warehouse. The data acquisition system records the data for & this data is then retrieved & downloaded to derive reports indentifies the potential Hot or Colds pots such as windows or HVAC vents.

 

AUTOCLAVE

We use wireless or wired data loggers to perform Empty Chambers-Heat, Loaded Chamber & Heat penetration studies to provide report which includes the FO (Kill Factor).

 

STABILITY CHAMBER

Stability Chambers are held at 25°c, 60%RH & 40°c, 75%RH. We have option of using wireless as well as wired data loggers to map & identify the hot or cold spots resulting in saving time & money in products & samples.

 

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