2
VAPORIZED PERACETIC ACID (VPA) STERILIZATION Peracetic Acid as a Biocide REVOX™ sterilization technology uses a room tempera- ture vapor composed of three active compounds; hydro- gen peroxide (H 2 O 2 ), acetic acid and peracetic acid (PAA). PAA is formed by the reaction of acetic acid and H 2 O 2 with the addition of a catalyst; these compounds exist in equilibrium and their eventual decomposition results in oxygen, carbon dioxide and water. PAA was introduced as an antibacterial agent in 1955 and is used extensively in the food industry and for disin- fecting sewage sludge 1 . Although all three compounds provide antimicrobial activity, PAA delivers the most according to the Canadian Journal of Microbiology 2 . PAA is a highly biocidal oxidizer that maintains its efficacy in the presence of organic soil while also removing surface contaminants 3 . As with any gas sterilization process, the system will only sterilize surfaces that are contacted by the sterilant. Peracetic acid is a highly effective chemical sterilant, and by using it in a vaporized form, the REVOX™ method can easily disinfect products safely that would normally be damaged by a liquid chemical or by moisture and heat. Test data shows vaporized PAA is less corrosive and has a better material compatibility then liquid PAA. The REVOX™ sterilization process includes mechanisms to confirm the efficacy of the sterilization system. Testing with multiple organisms reveals that biological indicators (BIs) should be inoculated with Geobacillus stearother- mophilus; Test data finds that G. stearothermophilus is the most resistant organism (MRO). These BIs ensure that inactivation of this organism will result in killing of other microbes. A chemical monitoring strip that detects the ac- tive ingredient is used routinely as an additional process control for REVOX ® Sterilization Solutions. Mode of Action The mechanism of action of VPA is thought to function as other oxidizing agents, i.e., it denatures proteins, dis- rupts cell wall permeability, and oxidizes sulfhydral and disulfide bonds in proteins, enzymes, and other metab- olites 4 . The VPA interacts with numerous cellular con- stituents breaking them down and inactivating routine functionality. With the disintegration of the bacterial cell wall, internal components will no longer be contained. Proteins are rapidly attacked by VPA through oxidation of amino acids to carbonyls, particularly tryptophan, cysteine and methionine 5 . Microbiocidal Activity VPA will inactivate gram-positive and gram-negative bacteria, fungi, and yeasts in <5 minutes at <100 ppm. In the presence of organic matter, 200-500 ppm is re- quired. For viruses, the dosage range is wide (12-2,250 ppm), with poliovirus inactivated in yeast extract in 15 minutes with 1,500 to 2,250 ppm. Bacterial spores in suspension are inactivated in 15 seconds to 30 min- utes with 500 to 10,000 ppm (0.05 to 1%) 4 . Dr. Michelle Alfa, Clinical Microbiologist, along with her co-workers, compared a VPA system with ethylene oxide (ETO) and demonstrated the high efficacy of such a VPA system. Only the VPA system was able to completely kill 6-log 10 of Mycobacterium chelonae, Enterococcus faecalis, and B. atrophaeus spores with both an organic and inorganic challenge 6 . Like other sterilization processes, the efficacy of the process can be diminished by soil challenges and test conditions 7 . TECHNICAL BULLETIN O O O OH H 3 C OH H 2 O 2 CATALYST H 3 C ACETIC ACID PERACETIC ACID Chemical formulation of peracetic acid. Continued on back REVOX ® Sterilization Solutions utilize VPA technology.

TECHNICAL BULLETIN - PAA Peracetic Acid … · REFERENCES 1. Hugo et al. Principles and Practice of Disinfection, Preservation and Sterilization. Third Edition, Blackwell Science

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Page 1: TECHNICAL BULLETIN - PAA Peracetic Acid … · REFERENCES 1. Hugo et al. Principles and Practice of Disinfection, Preservation and Sterilization. Third Edition, Blackwell Science

Revo

xSte

riliz

atio

n.co

2015

MAR

COR A

ll Righ

ts Re

serve

d. PN

XXXX

X-XXX

/A RE

VOX®

is a

regist

ered t

radem

ark of

MAR

COR,

A Can

tel M

edica

l Com

pany

.

REVO

X St

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on S

olut

ions

1460

5 28

th A

venu

e N

orth

Min

neap

olis

, MN

554

47

VAPORIZED PERACETIC ACID (VPA) STERILIZATION

Peracetic Acid as a BiocideREVOX™ sterilization technology uses a room tempera-ture vapor composed of three active compounds; hydro-gen peroxide (H2O2), acetic acid and peracetic acid (PAA). PAA is formed by the reaction of acetic acid and H2O2 with the addition of a catalyst; these compounds exist in equilibrium and their eventual decomposition results in oxygen, carbon dioxide and water.

PAA was introduced as an antibacterial agent in 1955 and is used extensively in the food industry and for disin-fecting sewage sludge1. Although all three compounds provide antimicrobial activity, PAA delivers the most according to the Canadian Journal of Microbiology2. PAA is a highly biocidal oxidizer that maintains its efficacy in the presence of organic soil while also removing surface contaminants3. As with any gas sterilization process, the system will only sterilize surfaces that are contacted by the sterilant.

Peracetic acid is a highly effective chemical sterilant, and by using it in a vaporized form, the REVOX™ method can easily disinfect products safely that would normally be damaged by a liquid chemical or by moisture and heat. Test data shows vaporized PAA is less corrosive and has a better material compatibility then liquid PAA.

The REVOX™ sterilization process includes mechanisms to confirm the efficacy of the sterilization system. Testing with multiple organisms reveals that biological indicators (BIs) should be inoculated with Geobacillus stearother-mophilus; Test data finds that G. stearothermophilus is the most resistant organism (MRO). These BIs ensure that inactivation of this organism will result in killing of other microbes. A chemical monitoring strip that detects the ac-tive ingredient is used routinely as an additional process control for REVOX® Sterilization Solutions.

Mode of Action The mechanism of action of VPA is thought to function as other oxidizing agents, i.e., it denatures proteins, dis-rupts cell wall permeability, and oxidizes sulfhydral and disulfide bonds in proteins, enzymes, and other metab-olites4. The VPA interacts with numerous cellular con-stituents breaking them down and inactivating routine functionality. With the disintegration of the bacterial cell wall, internal components will no longer be contained. Proteins are rapidly attacked by VPA through oxidation of amino acids to carbonyls, particularly tryptophan, cysteine and methionine5.

Microbiocidal ActivityVPA will inactivate gram-positive and gram-negative bacteria, fungi, and yeasts in <5 minutes at <100 ppm. In the presence of organic matter, 200-500 ppm is re-quired. For viruses, the dosage range is wide (12-2,250 ppm), with poliovirus inactivated in yeast extract in 15 minutes with 1,500 to 2,250 ppm. Bacterial spores in suspension are inactivated in 15 seconds to 30 min-utes with 500 to 10,000 ppm (0.05 to 1%)4. Dr. Michelle Alfa, Clinical Microbiologist, along with her co-workers, compared a VPA system with ethylene oxide (ETO) and demonstrated the high efficacy of such a VPA system. Only the VPA system was able to completely kill 6-log10 of Mycobacterium chelonae, Enterococcus faecalis, and B. atrophaeus spores with both an organic and inorganic challenge6. Like other sterilization processes, the efficacy of the process can be diminished by soil challenges and test conditions7.

TECHNICAL BULLETINPeracetic Acid as a Biocide

REVOX™ sterilization technology uses a room temperature va-

por composed of three active compounds; hydrogen peroxide

(H2O2), acetic acid and peracetic acid (PAA). PAA is formed by

the reaction of acetic acid and H2O2 with the addition of a cata-

lyst; these compounds exist in equilibrium and their eventual

decomposition results in oxygen, carbon dioxide and water.

PAA was introduced as an antibacterial agent in 1955 and is

used extensively in the food industry and for disinfecting sew-

age sludge1. Although all three compounds provide antimicro-

bial activity, PAA delivers the most according to the Canadian

Journal of Microbiology2. PAA is a highly biocidal oxidizer that

maintains its efficacy in the presence of organic soil while also

removing surface contaminants3. As with any gas sterilization

process, the system can only sterilize surfaces that are con-

tacted by the sterilant.

The REVOX sterilization process includes mechanisms to

confirm the efficacy of the sterilization system. Testing with mul-

tiple organisms reveals that biological indicators (BIs) should be

inoculated with Geobacillus stearothermophilus; MEDIVATOR

QP 202596 finds that G. stearothermophilus is the most resis-

tant organism (MRO). These BIs ensure that inactivation of this

organism will result in kill of other microbes. A chemical moni-

toring strip that detects the active ingredient is used routinely as

an additional process control for REVOX Sterilization Solutions.

Mode of Action

The mechanism of action of PAA is thought to function as other

oxidizing agents, i.e., it denatures proteins, disrupts cell wall

permeability, and oxidizes sulfhydral and disulfide bonds in pro-

teins, enzymes, and other metabolites4. The PAA vapor inter-

acts with numerous cellular constituents breaking them down

and inactivating routine functionality. With the disintegration of

the bacterial cell wall, internal components will no longer be

contained and are unable to organize. Proteins are rapidly at-

tacked by PAA through oxidation of amino acids to carbonyls,

particularly tryptophan, cysteine and methionine5.

Microbiocidal Activity

PAA will inactivate gram-positive and gram-negative bacteria,

fungi, and yeasts in <5 minutes at <100 ppm. In the presence of

organic matter, 200-500 ppm is required. For viruses, the dos-

age range is wide (12-2,250 ppm), with poliovirus inactivated

inyeast extract in 15 minutes with 1,500 to 2,250 ppm. Bacterial

spores in suspension are inactivated in 15 seconds to 30 min-

utes with 500 to 10,000 ppm (0.05 to 1%) 4. Dr. Michelle Alfa,

TECHNICAL BULLETINPERACETIC ACID VAPOR STERILIZATION

REVOX® Sterilization Solutions utilize peracetic acid technology

O O

O

OH

H3C OH

H2O2

CATALYST H3C

ACETIC ACID PERACETIC ACID

Chemical formulation of peracetic acid.Chemical formulation of peracetic acid.

Continued on back

Peracetic Acid as a Biocide

REVOX™ sterilization technology uses a room temperature va-

por composed of three active compounds; hydrogen peroxide

(H2O2), acetic acid and peracetic acid (PAA). PAA is formed by

the reaction of acetic acid and H2O2 with the addition of a cata-

lyst; these compounds exist in equilibrium and their eventual

decomposition results in oxygen, carbon dioxide and water.

PAA was introduced as an antibacterial agent in 1955 and is

used extensively in the food industry and for disinfecting sew-

age sludge1. Although all three compounds provide antimicro-

bial activity, PAA delivers the most according to the Canadian

Journal of Microbiology2. PAA is a highly biocidal oxidizer that

maintains its efficacy in the presence of organic soil while also

removing surface contaminants3. As with any gas sterilization

process, the system can only sterilize surfaces that are con-

tacted by the sterilant.

The REVOX sterilization process includes mechanisms to

confirm the efficacy of the sterilization system. Testing with mul-

tiple organisms reveals that biological indicators (BIs) should be

inoculated with Geobacillus stearothermophilus; MEDIVATOR

QP 202596 finds that G. stearothermophilus is the most resis-

tant organism (MRO). These BIs ensure that inactivation of this

organism will result in kill of other microbes. A chemical moni-

toring strip that detects the active ingredient is used routinely as

an additional process control for REVOX Sterilization Solutions.

Mode of Action

The mechanism of action of PAA is thought to function as other

oxidizing agents, i.e., it denatures proteins, disrupts cell wall

permeability, and oxidizes sulfhydral and disulfide bonds in pro-

teins, enzymes, and other metabolites4. The PAA vapor inter-

acts with numerous cellular constituents breaking them down

and inactivating routine functionality. With the disintegration of

the bacterial cell wall, internal components will no longer be

contained and are unable to organize. Proteins are rapidly at-

tacked by PAA through oxidation of amino acids to carbonyls,

particularly tryptophan, cysteine and methionine5.

Microbiocidal Activity

PAA will inactivate gram-positive and gram-negative bacteria,

fungi, and yeasts in <5 minutes at <100 ppm. In the presence of

organic matter, 200-500 ppm is required. For viruses, the dos-

age range is wide (12-2,250 ppm), with poliovirus inactivated

inyeast extract in 15 minutes with 1,500 to 2,250 ppm. Bacterial

spores in suspension are inactivated in 15 seconds to 30 min-

utes with 500 to 10,000 ppm (0.05 to 1%) 4. Dr. Michelle Alfa,

TECHNICAL BULLETINPERACETIC ACID VAPOR STERILIZATION

REVOX® Sterilization Solutions utilize peracetic acid technology

O O

O

OH

H3C OH

H2O2

CATALYST H3C

ACETIC ACID PERACETIC ACID

Chemical formulation of peracetic acid.

REVOX® Sterilization Solutions utilize VPA technology.

Page 2: TECHNICAL BULLETIN - PAA Peracetic Acid … · REFERENCES 1. Hugo et al. Principles and Practice of Disinfection, Preservation and Sterilization. Third Edition, Blackwell Science

REFERENCES1. Hugo et al. Principles and Practice of Disinfection, Preservation and Sterilization. Third Edition, Blackwell Science. 1999, pg. 54.2. Alasri et al. Sporicidal properties of peracetic acid and hydrogen peroxide, alone and in combination, in comparison with chlorine and formalde-

hyde for ultrafiltration membrane disinfection. Canadian Journal of Microbiology. 1993.3. Malchesky PS. Medical applications of peracetic acid. In: Block SS, ed. Disinfection, sterilization, and preservation. Philadelphia: Lippincott Williams

& Wilkins, 2001:979-96.4. Block SS. Peroxygen compounds. In: Block SS, ed. Disinfection, sterilization, and preservation. Philadelphia: Lippincott Williams & Wilkins,

2001:979-96.5. Kerkaert et al., Hypochlorous and Peracetic Acid Induced Oxida-tion of Dairy Proteins, J Agric. & Food Chemistry 2011;59:907-914.6. Alfa MJ, DeGagne P, Olson N, Hizon R. Comparison of liquid chemical sterilization with peracetic acid and ethylene oxide sterilization for long

narrow lumens. Am. J. Infect. Control 1998; 26:469-77.7. Rutala WA, Gergen MF, Weber DJ. Comparative evaluation of the sporicidal activity of new low-temperature sterilization technologies: Ethylene

oxide, 2 plasma sterilization systems, and liquid peracetic acid. Am. J. Infect. Control 1998; 26:393-8. Describing Peracetic Acid Vapor Sterilization

Revo

xSte

riliz

atio

n.co

2015

MAR

COR A

ll Righ

ts Re

serve

d. PN

XXXX

X-XXX

/A RE

VOX®

is a

regist

ered t

radem

ark of

MAR

COR,

A Can

tel M

edica

l Com

pany

.

REVO

X St

erili

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on S

olut

ions

1460

5 28

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venu

e N

orth

Min

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, MN

554

47

How VPA WorksThe ideal sterilization system involves an active component with high microbiocidal activity, a wide range of compat-ibility with materials, operation at temperatures that do not affect the product or packaging, low/no residuals, safe to use for operators, and short processing times. REVOX® Sterilization Solutions uses a chamber at room tempera-ture (18 - 30°C), has a wide range of material compatibility, maintains a low level of residuals that breaks down into ox-ygen & water and provides turnaround times as quickly as same day. REVOX™ sterilization technology can be used to terminally sterilize medical, pharmaceutical and industrial products.

The VPA sterilization cycle consists of four phases and a hold time. They are:

1. Chamber Evacuation Phase: Removes the air from within the chamber and the packaging of the product being sterilized.

2. Chemical Injection Phase: Vaporizes the PAA sterilant while raising the pressure within the chamber.

Hold Time: The time between chemical injection and dehumidification. This phase allows the chemical to re-main in contact with the product for an amount of time sufficient to ensure sterilization.

3. Chamber Dehumidification Phase: Removes the chemical from the chamber.

4. Ventilation Phase: Removes any residual chemical from the chamber and product.

The REVOX™ non-toxic sterile processing solution leaves behind no harmful residuals. After sterilization, the steril-ant breaks down into carbon dioxide, oxygen, and water, and leaves products sterile, dry, and free from residuals.

The PAA vapor interacts with numerous cellular constituents breaking them down and inactivating routine functionality.

www.revoxsterilization.com ● Call us at 855.473.56902014 MEDIVATORS INC. All Rights Reserved. PN: 50097-772/D. REVOX® is a registered trademark of Medivators Inc., A Cantel Medical Company.

14605 28th Avenue North Minneapolis, MN 55447

The PAA vapor interacts with numerous cellular constituents breaking them down and inactivating routine functionality.

Clinical Microbiologist, along with her co-workers, compared a

PAA system with ethylene oxide (ETO) and demonstrated the

high efficacy of such a PAA system. Only the PAA system was

able to completely kill 6-log10 of Mycobacterium chelonae, En-

terococcus faecalis, and B. atrophaeus spores with both an

organic and inorganic challenge6. Like other sterilization pro-

cesses, the efficacy of the process can be diminished by soil

challenges and test conditions7.

Uses of Peracetic Acid

The ideal sterilization system involves an active component

with high microbiocidal activity, a wide range of compatibility

with materials, operation at temperatures that do not affect the

product or packaging, low/no residuals, safe to use for opera-

tors, and short processing times. REVOX Sterilization Solutions

uses a chamber at room temperature (18 - 30°C), has a wide

range of material compatibility, maintains a low level of residual

that breaks down into oxygen & water and provides turnaround

times as quickly as same day. REVOX™ sterilization technology

can be used to terminally sterilize medical, pharmaceutical and

industrial products.

References1. Hugo et al. Principles and Practice of Disinfection, Preservation

and Sterilization. Third Edition, Blackwell Science. 1999, pg. 54.

2. Alasri et al. Sporicidal properties of peracetic acid and hydrogen

peroxide, alone and in combination, in comparison with chlorine

and formaldehyde for ultrafiltration membrane disinfection. Cana-

dian Journal of Microbiology. 1993.

3. Malchesky PS. Medical applications of peracetic acid. In: Block

SS, ed. Disinfection, sterilization, and preservation. Philadelphia:

Lippincott Williams & Wilkins, 2001:979-96.

4. Block SS. Peroxygen compounds. In: Block SS, ed. Disinfec-

tion, sterilization, and preservation. Philadelphia: Lippincott Wil-

liams & Wilkins, 2001:979-96.

5. Kerkaert et al., Hypochlorous and Peracetic Acid Induced Oxida-

tion of Dairy Proteins, J Agric. & Food Chemistry 2011;59:907-914.

6. Alfa MJ, DeGagne P, Olson N, Hizon R. Comparison of liq-

uid chemical sterilization with peracetic acid and ethylene oxide

sterilization for long narrow lumens. Am. J. Infect. Control 1998;

26:469-77.

7. Rutala WA, Gergen MF, Weber DJ. Comparative evaluation of

the sporicidal activity of new low-temperature sterilization tech-

nologies: Ethylene oxide, 2 plasma sterilization systems, and liquid

peracetic acid. Am. J. Infect. Control 1998; 26:393-8. Describing

Peracetic Acid Vapor Sterilization

REVOX® Sterilization Solutions PAA technology leaves no residualsREVOX® Sterilization Solutions VPA technology leaves no residuals.

WWW.REVOXSTERILIZATION.COM | 1.855.473.8690© 2016 Mar Cor Purification Inc., A Cantel Medical Company. All Rights Reserved. PN3028945/A REVOX,® JUST IN TIME STERILIZATIONTM and Make it possible.™ are registered trademarks of Mar Cor Purification Inc., A Cantel Medical Company.

REVOX Sterilization Solutions14605 28th Avenue North

Minneapolis, MN 55447