FACILITY UTILITY PURE STEAM VALIDATION
Click anywhere on this image for further information.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.
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.
21 Years of retailing cGMP - 35k templates supplied to the industry.
Validation Risk Assessment (Issue 11) $125.00
Risk Mitigation in Validation template (Issue 11) $125.00 The Risk and Part 11 Validation Risk Assessment(VRA) protocol is becoming the most important document in the validation online 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 Risk Mitigation in Validation template.
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).
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 Risk Mitigation in Validation risk Assessment template. As per 21 CFR Part 11.
The Installation Qualification Template or IQ 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; The User Requirements Specification template
Installation Qualification. SOP & Protocol (Issue 9.) $115.00 10000020
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.
Operational Qualification, SOP & Protocol (Issue 10.) $115.00
You will find this validation online intuitive 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.
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.
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.
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.