FACILITY UTILITY PURE STEAM VALIDATION


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Facility Utility Pure steam validation, an Introduction.

The testing involved in Facility Utility pure steam validation requires a continuous supply of saturated steam; preferably sourced from the actual line that supplies your sterilization systems. Too high a level of non condensible gases will prevent the attainment of sterilization; too little moisture carried in suspension may allow the steam to become super-heated during expansion into the chamber, while excess moisture may cause damp loads. Where steam systems are either routinely or irregularly shut down, large quantities of air will be present in the distribution system on restarting. It is recommended that in such circumstances a comprehensive and validated venting procedure should be applied and testing steam quality should be routinely executed.


Non-condensible gases.

Non-condensible gases originate from the water that the steam is generated from. These gases will usually be air, although carbon dioxide may be present, caused by certain water treatment processes, typically water softeners. This is exacerbated by excessive aeration that can exist in many pharmaceutical water treatment plants where water is constantly recirculated and sprayed into the top of storage vessels. The effect of such gases being present in the steam supply to a sterilizer can be the same as air, none sterilization of the volume they occupy.


Combined IQ/OQ/PQ Protocol for Testing Steam Quality.

The facility utility pure steam validation protocol is a very detailed and comprehensively scripted protocol.  All the test scripts required for IQ/OQ/PQ execution are in place ready for editing to represent your installation exactly.  Tests scripts are very detailed and all calculations are broken down into simple stages.  Illustrated equipment hook up diagrams and sequential instructions further ensure that this testing is easily within the skills of the average technician. 

All sterilization tasks using steam attract the attention of the regulators.  There are often serious problems that inhibit or reduce the sterilizing efficacy of steam that remain obscure to the operator and only become apparent to the end user. 

The power of steam to sterilize is very closely linked to the characteristics of that steam.  Routine facility utility pure steam validation of your steam quality must be carried out to ensure that your sterilization processes are never compromised.  Annual testing of steam automatically attracts auditor attention.  Steam quality must be re-verified when ever any changes or disturbances affect a qualified quality steam system.


Combined IQ/OQ/PQ Protocol for Quality Steam -- $565.00
Includes Expansion and Pitot tubes.

Quantity

SOP for GMP Testing Steam Quality (SOP-QST).

This is a fully documented and detailed SOP that you will use every time you execute your periodic facility utility pure steam validation of your quality steam system(s).  Tests scripts are very detailed and all calculations are broken down into simple stages.  Illustrated equipment hook up diagrams and sequential instructions further ensure that this testing is easily within the skills of the average technician. 

The main reason companies have not executed steam quality testing in-house; was that the hardware (pitot and expansion tubes) were extremely difficult to source.  This induced us into having these manufactured for our own use manufactured and offer them for sale on this site.  All other test equipment required is readily available in most laboratories (tubing, glassware and multi-meter). 

This SOP is an absolute must for companies that want to be certain that their sterilization processes are never compromised.  Annual testing of steam automatically attracts auditor attention.  Steam quality must be re-verified when ever any changes, including software, affect a qualified quality steam system.   


Super heated Steam.

Superheated steam is steam at a temperature above its boiling point for its pressure. Superheated steam is a clear colour-less gas that will not condense until its temperature drops to its boiling point. Until this occurs the moisture necessary for sterilization cannot be produced and therefore presents a risk to the process. Superheated steam acts as hot air and requires sustained high temperatures and long hold times before sterilization can occur. It is essential in facility utility pure steam validation to verify that the steam being tested is not superheated.


Dryness Value Test.

Wet steam is undesirable as it has less energy than dry steam and more importantly can cause wet loads. The packaging used for sterile products prevents reinfection when dry, but its bacterial retentive properties will be adversely affected by the presence of moisture. Wet loads can be considered to be un-sterile.  The dryness fraction describes how dry steam is, with a value of 1 representing steam that is 100% dry, and therefore free of entrained moisture. Steam with a dryness fraction of 0.99 consists of 99% steam and 1% water.  If we measure the latent heat present in steam that has a dryness fraction of 0.99 we will find that it possesses 99% of the full quotient of latent heat.


Pitot & Expansion Tubes

The draw back to carrying out in-house facility utility pure steam validation has always been the lack of the correct Pitot and Expansion Tubes, along with difficulty of generating a quality protocol for qualification purposes.  Now these excuses are gone, a quantity of the tubes have been manufactured to a tried and tested design, and are now in stock.  The Testing Steam Quality protocol is also available for direct download.  This document is not a template, it is a finished document.  There is a prefixed SOP which will auto populate the document for you, with your company’s names and addresses, other than that the document is ready to execute.



Combined IQ-OQ-PQ Computer (Issue-4) $159.00

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 A Plan template. As per 21 CFR Part 11.

The Installation Qualification Template section establishes documented verification that all medical device validation template online executables are catered for and that key aspects of the equipment Qualification adhere to approved design Qualification template and the recommendations of the manufacturer have been suitably considered. The Operational Qualification Template section establishes that there is documented verification that the installed system functions as specified and that there is sufficient documented process validation A 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 medical device validation template; i.e, The User Requirement Specification template. 



User Requirements Specification (Issue 8) $115.00

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.



Installation Qualification. SOP & Protocol (Issue 9.) $115.00 10000020

The Standard Operating Procedure template (SOP) used to generate this pharmaceutical validation 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 Protocol. 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 medical device validatioN  TEMPLATE or for being able to produce 4 to 8, IQ protocols per 8 hour day.



Operational Qualification, SOP & Protocol (Issue 10.) $115.00 

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.



Quality Steam Validation Kit.
$499.00

This is a fully documented and detailed SOP that you will use every time you execute your periodic re-qualification of your quality steam system(s) Tests scripts are very detailed and all calculations are broken down into simple stages Illustrated equipment hook up diagrams and sequential instructions further ensure that this testing is easily within the skills of the average technician. The main reason people have traditionally contracted steam-quality-testing-out, was that the hardware (pitot and expansion tubes) were extremely difficult to obtain. We have had these manufactured for our own use and include them in this offer. All other test equipment required is readily available in most laboratories (tubing, glassware and multi-meter).
Price of kit includes expansion and pitot tubes.

Quantity

Combined IQ/OQ/PQ Protocol for Quality Steam (Issue-4)  $185.00

This is a very detailed and comprehensively scripted protocol.  All the test scripts required for IQ/OQ/PQ execution are in place ready for editing to represent your installation exactly.  Tests scripts are very detailed and all calculations are broken down into simple stages.  Illustrated equipment hook up diagrams and sequential instructions further ensure that this testing is easily within the skills of the average technician.  All sterilization tasks using steam attract the attention of the regulators.  There are often serious problems that inhibit or reduce the sterilizing efficacy of steam that remain obscure to the operator and only become apparent to the end user. 

Quantity

10000149 PQ Steam    (Issue 2.)

This a high quality protocol listing all component parts that required for setting up and executing of the three main steam quality tests.  All the operator has to do is use the auto fill function to personalize the PQ, then follow through the detailed test methods recording the results as they go.

Quantity