CLEANROOM VALIDATION
HEPA FILTER TESTING
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FUME CUPBOARD TESTING
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BIOLOGICAL SAFETY CABINETS
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CLEAN WORK STATIONS
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CYTOTOXIC DRUG SAFETY CABINET TESTING
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CLEANROOM VALIDATION
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HEPA FILTER TESTING / FUME CUPBOARD TESTING / BIOLOGICAL SAFETY CABINETS / CLEAN WORK STATIONS / CYTOTOXIC DRUG SAFETY CABINET TESTING / CLEANROOM VALIDATION /
Cleanrooms and contamination-controlled environments - including operating theatres, isolation rooms, and sterile processing areas - are engineered to regulate particulates and environmental conditions. These critical spaces rely on HEPA filtered air and pressure systems to maintain cleanliness levels that protect patients, staff, and products.
Why Is Certification
Critical?
Regular inspections, testing, and certification ensure your facility remains safe, compliant, and operational.
Patient Safety: In hospitals, operating theatres and sterile processing areas directly impact patient outcomes and infection control.
Personnel Protection: Cleanrooms, workstations and safety cabinets serve as essential barriers against airborne contamination.
Regulatory Compliance: Healthcare facilities must meet stringent Australian and international standards for contamination control.
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Our cleanroom validation follows AS/ISO 14644.2 and AS 1807.x methods, including:
Air velocity and uniformity in work zones.
HEPA filter installation integrity verification (AS/ISO 14644.3 B7).
Air cleanliness classification by particle counting (AS/ISO 14644.1:2017).
Room pressure differential measurement AS/ISO 14644 B.1
Air velocity and Air Changes Rate AS/ISO 14644 B.2
Smoke visualisation in compliance with AS/ISO 14644 B.3.
Recovery time testing (Grade C and above). AS/ISO 14644 B.4
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To optimise performance, we also offer:
Environmental comfort checks (temperature, humidity, noise, and luminance).
Airflow and pressure system optimisation.
Magnehelic gauge calibration.
New cabinet/isolator IOPQ validation.
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Hospital and healthcare facilities present complex environments requiring specialised knowledge. AG&G Services has extensive experience validating critical areas including:
Operating theatres: Surgical suite contamination control.
Isolation rooms: Infection control environments.
Sterile stores and CSSD: Central sterilisation departments.
ICU and critical care areas: Patient protection environments.
Our healthcare validation follows AS 1668.2, DHS and NSW guidelines, and all applicable Australian and international standards, ensuring facilities meet the highest safety and compliance requirements.
AG&G Services provides the assurance that your cleanrooms and contamination-controlled environments meet the standards required to protect patients, staff and operations.
What makes us different
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CUSTOM PROTECTION PLANS
Maintenance programs tailored to your operations and risk profile.
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CUSTOMER-FIRST PHILOSOPHY
Responsive cleanroom validation serviceand a focus on ensuring your needs meet evolving contamination control standards.
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FORENSIC DOCUMENTATION
Every test report is audit-ready, with calibrated equipment, references and detailed analysis.
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STRATEGIC INSIGHTS
We identify optimisation opportunities and recommend preventative measures before issues arise.
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QUALITY GUARANTEE
Replacement parts always meet or exceed original specifications.
AG&G Services provides the assurance that your cleanrooms and contamination-controlled environments meet the standards required to protect patients, staff, and operations.
Our Cleanroom Testing & Validation Process
Facility Assessment & Classification Review
We begin by reviewing your cleanroom classification, operational use, and design specifications to determine required testing parameters.
Environmental Performance Analysis
We analyse all collected data to confirm whether your cleanroom meets required AS/ISO cleanliness classifications and performance criteria.
Cleanroom Testing Services
We conduct detailed cleanroom testing services, including:
- Particle counting at rest and in operation
- Airflow velocity and uniformity testing Air Changes Rate
- Pressure differential measurements
- HEPA filter performance verification
- Recovery Time rate and air change validation
Cleanroom Certification
You receive a fully documented cleanroom certification report that confirms compliance status and provides clear audit-ready evidence.
Corrective Guidance & Optimisation
If any deviations are detected, we provide practical corrective recommendations to restore compliance and improve long-term system performance.
Benefits of Cleanroom Validation Services
Regular cleanroom testing is essential for maintaining controlled environments that support safe and compliant operations.
Key benefits include:
Reduced Contamination Risk
Proper validation ensures airborne particles remain within acceptable limits, protecting products, patients, and research integrity.
Regulatory Compliance
Our cleanroom validation services ensure your facility meets AS/ISO 14644 and GMP requirements, reducing audit risk.
Improved Operational Stability
Validated cleanrooms perform more consistently, reducing fluctuations that can impact production or research outcomes.
Early Fault Detection
Routine cleanroom testing services identify airflow, pressure, or filtration issues before they escalate into system failures.
Audit-Ready Certification
Professional cleanroom certification provides documented proof of compliance, simplifying inspections and accreditation processes.
Cost Efficiency
Preventing contamination events and system failures significantly reduces long-term operational and maintenance costs.
Explore More
AG&G Services provides a full suite of contamination control and compliance solutions:
HEPA Filter Testing →
Ensuring filtration systems meet performance standards
Fume Cupboard Testing →
Laboratory ventilation and safety compliance
Biological Safety Cabinet Testing →
Cabinet airflow and containment certification
Cytotoxic Drug Safety Cabinets Testing →
High-risk pharmaceutical handling compliance
FAQS
1. What is cleanroom validation and why is it required?
Cleanroom validation is the process of verifying that a controlled environment consistently meets the required cleanliness and performance standards. It ensures that your cleanroom is operating within AS/ISO 14644 guidelines for particle control, airflow, and environmental stability. It is required to maintain compliance, ensure product safety, and be audit-ready in regulated industries.
2. What is included in cleanroom testing services?
Cleanroom testing services include a full set of performance checks such as particle counting, airflow velocity testing, pressure differential measurement, HEPA filter verification, and air change rate analysis. These tests confirm whether your cleanroom is maintaining the correct environmental conditions for its classification level.
3. What is cleanroom certification?
Cleanroom certification is the formal documentation confirming that your cleanroom meets the required AS/ISO standards. It is issued after successful testing and provides evidence that your facility is compliant, safe, and suitable for regulated operations such as pharmaceutical manufacturing or laboratory research.
4. How often should cleanroom validation be carried out?
Most cleanrooms require validation every 6 to 12 months, depending on the industry, risk level, and regulatory requirements. High-risk environments such as pharmaceutical production or sterile compounding may require more frequent testing to ensure continuous compliance.
5. What happens if a cleanroom fails testing?
If a cleanroom fails testing, it means certain environmental conditions such as particle levels, airflow, or pressure differentials are outside acceptable limits. A detailed report is provided that outlines the issue and the corrective actions required before certification can be achieved.
6. What standards apply to cleanroom validation in Australia?
Cleanroom validation is primarily governed by AS/ISO 14644 standards, which define cleanliness levels, airflow requirements, and testing procedures. In pharmaceutical environments, GMP (Good Manufacturing Practice) guidelines also apply to ensure product safety and quality control.
