Are you validating your facility air system to ISO8573.1?
This Facility Utility air ISO is an international standard that specifies the quality of facility utility air system. The standard defines limits for three categories of air quality:
Each category is given a quality class number between 1 and 6 according to the reference values shown in the table below. As an example, a system that conforms to ISO8573.1 and is rated for class 1.1.1 will provide air with a dewpoint no higher than -94 °F (–70 °C). All remaining particles in the air will be 0.1 um or smaller, and the maximum oil content will be 0.01 mg/m3. There are other standards for high pressure air quality, such as ANSI/ISA-7.0.01-1996 for instrument air.
ANSI/ISA-7.0.01-1996 for instrument air.
ISO 8573-1 (2001) Changes:
The standard now speaks about total oil content (aerosol, liquid and vapour).
A standard was introduced on measurement of oil vapour ISO 8573 part 5.
A new class (Class 0) was introduced to cover more stringent quality requirements.
The clause which recommended ways to remove oil was deleted.
Representative samples were asked.
Some principles of dewpoint measurement apply to all types of instruments, regardless of manufacturer. However the single most important thing is to:
• Select an instrument with the correct measuring range:
A low pressure instrument connected to a high pressure system may explode and cause serious injury to anyone in the vicinity. Some instruments are suitable for measuring high dewpoints, but not low dewpoints. Similarly, some instruments are suitable for very low dewpoints but are compromised when exposed to high dewpoints.
• Understand the pressure characteristics of the dewpoint instrument:
Some instruments are not suitable for use at process pressure. They can be installed to measure high pressure air after it is expanded to atmospheric pressure, but the measured dewpoint value will have to be corrected if pressure dewpoint is the desired measurement parameter.
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The SOP for Computer Equipment Validation continues to be an extremely popular document. This document leads you through the validation process, from the URS to the final P2Q.
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The Risk and Part 11 Validation Risk Assessment (VRA) protocol is becoming the most important document in the validation train. The VRA reassures the regulators that you have looked at specific equipment functionality and considered the appropriate level of validation that is required. You have also considered various aspects of its use and the implications of any malfunctions. From the results of this exercise the scope of all validation activity can and must be justified. This is a robust and simple to execute document, one that will lead you through the process and deliver a result that can be used as the foundation for your validation activities.
This VRA now includes the assessment table for categorizing and documenting the new 21 CFR Part 11 guidance ruling on what predicate data must be stored in a Part compliant system, along with the new broadsheet to establish your new database of part 11 records. (now mandatory).
Equipment combined IQ/OQ/PQ Protocol.
This combination protocol has been produced in response to several
hundred reader suggestions we received in our ‘Suggestions Section’. It
has been carefully designed to make it the preferred choice for Process
and Laboratory stand alone equipment. It is interactive, easy to use and
suitable for all mixes of equipment with and without software.
The IQ section establishes documented verification that key aspects of the equipment adhere to approved design intentions and that the recommendations of the manufacturer have been suitably considered. The OQ section establishes that there is documented verification that the installed system functions as specified and that there is sufficient documentary evidence to demonstrate this. The PQ section gives documented verification that the equipment performance in its normal operating environment is consistently exactly as specified in the URS.