Indoor Air Quality

• HVAC Validation of Cleanrooms and Associated Controlled Environments
• Verification & Validation of Specialised Ventilation Systems

 

HVAC Validation of Cleanrooms and Associated Controlled Environments

 

Many products and processes require the control of airborne contamination during manufacturing and processing including aerospace, food & drink, healthcare, medical devices, microelectronics, pharmaceutical, biotechnology and automotive industries.

Cleanrooms and associated control environments require continuous testing, monitoring and routine re-qualification to ensure compliance with the controlled low levels of environmental pollutants such as dust, airborne microbes, aerosol particles and chemical vapours, sometimes using separate devices such as Clean Airhoods, Gloveboxes, Isolators and mini environments.

Some HVAC systems also control temperature, pressure and humidity using ionizers to prevent electrostatic discharge problems. All these systems require routine re-qualification, testing and monitoring to provide evidence of continual compliance with the legislation.

The Legislation

The relevant standards are ISO 14644 ‘Cleanrooms & Associated Control Environments’; ISO 14698 ‘Cleanrooms and Associated Control Environments – Biocontamination control’ and EU GMP.
HBI provides a service to verify the continued compliance of an installation to approved standards by performing specified tests and by documenting the results.

Our Services

 

Our Services include:

• Particle count test
• Airflow volume and airflow velocity test
• Room air change rate calculation
• Air pressure difference test
• Installed filter system leak test
• Recovery test
• Airflow visualization test
• Containment test
• Temperature and relative humidity test
• Noise level test
• Lighting level test
• System rebalancing
• Microbiological safety cabinets
• Glove box verification
• Hepa filter replacement
• LEV/fumehood verification

Verification & Validation of Specialised Ventilation Systems

Modern systems must be designed and operated to achieve a proper balance between air quality, thermal comfort and energy consumption. In healthcare premises, ventilation is used extensively in all types of facilities to provide a safe and comfortable environment for patients and staff. Specialised ventilation is provided in primary patient treatment areas such as operating departments, critical care units and in sterile services departments and pharmacies to ensure compliance with quality assurance.

If ventilation systems do not achieve and maintain the required standards there is an increased health risk to patients. Indeed the link between surgical site infection and theatre air quality has been well established. UCV systems are designed to provide a zone around the patient that is effectively free of bacteria-carrying airborne particles during an operation.

Ventilation systems in healthcare premises are becoming increasingly sophisticated.

Patients and employees have a right to expect that these systems will be designed, installed, operated and maintained to standards to ensure it will adequately and satisfactorily fulfil its desired functions.

Health Technical Memorandum 03-01

The Health Technical Memorandum (HTM) 03-01 – “Specialised ventilation in healthcare premises” has been produced to supersede ALL previous versions of HTM 2025 – “Ventilation in healthcare premises”.

Key issues HTM 03-01 addresses include:

• The Verification testing of Critical Ventilation Systems, including pre 2007/8 theatres.
• The Validation testing of New Build conventional and ultra-clean ventilation (UCV) systems.
• The prevention and control of healthcare related infections.
• Layout of minimum requirements for the design of air handling units (AHU) with regard to safe access for routine inspection and maintenance and the control of Legionella.
• Controlling exposure to harmful organisms, toxic and anaesthetic substances.

1) The AHU conforms to minimum standards;

2) The fire containment has not been breached;
3) The general condition of the ventilation
system is adequate;
4) The fabric of the area served is satisfactory;
5) The system performance is adequate with respect to the functional requirement:

a) The measurement of room temperatures and relative humidity;
b) A full measure of the supply and
extract air flow rates;
c) The calculation of room air-change
rates if applicable;
d) The measurement of room differential pressures if applicable;
e) The measurement of room noise levels;
f) Air-quality checks if appropriate;
g) A check on control functions. 

Verification

The objective of the Verification processes is to establish that the critical ventilation systems, as defined by HTM 03-01, remain fit for purpose and are achieving an adequate operating capacity by satisfying the following criteria:

 

New Build Conventional &Ultra Clean Ventilation (UCV) Unit Validation

In order to ensure the complete system operates correctly and achieves design requirements, it will be necessary to validate the system as a whole from the air intake through to the extract discharge. Healthy Buildings International (HBI) can offer the following services to ensure compliance with HTM 03-01 and hence validate the suitability and performance of an UCV suite.

 

(1) Conventional Theatre Standards:

• Supply AHU will have achieved the minimum standard;
• Operation of Fire Dampers will have been proved;
• Supply & Extract Flow rates will have achieved their design values;
• Room temperature, humidity & differential pressures will be correct.

 

(2) Challenge tests:

• The UCV terminal is correctly assembled and sealed;
• The terminal filters are correctly sealed in their housings;
• The terminal filters are of the same grade, of uniform quality and undamaged.

 

(3) Air velocity measurements:

• A sufficient quantity of air is being delivered to the terminal;
• The terminal quadrants are in balance;
• The air flow has sufficient velocity to reach the working plane.

 

(4) An entrainment test:

• Outside contaminants are not drawn into the UCV terminal.

 

(5) Visualisation techniques:

• Establish an understanding of overall system performance.

 

(6) Noise measurement:

• Working conditions are satisfactory.

 

(7) Control systems checks:

• The system operates as specified.

 

(8) Biological monitoring:

• Determine the effectiveness of the system in use.

Our Services

 

• HTM 03 Verification testing of Critical Ventilation Systems;
• HTM 03 Validation testing of New Build Conventional & UCV;
• Assessment of Category 3 & 4 Laboratories - as required by the HSE & the Advisory Committee on Dangerous Pathogens;
• Pharmacy Aseptic Suites – should conform to the European Guide to Good Manufacturing Practice;
• Sterile Services Dept; Inspection & Packing Rooms – ISO 14644 & Building Note 13;
• LEV Systems – CoSHH Regs.

Data at your Fingertips

We understand how important it is to have access to up-to-date information. With HBI, you will have secure on-line access to a report in our MBR Risk Management System. This report will conclude with a clear statement as to whether the ventilation system achieved or did not achieve the desired standard and highlight any actions that need to be taken.

For more information about our specialist Indoor Air Quality services call your local HBI office or email sales@hbi.ie