cleanroom and critical environment air quality testing

Covering cleanrooms, pharmaceutical suites, operating theatres, CSSD, isolation rooms where NATA accredited testing is required

Cleanrooms are built environments designed to meet ISO 14644 that are often utilised for critical applications. Regular cleanroom testing can help to identify and address any issues with the cleanroom. The environment must be used in a way that minimises the introduction, generation and retention of particles and microbes inside the room, and in which other relevant parameters such as temperature, humidity and pressure are controlled.
Contamination is one of the biggest risks to people, products, and the cleanroom environment, so these spaces must be constantly monitored and precisely controlled. This can for instance stop the spread of virulent bacteria and viruses in the healthcare industry.
A critical component is the High Efficiency Particulate Air (HEPA) filter used to trap particles 0.3 microns and larger. All air supplied to the cleanroom passes through a HEPA filter, and ULPA (Ultra Low Particulate Air) filters are used when stringent cleanliness requirements and required, such as within the semi-conductor industry.

APPLICATIONS

Cleanrooms are required across a wide range of industries, such as:

  • Hospitals
  • Labs
  • Pharmaceuticals
  • Research and development
  • Military manufacture & maintenance
  • Fibre optics

AES Environmental has a dedicated team that is capable of carrying out assessment and validation work within cleanrooms. Our cleanroom team is discrete, reliable and applies the latest reporting techniques to ensure that the user has access to all information in a timely manner.

CLEANROOM MAINTENANCE

Unplanned downtime caused by malfunctions and breakdowns can be costly, consuming a lot of time and resources. The likelihood of plant failure and production downtime will be decreased by performing preventative maintenance. Your cleanroom facility’s mechanical components are crucial, especially when it comes to preserving the highest possible levels of containment and air sanitization. Components include:

  • Air Handling
  • Heating and Cooling Systems
  • Duct Work

COMPLIANCE

AES is an ILAC accredited NATA testing organisation that provides validation services to ensure that the cleanroom and operator can comply with relevant TGA, GMP, FDA and other regulatory requirements, either regional or corporate.
AES partners with NATA and BSI to ensure that its technicians and processes are current to industry standards. The latest state of the art equipment and methodology is employed to ensure that validation services are conducted accurately and promptly.
Our validation team is there to work with quality and compliance team. We spend the time with users on-site to ensure that they are aware of any areas of concern, we can offer guidance or provide corrective action and ensure that expected performance meets actual performance.

Enhanced Healthcare and Critical Environment Air Quality Services

AES Environmental’s expertise extends beyond traditional cleanrooms into specialist healthcare environments where air quality is directly linked to safety outcomes. We provide testing, validation and certification services for controlled environments that rely on precise air filtration performance to protect patients, staff and sterile processes.

HEPA Filter Integrity and Certification
High Efficiency Particulate Air (HEPA) filters are used in critical environments to control airborne particulate contamination. HEPA filters are defined by a minimum efficiency (usually greater than 99.95%) when tested at the most penetrating particle size (MPPS), typically around 0.3 micron. AES Environmental provides NATA accredited HEPA filter integrity testing and certification to verify that each installed filter performs as designed and remains compliant with applicable standards.

Operating Theatre Ventilation Validation
Operating theatres require tightly controlled airflow and pressurisation to minimise infection risk during surgical procedures. AES provides operational assessment and validation of theatre ventilation incorporating HEPA filtration and Ultra Clean Ventilation UCV systems, including verification of positive pressure to adjacent areas in accordance with AS 1668. Testing assesses airflow patterns and air change rates and air delivery at the operating table to confirm that clean air is supplied effectively to the critical zone and that contaminated air is displaced as intended. This provides confidence that theatre environments perform in line with design intent of AS 1668 and support safe and repeatable surgical outcomes.

Isolation Ward Air Quality Assessment
Isolation wards rely on carefully controlled airflow and pressurisation to limit the transmission of airborne infectious agents and protect both patients and staff. Depending on clinical function, these areas may operate under negative pressure to contain contaminants within the room, or positive pressure to protect immunocompromised patients from contamination. AES provides validation of isolation spaces, including verification of pressure differentials to adjacent areas, assessment of airflow direction and stability, and evaluation of HEPA filtration performance. Testing confirms that the rooms perform in line with design intent and relevant healthcare engineering requirements, including applicable NSW Health and state based guidelines. This reduces the risk of cross contamination and supports infection control, improving patient outcomes.

CSSD Air Quality Assessment
Central Sterile Services Departments (CSSD) are critical hospital environments responsible for the cleaning, disinfection, inspection and sterilisation of reusable medical instruments. Air quality and airflow control within CSSD areas are essential to prevent contamination of instruments and to maintain separation between dirty and clean equipment. Testing confirms HEPA Filter Integrity, room pressures and that airflow complies with AS 1668, facility design intent and relevant healthcare engineering guidelines, supporting infection control outcomes and accreditation requirements

PHARMACY SUITES

The use of cytotoxic drugs creates a need for a different set of solutions with their preparation, manipulation and compounding. According to AS 2252.5, many cytotoxic drugs have been demonstrated to be mutagens. Some have shown to be carcinogenic or teratogens in cell DNA. Some chromosomal studies have shown that the effects may not present themselves for many years after exposure. Therefore, it is essential to ensure that:

  • There is effective protection of personnel
  • Protection of the immediate surrounding environment and discharge
  • Protection of the products, to ensure that they are manipulated within a clean and controlled environment

There are a special set of standards and procedures for ensuring that pharmacies are safe. Any Cytotoxic Drug Safety Cabinets should comply with AS 2252.5 and the rooms must meet a strict criteria in accordance with AS 1668.2. AES Environmental technicians are specially trained to identify hazards and operate safely within Cytotoxic Suites. The TGA has adopted PE009 PIC/S for GMP. AES Environmental has the knowledge and experience to assist with Pharmacy design, maintenance and review. Our experience with major global pharmaceutical companies and dedication to working within all compliance and regulatory requirements is essential in providing a safe, compliant work space.

CLEANROOM STANDARDS

There is a particular application area for each clean room classification standard. The standard ISO 14644 has been adopted into Australian standards as AS/NZS 14644 2017. This is an international standard that aims to achieve the international standardisation of manufacture.
Your company should also look into relevant therapeutic goods or equivalent regulatory standards to determine any additional requirements. AES can assist with this investigation as a consultancy service.

Our Cleanroom Services

AES Environmental is able to provide packages for both routine and urgent cleanroom maintenance. We offer an extensive maintenance and repair service for all elements of your cleanroom; including the ventilation system, fixtures, and building materials like floors, ceilings and furniture.

VALIDATION DESIGN

Cleanrooms are now validated in two starts, in-use and at-rest. In-use testing was developed because at-rest testing may not generate a real-world result. There are many factors to consider as no two cleanrooms are ever the same. Because of this, our experienced team is able to sit with you and design a testing program, designate the optimal sample locations and then work within the on-site requirements to deliver that program.

VALIDATION EQUIPMENT

Each site many have specific methods that need to be considered. However, the most common instruments applied by technicians are photometers, particle counters, aerosol generators, pressure monitoring equipment and temperature monitoring equipment. All of the equipment used by AES technicians is itself validated to current standards and test reports are always made available to the user.

VALIDATION METHODS

Validation methods are typical within the cleanroom industry and there is good standardisation. Room recovery rates and particles counting for room classification along with leak testing of HEPA filters, air flow, pressure and temperature monitoring are critical components of cleanroom validation. Comfort tests related to sound and light are also significant as optimal operating conditions are critical to reduction of employee error.

COMPLETE COMPLIANCE

AES Environmental brings together the idea of designing a testing program, ensuring all equipment is compliant and current and then adopting the latest validation methods, to deliver on its goal of making compliance simple and accessible for its customers.

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