USP 797 requires objective verification of aseptic technique—and gloved fingertip sampling provides the documented proof that compounding personnel maintain proper sterile practices. Since 1976, we’ve helped thousands of compounding facilities pass state board inspections with testing services designed specifically for the demands of pharmaceutical quality management.
Our gloved fingertip sampling services deliver exactly what inspectors require—no guesswork, no documentation gaps. Whether you’re conducting initial competency assessments, routine monthly monitoring, or preparing for state board inspections, we make testing straightforward. Choose convenient kits shipped directly to your facility, or schedule onsite sample collection by our trained technicians. Either way, you receive fast results, detailed reports, and documentation formatted for audit readiness.
We serve compounding pharmacies, hospital sterile compounding operations, and radiopharmacies nationwide—helping you demonstrate compliance with measurable data rather than assumptions about technique.
Gloved Fingertip Sampling for USP Compliance
Gloved fingertip sampling verifies that compounding personnel maintain proper garbing competency prior to compounding. This testing is required for initial competency evaluation, media fill challenges, and ongoing quality assurance—making it a cornerstone of regulatory compliance, like USP 797 for compounding facilities and USP 825 for radiopharmacies. [1] [2]
What We Provide:
- Ready-to-use contact plates with appropriate growth media for viable microbial count determination
- Clear sampling instructions ensuring consistent technique across all personnel
- Results log sheets that simplify documentation and trending over time
- Fast turnaround times so you can address concerns immediately and maintain uninterrupted operations
Testing Applications:
- Initial personnel competency qualification (pass requirements before independent compounding)
- Media fill challenge test verification (required per USP 797)
- Routine re-evaluation at prescribed intervals
- Random end-of-day technique monitoring
- Investigation of suspected contamination events
Our sampling solutions work for facilities of any size—whether you’re testing a single pharmacist or an entire cleanroom team across multiple shifts.
Media Fill-Kits for Complete Aseptic Technique Verification
While gloved fingertip sampling monitors personnel personnel garbing competency, media fill-kits verify the entire aseptic process from start to finish. We recommend combining both services for the most thorough compliance program—and many facilities order them together for convenient monthly monitoring.
Our Media Fill-Kits Include:
- Risk-level specific options: Low, medium, and high-risk procedure kits tailored to your compounding activities
- Self-contained testing components: Everything arrives ready to use—no assembly or preparation required
- Step-by-step instructions: Clear guidance ensures consistent execution across different shifts and personnel
- Results documentation: Pre-formatted log sheets make record-keeping simple and audit-ready
Why facilities combine media fill-kits with glove fingertip sampling:
- Addresses multiple competency requirements in one monitoring cycle
- Creates a complete picture of contamination risk in your cleanroom environment
- Simplifies ordering and scheduling when bundled together
Together, these services help you demonstrate that your processes, your equipment, and your people are maintaining the sterile conditions your patients depend on.
Order Gloved Fingertip Sampling 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!
Monthly Sampling Programs That Simplify Compliance
Compliance isn’t a one-time event—it’s an ongoing commitment. Our monthly sampling programs take the administrative burden off your shoulders while ensuring you never miss a required monitoring cycle.
Choose From Two Convenient Monthly Service Options:
Direct-Ship Monthly Kits:
- Kits arrive at your facility on your preferred schedule
- Your team collects samples at convenient times
- Return samples to our lab using provided prepaid shipping
- Receive detailed results and trending reports
- Maintain full control over sampling timing
Onsite Collection Service:
- Our trained technicians visit your facility
- We handle all sample collection according to USP guidelines
- Scheduled at times that minimize disruption to your operations
- Immediate professional answers to sampling questions
- Perfect for facilities with limited staff availability
Monthly Sampling Program Benefits:
- Predictable compliance: Never worry about missing a monitoring cycle or falling behind on requirements
- Simplified budgeting: Consistent monthly costs make planning easier for finance teams
- Expert partnership: Build a relationship with technicians who understand your specific facility and needs
Whether you choose kits or onsite service, you’ll receive the same quality results, detailed reporting, and expert support that compounding pharmacies have trusted since 1976.
Facilities That Rely on Glove Fingertip Sampling for USP Compliance
Compounding Pharmacies: Independent and hospital-based compounding pharmacies face rigorous USP 797 requirements. Our sampling services provide the objective competency documentation state boards expect during inspections, helping you address deficiencies and maintain compliance between audits.
Hospital Pharmacy Cleanrooms: Hospital pharmacies managing high-volume sterile compounding need consistent monitoring that fits within patient care workflows. Our programs integrate with your quality protocols, providing documentation for Joint Commission readiness and internal reviews.
Sterile Manufacturing Facilities: cGMP environments require extensive personnel qualification protocols. Our GFTS services support your routine monitoring schedules, competency assessments, and deviation investigations with data that meets regulatory expectations.
Radiopharmacies: Time-sensitive radioactive drug preparation demands efficient testing. Our technicians understand your operational constraints and provide sampling solutions that accommodate the unique challenges of radiopharmaceutical compounding.
Academic Medical Centers: University hospital pharmacies balancing teaching, research, and patient care need flexible sampling that accommodates rotating staff while maintaining quality standards. Our programs adapt to your educational mission without compromising compliance.
No matter your facility type, we bring the same commitment to accuracy, fast turnaround, and expert support that has made us a trusted partner across the pharmaceutical industry.
Why Pharmaceutical Quality Managers Choose Allometrics for Glove Fingertip Sampling
When regulatory compliance determines whether you can continue operations, you need a testing partner with proven reliability and pharmaceutical expertise.
Five Decades of Pharmaceutical Service
Since 1976, we’ve supported quality programs at thousands of compounding facilities nationwide. That longevity represents consistent service through multiple regulatory updates, evolving USP standards, and countless successful inspections. We’ve helped facilities adapt to every major guideline change—we’ll help you navigate the next one.
Nationwide Service Consistency
From coast to coast, we deliver the same quality and responsiveness at every location. Multi-site operations choose us specifically because we eliminate the complexity of coordinating different vendors across different states. One partner, consistent methodology, unified documentation.
A2LA ISO 17025 Accredited Organization
Our laboratory holds A2LA ISO 17025 accreditation for calibration services, demonstrating our commitment to rigorous quality management systems across all service lines. When you work with an accredited organization, you work with a team that understands documentation, traceability, and quality at the highest technical level.
Expert Technical Support When You Need It
Our experienced staff provides guidance on sampling technique, result interpretation, and compliance strategy. When unexpected results appear or inspection questions arise, you get real answers from pharmaceutical quality professionals—not generic call center responses.
Audit-Ready Documentation
Our detailed reports include everything inspectors expect: sampling dates, locations, results, trends, and deviations from acceptance criteria. We format documentation to support your quality management system, not create extra administrative work.
Glove Fingertip Sampling Requirements and Why It Matters
What is Glove Fingertip Sampling?
Glove fingertip sampling measures viable microbial contamination on personnel gloves. Personnel press their gloved fingertips onto specialized agar contact plates, which are then incubated to reveal any captured microorganisms as visible colonies counted in colony-forming units (CFU).
Testing is performed for:
- Initial competency qualification – Personnel must pass multiple consecutive tests before compounding independently
- Media fill challenges – Required verification per USP 797 during simulated procedures
- Routine re-evaluation – Prescribed intervals to verify continued competency
- Random monitoring – End-of-day or periodic sampling for ongoing technique assessment
Results are evaluated against your facility’s established acceptance criteria, revealing whether hand movements or technique breaks are introducing contamination—allowing you to address training needs before issues reach patients.
Benefits of Regular Glove Fingertip Sampling
Verify Personnel Competency Regular testing provides objective proof that personnel maintain proper aseptic technique. You get measurable data showing training translated into consistent performance, not just assumptions based on observation.
Identify Training Needs Early When results exceed acceptance criteria, you can intervene with targeted retraining before contamination reaches patients. Data pinpoints which personnel need coaching and which techniques require reinforcement.
Demonstrate Regulatory Compliance Documented monthly sampling exceeds minimum requirements and shows regulators your proactive commitment to quality. You enter inspections with confidence, not anxiety about documentation gaps.
Support Quality Improvement Trending results over time reveals patterns—like increased contamination during busy periods—that drive meaningful process improvements and reduce overall contamination risk.
Protect Patient Safety Every compounded preparation enters vulnerable patient sites. Regular sampling helps ensure your greatest contamination risk—human technique—stays under control.
Risks of Neglecting Glove Fingertip Sampling
Regulatory Non-Compliance Multiple guidelines require personnel qualification through glove fingertip sampling. Facilities without proper documentation face inspection deficiencies, operational suspensions, and enforcement actions. [3]
Failed Inspections Inadequate sampling documentation frequently results in immediate operational restrictions until deficiencies are corrected—stopping your compounding operations and leaving patients without needed medications.
Undetected Contamination Without routine testing, poor technique can continue for months unnoticed, potentially affecting numerous patients before visible problems appear.
Increased Liability If contamination causes patient harm and investigation reveals missing required testing, your legal position becomes indefensible and insurance coverage may be limited.
Staff Competency Gaps Without objective data, you’re assuming technique remains adequate based on initial training alone. Skills drift over time—regular sampling catches issues while they’re small and correctable.
Get Started with Glove Fingertip Sampling Services Today
Proactive glove fingertip sampling protects patients and prevents audit findings. Whether you need monthly kits shipped direct or prefer onsite collection by our technicians, we’ll have you running your first sampling cycle within days.
Choose From Two Convenient Service Options:
- Monthly kits: Shipped to your facility with prepaid return labels
- Onsite collection: Our technicians handle sampling at your convenience
Nationwide service: Supporting compounding facilities across all 50 states since 1976
What’s included: Contact plates, detailed instructions, results analysis, audit-ready documentation, and expert technical support throughout the process.
Ready to strengthen your compliance program?
Call (281) 474-3329 or visit us at
1425 Atlantis Dr Suite B, Webster, TX 77598
Serving pharmaceutical quality professionals nationwide since 1976.