Semiconductor Assembly - ISO 7

The Challenge

The client needed to upgrade an existing warehouse facility to a GMP-compliant sterile pharmaceutical production facility within a tight 12-week timeline. The challenge involved transforming a non-controlled environment into an ISO 5 (Class 100) cleanroom capable of supporting sterile vaccine manufacturing operations while maintaining strict compliance with Annex 1 requirements and international validation standards.

The Solution

We implemented a modular hardwall cleanroom system with integrated flush lighting to minimize dust traps and contamination risks. The solution included:

• Complete HVAC system with 45 HEPA filters providing 60 air changes per hour
• Optimized airflow patterns to ensure unidirectional flow in critical zones
• Pressure cascade system maintaining positive pressure differentials
• Integrated monitoring systems for particle counts, pressure, temperature, and humidity
• Dedicated gowning areas and material pass-through systems
• Full validation package including IQ, OQ, and PQ protocols

The Outcome

The facility passed SABS validation on the first attempt, meeting all ISO 14644 and GMP Annex 1 requirements. The project was delivered 1 week ahead of schedule, allowing the client to begin production operations earlier than planned. Since commissioning, the facility has maintained consistent ISO 5 classification with zero contamination incidents, supporting continuous sterile vaccine manufacturing operations.

"They retrofitted our facility without halting production and guided our team through the entire validation process with zero surprises. The attention to detail and commitment to compliance was exceptional."