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:
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.
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.
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.
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.
When goods or services are purchase by a cGMP approved organization from a none cGMP approved vendor; it is a legal requirement that the would-be purchaser audits the supplier to establish the scope of any work required to render the item or process cGMP compliant
This elevates the Vendor Audit (VA) Document to a “Must be in Place” status. So, your list of pre validation doc's must include: (VA) + (FAT) + (SAT)
These are mandatory & available as a package;
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 (weeks of work 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.
Equipment combined IQ/OQ/PQ Protocol. $159.00
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 and associated standard operating procedures. The associated Validation Master Plan is interactive, easy to use and
suitable for all mixes of equipment with and without software.
The IQ section establishes documented verification that all validation Online executables are catered for and that key aspects of the equipment adhere to approved design intentions and 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 documented process validation executables to demonstrate this. The PQ section develops documented evidence that all the requirements specified in your corporate validation 4U manual have been verified as operating consistently and exactly as specified in the URS.
The Process Validation or Qualification is the culmination of the validation process. The protocol is used in conjunction with the SOP for the process, to run three batches through the process being qualified and verify that the process consistently produces product to within the process specified tolerances. The results of the process must be recorded and reviewed with a view to ensuring that the deviances (within permitted tolerances) that exist are random and not a trend that could lead to out of specification produce being produced.
12000002 VrrP Equipment $298.00
This Validation 4U, Risk & Requirements Plan (VrrP) is one document designed specifically to replace three. The contents of the three original documents were completely revised and edited into a more compact and interactive format. This new format will make a significant difference to the man hours required to produce and execute these standard operating practice process validation master plan executables. There will also be a very noticeable reduction in the time required for the reviewing and approving tasks. This new document titled the VrrP replaces the VP, VRA & URS and now compliments our equally new 4Q Protocol, which integrates the DQ/IQ/OQ/PQ into one document.
This is an essential step forward for companies seeking to reduce validation 4U costs whilst remaining compliant with their Corporate Validation Manual.
4Q Equipment Validation 4U Protocol (4Q-Equip) has been designed specifically to replace four standard protocols. By taking the contents of the four protocol and carefully weaving them into one notably easy to use protocol, we have made a significant advance in the task of streamlining process validation Online executables documentation and associated standard operating procedures, by reducing protocol numbers by close to 75%. The new bang up to date 4Q protocol replaces the DQ, IQ, OQ & PQ and now compliments our equally new VrrP Protocol. By integrating the old style DQ/IQ/OQ/PQ into one 4Q document there will be enormous savings in man hours in the authoring, reviewing, updating and approving tasks.
For everyone's convenience, the Corporate Validation 4U Manual template is written in written in word.