Environmental Monitoring & Cleanroom

Environmental Monitoring & Cleanroom Qualification & Certification Support

A successful environmental monitoring program begins with the appropriate qualification and certification activities that will lay the groundwork for routine testing. Our team is well-versed in the current industry and regulatory standards and can assist with the following qualification and certification activities:

• Baseline studies
• Room recovery studies
• Cleanroom qualification activities
  • At rest (static) performance qualification
  • Operational (dynamic) performance qualification
• Cleanroom certification per ISO 14644-1:2015, ISO 14644-2:2015, and EU Annex 1
• Utilities qualification activities per ISO 8573-1:2010 and USP<1231>

Environmental Monitoring & Cleanroom Utilities Sampling

Most environmental monitoring qualifications are accompanied by utility qualifications — such as water for injection, USP water, reverse osmosis, and city water, along with clean steam, compressed air, oxygen, carbon dioxide, and nitrogen.

These utilities must meet the prescribed specifications to ensure the manufacturing process isn’t compromised. Our trained analysts can perform testing on compressed air and gas systems on-site, as well as collect water samples for analysis at our state-of-the-art laboratory facility.

Microbial Identification

Microbial identification is integral to ensuring the highest quality in cGMP manufacturing. By implementing rigorous environmental monitoring programs, Alcami identifies microorganisms to the species level, helping to maintain contamination-free cleanroom environments and comply with regulatory requirements. This precise identification supports effective microbial control, ensuring the delivery of safe and compliant drug products.

MODA-EM Labeling

Alcami utilizes MODA-EM™ software for efficient and compliant environmental monitoring. This paperless system streamlines data collection, analysis, and reporting, enabling real-time monitoring and trend analysis. By integrating with laboratory equipment and inventory, MODA-EM™ enhances data integrity and ensures regulatory compliance.

Environmental Monitoring & Cleanroom Sample Collection & Analysis

After a cleanroom is qualified and certified, it’s essential to establish a routine environmental monitoring program. This program outlines the sampling types, frequencies, and trending requirements necessary to maintain cleanroom control. The effectiveness of an environmental monitoring program is measured by its ability to provide meaningful data that:

• Mitigates risk
• Proactively identifies trends
• Evaluates the effectiveness of cleaning and personnel practices

Beyond on-site sample collection, we also incubate and analyze environmental monitoring samples collected by your team. Our laboratories are equipped with advanced technology that meets strict regulatory standards, including compliance with 21 CFR part 11.

We use Met-One 3400 series units for total particle count testing, MAS-100 units for viable active air testing, and compressed gas units like Pinocchio viable air samplers for comprehensive analysis. Additionally, Drager Aerotest units are employed for hydrocarbon and moisture content analysis of compressed gas systems.

Along with routine environmental and utilities monitoring, we support personnel plating and sampling during manufacturing activities. Our team is also available to assist with remediation efforts in case of unexpected events, such as HVAC system failures, power outages, breaches of cleanroom integrity, or spills.