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Supporting Compliance In Highly Regulated Manufacturing Environments

100%

of cleanrooms passed certification on the first attempt post-remediation

100%

of the client's Australian facilities now under NXTGEN care

The Challenge
‍GMS was in the construction phase of a new pharmaceutical manufacturing facility when the project stalled. The Grade B cleanroom could not be brought to a standard where it could be handed over, cleaned and presented for certification. Until that was resolved, everything downstream — classification, validation, qualification and production — sat behind a single unresolved problem.

‍Identifying The Root Cause
‍NXTGEN Air Solutions was engaged to assess the environment and establish why it would not hold specification. Rather than treating symptoms, we traced the fault to its origin in the design and implementation of the system — the point at which it could still be corrected without reworking the completed build.

‍Implementing The Solution
‍Working alongside the project team, we designed the remediation and carried it out on site. Addressing the cause rather than the effect meant the facility could be brought to specification without the cost and delay of tearing back finished work, and without compromising the compliance position GMS would need to hold from day one of production.

‍Certification
‍We then performed the cleanroom certification ourselves, taking the facility from a state where handover was not possible to one certified to Grade B — the standard required for production under the TGA's adoption of the PIC/S Guide to GMP.

‍An Ongoing National Partnership
‍The relationship that began with a single stalled project now spans Six facilities. NXTGEN Air Solutions provides ongoing testing, validation and certification across GMS sites throughout Australia, supporting consistency of standards from one facility to the next.

Maintaining Compliance Across Critical Healthcare Environments

80%

decrease in dust flow from 20% to 3%

90%

increase in filter integrity

Gold Coast Private Hospital required reliable HVAC validation across operating theatres and other critical healthcare spaces where infection control, air quality, and system performance directly impact patient safety.

NXTGEN Air Solutions was engaged to investigate ongoing pressurisation issues affecting several departments. Through detailed testing, independent validation, and specialist diagnostics, our team identified the underlying cause and implemented a long-term solution that restored stability and compliance across the affected areas.

Beyond resolving the immediate issue, we continue to support the hospital through ongoing certification and validation services, including HEPA filter integrity testing, particle counting, airflow verification, and environmental monitoring. By providing a single point of accountability and flexible after-hours delivery, we help ensure critical spaces remain operational, compliant, and ready for use when needed most.

Delivering Confidence Before Occupancy

80%

decrease in dust flow from 20% to 3%

90%

increase in filter integrity

Large commercial developments contain hundreds of interconnected systems that must perform correctly before a building can achieve practical completion and occupancy certification.

NXTGEN Air Solutions was engaged to test, certify, and validate critical fan coil, stair pressurisation, and air conditioning ventilation systems throughout the Esprit Building. Our role extended beyond testing alone, with a strong focus on identifying defects, resolving issues, and ensuring all systems met required performance standards prior to handover.

By taking ownership of problems as they were discovered and working collaboratively with project stakeholders, we helped reduce delays, close out defects efficiently, and support a smooth path to occupancy. The result was greater confidence for both the client and project team that the building was ready for operation.

Case studies

Explore Our Client Success Stories

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