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COMPRESSED AIR VALIDATION.

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Quality of compressed air.

What are the standards for the quality of compressed air?

ISO8573.1 is an international standard that specifies the quality of compressed air validation . The standard defines limits for three categories of air quality:

• Maximum particle size for any remaining particles

• Maximum allowable dewpoint temperature

• Maximum remaining oil content

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.

Quality Class	Particle Size (um)	Dewpoint ° C	Dewpoint ° F	Oil Content (mg/m₃)
1.	0.1	-70	-94	0.01
2.	1	-40	-40	0.1
3.	5	-20	-4	1
4.	15	3	37	5
5.	40	7	45	25
6.	-	10	50	-

Measuring the dewpoint.

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.

Although ISO 8573 Air Quality standard is serving the industry well by raising end user awareness of how to measure and define the quality of compressed air validation. Using this, the end-user can make educated decisions as to the filtration performance required to generate a certain quality level. However, this standard does not address how manufacturers are to test and rate the filters. The playing field is not level and consumers become confused. The ISO 12500 filter standard addresses this issue and establishes how manufacturers test and rate compressed air filters.

COMPRESSED AIR VALIDATION

SOP for Spreadsheet Creation.

Why does something as simple as a spreadsheet figure in so many regulatory citations? Good question; and at times a difficult one to answer. When you ask a group of compliance personnel the same question you will be informed that Excel cannot be validated because it does not seal the original copy (of the spreadsheet), allows the original to be modified and has an audit trail that can be disabled. All true, but none of these problems interfere with your ability to validate that the spreadsheet is fit for purpose. They only preclude you from using the spread sheet as a compliant repository for any data that has to be store in compliance with 21 CFR Part 11.

If the spreadsheet is signed off and dated by the user, their supervisor and QA, it becomes regulatory acceptable data stored in hardcopy, and Part 11 does not apply.

After numerous requests for this, we have launched our brand new SOP for Spreadsheet Creation to cover these and other known target points that the regulators consistently hone into as soon as they find that spreadsheets are being used. Use this Spreadsheet Creation SOP to ensure that you create spreadsheets that are validatable. Then use our spreadsheet validation pack to validate them.

SOP for Spreadsheet Creation. -- $125.00

Spreadsheet Validation Package. (Issue-1) -- $525.00

SOP Equipment Validation.

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.

Purchase your copy now at Special Price of $22.00.

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.

Equipment Combined IQ/OQ/PQ Protocol (Issue-2). -- $159.00

Validation Risk Assessment.

It now appears that the current FDA Guidance rules pertaining to 21 CFR Part 11 may be with us for a longer time than was originally anticipated. So we have incorporated the guidance suggestions in their latest guidance document, into our current Validation Risk Assessment (now issue 10), which is now available for immediate download. This VRA document now comes with a downloadable matrix for registering the justification for all your Part 11 assessments as this is now a mandatory requirement.

Now click here for further details on this SOP covering Validation Risk Assessment and 21 CFR Part 11 application.

Validation Risk Assessment (Issue10.) -- $125.00

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