Precision-Driven Cleanroom Certification & Consulting
Accurate, Reliable Compliance, and Professional Testing Built on a Robust Background in Pharmacy Sterile Compounding.
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About Us
At Florida Cleanroom Certification & Consulting Services (FCCCS), we believe that cleanroom compliance shouldn’t be a guessing game. Founded on a robust, specialized background in pharmacy sterile compounding, FCCCS was built to bridge the critical gap between technical engineering standards and practical, day-to-day pharmacy workflows.
We don’t just look at the machinery; we understand exactly what happens inside the cleanroom. Our deep clinical roots give us a unique perspective on the operational challenges facilities face when striving to meet rigid USP <797>, USP <800>, and cGMP regulations. We know that behind every piece of precision-driven data we collect is a patient relying on a safe, sterile product.
Why Us?
We don’t just test cleanrooms; we understand what happens inside them. With deep roots in pharmacy sterile compounding, our team brings unique insights into USP <797>, USP <800>, and cGMP compliance. We bridge the gap between engineering standards and practical pharmacy workflow to ensure ultimate patient safety.
Services
Sterile compounding and cleanroom services
01.Cleanroom Testing & Certification
Comprehensive environmental monitoring, HEPA filter integrity testing, and viable/non-viable particle counting compliant with ISO standards.
02.USP <797> & USP <800> Compliance Consulting
At FCCCS, our Compliance Consulting service provides tailored solutions to ensure your pharmacy practices meet the standards for sterile compounding and hazardous drug handling. Our experienced consultants work closely with your team to implement best practices, improve safety protocols, and streamline compliance processes, safeguarding patients and staff. Partner with us to enhance the quality and safety of your pharmaceutical services, ensuring regulatory alignment and operational excellence.
03.Facility Design & Engineering Support
Expert guidance on cleanroom layouts, HVAC requirements, and material finishes to ensure your build is both durable and compliant from day one.
04.Pharmacy Staff Training, Testing, and Competencies
Professional, hands-on training for aseptic technique, garbing, and cleanroom behavior to minimize contamination risks.
05.Viable and Non-viable testing
At FCCCS, we specialize in Viable and Non-viable testing to determine the quality and safety of your products. Our professional team utilizes state-of-the-art techniques to identify microbial presence in viable samples and ensure compliance through thorough non-viable assessments. Trust us for reliable results that help your local business maintain high standards and enhance customer confidence.
06.Create facilities Standard Operating Procedures
At FCCCS, we specialize in creating tailored Standard Operating Procedures (SOPs) that ensure compliance with USP 797 and USP 800 regulations. Our expert team collaborates with local businesses to establish safe and efficient practices that enhance operational integrity and patient safety. Trust us to deliver comprehensive SOPs that align with your facilities' unique needs and uphold the highest industry standards.
Testimonials
Client Review
FCCCS brought an incredible level of clinical insight to our recent USP <797> gap analysis. Because of their extensive background in sterile compounding, they didn't just point out compliance issues—they gave us practical, workflow-friendly solutions that made our upcoming state board inspection seamless.
Cleanroom Certification Process for Facilities Across the Southeast
Accurate, Reliable Compliance, and Professional Testing Built on a Robust Background in Pharmacy Sterile Compounding.