Our convenient, ready-to-use media fill-kits help facilities maintain USP 797, USP 800, and USP 825 compliance with the audit-ready documentation regulators demand. Since 1976, we’ve delivered cleanroom certification and testing solutions to pharmaceutical operations.
Each kit includes sterile growth media, detailed instructions with visual diagrams, and results logging sheets. Choose between self-collection kits shipped directly to your facility or schedule our experienced technicians for onsite sample collection, reducing your staff’s workload and allowing them to focus on production. Either option delivers results backed by our 50+ years of cleanroom certification and sampling expertise.
Our kits validate low-risk, medium-risk, and high-risk procedures, helping you demonstrate personnel competency, identify contamination risks before they impact patients, and maintain defensible documentation needed during state board inspections and accreditation surveys.
Media Fill-Kit Solutions for Every Risk Level
USP 797 and 800 Requirements
USP 797 requires media fill testing to validate personnel competency in aseptic technique for sterile compounding operations. USP 800, which governs hazardous drug handling, references USP 797 sampling requirements when sterile hazardous drugs are prepared.
USP 825 Requirements for Radiopharmaceuticals
USP 825 establishes separate aseptic qualification requirements for radiopharmaceutical preparation. Personnel must demonstrate competency through media fill testing and gloved fingertip sampling initially and at defined requalification intervals.
Each Media Fill Testing Kit Contains:
- Sterile growth media in appropriate containers
- Step-by-step instructions with visual diagrams
- Results documentation and logging sheets
- Chain of custody forms
We incubate samples under controlled conditions, examine for microbial growth, and provide clear pass/fail results with detailed observations.
Glove Fingertip Sampling for Personnel Monitoring
USP 797 requires glove fingertip sampling at initial competency evaluation and with each media fill challenge test. Our contact plates provide a convenient method for monitoring microbial burden on compounding personnel’s gloved hands during actual sterile preparation activities.
Personnel sample their gloved fingertips onto the contact plate surface during or immediately after compounding. We incubate the samples and provide results with organism identification when growth occurs, and deliver pass/fail determinations based on established acceptance criteria.
Most facilities combine fingertip sampling with media fill testing during the same validation session. We provide coordinated kits that include both testing components, simplifying your compliance workflow.
Monthly Sampling Program
USP 797 and 800 require regular personnel validation between initial competency assessments. Our monthly programs provide scheduled kit shipments that arrive automatically each month, ensuring consistent compliance documentation without managing reorders.
Monthly shipments include:
- Media fill-kits for ongoing aseptic technique validation
- Glove fingertip sampling plates for personnel monitoring
- All instructions, documentation forms, and prepaid return shipping
We provide monthly summary reports with pass/fail determinations and trending analysis, ready for your quality assurance reviews. This regular testing identifies technique degradation early, allowing corrective action before regulatory findings or patient safety events.
Choose self-collection kits or schedule our technicians for monthly onsite visits. Both options deliver identical analysis quality and audit-ready documentation while accommodating your operational calendar.
Order Your Media Fill-Kits Today
Call or email us today; to learn more about how we can help you remain compliant with current USP 797 and USP 800 guidelines. Our expert technicians are available to answer your questions.
Keep your company safe!
Industries We Support with Media Fill-Kit Testing
Compounding Pharmacies – Independent community pharmacies, regional compounding centers, and pharmacy chains preparing low-risk through high-risk hazardous drug preparations. [1]
Hospital Pharmacy Operations – Community hospitals and academic medical centers producing sterile preparations for patient care, from limited volumes to hundreds of CSPs daily.
Radiopharmacies – Nuclear medicine facilities compounding within hot cells and lead-shielded areas under strict time constraints while maintaining sterility.
Oncology Infusion Centers – Facilities preparing chemotherapy and immunotherapy infusions requiring validated aseptic technique during dose preparation and IV bag compounding.
Home Infusion Providers – Healthcare companies preparing IV medications, total parenteral nutrition, and infusion therapies for home administration.
We also support cleanroom manufacturers, research institutions, veterinary compounding facilities, and other regulated operations where sterile preparation and contamination control are mandatory. Our 50-year history includes thousands of validations across diverse pharmaceutical and healthcare sectors.
Why Laboratories Choose Allometrics for Media Fill Testing
Specialized Cleanroom Certification Expertise
We are one of few A2LA ISO 17025 accredited laboratories providing both calibration services and cleanroom environmental testing. Our highly-trained technicians also hold certifications for biological safety cabinet testing, chemical fume hood testing, and USP 797/800 cleanroom certification. This specialized expertise means your media fill testing comes from professionals who understand controlled environments, not just general microbiological testing.
A2LA Accreditation Provides Regulatory Credibility
Our ISO/IEC 17025:2017 accreditation through A2LA demonstrates independent verification of our technical competence, measurement traceability, and quality systems. This third-party validation provides objective evidence that we, your testing partner, holds itself to the highest standards not only in cleanroom applications but in instrument calibration as well.
50+ Years Serving Pharmaceutical Operations
Since 1976, we have supported regulated facilities through evolving USP standards and FDA guidance. This experience includes cleanroom certifications and validation testing across pharmaceutical compounding, hospital sterile preparation, and healthcare cleanroom operations. [2]
Nationwide Service with Consistent Documentation
We serve facilities throughout the United States, helping multi-site organizations standardize testing and documentation across their networks. Whether you operate one location or dozens, you receive consistent technical support, analysis quality, and regulatory compliance documentation.
Key Facts About Media Fill Testing and Environmental Monitoring
What is Media Fill Testing?
Media fill testing simulates actual sterile compounding using microbiological growth medium instead of drug products. Personnel simulate actual compounding procedures, performing the same manipulations and using the same equipment as during routine operations. After completing the simulated preparation, media-filled containers return to our laboratory for incubation.
If microorganisms were introduced during compounding, they multiply and become visible as cloudiness or particulates. Clear media after appropriate incubation indicates proper aseptic technique was maintained.
This directly validates human performance under actual working conditions rather than relying on written tests or observed behavior during evaluation. Testing validates aseptic technique across low-risk, medium-risk, and high-risk procedures. [3]
Benefits of Validation and Risks of Neglecting Testing
Regulatory Compliance and Audit Defense
Media fill results provide objective evidence that withstands state board inspections, FDA investigations, and accreditation surveys. This documentation proves technical competence far better than training records alone. Facilities lacking validation programs face citations, fines, operational restrictions, and potential license suspension.
Patient Safety and Liability Protection
Regular testing identifies technique deficiencies before contaminated preparations reach patients. Without validation, undetected contamination risks serious infections, treatment failures, or deaths. Historical media fill records demonstrate appropriate quality programs during contamination investigations, insurance claims, or legal proceedings. Professional liability insurers increasingly require documented validation as coverage prerequisites.
Operational Confidence and Market Position
Successful testing validates that environmental controls, cleaning procedures, and personnel training function as intended. Hospital systems and healthcare organizations scrutinize compounding pharmacy quality programs—robust validation wins contracts while inadequate testing loses business to competitors demonstrating commitment to patient safety.
Order Your Media Fill-Kits Today
Maintain USP 797/800/825 compliance with media fill-kits from an A2LA accredited laboratory. We provide complete testing solutions for low, medium, and high-risk procedures with the documentation quality your audits demand.
Two convenient service options:
- Order self-contained kits shipped directly to your facility, complete with instructions, collection materials, and prepaid laboratory return shipping.
- Schedule our experienced technicians for onsite sample collection, reducing your internal resource requirements while maintaining compliance.
Nationwide service coverage supports single locations and multi-site organizations. Our technical support team answers questions throughout your testing cycle, interprets results, and helps you maintain audit-ready documentation.
Contact Allometrics to discuss your media fill testing needs:
Call (281) 474-3329 or email us to speak with a pharmaceutical compliance specialist. We help you select appropriate testing frequencies, establish sampling protocols, and maintain the validation programs regulators expect.