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Case Studies
Oct 14, 2026

Pharmaceutical Manufacturer Restores ISO 7 Cleanroom After HEPA Failure Threatens Production

By Albert Estrada

Shutterstock 1042382977 (1)

A pharmaceutical manufacturer producing sterile injectable products, engaged Promera’s Sterile Science team after unexpected contamination halted production in a critical cleanroom environment.

Challenges 

Multiple product batches began failing release testing due to unknown microbial contamination, forcing production to a standstill. The contamination originated within an ISO 7 cleanroom, raising immediate concerns around product integrity, regulatory compliance, and financial impact. With no clear source identified and mounting pressure to resume manufacturing, the client required a rapid, scientifically defensible investigation to determine root cause and restore operations.

Solution 

Sterile Science, a Promera Company, deployed a structured forensic investigation to isolate the source of contamination. The engagement included a full review of environmental monitoring data, targeted visual inspections of HVAC components and moisture-prone areas, and strategic surface and air sampling using TSA and SDA media. Advanced PCR testing enabled precise organism identification.

Smoke testing ultimately revealed the root cause: a faulty HEPA filter allowing unfiltered air to breach the sterile envelope, introducing Aspergillus contamination into a single production room. Promera then executed a comprehensive remediation protocol, including a triple-clean methodology using Vesphene for soil load removal, Spor-Klenz for endospore destruction, sterile 70% IPA for final disinfection, and a terminal dry fog treatment with peracetic acid.

Results 

·       Complete elimination of Aspergillus contamination

·       ISO 7 classification fully restored

·       Affected product batches cleared for release

·       Production resumed without further incident

This case underscores a critical truth in sterile manufacturing: cleanroom integrity is only as strong as its weakest HEPA filter. Regular integrity testing is not optional—it is essential to protecting product quality and operational continuity. Sterile Science delivers rapid root-cause analysis and proven remediation to protect compliance, products, and uptime 

Tags: Sterile Science

Director of National Operations, Sterile Science

Albert leads national operations in cleanroom decontamination, biodisinfection, and GMP compliance consulting for Sterile Science. With nearly 10 years of experience in highly regulated environments, he brings deep technical expertise across university lab management, Class II medical device compliance, EPA-regulated industrial wastewater analysis, and controlled environment operations.

Albert holds a Bachelor of Science degree in Pre-Medicine and multiple advanced certifications, including Industrial Wastewater Operator, Certified Environmental Specialist, and cGMP Cleaning & Sanitation. He is also a Council-certified Microbial Investigator (CMI) through the American Council for Accredited Certification (ACAC), enabling him to perform validated microbial investigations with board-certified expertise.

Through his work, Albert helps organizations strengthen contamination control programs, maintain compliance, and protect the integrity of critical environments.