Precision Airtightness Compliance for Sterile Production & Lifecycle Assurance
Pharmaceutical manufacturing environments demand the highest precision in environmental control and regulatory compliance. In Australia, maintaining cleanroom integrity is essential for Therapeutic Goods Administration (TGA) licensing, ISO 14644 performance classification, and contamination control. Aerotight provides specialist airtightness services uniquely crafted for pharmaceutical facilities, ensuring your design intent, construction quality, and commissioning documentation are audit-ready and scientifically robust.
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In sterile manufacturing and containment spaces, the building envelope is a critical piece of equipment: if it isn’t airtight, the HVAC system cannot maintain the pressure cascade required to separate clean zones, prevent particulate intrusion, or uphold Good Manufacturing Practice (GMP).
Uncontrolled leakage can:
An Aerotight Strategy starts early, identifying microscopic leakage paths before they compromise performance or regulatory filings.
Pharmaceutical cleanrooms and containment areas require precise verification to ensure safety, regulatory compliance, and controlled airflow between critical zones.
Aerotight provides specialist testing services to confirm that your facility’s physical envelope and containment systems perform exactly as required.
We verify the physical boundaries of your cleanrooms as part of ISO 14644 performance criteria, ensuring HEPA filters and air handling systems maintain specified airborne particle concentrations and class designations.
We measure and certify differential pressure profiles (typically 10–15 Pa or as designed) between clean zones, ensuring compliance with validation protocols and GMP quality systems.
For high-containment laboratories (PC3/PC4 or similar), Aerotight provides high-pressure integrity tests and containment suite assessments, essential for both safety and regulatory scrutiny.
Whether commissioning a fit-out, conducting scheduled maintenance, or updating your Validation Master Plan (VMP), Aerotight delivers documentation and data that satisfy auditors and regulators alike.
Cleanroom classification, particle concentration limits, air velocity, pressure, and airflow testing.
Section J energy efficiency mandates impacting cleanroom envelope design and HVAC loading.
Requires documented proof of environmental control.
Integrity Standards: Supports HEPA installation verification and penetration testing.
An effective airtightness regime begins in design. Aerotight collaborates with engineers and architects to Aerotight design specifications, optimise envelope detailing, and embed leak-risk mitigation into project documentation – reducing rework and validation delays later. Early engagement benefits both performance outcomes and construction budgets.
Aerotight’s precision measures integrate with validation plans and compliance frameworks, going beyond standard construction testing.
Our test reports are TGA-ready, supporting licensing applications and audit submissions with traceable data.
We balance high air change requirements with tight building envelopes to reduce HVAC energy usage while maintaining environmental classification demands.
Integrity Standards: Supports HEPA installation verification and penetration testing.
Real-world airtightness results across Australia, delivered by Aerotight. Explore how precision testing, compliance expertise, and proven outcomes help projects meet strict performance standards with confidence.
Hear directly from builders, architects, and project teams across Australia who trust Aerotight for accurate testing, smooth compliance, and dependable results on every project.
For pharmaceutical manufacturers in Australia, airtightness is a regulatory requirement under the PIC/S Guide to Good Manufacturing Practice (GMP). The Therapeutic Goods Administration (TGA) mandates that cleanrooms maintain specific pressure gradients to prevent cross-contamination. Aerotight provides the certified blower door testing and integrity verification required to pass TGA audits and ensure product safety.
Pharmaceutical facilities must strictly adhere to ISO 14644 (Parts 1, 2, and 3) for cleanroom classification and AS/NZS 14644:2017. For facilities involving hazardous substances, AS 2252 standards for cytotoxic safety cabinets and clean workstations also apply. Aerotight’s technicians are ATTMA-certified to test against these specific Australian and international benchmarks.
GMP compliance relies on "Environmental Control." If a pharmaceutical suite is not airtight, the HVAC system cannot maintain the "cascading pressure" required to keep contaminants out of Grade A and B zones. Aerotight's testing identifies hidden leakage paths in the building fabric, ensuring that your facility maintains the sterile integrity required for Grade A aseptic processing.
In accordance with ISO 14644-3 and GMP guidelines, a minimum pressure differential of 10 Pa to 15 Pa is typically required between rooms of different cleanliness classes. Aerotight utilizes high-resolution digital manometers and blower door systems to verify that these pressure regimes are stable and meet the design intent of the facility.
Yes. We use ultrasonic leak detection and theatrical-grade non-toxic smoke testing to visualize air bypass. In pharmaceutical settings, leaks often occur at HEPA filter housings, service penetrations, and door seals. Our diagnostic tools allow for the pinpointing of leaks without introducing contaminants, enabling precise rectification before the final validation.
Absolutely. Physical Containment level 3 and 4 (PC3/PC4) facilities must meet extreme airtightness standards to prevent the release of hazardous pathogens. According to AS/NZS 2243.3, these facilities must undergo mandatory integrity testing (often achieving leakage rates as low as 12 L/min @ 200Pa). Aerotight specializes in high-pressure integrity testing for these critical environments across Australia.
While initial "as-built" testing is required for commissioning, the TGA and ISO 14644-2 recommend periodic re-qualification. Typically, room integrity should be re-verified annually or whenever significant modifications are made to the building envelope or HVAC system. Aerotight offers scheduled maintenance testing to ensure ongoing compliance.
Yes. A leaky room forces HEPA filters to work harder to maintain pressure, shortening their lifespan and increasing the risk of "dirty" air being pulled into the room via bypass. By ensuring the room is airtight with an Aerotight certified test, you optimize the laminar airflow and protect your HEPA filtration investment.
Yes. We provide a comprehensive, NATA-traceable and ATTMA-certified report. This documentation includes air leakage rates, pressure-flow curves, and diagnostic evidence (smoke/thermal imagery). This report is a "ready-to-submit" document for validation master plans (VMP) and TGA licensing applications.
1. Initial Consultation & Scope Definition
2.Pre‑Construction Aerotight Strategy
3. On‑Site Testing & Diagnostics
4. Comprehensive Reporting & Compliance Documentation
Secure the sterile integrity of your pharmaceutical facility with airtightness testing grounded in engineering excellence and regulatory authority.
Contact Aerotight today to discuss your project requirements and schedule an assessment.
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