What should be the PQ of pure steam like? Do we need to under take qualification in three phases as for water system. If yes than what should be the schedule.
Dear sb522,
Atleast You must qualify the first phase of water system validation and after getting satisfactory results of first phase of water system , you may conduct PQ of pure steam generator.
Performance Qualification:-
The basic strategy of pure steam generator is to maintain the system under normal operating conditions during which frequent sampling and testing are performed, in order to profile the system. The following tests will therefore be performed once at the use points of pure steam generator. Samples of pure steam will be taken each day from selected points-of-use over a three consecutive working day schedule. The sites selected will be rotated among all use points so that each point will be tested for pH, conductivity micro-organism, non-condensable gases and Endotoxin during the study.
The performance of each major system component and all user points will be verified during testing. This will be accomplished by sampling the system for days and performing analyses and microbiological evaluation on these samples.
Test Specification
pH 5.0-7.0
Conductivity < 1.3µS/cm
Micro-organism Absent
Endotoxin 0.25 EU/ml
Non-Condensable gases Non-condensable gases should not exceed 7ml for every 200 ml of condensate collected.
Thanks
thanks. This solves the issue
Thanks Shahnawaz
Its great to see this site is providing valuable answers
[quote=Shahnawaz]Dear sb522,
Atleast You must qualify the first phase of water system validation and after getting satisfactory results of first phase of water system , you may conduct PQ of pure steam generator.
Performance Qualification:-
The basic strategy of pure steam generator is to maintain the system under normal operating conditions during which frequent sampling and testing are performed, in order to profile the system. The following tests will therefore be performed once at the use points of pure steam generator. Samples of pure steam will be taken each day from selected points-of-use over a three consecutive working day schedule. The sites selected will be rotated among all use points so that each point will be tested for pH, conductivity micro-organism, non-condensable gases and Endotoxin during the study.
The performance of each major system component and all user points will be verified during testing. This will be accomplished by sampling the system for days and performing analyses and microbiological evaluation on these samples.
Test Specification
pH 5.0-7.0
Conductivity < 1.3µS/cm
Micro-organism Absent
Endotoxin 0.25 EU/ml
Non-Condensable gases Non-condensable gases should not exceed 7ml for every 200 ml of condensate collected.
Thanks[/quote]
Dear sb522,
I agree with Shahnawaz and I would like to add something more to this.
As part of PQ for Pure Steam, we need to do the following tests w.r.t Non-Condensable gases: (Refer EN285 & EN554)
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.
Superheated steam
Superheated steam is steam at a temperature above its boiling point for its pressure. Superheated steam is a clear colourless 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 unsterile. 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.
NOTE: Particulate Matter should be checked in the condensate of Pure Steam, as it contact the product / load pattern of Moist Heat Steam Sterilizer.
With Best Regards,
Sudarshan Reddy
ys.sudarsan@gmail.com
Dear All
Total Organic Carbon (TOC) limits must meet with the specs of WFI in the condensate of the pure steam along with the acceptance criteria as mentioned by Shahnawaz.
for sampling frequecy it was already mentioned but the sample of condensate of pure steam can be taken with the following pure steam sampler.Links are as follows.
http://www.staitech.com/Resources/HSC50.pdf
I hope this will add values in performing PQ of a pure steam system
Thanks
Why would you test a steam system for micro organisms? Wouldn’t any viable organism be due to poor sampling technique and not intrinsic to the system that is maintained above 121 for hours.
[quote=Ahsan Khan]Dear All
Total Organic Carbon (TOC) limits must meet with the specs of WFI in the condensate of the pure steam along with the acceptance criteria as mentioned by Shahnawaz.
for sampling frequecy it was already mentioned but the sample of condensate of pure steam can be taken with the following pure steam sampler.Links are as follows.
http://www.staitech.com/Resources/HSC50.pdf
I hope this will add values in performing PQ of a pure steam system
Thanks[/quote]
Dear Khan,
For sampling diagrams, you can refer (Refer EN285 & EN554)
With Best Regards,
Sudarshan Reddy
ys.sudarsan@gmail.com
Dear Meyert,
The reasons may be as follows:
a) Poor sampling technique
b) Condensate can not collected in Hot condition. So, as soon as it is cooled, we collect the sample, which may contains micro-organisms.
c) Surrounding environment
We can’t predict, whether the pure steam is having microbes / it was happened to the above mentioned reasons.
If anything else, please do let me know…
With Best Regards,
Sudarshan Reddy
ys.sudarsan@gmail.com
[quote=ys.sudarsan]Dear sb522,
I agree with Shahnawaz and I would like to add something more to this.
As part of PQ for Pure Steam, we need to do the following tests w.r.t Non-Condensable gases: (Refer EN285 & EN554)
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.
Superheated steam
Superheated steam is steam at a temperature above its boiling point for its pressure. Superheated steam is a clear colourless 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 unsterile. 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.
NOTE: Particulate Matter should be checked in the condensate of Pure Steam, as it contact the product / load pattern of Moist Heat Steam Sterilizer.
With Best Regards,
Sudarshan Reddy
ys.sudarsan@gmail.com[/quote]
Dear Reddy
I agree with you.
Acceptance criteria for Pure steam:
Testing as per WFI Specification
Three test additional
Non-Condensable Gases : NMT 3.5 % ( NMT 3.5 ml in 100 ml)
Super Heat : NMT 25 Degree C
Dryness : Porous 0.95 to 1.0 %
: Non-Porous 0.90 to 0.95% (as per HTM 2010 & as per EN 285)
Hi,
If pure stem is used only for humdification ( directly coming in contact with product)then whether its mandatory to meet WFI specification and if not what are test that should be performed during ?
Regards
Sabina
Normally utility steam is used in humidefication, but pure steam may be used for some other functions where conventional utility steam might cause contamination, such as humidification in some clean rooms, and injection into high purity water for heating in such cases yes you need to test as per the same protocol.
Thanks shahid
I also agreed that Pure Steam generator can be qualified by conducting those test:
- Non-Condensable gas.
- Dryness Test
- Superheat test.
- Microbial contamination.
Another question is, What is the ideal frequency to run the test. It is not as simple as doing lab test.
I’ve come across this question and decide to do it monthly. But the GMP inpector advised to increase the frequency.
The same question is, What is the ideal frequency?
Please provide the web address for getting EN285 and EN554
Thanks,
Ravindra.
Is it necessary to test steam condensate in case of steam used in Drying and coating operations Non-sterile Oral Solid Dosage forms?
Regards…
Hi everybody.
We have a pure steam system with 14 used points but, we only have 
3 sampling points. Is it correct to develop PQ only with 3 sample points?.
Do you know some references about PQ pure steam?
Thanks for your attention ti this matter
Ghost
Even though you have 3 sampling points and 14 Points of use (POU) you must sample at each and every point.
There is a regulatory reason for this. Pure steam is always genertared by using Highly purified water(HPW) or at times Water For Injection (WFI). At most of points of contact of a super heated steam it forms a Rouge.
Rouge is rust, which is the byproduct of corrosion that occurs on stainless steels surfaces that are exposed to a corrosive environment, in this case high purity water or pure steam. The main constituents of rouge are iron oxides (ferric oxide & ferrous oxide ), but may include iron, chromium, nickel and other elements.
Although rouge may be found in ambient water systems, it is more prevalent in hot high purity water systems, in pure steam generators, and pure steam distribution piping. Typical locations in water systems where rouge first appears include:
[b]- Heat exchangers, particularly hot ends
- Pump casings and impellers
- Spray nozzle orifices and spray areas of WFI storage tanks
- Deadlegs and condensate collection areas
- Heat affected zone (HAZ) of welds
- Areas that have been ground or mechanically polished but not properly cleaned and passivated
- Valve diaphragms
- Stress Corrosion Cracking (SCC) affected areas[/b]
As the temperature increases, the color becomes darker. In pure steam systems, it may appear gray or black. In the early stages, rouge is powdery loose and can be easily wiped off.
Iam sure FDA/EMEA/MHRA/TGA/WHO/MCA will be very keen in knowing the status of this rouge and how the quality of steam is effected at each POU.Keeping the above discussion in view you might need to qialify all POU’s by testing Steam quality.
More experts shall join soon to have their say about the subject matter.
Regards
During Performance Qualification procedure its a requirement to test the Clean steam for all parameters including the condensate from all Traps and Points of Use (POU)- If you cannot test at all POU’s you can test at Sampling points. You must test at each point over 2 weeks . These tests might include Conductivity, TOC , Endotoxin, Microbial load and other test those are relevant to USP or EP requirements.
Some of the guidelines which might be helpful to you will be:
[b]DIN 58950 (2003) Sterilization – Steam sterilizers for pharmaceutical products
Part 7: Requirements on services and installation
DIN EN 13824 (2005) Sterilization of medical devices – Aseptic processing of
liquid medical devices – Requirements
ISPE Water Steam Guide
DIN EN 285 (2006) Sterilization – Steam Sterilizers – Large Sterilizers
HTM 2010 Sterilization – Steam Sterilizers – Large Sterilizers
USP 29-NF24[/b]
Hi Durga Prasad
First of all thanks for your advice. Sorry my english is not very well.
Our Pure steam is generated by HPW. We´ve planned to do IQ, OQ an PQ for Generator Steam (GS) and IQ/OQ for System Distribution, we cannot to sample and test at all POUs (14), we want to test 3 sample points during 4 weeks. The 3 sample points are GS, in the middle System Distribution and the end of System Distribution. Is it enough for FDA/EMEA/WHO/etc.?
Regards
Ghost