SYSTEM PROCESS AIR.



System Process Air Quality.

The System Process Air ISO is an international standard (ISO8573.1) that specifies the quality of facility utility air system. 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 System Process air.

Graph is for System Process Air utility air systems in use.

ISO 8573:2010 Explanation

Of the separate parts in the standard, ISO 8573-1:2001 part 1 relates to defining the quality of compressed air used in different applications. The other parts are concerned with the methods to test the air for a range of parameters used to indicate the level of contamination.

ISO 8573-1 specifies purity classes of compressed air in respect of particles, water and oil. The purity classes can be used to describe the current quality of a compressed air system or to specify the required quality for a precise application.

This image represents legal limits for contaminants in system process air.

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.



System Process air piping.

The piping and compressed air treatment equipment should have characteristics rated at 2,000 scfm at pressures as low as 85 psig; not to exceed 20 fps pipeline velocities.

  1. Interconnecting piping from the compressor discharge to the filter/dryer and from the filter/dryer should be design to have negligible pressure loss.
  2. The coalescing pre-filter should be sized to handle a flow rate of 2,000 scfm/minimum and still be effective at flows as low as 100 scfm or less. The filter should have a full load pressure loss of 1 psid or less when new and wet. Filter change is due at 3 psid or less. Filter life must exceed 1 year with no particulate filter installed ahead.
  3. The dryer should be rated for 2,000 scfm flow rate at 100/100/100. It should be a full cycling “heat sink” or “thermal mass” type refrigerated compressed air dryer capable of running with the refrigeration system only in direct response to actual heat load.
  4. Dryer refrigeration compressor starts should be limited to 6 starts per hour based on the size and type of heat sink. The refrigeration compressor will shut off, not just unload.

SYSTEM PROCESS AIR



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Validation Risk Assessment template (Issue 11) $125.00 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 risk assessment template.

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This Pharmaceutical Validation 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 and associated standard operating procedure TEMPLATE. The associated medical device validation  Master Plan template is interactive, easy to use and suitable for all mixes of equipment with and without software. Where temperature mapping is required it will included in this section. This of course may well be a validation risk Assessment template. As per 21 CFR Part 11.

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This document was designed to be used as a live document up until the DQ is completed and approved. It uses three levels of URS, URS Level 1, 2 and 3, and is the only URS to guarantee traceability from the User requirements specification template through to the final PQ and OQ functionality testing. A mandatory requirement for Full Life Cycle Validation of computer systems and compliance with Current Good Manufacturing Practice legislation. It can be used on mechanical, electrical and software controlled, monitored or driven systems and of course medical device validatioN Template along with the Software Qualification template.



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The Standard Operating Procedure template (SOP) used to generate this installation Qualification template (IQ), takes you through the process line by line, chapter by chapter. It really is unique to find a SOP document so easy to use, all the work is done for you. All the documents are detailed, all the drawings listed and all the checks and tests detailed. The final product is a professional and comprehensive Installation Qualification template. One that you can produce in less than 60 minutes. Yes, think about it, we all know how long producing IQ documents has taken in the past, whether for current Good Manufacturing Practice use medical device use or a simple installation qualification template. 



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You will find the Operational Qualification template (OQ) delightfully simple and straightforward to use, as it takes you through the process of customization of your Operational Qualification Protocol template. Following the attached SOP will quickly and smoothly convert your template into an equipment specific 21 CFR Part 11 compliant Installation  Qualification Template. The OQ template comes complete with all the standard test scripts, more specialist test scripts can be found listed below. These can easily be pasted into the standard OQ, allowing you to quickly build your own fully detailed and referenced company bespoke Operational Qualification Protocol, along with the installation qualification template.



User Requirements Specification Template
$115.00

The User Requirements Specification template is the document that sets the standard, and specifies your requirements in a manner that ensures when a system or piece of equipment is selected for cGMP use that all essential support elements; i.e. maintenance, parts, operator & maintenance training, are planned and budgeted for.  It uses three levels of User Requirements Specification Template (URS), URS Level 1, 2 and 3, and is the only URS to guarantee traceability from the URS through to the final OQ and PQ functionality testing. A requirement mandated by cGMP regulations. It can be used on mechanical, electrical and software controlled, monitored or driven systems. 



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This definitive 1000 + page (including all attachments) Corporate Validation Manual arrives with you in USB memory stick format, this enables you at any time to download protocol or test-scrips documents and quickly edit them into company bespoke documents. In fact there are over $3,500.00 worth of superb documents, that form attachments to the DVM manual, which can be instantly copied. Once copied, the unique document interactive editing, allows you to produce high quality bespoke company documents; Such as the Validation Plan Template or the equally ubiquitous User requirements Specification template Design Qualification (DQ); in a few hours. The cost of the Definitive Validation Manual, will be recouped in the first few weeks of use. It will then go on to show a massive return on your original investment.