Meeting all the appropriate requirements takes on even greater importance in an environment such as the operating room, given the need to ensure air quality for both patients and operators. Operating room testing must be annually verified and this is usually arranged by the facility managers.
A preventive maintenance programme coupled with regular inspection is essential. Therefore, the verification of the operating room becomes a necessary and mandatory step in accordance with national and regional legislation. Total Clean Air performs a range of services that cover operating theatre verification and validation, in both conventional and ultra clean ventilation (UCV) theatres, to guarantee point of care testing.
Our highly qualified and knowledgeable team of engineers are trained to meet the needs of your operating rooms, irrespective of complexity, scale or the solutions required.
We can promptly identify any problems with the air quality and ensure all work is completed on time, using a range of sophisticated validation testing equipment to compliment the operating room environment.
We provide comprehensive experience and skills in the testing and evaluation of advanced ventilation for healthcare premises and can guarantee we work in a way that fits into your schedule and minimises downtime. Our engineers’ are trained to HVAC (HTM 03) ‘competent person’ level and have over 20 years’ experience in working in all types of operating theatres. We work with facility managers and estates teams to ensure that the operating room testing is planned and completed on time.
What is Operating Theatre Verification and Validation?
Operating Theatre Verification and Validation is performance testing of the operating rooms inline with the regulations of HTM 03-01, designed to evaluate the air quality and environmental hygiene of operating theatres and their compliance. The operating room environment is so important to providing point of care testing to the patients.
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Theatre Verification and Validation Protocol
The verification of critical ventilation systems include:
Air Change Rates (ACH)
An air change is how many times the air enters and exits the room. It’s a basic measure of the volume of air added to or removed from a room. Air changes have a minimum requirement to meet the operating theatre ventilation standard but may not be sufficient to control the contaminants that are airborne. Air change rates are a fundamental baseline of air supply or extract in operating theatres and have acceptance criteria they must adhere to.
You should note that a supply of air quantity that achieves at least 25 air changes is not likely to be enough for a laminar flow or UCV system.
The measurements of air volume flow rate are to ascertain the total volume flow rate. This is then calculated as air changes serving the operating room and other operating room environments. The attained air volume flow rates are compared with design requirements.
Operating theatres allow for a tolerance in the acceptance criteria specification. Up to 75% of the design requirements are allowed for in the HTM 03-01 guideline. An air change rate requirement of 25 per hour, can be as low as 18.75 and still pass. This allows for a certain amount of degradation of the HVAC systems over it’s lifespan. An HVAC system or AHU is expected to have a useful lifespan of 20 years. Operating rooms typically outlast the HVAC systems but repairs and modifications are always necessary.
To ensure proper verification of your operating theatres, you should only work with contractors whose technicians are sufficiently trained and skilled to carry out the necessary verification and validation checks.
Total Clean Air’s technical personnel consist of highly trained and skilled engineers and competent persons who can verify and maintain a wide variety of operating theatres and equipment to HTM 03-01, ISO 14644 and cGMP standards.
Contact sales@tca.group for further information, and to see what we can do for your operating theatres.
Air Velocities
Air velocity explains the air speeds that are present under a UCV canopy. Air velocity is an important factor in thermal comfort for the surgeons and operating theatre staff. The air velocity plays a key part in the air quality inside the UCV canopy.
The air velocity inside a UCV canopy needs to be precisely measured to ensure the accuracy across the entire canopy zone and for each quadrant. The velocity is measured at both 1 metre and 2 metre heights from the floor to simulate patient operating height and the speed at which the air enters the critical zone. It’s imperative that both velocities perform in accordance which HTM 03-01.
To confirm that the air velocity in the UCV is up to the approved standard, an air velocity test, amongst others, is required.
Call 01737 924700 to book a test today, or alternatively, contact sales@tca.group for further information
Pressure Differentials
Pressure differential is the difference in pressure between two points. This is extremely important to help create an invisible barrier to keep contamination out of a clean area or to contain an infectious patient in an isolation ward. Pressure differentials play an important role in infection control and have to be carefully balanced between dedicated HVAC systems and sensitive manual and automatic damper adjustments. All pressure differentials are a known quantity, according to the HTM 03-01 standards, however, they are subject to the 75% of design specification. This does not apply to an anaesthetic room pressure due to the presence of medical gases.
Patients, visitors, and staff are concerned with the transmission of respiratory infectious diseases in health care facilities. To mitigate the spread of respiratory pathogens, some hospital rooms are built as Airborne Infectious Isolation or Protective Environments. Infection control teams play an important role in determining their safety for all users.
When doors are closed, differential pressure will prevent contamination between areas.
Regulatory guidelines require that each isolation room has a permanently installed visual device or mechanism for continuous monitoring of the room’s air pressure differential when occupied by a patient requiring isolation. Due to their nature, isolation wards are guided by a separate standard, HBN 04-01.
Using an electronic pressure monitor is the most reliable way of monitoring room pressure. If correctly designed and installed, an electronic air-pressure sensor will provide continuous confirmation over the space boundary of the necessary pressure differentials.
In addition to regular operation theatre room monitoring, the hospital personnel who may enter or operate the space will be instructed in the safe usage of the room, and how the pressure metre functions. An advantage of having a continuous pressure sensor attached to the building control network is that the pressure differential can be tracked, trended, and evaluated. This may also be used to alert hospital employees if the room is not working as expected.
At Total Clean Air, we are qualified to handle room pressure and pressure differential testing to verify that the operating theatres and room environments meets the approved HTM 03-01 and HBN 04-01 standards. Call 01737 924700 today to inquire or contact sales@tca.group for more information.
HEPA Filter Integrity Leak Testing
HEPA (High Efficiency Particulate Air) filters trap fine, microscopic particles such as dust, pollen, mould, and bacteria. They are used in the treatment of ultrafine particles, aerosols and viable organisms and are commonly used in operating theatres, cleanrooms, and laboratories.
HEPA filter installations are mandatory in all UCV canopies. Although they only have to fit H11 in a HEPA filter installation, the vast majority of companies and contractors install H14 HEPA filters. This not only aides performance testing but will help to clean the environment to a higher standard and boost infection control rates. A conventional theatre may have an HEPA filter installation that is ‘inline’ in the duct or AHU mounted.
HEPA filter performance testing, or integrity leak testing, only needs to be carried out when the HEPA filter is replaced. This is when the verification becomes known as a validation. By only testing the filters on installation, it prevents over-contamination, or loading, of the filter media.
The HEPA filter lies at the core of UCV operating theatres. Enhanced HEPA leak testing is advised to protect sensitive operating procedures and maintain pollution-free hospital environments.
Failure or incorrect implementation of the HEPA filter may affect the quality of the air in the operating theatres or wards. Consequently, if the HEPA filter is checked to decide whether it has passed, you can ensure that the air brought into the cleanroom is particulate-free.
At Total Clean Air, we have a wealth of experience testing all types of hospital areas and facilities. We can provide expert testing and servicing in cleanrooms for HEPA filters’ integrity testing and replacement.
Our professional staff will assist with the collection, sourcing, installation, and review of HEPA filters, taking full responsibility for their purchase, replacement, and validation. Our routine performance testing and verification help to identify any problems and we will work with our clients to determine the best schedule to replace HEPA filters.
Benefits of Using our HEPA Filter Replacement and Integrity Testing
Using our HEPA filter replacement and integrity service ensures that you comply with regulations by maintaining adequate levels of cleanliness and air quality. As soon as a HEPA filter is installed, it must be validated to confirm compliance with ISO 14644 -3 (2019).
We offer an independent, unbiased, service as we are not a supplier or manufacturer of filters and are not involved in the sale of filters.
Contact us for more information on our HEPA validation service, or get in touch with sales@tca.group for more information.
Particle Counts (also known as ‘Airborne Particle Counts’ or ‘Non-Viable Particle Counts’)
An ongoing air monitoring and testing programme is the only way to ensure that the operating facilities have the level of cleanliness needed during sensitive procedures and to prevent down times. Operating theatres no longer have a requirement to meet particle standards since the superseding of HTM 2025. The infection control teams now play an important role in gathering microbial data.
Particle counters will trigger alarms when contamination poses immediate threats to operating theatre room processes and thus alerts the operators of possible contamination or danger.
Such cleanroom particle counters will also record evolving pollution patterns and weak points and, in the process, assist any cleaning workers to improve the air quality in their sensitive environments.
Total Clean Air provides trained and friendly cleanroom testing engineers, providing comprehensive and proactive validation service to meet all current ISO standards and requirements of relevant guidelines.
If you need additional details about airborne particulate testing please contact us now.
Magnehelic Gauge Calibration
Quality management systems demand an effective calibration system including formal, periodic, and documented calibration of all measuring instruments.
Effective calibration systems are required by ISO 9001 and ISO 17025.
Magnehelic gauges are designed for versatile, low-differential pressure gauges for a wide range of models based on different ranges used in fan pressure indication, duct, room or building pressure, and positive pressure indication for the cleanroom or operating theatre.
The Magnehelic gauge has an extremely sensitive diaphragm that responds to pressure changes. The Magnehelic dial responds accordingly when pressure is exerted on the diaphragm and moves at the appropriate pressure.
Our experienced engineers at Total Clean Air can come to your UK site to perform a periodic calibration that meets national standards. A testing service on-site minimises downtime, saves resources and time for the organisation.
We are also willing to provide a small on-site maintenance service.
(We start as early as possible and work as late as necessary to match your schedule. We also allow customers to view and print their certificates on our website 24/7, using an easy-to-use interface.) Call 01737 924700 today to find out more.
Temperature, Humidity, Light and Noise Testing (collectively referred to as ‘Ambient’ Condition Testing)
A set of parameters used by engineers for the dimensioning of ventilation and cooling systems is called ambient condition testing.
Typically, the ambient conditions include temperature, humidity, light, noise and air pressure. The results achieved give a representation of the operating theatres condition at the time of testing. There are specific boundary limits for the operating theatres to adhere to and these are captured using sensitive, calibrated equipment for operating room testing.
Ambient air testing assesses levels of contamination to improve air quality. We can measure the concentration of pollutants in surrounding outdoor air using sophisticated technology
Samples are gathered, processed, treated, and analysed by professional, field services staff to globally recognised and locally accepted standards.
With more than 20 years of experience in the field, Total Clean Air will help you plan and execute ambient testing in your operating facility.
Contact your local Total Clean Air office to find out more about our ambient testing services.
Microbiological Active Air Sampling
Microbiological air sampling is a critical function of any laboratory associated with pharmaceutical, biotech, or health-care facilities for quality control (QC) or infection control in operating rooms
Sampling active air is a way of measuring any airborne contamination accurately.
To sample active air, an air sampler draws a fixed air volume using an agar plate. An analysis of the culture, following a period of incubation, is then carried out to provide critical information such as the bacterial or fungal count.
Total Clean Air provides a range of active microbial air testing solutions for theatre testing and validation as standards are becoming stricter and regulations are increasing.
We have a broad variety of air samplers for operating theatres, cleanrooms, isolators, and other controlled rooms for a wide range of environmental testing applications.
Worried that your current microbial air samplers do not provide accurate results anymore? We also offer a testing service for the instrument to keep the instruments running at optimal rates.
Settle Plate Testing
Effective air testing is urgently required in all environments where airborne microorganisms may contaminate industrial materials and systems or affect them.
Air quality is therefore especially relevant and particularly for operating rooms.
Effective air testing with settle plates or touch plates involves the use of a microbiological air sampler to manually draw a fixed air volume and move it over to the agar. The plate is then withdrawn from the air sampler and immediately incubated allowing for the creation and eventual counting of visible colonies. The number of visible colonies provides an estimate of the number of units forming a colony.
There are several methods for testing the air for mould or other microbial contamination. The settle plate method is one of the oldest methods of testing the air for microbial contamination. Although it is a semi-quantitative method, it is still considered a valuable tool.
In operating theatres, the system is used to determine the possible number of microorganisms depositing on the surface in a given period.
This process is a vital part of your operating theatre validation and should be done by an accredited company.
To book a test, call 01737 924700 today.
Contact Plate Testing
Operating theatre rooms are highly controlled facilities, but these aseptic processing areas can be polluted by machinery and staff. Therefore, the use of the right methods to detect any microbial behaviour is extremely necessary.
Tryptic soy agar (TSA), a non-selective medium known for its ability to allow a wide variety of organisms to grow, is the most used media to this end.
However, the option to use contact plates for a settle plate test enables the use of a single consumable contact plate for environmental control testing.
The shape of the contact plate offers more stability than the Petri plate, plus a significant, tangible benefit: the use of one consumable. Contact plates are the main instruments used to track surfaces and staff gowning procedures in operating theatre rooms, cleanrooms, and critical environment.
Airflow Visualisation (Smoke Visualisation)
For satisfactory operations in sensitive operating theatres or cleanroom environments, a significant amount of purified air is needed to eliminate or dilute pollutants.
Test of airflow visualisation, or smoke visualisation, can help in knowing how air moves in a cleanroom and how it affects any possible contamination. It can provide a useful visual demonstration of how air movement performs, particularly in a UCV.
In the event of problematic airflow patterns, the cleanroom manager should either attempt to engineer these out, undertake an appropriate risk assessment or target environmental monitoring samples to the areas of concern.
This type of test has the purpose of verifying and certifying that the airflow set up to protect critical areas is working efficiently.
Total Clean Air provides a regular testing service to ensure that operating theatres are completely compliant with the standard approval tests.
If you have any concerns or would like more information on either of our programs, please contact our polite and professional workers.
We are glad to be of help and support in whatever way we can. Call us on 01737 924700 or contact sales@tca.group for more information.
