Medical devices
Development of a new disinfection device using Pernitric acid solution
Division of Sustainable Energy and Environmental Engineering,
Graduate School of Engineering, Osaka University

Principal
Investigator

Associate Professor Katsuhisa KITANO

Project Outline
Chemical synthesis

Sterilization by Peroxynitric acid (PNA)
Name

Peroxynitric acid (PNA)

Formula

HNO4 (HOONO2)

CAS number

26404-66-0

HNO2

It has been known to exist, but has no applications due to its instability.
There has never been a paper orpatent on the use of PNA forsterilization, making it the world's
first and only technology [1].

+ H2O2 → HOONO +H2O

Patent

HOONO + H2O2 → HOONO2 +H2O

Steriliza�on method, prepara�on for steriliza�on, anddevice for producing bactericidal liquid[2] F. Raschig, Angewandte Chemie, 17, 1419 (1904).

Patented in Japan, US, UK, Germany, Italy, France, SpainPNA synthesizer

peroxynitrite

PNA

Many types pf synthesizer can be provided※~1M PNA[1] S. Ikawa, A. Tani, Y. Nakashima, K. Kitano, Journal of Physics D: Applied Physics, 405401(2016).

viable bac生ter菌ia数
co[uCnFtU[/CmFU
L]/mL]

Sterilization of spore

Concentration of PNA

6.5mM PNA

There is a need for disinfectants to be used at lower concentra�ons than can beharmful. Hydrogen peroxide at 3% is used as oxydol in disinfectants, but atconcentra�ons on the order of 10% it can cause chemical burns, and atconcentra�ons on the order of 90% there is a risk of explosion.

710610510

The D value (time to reducethe bacteria count by one
digit) is 1.1 seconds, which is
the highest level in the world.

410310210

detection limit110PNA conc.
undiluted solution
Medical device sterilization
Disinfection

0100246810

1,000 mM～10 mM～2 mM

equivalent H2O2conc.
10,000 %
100 %
20 %

For fungicides, the ra�o of fungicidal power to toxicity is important.

殺菌時間[秒]�me[second]Material compatibility test

Safety studies with animals
Acute oral toxicity test

Skin irritation test

animalrat

rabbitguideline

OECD TG420

OECD TG404

Endurance tes�ng with various materials
Steriliza�on, washing and drying process ~1000 �mes

No damage to SUS, O-rings, medical device parts, etc.

photo

Sterilization level of disinfection can be applied to living organisms
without any problem with 100 mM PNA (1,000% H2O2 equivalent).

Comparison with other bactericides

Disinfection of a skin contamination model (pig skin)using spore solutionPNA
1M HOONO2

Oxydol
3% H2O2

Antiformin
6% NaClO

Peracetic acid
6% CH3COO2H

relative bactericidal activity

3300

1

9.6

400

cost [JPY/L]

1100

1200

28000

27000

cost [JPY/L/bactericidal activity]

0.33

1200

2900

68

Sterilization of vegetative cells (Staphylococcus aureus) was simple. Spray jet ofPNA solution was applied to pig skin contaminated with spores (Bacillus subtilis).
The evaluation criteria fordisinfectant efficacy are~2LogR

PNA solution is odorless.

Unprecedentedly high sterilizing power (equivalent to 10,000% H2O2) at low cost

The world's first successful sterilization of spores on skin contamination
models to the detection limit using disinfectants at concentrations thathave been confirmed safe in animal studies

The world's ﬁrst disinfectant, PNA has an excellent ra�o of safety and disinfec�ng power, and can be applied tovarious ﬁelds from biological disinfec�on to medical equipment steriliza�on. The basic patent has been granted inJapan and overseas. Currently, we are building a consor�um for research and development of PNA applica�on(h�p://www.ppl.eng.osaka-u.ac.jp/pna/), in which several companies are par�cipa�ng, and we are looking for
new companies to join us.
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