Autoclave / Sterilizer Advice

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Hi,
Thought I'd start a thread for posts with questions about the capabilities / type / reliability of various autoclaves on the Aussie market as well as assistance with validation questions. If you have a question, please post & I will try to help.

Fire away.......

 

Hi Steam Guru,
Just have a query regarding Sun autoclaves. They are a b class vacuum autoclave. Have you heard anything about their reliability? They are from China and I am trying to keep an open mind here. They are cheaper which has certainly caught my eye.
Cheers

 

Oh dear, where to begin...

A quick look at these shows the round door knob common to a whole bunch of machines made in Ningbo (Runyes, Mingtai etc etc ) ....

About the only thing "B" class about them is the letter B is used in the user manual.

A few basic requirements of a B class autoclave made to EN 13060 standards are:
1. Temperature display to 0.1C resolution - Not present on the LED display (1C only)
2. Pressure display to 1kPA - LED display shows 2.1 bar, not 2.10
(These 2 might seem insignificant, but shows a lack of compliance)
3. The standard says the door must be locked BEFORE the commencement of the cycle. The first version of these had NO door lock, it merely latched closed & could be opened at various points during the cycle. Newer version of the Runyes has a pressure activated door lock, but thus it is still not locked before cycle or all the way through..
4. The units I looked at had no standards/approvals markings on various mains components like fuse holders / power switch etc. - SHould never pass electrical safety approval.
5. EN13060 requires that steam in the chamber be:
. within 2C between any 2 positions
. within 2c at any one point over the holding time
/ within 2c of 'ideal' or saturated steam at that pressure.
Again, units I tested for an importer a few years back did not meet any of these.

Temperatures as high as 145 were recorded in the chamber during sterilising.
This indicates BADLY superheated steam - inhibiting sterilisation....
The cause of this was twofold, the steam leaving the generator was superheated as they ran it too hot, as well as the jacket heater being on during the cycle at very high wall temps, heating the steam even higher.

Someone tried to 'fix' later ones by turning down the safety thermostat on the generator so it interrupted the heating at lower temps. Generally we saw this result in the Chamber temp falling to 132 or lower during sterilise
(with NO alarm generated, yet another point of non-compliance) .
The safety thermostat is also self reetting , not manual push button (again a fail) .
6. The vacuum test was not compliant with EN13060 (fail on 1.3 kPa leak in 10 min) it allowed 1.3 kPa PER min (10x normal) without failing.

I could go on and on, but I hope you get my point. :deadhorse:
The original report I wrote on one of these ran to 3 pages , but could be summarised in one word. "DON'T"

As a company, we have refused to service, repair or validate these units, because I do not want my name on it when something goes wrong. Most reputable service companies in Australia are the same.

The other point to bear in mind is this: Many tattooists (& even a couple of dentists!) have bought these things off 'the bay of E' direct from China.
= No TGA registration >> no aprroval for human use in Australia (potentially a large fine & NO legal protection if ever in court)
= No Worksafe pressure vessel registration >> Big trouble if ever inspected.
= No Electrical approval in australia >> Again legal / insurance problems...

Quality doesnt come cheap. Dont get me wrong, Chinese manufacture can turn out some wonderful things at great pricing. But as far as this stuff goes, I have yet to see ANY of the that are acceptable, let alone 'good' :bang:

Oh, and to answer the original question on reliability, the material they use to seal the steam generator & the temps it runs at, basically ensures a breakdown every 6 months !

Rant over, hope I was of some help.

 

Thanks Steam Guru.

 

Hi Steam Guru,

The new Sun Class B autoclaves (which do seem different to the older models you have tested) state that they have CE certification and ISO cert:

1. The autoclave strictly meets the standard of EN13060 and adopts European B standard with 3-time pre-vacuum preceding vacuum drying, having passed Vacuum test, Helix test and B&D test. Vacuum measurement reaches -0.8 bar and residual humidity is less than 0.2%.

Specifications

1.Motorala chip
2.Fuzzy control
3.World famous PARKER valve
4.Italy ULKA pumps
5.Established the ISO-13485-2003 and CE

PRODUCT FEATURE:

1. Unifies the European B level standard, Has 3 times of pulsation types initial vacuum dry function, The vacuum degree mayreach-0.80bar,Is suitable is antiseptic in the clinic each kind of instrument disinfection, the instruments surplus humidity <0.1%,and the success solved the sterilizer not to be able to disinfect the plastic instrument difficult problem;"

Here is a link to their CE and ISO certificates/qualifications for their autoclaves:

http://www.mtsun.com.cn/honor.asp?id=30

The price of these autoclaves are obviously quite a bit cheaper than most other European models and therefore there is interest in the medical field.

Is the autoclave 'validation' industry refusing to validate these Chinese autoclaves due to pricing and a way to keep these machines from entering a lucrative autoclave industry in Australia? Because if the new Chinese autoclaves are fine and all technicians and autoclave companies have colluded NOT to validate them this doesn't seem fair or ethical to me.

I am just a neutral observer trying to find what is best for my practice at a reasonable cost that is all.

I am also wondering what you think is the best class B steriliser on the market at present?

Kind Regards :drinks
Fast

 

Hi Fastpoose,
Sorry, haven't been on here in a while, due to work commitments..
In relation to the post above, I will try and answer what I can.

Yes, the new '-III' models appear a little different to the older '-II' type ones that I have had a close examination of. I have had a brief look at one that looks almost exactly the same. VERY similar models come from Nigbo Runyes, Ningbo Mingtaim etc etc. China is the land of badge engineering after all.

With regard to the compliance with CE & ISO.
ISO13485 certificate ONLY shows. that the company has a quality system (you make the product the same way every time...) It does NOT certify that the product/s are in compliance with other standards.

The construction standard (Euro) for autoclaves is EN/ISO 13060 (now final not the provisional prEN one)
For a manuf. to claim compliance with EN13060, then they should be able to provide certification from an external compliance auditor to that effect.
Perhaps someone can ask Ningbo for this ? Also they should be able to provide a copy of a sample 'works test' for a machine (quite a detailed document generated in-house assessing the performance of the unit against certain critical parts of the standard. If they cant, then why not as that testing is an integral part of compliance.


OK the other parts you quoted (Im not sure from whence they came, couldn't see this on their website)

"The autoclave strictly meets the standard of EN13060 and adopts European B standard with 3-time pre-vacuum preceding vacuum drying, having passed Vacuum test, Helix test and B&D test. Vacuum measurement reaches -0.8 bar and residual humidity is less than 0.2%. "
- There is a LOT more to compliance than 3 vac pulses..
The old units would make -0.8 on the first pulse & then just time the last ones, even if only making -0.5 say. Hopefully these have alarms for both value & duration on each part of the cycle (part of 13060)

OK:
[[Specifications
1.Motorala chip
2.Fuzzy control
3.World famous PARKER valve
4.Italy ULKA pumps
5.Established the ISO-13485-2003 and CE ]]

1,2 - So what. (Also, it's Motorola). Fuzzy logic. Pfft.
3. Parker valves - good improvement if the right ones.
4 Ulka pumps are used in all the decent sterilisers. If genuine , good, We have seen fake copies out of China.
5. See above

AND:
[[PRODUCT FEATURE:
1. Unifies the European B level standard, Has 3 times of pulsation types initial vacuum dry function, The vacuum degree mayreach-0.80bar ]]

Not really much in this apart from poor use of English.

"The price of these autoclaves are obviously quite a bit cheaper than most other European models and therefore there is interest in the medical field."

Price vs quality is not a myth. Truly.
Your question: -- "Is the autoclave 'validation' industry refusing to validate these Chinese autoclaves due to pricing and a way to keep these machines from entering a lucrative autoclave industry in Australia? Because if the new Chinese autoclaves are fine and all technicians and autoclave companies have colluded NOT to validate them this doesn't seem fair or ethical to me. "

OK. A multi part answer to that.
Firstly, NO. I refuse to have anything to do with the current crop of Chinese autoclaves, because I have better things to do.
Contrary to widely held opinion, your service company/technician does NOT make his income from repairs. We operate a booking calendar for routine service/validation work, much as most practices operate on bookings.
Repairs are the quickest way to louse up your technicians day.
My words to a client who once said 'You'll be happy our machine is broken again' were: "Given that I had a whole day of planned routine service work today, all of which had to be dropped to come and deal with this one small repair & will now have to be rescheduled (in spare time that doesn't exist) , annoying 3 separate customers, to run out tho this repair in the opposite direction & all you are being charged is 2hrs of travel & 1/2 hour labour, which is all I will probably charge out today, which part of your breakdown am I happy about "
(a lil' facetious, I know, but there is truth in it).
We are happiest if we can do the annual service & then 'see you next year'.

As far as preventing them from entering the market, again, your tech does NOT make his living from sales.
And, given that we charge the same fee for service/validation of nearly all brands/models, then which one you buy is not our concern, generally, other than making our life easier in the long run (less breakdowns) ...
We could probably make a killing in the short term from the amount of work that is to be had from these things. BUT, when you car keeps breaking down, do you blame the car, or the mechanic ? I don't want my companies reputation tarnished with a customer feeling " This thing is forever breaking down & they cant never get it to stay fixed".
From a validation point of view we have legal responsibility for the results we obtain / interpret & certify. If I pass something that is not compliant, then who gets the blame if there is ever a court case. No thanks.
Just the same as we will not pass an old 1980's steriliser for hollow dental instruments, we wont pass units that don't provide correct chamber temp/pressure or printout etc etc.

I know this has been a long winded rant to try & make a point, but ask yourself what kind of car you drive, what quality of instruments do you buy ?
There is a reason that not everyone drives a Tata, or a Great Wall.
If you are happy with a "Great Wall" cars, then perhaps you will be happy with a chinese autoclave..
Me, I buy Australian cars (a balance of price vs performance vs reliability)
But, I buy Italian coffee machines (the only good ones) other than the Kees.

Quote:
"I am just a neutral observer trying to find what is best for my practice at a reasonable cost that is all.
I am also wondering what you think is the best class B steriliser on the market at present?"

That is a how long is a piece of string question. If you are in Australia, there isn't yet a requirement for a B class in podiatry afaik. (Not a bad choice though, at a cost)
If you trust the people that have looked after your current one, then they probably know your needs. (Load type, usage pattern, etc) Ask them. Ask for some other practices that you could talk to that have the types they suggest.
Also ask your peers. Next time your at a conference dinner ask around the table who has an XYZ & what do you think of it. Sometimes a good autoclave can be tainted by bad service, but not usually.

Brands that are good quality in the Aus Market at the moment include Melag (German) & Mocom (Italian). Both have slower (cheaper) models through to the faster (more expensive) units. Expected lifespan 10 years + .

Maybe this helps ? Maybe not ? :craig:

But as it is one of the more expensive items in the average Dr/Pod surgery, pays to do research & buy wisely. Whatever you choose don't buy an ebay job from China direct as you will have no worksafe, no TGA, no electrical approval, no warranty support & no reputable tech will touch it as they don't want the liability.

A final thought. I', sure eventually there will be a decent unit from China, at a competitive price. I just haven't seen it yet...
We do see fakes of some well know models too.
http://www.alibaba.com/countrysearch/CN/sterilizer.html - This is good for a laugh to see the number of copies of the same thing.

Regards

 

Oh, couldn't resist a quote from a Runyes service manual that is famous:

Code E1-C1: the chambers inner temperature sensor has short circuited and cut off or the inner
temperature sensor and inspect the electric circuit which on mainboard is failed.
Solution:
If the machine is still very hot, please allow it to cool down first
A. Use the multimeter to check the resistance data of the inner temperature. Normally, the resistance will be 1-2k, if not, please change the sensor B. Turn the power off then check the magnified chip temperature (LT1014 or MAX478) if its hot or not. If it is hot please replace the chip.
C. If the above inspections are normal the inner temperature sensor does not have a problem.

Yep ! The recommended fault finding procedure for a temperature sensor / board fail asks you to put your finger on the chip & see if its hot . If so , the magic smoke must have got out....

 

Hi,

sorry for a very delayed response...
I was just wondering if anyone could tell me if there are any specific requirements an autoclave must meet... Im worried these cheaper (under 2000) autoclaves don't meet a required standard? or is it simply the quality that is lacking?

Thanks a bunch!

Sophie

 

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