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Last Modified: Friday, July 24, 2015

Glossary

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21CFR Part 11

Title 21 CFR Part 11 of the Code of Federal Regulations deals with the United States Food and Drug Administration (FDA) guidelines on electronic records and electronic signatures (ERES).

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Autoclave Validation

Thermal validation of autoclaves consists of accurately measuring the temperature at critical points within the autoclave chamber throughout the process.

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Data Logger Calibration

Calibration is the process of establishing the relationship between a measuring device (Data Logger) and the units of measure.

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Depyrogenation

The removal of pyrogens from glass and lab equipment in dry heat autoclaves is called Depyrogenation.

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Dry Heat Sterilizer Validation

Dry heat sterilizer validation consists of accurately measuring the temperature at critical points within the sterilization chamber throughout the process.

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EtO Sterilization Validation

EtO sterilization is used on heat sensitive products. Consequently, validation exercises must verify that temperature remains within specified parameters.

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Freeze Drying Validation

The freeze drying or lyophilisation process requires both monitoring and validation of the process chamber.

This will give assurance that the specified critical parameters of temperature and pressure are achieved; thereby increasing assurance that the determination of residual moisture standards issued by the FDA under 21 CFR 610.13 will be satisfactory.

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GAMP

Good Automated Manufacturing Practice (GAMP) is both a technical subcommittee of the International Society for Pharmaceutical Engineering (ISPE) and a set of guidelines for manufacturers and users of automated systems in the pharmaceutical industry (Wikipedia).

Hot Air Tunnel Validation

Dry heat is sometimes used for sterilization instead of the much more efficient moist heat
because some materials are sensitive to moisture.

Dry heat is often used to ensure that glass and other laboratory equipment is free of pyrogenic material.

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Incubator Validation

Laboratory Incubators require validation according to the normal pattern of installation qualification, or IQ, operational qualification, or OQ, and performance qualification, or PQ.

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Lyophilization Validation

The freeze drying or lyophilisation process requires both monitoring and validation of the process chamber.

This will give assurance that the specified critical parameters of temperature and pressure are achieved, thereby increasing assurance that the determination of residual moisture standards issued by the FDA under 21CFR 610.13 will be satisfactory.

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NADCAP Pyrometry Audit

The National Aerospace and Defense Contractors Accreditation Program (NADCAP), AMS2750 revision D, now demands that Heat Treatment companies supplying the aerospace industry provide proof of their compliance with procedures laid out in the standard.

The standard demands adherence to rigorous thermal validation and reporting practices which are comparable to requirements, standards and procedures that have been current in areas such as autoclave validation for some time.

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Oven Dryer Validation

Dry heat is sometimes used for sterilization instead of the much more efficient moist heat because some materials are sensitive to moisture. The process of sterilization within an oven dryer is a critical process and there is a regulatory requirement for validation of the process in most countries.

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Real Time & Historic Calculations Display

Provides the ability to display all standard calculations in real time.

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RTDs

Resistance temperature detectors (RTDs), are sensors used to measure temperature by correlating the resistance of the RTD element with temperature.

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Sensor Position Management

Allows validation engineers to setup and manage a 3D wire diagram of the chamber space.

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Stability Chamber Validation

Stability chambers are designed to control environmental parameters such as temperature, humidity and radiation levels.

After the initial validation exercise many companies proceed to monitor these chambers with alarms on the critical parameters. Strictly these chambers should operate with levels of assurance similar to those achieved in the validation of autoclaves. So a periodic re-validation exercise is necessary.

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Steam Sterilizer Validation

Problems with sterilization can occur with the spread of temperatures within the load. It is essential to identify the coolest and hottest part of the load and calculate deviations and fluctuations.

The accuracy of the sensors and data acquisition hardware used to perform thermal validation is critical.

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Sterilizer Temperature Distribution

Thermal distribution studies are essential throughout the food, pharmaceutical, biotech and other industries, where temperature is a critical parameter in the processing.

Temperature distribution studies involve accurately measuring the temperature at various locations throughout an empty and a fully loaded process area.

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Sterilizer Validation

Although validation requirements and quality assurance requirements vary in detail, the common theme is that it must be shown that sterilization has been achieved. Validation is defined as the documented procedure of obtaining, recording and interpreting results to ensure that the sterilization process has been and will be consistently effective.

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Storage Area Validation

Most phases of processing of product within the pharmaceutical and food industry specify controls parameters for temperature, pressure, and humidity. Thus thermal mapping is essential to control these processes.

Data is collected and analyzed for cold spots or hot spots. Mapping tests must be made on empty chambers and fully loaded chambers.

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Temperature Mapping Validation

Data is collected and analyzed for cold spots or hot spots. Mapping tests must be made on empty chambers and fully loaded chambers. Most types of chambers require this treatment from incubators and storage areas and warehouses to autoclaves, EtO chambers, stability chambers, tunnels, dry heat sterilizers. Mapping must be performed on a quality schedule and in special circumstances.

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Temperature Uniformity Survey

Comply with AMS 2750, CQI-9, BAC 5621 for NADCAP audits.

These standards require heat treatment processes to be validated by Temperature Uniformity Survey (TUS) procedures and System Accuracy Test (SAT) procedures.

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Thermistor

Thermistors are widely used as inrush current limiters, temperature sensorsself-resetting overcurrent protectors, and self-regulating heating elements.

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Thermal Mapping Validation

Data is collected and analyzed for cold spots or hot spots. Mapping tests must be made on empty chambers and fully loaded chambers.

Three mapping tests are required, and if there is a discrepancy between tests another mapping must be performed.

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Thermal Validation Systems

Problems with sterilization and process can occur with the spread of temperatures.

The accuracy of the sensors and data acquisition hardware used to perform thermal validation is critical. Calibration and Calibration Check operating procedures are indispensible to normal acceptable validation practice, no matter what sensors are used (RTDs, thermistors or thermocouples).

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Thermocouple Calibration

Thermocouple Calibration is the process of establishing the relationship between a measuring device and the units of measure.

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Thermocouples

Thermocouples are a widely used type of temperature sensor for measurement and control.

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TQ

Thermal Qualification

Washer Disinfector Validation

ISO 15883-1:2006 specifies general requirements for washer disinfectors validation and their accessories that are intended to be used for cleaning and disinfection of re-usable medical devices and other articles used in the context of medical, dental, pharmaceutical and veterinary practice.

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