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Solutions for a Smarter Future Peracetic Acid (PAA) Monitoring Endoscopy reprocessing / Sterilisation / Leakage / Perfusion / Decontamination / Health & Safety

Peracetic Acid (PAA) Monitoring pdfs/ATi UK... · Model H10-51 peracetic acid vapour sensor is an electrochemical device used for the selective detection of PAA vapour in ambient

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Page 1: Peracetic Acid (PAA) Monitoring pdfs/ATi UK... · Model H10-51 peracetic acid vapour sensor is an electrochemical device used for the selective detection of PAA vapour in ambient

Solutions for a Smarter Future

Peracetic Acid (PAA) MonitoringEndoscopy reprocessing / Sterilisation / Leakage / Perfusion / Decontamination / Health & Safety

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Intelligent Solutions from ATi UK

ATi are a specialist manufacturer of analytical sensors.

We are a trusted global supplier to the healthcare and pharmaceutical industry, delivering outstanding results in the most challenging environments. Our pioneering and innovative Pharmasafe range of engineered gas detection solutions for decontamination and sterilisation applications are relied upon the world over and come with our award-winning customer support.

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Peracetic Acid (PAA)

Peracetic, or peroxyacetic acid, is an organic compound that is characterised by a very rapid action against all micro-organisms.

Certain areas in hospitals/medical facilities use equipment that requires continuous sterilisation, such as perfusion and endoscopy re-processing. peracetic acid (PAA) is used for sterilisation because of its effectiveness in killing bacteria and microbes, however peracetic acid is also a high strength oxidant and is dangerous to all living cells.

The best way to ensure safety of staff working in these departments is to monitor and alarm where levels exceed that of the exposure guidelines, by using fixed or portable detection with reliable and accurate PAA sensors.

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Monitoring background levels of PAA in the workplace is not easy. ATi are one of only two gas sensor companies in the world that can make an accurate sensor that can be used to protect staff. PAA is released into the air during sterile processing and ought to be monitored as part of your Quality Controls Program.

Monitoring for chemicals such as PAA enable you to effectively manage the breathing environment, this continuous monitoring allows you to validate that the vapour in the air is safe and can also be used to demonstrate and prove that staff and patients are at no risk when working in these potentially hazardous areas.

Medical instruments such as endoscopes can be sterilized multiple times per day with higher levels of PAA than ever before. The increase in usage of re-processing cabinets can lead to issues created from wear and tear on sterilizers and re-processors, which can increase the risk to those working close to them. It is therefore essential to understand and to monitor PAA vapour levels.

Working with Peracetic Acid

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COSHH Assessment

The Control of Substances Hazardous to Health Regulations 2002 (COSHH) requires employers to prevent or control exposure to hazardous substances. Where exposure cannot be prevented, employers are required to assess the risk to health, and provide adequate control measures when using hazardous chemicals’.

Ref: https://www.hse.gov.uk/food/disinfectants.htm

Health and Safety Executive

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The ATi UK range of Peracetic Acid fixed and portable

monitoring solutions

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Model H10-51 peracetic acid vapour sensor is an electrochemical device used for the selective detection of PAA vapour in ambient air.

Peracetic acid is a liquid in which PAA and hydrogen peroxide are both present. The H10-51 is designed to measure peracetic acid vapor without response to H2O2. It is used in conjunction with ATI’s Model D16 PortaSens lll portable leak detector or F12/D fixed, toxic gas monitor.

H10-51 sensors contain internal electronics and memory that control sensor bias and store calibration data, calibration history, and limited data log. The PAA sensor is a 2-electrode electrochemical cell and operates by generating a small electrical current proportional to the partial pressure of PAA vapour in the surrounding air. The current results from the reduction of peracetic acid to acetic acid on the measuring electrode. Reduction of PAA is shown in the formula below.

PAA Smart Sensor H10-51

For further details please contact us on [email protected]

C2H4O3 + 2e- + 2H+ C2H4O2 + H2O

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The F12D (PAA) monitor is a continuous detector that can be positioned anywhere in a room to alarm for if safe limits are hit. The system uses a pre-calibrated ‘vapour’ sensor that requires an annual replacement with no calibration.

The system can be used independently with options for connectivity to an existing Central/Fire alarm system. The display of the unit can be positioned outside of a room with the sensor positioned close to the stored source or where staff work. The F12/D fixed (PAA) monitor is manufactured by ATi, who are one of only a few gas sensor manufacturing experts operating in this type of industry. The chemists at ATi are experts in electro-chemical sensors and have made a system that does not require calibration. The sensor can be replaced each year without fuss and without resource to minimise staff intervention.

The ATI fixed (PAA) monitor has a built-in data logging facility for historical data capture which can then be used to prove or disprove claims of exposure. The system gives ‘peace of mind’ to the health & safety staff that all stakeholders are protected with alerts or if limits are exceeded.

Fixed Peracetic Acid MonitorF12/D

For further details please contact us on [email protected] for illustration purposes only and is subject to change

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The D16 PortaSens is a versatile, portable leak detection system that uses the same sensor technology as our fixed (PAA) monitor.

This innovative device is a handheld monitor which uses a pump to speed up gas detection for the protection of staff, yet still offers alarms and a data logging facility. The D16 portable system can be carried around when performing audits, re-entering a room after decontamination, checking for leaks and for protection whilst PAA is being used.

Portable Peracetic Acid Monitor D16 PortaSens lll

For further details please contact us on [email protected]

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• ATi manufactured, interchangeable sensors for quick replacement • Pre-calibrated ‘vapour’ sensor with full certification • Annual replacement with no calibration reduces staff responsibility • Visual and audible alerts when limits are met • Reduces the need for a costly and time consuming maintenance schedule • Built-in data logging facility for historical data capture • Acts as an early warning system for staff well-being • Same sensor technology used in both fixed and portable monitors • Accurate and reliable sensors proven through years of industry experience • Cost-effective solution offering complete peace of mind • Access to ATi UK’s award winning customer support

The benefits of using ATi Peracetic Acid smart sensor technology

For further details please contact us on [email protected]

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For further details please contact us on [email protected]

Applications

The ATi fixed F12/D and portable D16 PortaSens lll can be used in a variety of applications, offering complete confidence and peace of mind while maintaining the safety of your staff in the workplace.

Endoscopy re-processing Perfusion Sterilisation Decontamination Infection control Leakage Spillage Risk assessment

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‘ATI’s PortaSens III was vital in the validation of our ventilation system during the cleaning of LivaNova 3T Heater/Coolers.

We were able to effectively assess peracetic acid (PAA) vapours in real time informing technicians of any leaks or spills that might cause the environment to become unsafe.

The findings of our validation prove that our ventilation system provides a safe environment below EPA time weighted average guideline levels for PAA during routine cleaning and small dilute spills. Furthermore, PortaSens provides peace of mind in providing a finite figure regarding staff safety as well as a threshold for evacuation.

I would strongly recommend that any centre carrying out cleaning of 3T Heater/Coolers using Puristeril 340 or other PAA disinfectants validate their working environment with such a gas monitor’.

Jacob Garthwaite, Perfusionist - Freeman Hospital, Newcastle

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Exposure to Peracetic Acid

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The American Conference of Government Hygienists (ACGIH) states that the exposure guidelines for PAA is 0.4 PPM (parts per million) for 15 minutes (this is the room average exposure).

Although there are no current UK/European OEL’s (Occupational Exposure Limits) currently for PAA, there is an obligation under COSHH legislation to protect staff from toxic/harmful gases (see page 5). Therefore, to protect staff and to protect from mitigation, continuous monitoring should be carried out with alarms set to protect staff from such harm.

Storage of PAA can also prove to be hazardous. Aqueous PAA contains a percentage of peracetic acid. If the solution consists of 5% PAA, this equates to 50,000 PPM. If this leaks or is spilled, the risk to human life can be great. Without detection, this type of spillage can be extremely dangerous, even background levels of PAA proving harmful over time with frequent exposure.

Departments such as ‘perfusion’ where PAA is used to sterilize heater/coolers for operations/transplants, there is little protection or monitoring, if any. Extraction may be available but without the correct monitoring, accidents can happen with long term disability for extended exposure.

What are the Occupational Exposure Limits for PAA?

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The high reactivity of PAA that underlies its benefits also means that excessive exposure to the vapour can be harmful and can cause health issues.

Health risks due to exposure of PAA include:

The Risks

Burns to skin

Permanent damage to

lungsPulmonary

edema

Permanent damage to eyes/sight

Damage to ‘mucous

membranes’

1 2 3 4

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The acute exposure guideline levels for selected airborne chemicals states that the levels of classification demonstrates:

Exposure Guideline Levels

Classification 10 min 30 min 1 hour 4 hours 8 hours

AEGL – 1 (Non disabling)

0.17 ppm 0.17 ppm 0.17 ppm 0.17 ppm 0.17 ppm

AEGL – 2 (Disabling)

0.5 ppm 0.5 ppm 0.5 ppm 0.5 ppm 0.5 ppm

AEGL – 3 (Lethal)

20 ppm 10 ppm 5 ppm 2.1 ppm 1.4 ppm

Ref: Peracetic Acid Acute Exposure Guideline Levels. AEGL for selected airborne chemicals: Vol 8. National research council (US) committee on Acute Exposure Guideline Levels. Washington (DC): National Academies Press (US); 2010.

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Case Studies

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Asthma caused by Peracetic Acid-Hydrogen Peroxide MixtureWe report the cases of two subjects who developed cough, wheezing and shortness of breath after being exposed to PA-HP vapours.

Case Study 1A 48 year old man was employed as a hospital anaesthetist nurse in an endoscopy unit of a gastroenterology department. In his job, he managed and watched patients who came for invasive endoscopy explorations in an operating room and also sterilized flexible endoscopic equipment and accessories.

He was exposed to PA-HP vapours 5 days a week, particularly when he opened the machine washer 20 times a day and during manual decontamination. In the sterilizing room, a ventilation system with a chemical filter for extraction of PA-HP from the work area was used, but unfortunately there was no available data on area PA-HP concentrations.

During his job, he wore protective clothing and gloves. When he added disinfectant product to the washer, every 2 days, his mouth and nose were covered by a mask (without a vapour filter) and his eyes were protected by goggles. Five months after beginning PA-HP employment, he noticed rhinorrhea, conjunctivitis and dry cough without wheezing, whilst present at the workplace. These troubles usually started on Monday evening, eight hours after exposure to PA-HP vapours and lasted all the work week. The symptoms completely improved when the subject was off work for 3 weeks during holiday, but recurred upon his return to work associated with: continuous cough, breathlessness and chest tightness.

Ref: An extract taken fromhttps://www.jstage.jst.go.jp/article/joh/49/2/49_2_155/_pdf/-char/ja

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Asthma caused by Peracetic Acid-Hydrogen Peroxide MixtureWe report the cases of two subjects who developed cough, wheezing and shortness of breath after being exposed to PA-HP vapours.

Case Study 2A 47 year old woman worked as an auxiliary nurse in an otorhinolaryngology department for 5 years. Her daily duties consisted of preparing flexible endoscopic equipment for several patients’ examinations and performing mainly decontamination procedures (3 times a day), including bags of quaternary ammonium compounds (like subject no.1) and PA-HP, which was used to prepare tubs for the sterilisation process of soiled medical materials.

She was exposed to PA-HP mix vapours, 5 days a week for 8 hours a day, for 3 years without any problem. The decontamination room was located near the operating room and the ventilation system of the area was considered to be poor. During the sterilisation processes, the subject wore long gloves for the hands, covered her mouth and nose with a mask and protected her eyes with goggles.

After two and a half years of daily exposure to this sterilisation process, she developed chest tightness, rhinorrhea and conjunctivitis. Symptoms started 1-4 hours after the end of exposure and persisted for several hours. She was seen by her personal physician 3-4 days later who prescribed an antihistamine and an inhaled bronchodilator. She also described after the end of a working week, an episode of contact dermititis, epistaxis and dysphonia. These symptoms improved during weekends and completely disappeared on holidays. The subject associated all her troubles with the PA-HP exposure.

Ref: An extract taken fromhttps://www.jstage.jst.go.jp/article/joh/49/2/49_2_155/_pdf/-char/ja

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Technical Specification

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PAA Smart Sensor Operational and Performance Specifications

Primary Response Volume % Peracetic Acid (PAA)

Measuring Range Low range 0 – 1/5 PPM / High range 0 – 100 PPM (scaleable)

Sensor Current 0.25 μA/PPM Nominal

Sensor Current Variability 0.10 – 0.50 μA/PPM

Linearity ± 3%

Response Time T50 ≤ 15 Seconds, T90 ≤ 60 seconds

Temperature Range -20°C to +50°C

Memory Internal e2 memory for Calibration Data and Calibration History

Pressure Range - 5 to + 50 PSIG

Pressure Variability Output proportional to PAA partial pressure

Operating Humidity 0-99% RH Non-condensing (Intermittent) 20-90% RH Non-condensing (Continuous)

Zero Stability ± 0.02 PPM at constant temperature ± 0.05 PPM over ±10°C ambient temperature change

Span Drift < 2%/Month

Operating Life > 24 Months Typical in Clean Conditions

Storage Recommendation Recommended maximum of 1 year for best sensor performance Store at less than 25°C in a sealed container

Size 1” D x 1.25” H (25 mm x 32 mm)

Weight 17 grams

Data subject to improvement without notice

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ATi UKTechnology House, Gatehead Business Park, Delph New Road, Delph, Saddleworth, Greater Manchester OL3 5DE

+44 (0) 1457 873 318 [email protected] atiuk.com