PlazMax 2011 for printing.pdf

Pl M
PlazMax
Advantages of Plasma Technology
•Low Temperature Sterilization
•Can sterilize heat sensitive loads that cannot be subjected to steam
j
•Low energy requirements
L tilit i t ( l t ili i t d l t i it )
•Low utility requirements (only sterilizing agent and electricity)
•No drying stage
•No ventilation needed (like EtO)
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Pl M
PlazMax
•Cost‐Effective
•After sterilization loads are dry and available for immediate use or storage which
reduces the need for expensive backup inventories.
It is recommended to wait for a successful biological test
before using the sterilized loads.
•Sterilized loads can remain in packaging (no need for repackaging)
•Fast turnaround means increased inventory utilization
•Gentle sterilization extends your instrument’s useful life span by
minimizing damage and reducing costly repair or replacement
•Environmentally friendly due to no water consumption, no toxic exhaust,
and low electric power needs
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and low electric power needs
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What is Plasma?
What is Plasma?
Plasma was named after an American physicist, Irving Langmuir.
When gas is applied with a greater energy it turns into
When gas is applied with a greater energy, it turns into
plasma with ionized elements, which are different from the prior phases.
As the number of positive and negative ions compensates each other, the overall
electrical property of plasma. is neutralized
electrical property of plasma. is neutrali ed
Plasma is known as the fourth state of matter and 99% of all the materials in
space is known to be plasma. Solid has the lowest energy amongst all types of
matter. When solid acquires heat (energy), it transforms to phases of liquid
q ( gy) p q
and gas, sequentially.
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The application of Plasma in PlazMax
How is sterilization accomplished with H2O2?
The PlazMax utilizes the microbicidal (bacterium killing) power of free radicals
The PlazMax utilizes the microbicidal (bacterium killing) power of free radicals
released by applying energy (heating liquid into gas via the vaporizer) to hydrogen peroxide.
By definition, a free radical is any atom (e.g. oxygen, nitrogen) with at least one
unpaired electron in the outermost shell, and is capable of independent existence
p , p p
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A free radical is easily formed when a covalent
Hydroxyl (OHˉ)
Free radical
A free radical is easily formed when a covalent
bond between entities is broken (due to heating in our case) and one electron
remains with each newly formed atom. When free radicals steal an electron from a
surrounding compound or molecule a new free radical is formed in its place.
surrounding compound or molecule a new free radical is formed in its place.
In turn the newly formed radical then looks to return to its ground state by
stealing electrons with anti parallel spins from cellular structures or molecules.
Thus, the chain reaction continues and can be "thousand of events long”…
, g
Hydrogen peroxide is unique in that it can be converted to the
Hydroxyl radical (OHˉ) or be catalyzed (with the “Burner” in our case) and excreted
harmlessly as water and/or oxygen
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The sterilizing agent in PlazMax is H2O2,
namely Hydrogen Peroxide
namely, Hydrogen Peroxide.
Hydrogen peroxide was first isolated in 1818 by Louis Jacques Thénard ,
and H2O2 has long been widely used in the pharmaceutical industry.
Hydrogen peroxide has been utilized for a decade or more in a wide variety of
Hydrogen peroxide has been utilized for a decade or more in a wide variety of
facilities and has proven compatible with materials including sensitive electronics,
microscopes, stainless steel, and HEPA filters.
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Applying energy causes alteration of OHˉ (Hydroxyl) from a bonder between the
molecules in the liquid state into a free radical in the gas state
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Free
Radical
Example of an Electron “stealing” from the bacteria by the free radical
Bacteria Free
Bacteria
Radicals
After the alteration, the Bacteria ceases to function as Bacteria and becomes a free radical of its own. As one,
“steals” an Electron from another Bacteria, and alters it to a free radical and so forth. A chain reaction occurs
effecting and destroying all Bacterium and thus, sterilizing the material.
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The Plasma application is used in the Plazmax expressed by utilizing the “Burner”
The Plasma application is used in the Plazmax , expressed by utilizing the Burner
Its purpose is to “break” the H2O2 molecules down after the sterilizing phase.
The system consists of a high‐voltage generator, which applies high
voltage to two electrodes located a few millimetres apart from each other
voltage to two electrodes located a few millimetres apart from each other
Inside the Burner.
When high voltage is applied to the electric plates facing each other,
g g pp p g ,
the H2O2 that passes through the space between the plates is ionized and
Plasma is generated and “breaks” down the gas into molecules of water and oxygen.
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Vaporized Hydrogen Peroxide (H2O2) (A)
Vaporized Hydrogen Peroxide (H2O2) (A)
High
Voltage
Plasma
o tage
(B)
(C)
GND
2H2O (Water) + O2 (Oxygen)
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Cycle graphs
Cycle graphs
Normal cycle
Average cycle temp. 50 C
1000 mBar
Preparation
Aeration
Exhaustion
Preparation
For
diffusion
Diffusion
1
Plasma
1
Preparation
For
diffusion
Diffusion
2
Plasma
2
0
Vaporization
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Cycle graphs
Cycle graphs
Advanced cycle
1000 mBar
Preparation
Aeration
Exhaustion
Preparation
For
diffusion
Diffusion
1
Plasma
1
Preparation
For
diffusion
Diffusion
2
Plasma
2
0
Vaporization
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Cycle graphs
y g p
Preparation
Endoscope cycle
1000 mBar
For
diffusion
Aeration
Exhaustion
Preparation
For
diffusion
Diffusion
1
Plasma
1
Diffusion
2
Plasma
2
0
Vaporization
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Cycle graphs
y g p
Leakage test
1000 mBar
Achieving deep vacuum Chamber is sealed
and monitored for leaks
The line represents
the allowed limit of
pressure increase
0
p
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Cycle graphs
y g p
Penetration test
1000 mBar
Aeration
Exhaustion Preparation
For
diffusion
Diffusion Plasma
0
0
Vaporization
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Cycle graphs
y g p
Penetration & leak test combined
1000 mBar
Achieving deep
vacuum
Chamber is sealed
and monitored for leaks
Preparation
For
diffusion
Diffusion
Plasma Aeration
0
Vaporization
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Indicators & consumables
Biological indicator
The Biological indicator contains a defined quantity of
inoculated spores in population of 1.9 x 10⁶, placed on a
stainless steel disc.
The BI (biological indicator) has a breakable glass ampoule
The BI (biological indicator) has a breakable glass ampoule
which includes a culture media to allow the growth of the
spores. The disc and the ampoule are both placed inside a
plastic tube.
The BI has a chemical indicator which will indicate if the BI
The BI has a chemical indicator , which will indicate if the BI
was exposed to H2O2.
The BI is designed for hydrogen peroxide plasma sterilization
processes, and utilizes Geobacillus Stearothermophilus spores.
As the spores are highly resistant sterilizing them serves as a
As the spores are highly resistant, sterilizing them serves as a
good indication of the PlazMax abilities.
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Biological indicator
Plastic tube
Cap
Plastic tube
Breakable glass ampoule
Disc inoculated with spores
Exposed to H2O2
and sterilized
Exposed to H2O2
and was not
sterilized
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Incubators
Th i b t i d i d t t i th BI’ d l th t t
The incubator is designed to contain the BI’s and supply the correct amount
of heat needed for the spores to grow.
We currently have 24 hours results using the standard Brown incubator,
During the coming weeks we should have the Smart well incubator
During the coming weeks we should have the Smart‐well incubator,
Which includes printer, touch screen and results gathered in 6‐10 hours.
Smart Well incubator
Brown incubator
Smart‐Well incubator
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Chemical indicator
The chemical indicator
Indicates that the sterilizing agent underwent exposure.
If it was exposed to H2O2 the color will change from purple to pink.
.
H O
H2O2
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Chemical Tape
The chemical tape has two applications:
1. Indicates exposure to H2O2.
2. Tapes are used to close polypropylene Packaging materials
Before
After
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Lumens PCD kit
Monitoring the sterilization process can be performed with flexible lumen kits.
Th PCD (P Ch ll D i ) ki i 4 fl ibl l
The PCD (Process Challenge Device) kit contains 4 flexible lumens;
2 with openings on both sides,
And 2 with openings on one side:
10 meter Lumen:
Consists of a cylinder for positioning the indicators.
On each side of the cylinder is a lumen of 5 meters
long with 1 mm diameter.
g
5 meter Lumen:
Consists of a cylinder for positioning the indicators . On
y p g
each side of the cylinder is a lumen of 2,5 meters long with 1 mm diameter.
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Lumens PCD kit
3 meter Lumen:
Consists of a cylinder for positioning the indicators.
It is sealed on one end with a lumen of 3 meters
It is sealed on one end with a lumen of 3 meters
long with 1 mm diameter on the other side.
2 meter Lumen:
Consists of a cylinder for positioning the indicators .
It is sealed on one of the sides with a lumen of 2 meters long with
1 mm diameter on the other side.
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Lumens PCD kit
PCD’ di t ib ti di t l
PCD’s usage distribution according to cycles:
Advanced Cycle 4 PCD’s (10 meters, 5 meters, 3 meters and 2 meters)
Normal Cycle 2 PCD’s (5 meters and 2 meters)
Normal Cycle 2 PCD s (5 meters and 2 meters)
Endoscopes Cycle 4 PCD’s (10 meters, 5 meters, 3 meters and 2 meters)
Penetration Cycle 2 PCD’s (5 meters and 2 meters)
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Packaging materials
Tyvec Reels Tyvec Pouches
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Pl M
PlazMax
Sterilizing agent consumption
H2O2 Bottle
cat. no.
Supplier cat. No.
PlazMax
Model
No. of cycles
PLZ094-0001 AS040400 P50 12
PLZ094-0002 AS080400 P80 7
PLZ094-0003 AS100400 P110 5
PLZ094-0004 AS150400 P160 4
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Pl M d i i J&J
PlazMax advantages in comparison to J&J
Cycle duration:
1. Shorter cycle durations compared to both 100s & NX systems:
Cycle name Tuttnauer J&J
Cycle name Tuttnauer J&J
Tuttnauer J&J PlazMax NX system 100s
Normal Standard 26 Min. 28 Min. 51 Min.
Advanced Advanced 34 Min. 38 Min. 72 Min.
Endoscope
Not
Applicable
25 Min.
NA NA
Applicable
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Pl M d i i J&J
Test cycles:
3 test cycles in comparison to none on J&J,
They claim to do it as part of the cycle‐ we reach deeper vacuum on a test cycle
h h i l i
Than the operation cycles set points.
Installation:
V t i t ll l 1 h 230 i d i l i t d d
Very easy to install; only 1 phase 230v required, no special requirements needed
from the client.
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Pl M d i i J&J
Endoscope cycle:
We offer a specific cycle for Endoscopes, J&J perform it on their advanced cycle
at a higher temperature and exposure to H2O2.
The short cycle time helps insure that no damaging method is applied
Add d l l (4th l )
Added value cycle (4th cycle):
We give the ability to suit a special needed program to specific instruments that will allow
The client to monitor them in accordance to the strict manufacturer limitations.
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Pl M d i i J&J
Flexibility:
The machines can be changed from single door into a 2 door machine due to the
Design applied and the upgrade can be performed on site.
Comfortable operation:
Unlike J&J the chamber is not sensitive to touch.
O ti i d d t bli th li t t t k i l
Operating is very easy and does not obliges the client to take special
care in the load positioning.
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Pl M d i i J&J
H2O2 decomposing method:
J&J perform the decomposing in the chamber. It is less reliable than our
system that force all particles through the burner and decompose.
Maintenance costs:
Unlike J&J that charge big amounts on maintenance kits and service agreements
O i t t i l t d l b h
Our maintenance system requires less parts and labor hours.
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Pl M d i i J&J
Complete CSSD solution:
Tuttnauer has the ability to provide full CSSD solution and turn key projects
Unlike J&J that has no other technologies.
Useable Volume:
I i t 100 d l th t h d d h b
In comparison to 100s model that has rounded chambers,
resulting in a loss of about 30% in volume, we offer a rectangular
chamber with full usable volume.
In comparison to NX system that has an inner casing we have also an advantage on
In comparison to NX system that has an inner casing, we have also an advantage on
of 15% usable volume.
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s
PlazMax
Materials that can be sterilized by PlazMax
Common materials to sterilize with Plasma:
Common materials to sterilize with Plasma:
•Stainless steel
•Polyethylene
•Teflon
Teflon
Metals
Stainless steel 300 series
Aluminum 6000 series
Titanium
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Non-Metals
PlazMax
Materials that can be sterilized by PlazMax
Non‐Metals
Acryl nitrite butadiene styrene (ABS)
Delrin
EVA (Etheyl vinyl acetate)
Fluorinated ethylene propylene (PTFE)
Polycarbonate
Polyethylene terephthalate (PET)
Polymethyl methacrylate (PMMA)
Polyphenyl sulfone
Fluorinated ethylene propylene (PTFE)
Glass, USP type I borosilicate
Low density polyethylene
Latex
Polyphenyl sulfone
Polypropylene
Polystyrene
Polysulfone
Teflon (PTFE)
Monel
Neoprene rubber (polychloroprene)
Nylon
Phenolic resin
Teflon (PTFE)
Polyurethane
Polyvinyl chloride (PVC)
Silicone
Phenolic resin
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PlazMax
Materials that cannot be sterilized by the PlazMax
• Paper (but very small amounts of paper are possible. e.g: small barcode label).
• Absorbent materials (cellulose)
• Wood linen paper spongy materials
• Wood, linen, paper, spongy materials
• Liquids
• Powder
• Oil
• Oil
• Instruments with lumen, having less than 1 mm diameter and/or over 10 m length
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Whatever your application may be, Tuttnauer makes the right
A t l ith th i ht it !
Autoclave with the right capacity !
Tuttnauer Europe b.v.
Paardeweide 36 P.O.B. 7191
4800GD Breda, The Netherlands
Tuttnauer USA Co. Ltd.
25 Power Drive
Hauppauge, NY,11788,USA
Tel: (31) 76 5423510,
Fax: (31) 76 5423540
Email: tuttnauer@tip.nl
Tel: (631) 737 48 50, (800) 624 5836
Fax: (631) 737 07 20
Email: info@tuttnauer.com
98
www.tuttnauer.com www.tuttnauer.com
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