Welcome to Star Micro Labs – Experts in Microbiology & Envir

Star Micro Labs delivers robust environmental monitoring programs tailored for GMP-regulated cleanrooms, laboratories, and controlled environments. Our services include routine surface sampling, air monitoring, and personnel monitoring, with customized sampling plans designed around your facility’s layout and regulatory requirements. All incubation is performed in-house to ensure accuracy, providing precise colony-forming unit (CFU) counts, action level trending, and deviation analysis. Each monitoring program is supported by detailed, audit-ready reports that help maintain FDA, USP <797>/<800>, and ISO 14644 compliance while strengthening contamination control and process reliability.

When contamination occurs, rapid and accurate microbial identification is essential for maintaining GMP compliance and facility operations. Star Micro Labs provides comprehensive microbial ID services for both bacterial and fungal isolates, including gram staining, morphology analysis, and advanced identification techniques. These tools help pinpoint contamination sources, support root cause investigations, and guide corrective actions. Our experienced microbiologists deliver timely data, detailed reports, and expert insights—ensuring your cleanroom, laboratory, or controlled environment remains compliant, audit-ready, and fully operational. By combining scientific precision with regulatory expertise, we provide the clarity and confidence needed to safeguard your processes and products.

Through our trusted partners, Star Micro Labs offers cleanroom certification services designed to meet ISO 14644 and GMP regulatory standards. These services include non-viable particulate testing, HEPA filter integrity testing, airflow visualization (smoke studies), room recovery rate assessments, and pressure differential monitoring. Whether certifying a new cleanroom or maintaining an existing classified environment, our partner-led validation reports are comprehensive, audit-ready, and fully compliant—ensuring your facility consistently meets specifications from ISO Class 3 to ISO Class 8. By collaborating with industry-leading partners, we provide seamless service delivery backed by the same scientific expertise, quality systems, and compliance-driven approach that define Star Micro Labs.

Star Micro Labs provides flexible short- and long-term rental options for validated environmental monitoring equipment, offering scalable solutions for GMP-regulated facilities, cleanrooms, and laboratories. Available rental units include SAS air samplers for viable airborne microbial testing and non-viable particle counters for ISO-classified cleanroom validation. Each unit is fully calibrated to industry standards and supplied with up-to-date certification documentation to meet audit and regulatory requirements. In addition, we offer temperature-controlled RODAC plate delivery, ensuring sterile media integrity and immediate readiness for field use. To maximize success, every rental includes optional on-site or remote training covering equipment setup, proper sampling techniques, data interpretation, and regulatory considerations. Whether supplementing routine monitoring or supporting a specialized validation project, Star Micro Labs delivers the tools, training, and confidence you need to execute environmental testing with precision and compliance.

Star Micro Labs provides comprehensive sterilization validation support through biological indicator (BI) incubation and reporting services. We work with a wide range of BIs—including Geobacillus stearothermophilus and Bacillus atrophaeus—to verify the effectiveness of sterilization processes such as autoclaving, vaporized hydrogen peroxide (VHP), and ethylene oxide (EtO). Our controlled incubation protocols deliver accurate, reproducible results with detailed, audit-ready reports that strengthen GMP documentation and regulatory compliance. Beyond biological indicators, we also provide chemical indicator (CI) evaluation, guiding clients in the selection, application, and interpretation of Class 1 through Class 6 indicators to confirm exposure conditions during sterilization cycles. Whether validating cleanroom sterilizers or monitoring routine cycles, Star Micro Labs delivers the data, expertise, and confidence needed to maintain contamination control and meet compliance requirements.

At Star Micro Labs, we provide specialized training and consulting services to strengthen your team’s expertise and ensure your facility meets stringent regulatory requirements. Our training programs include GMP compliance, environmental monitoring, contamination control, cleanroom behavior, and microbiology fundamentals—delivered through hands-on instruction, mock cleanroom simulations, and SOP-driven modules customized to your operations. In addition, our consulting services support facilities navigating regulatory challenges, validation projects, or contamination events, offering expert strategies that improve compliance and process reliability. Whether you are developing a new monitoring program, optimizing quality systems, or preparing for an FDA or ISO audit, our experienced consultants deliver practical guidance and compliant solutions tailored to your facility.