Sam Calibration Lab Sam Calibration Lab
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Temperature Mapping & Validation

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Validation

Validation is the process of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in testing and then production maintains the desired level of compliance at all stages. In the pharmaceutical industry, it is very important that in addition to final testing and compliance of products, it is also assured that the process will consistently produce the expected results.The desired results are established in terms of specifications for outcome of the process. Qualification of systems and equipment is therefore a part of the process of validation. Validation is a requirement of food, drug and pharmaceutical regulating agencies such as the US FDA and their good manufacturing practices guidelines.

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Temperature Mapping

Temperature Mapping is the process of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in testing and then production maintains the desired level of compliance at all stages. In the pharmaceutical industry, it is very important that in addition to final testing and compliance of products, it is also assured that the process will consistently produce the expected results. The desired results are established in terms of specifications for outcome of the process. Qualification of systems and equipment is therefore a part of the process of Temperature Mapping. The Temperature Mapping is a requirement of food, drug and pharmaceutical regulating agencies such as the US FDA and their good manufacturing practices guidelines.

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HVAC Validation

Procedure for validation of HVAC system and details of tests in pharmaceutical industry: Air Flow Pattern, Air Flow Velocity & Change Per Hour, Filter Leak Test, Particles Count, Viable Monitoring, Filter Integrity Test ( DOP/PAO Test), Pressure Difference, Recovery, Temperature and Humidity Uniformity Test and Fresh Air Determination.