Home
Contact Details DOC  SHOP
Introduction.
Doc Applications
Validation Enquiry
Site Statistics
Site Problems
Phone; 703-9035
 Free Newsletter
Contact Us Directly.
Protocols & Plans: Agency Reviewed
Autoclave Validate
Computer Validation
Biotech Validation
Computer Qualify
Comb'd IQ-OQ-PQ
Utility Air Valid'n
Com. Vender Audit
Design Qualification
Design Validation
Facility Qualification
HVAC Qualification
Comb'd IQ-OQ
IQ/OQ/PQ Proto'ls
Installation Qualify
Installation Validation
LAN Validation
Operation Qualify
Operat'l Validation
Performance Qualify
Performance Validat
Pharma Validation
Process Qualification
Process Validation
Spreadsheet Validat
Software Qualify
Software Validation
Steam Quality
Temp. Mapping
User Requirements
Validation Plans.
Val. Master Plans
Validation Packages
Procedural Docs: FMEA
Gap Analysis Tool
cGMP Validation
Predicate Rules
Risk Assessment
SOP for SOP
SOP for cGMP Rev
SOP Validation
Validation Matrix
Vender Audit.
Hard Ware/Copy BSI Standards
Contracted Validate
Data Loggers
Quality Manual
Humidity Calibration
Validation Manual
Tele Conference
Technical Info: CSV Annex 11
Free Vendor Audit
GAMP 5
Glossary
GMP Problems.
Hardware Validation
Measuring Instr's.
Med Devise Validate
Mixing
21 CFR Part 11
Part 11 Update
21 CFR Part 211
21 CFR PART 820
Pharma Maint'ance
Protocol Standards
Validation Protocols.
Validation Blog
Video News
Retro-Validation
Warning Letters
Your Free Glossary
General Info: Calculators For All
Conditions of Use
Corpus Clock
Customer List
Easy Business
Procedures
Product for License
Regulat'y Authorit's
Computer Val Process
Useful Links.
Free Downloads
Advertising With us.
21 CFR Part 11.
CAPA Audit
Validation Academy

STEAM QUALITY TESTING.



Steam Quality.
A continuous supply of saturated steam is required for steam sterilization and for humidification in certain EO sterilizers. 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 superheated 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 for steam quality is appropriate.



Non-condensible gases

Non-condensible gases result from the water from which the steam is generated. These gases will usually be air, though 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 Quality Steam.

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. 

The power of steam to sterilize is very closely linked to the characteristics of that steam.  Routine steam quality testing 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 Quality Steam Testing (SOP-QST).

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 contract 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). 

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.    

SOP for Quality Steam Testing. -- $499.00
Includes Expansion and Pitot Tubes.

Quantity
 


Superheated 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.



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.



This graphic depicts both the pitot and expansion tubes used in steam quality testing. Bring Pure Steam Testing In House.

The draw back to carrying out steam quality testing 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 Pure 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.


STEAM QUALITY.