Allometrics provides monthly surface sampling services that meet USP 797, 800, 825, and other environmental monitoring requirements for a variety of facilities. With over 50 years of experience serving regulated environments, we deliver the environmental monitoring and laboratory analysis that quality assurance managers depend on for regulatory compliance.
We offer both onsite collection by certified technicians and self-collection programs—allowing you to choose the approach that best fits your operations and locations. Both options include expert laboratory analysis with detailed CFU count reports for your environmental monitoring documentation.
Our technical support team guides you through sampling locations, timing requirements, and proper collection procedures throughout the process. The documented results provide objective evidence during state board inspections, accreditation surveys, and internal quality reviews that your environmental monitoring program maintains contamination control as designed.
Monthly Surface Sampling Requirements
Monthly surface sampling detects viable microbial contamination on surfaces throughout classified compounding areas. This environmental monitoring verifies your contamination control measures function effectively where standard visual inspection cannot identify potential sterility risks.
Sampling locations include:
- Equipment contained within primary engineering controls (PECs)
- Direct compounding areas (DCA) and staging zones near the PEC
- Frequently touched surfaces including door handles, counters, and equipment controls
- Pass-through chambers connecting classified areas
- ISO Class 5, 7, and 8 environments based on your facility classification
Samples are collected at the end of compounding activities or shifts, before cleaning and disinfection occurs. This timing captures actual contamination from use rather than post-cleaning conditions, providing accurate assessment of your environmental controls during operations.
Frequency requirements:
- Category 1 and 2 CSPs: Monthly surface sampling minimum
- Category 3 CSPs: Weekly surface sampling, plus end-of-batch sampling within the PEC
Surface sampling must also be conducted in the direct compounding area during media-fill testing to assess aseptic manipulation competency. Allometrics provides media-fill kits and glove fingertip sampling for facilities needing competency evaluation documentation.
Facilities We Serve with Monthly Surface Sampling
Compounding Pharmacies: Independent retail pharmacies, regional compounding centers, and hospital-based facilities preparing patient-specific sterile formulations under USP 797. Our monthly surface sampling provides the environmental monitoring documentation state boards and accreditation surveyors expect during compliance reviews. [1]
Hospital Pharmacy Cleanrooms: Community and academic medical centers managing sterile compounding operations need consistent monitoring that integrates with existing quality protocols. Our flexible delivery options—self-collection kits or onsite visits—accommodate patient care workflows while maintaining Joint Commission readiness.
Radiopharmacies: Nuclear medicine facilities operating under USP 825 face unique challenges sampling within hot cells and lead-shielded work areas. [2] Our technicians understand these specialized environments and provide contact plate solutions that accommodate radioactive material handling protocols and time-sensitive compounding operations.
Oncology Infusion Centers: Cancer treatment facilities preparing chemotherapy and immunotherapy doses under USP 800 requirements need documented surface sampling of containment primary engineering controls. Our sampling programs support both routine monitoring and deviation investigations for hazardous drug preparation areas.
Home Infusion Providers: Companies preparing IV medications, total parenteral nutrition, and complex infusion therapies for home administration benefit from our nationwide service network and self-collection kit options that accommodate production schedules across multiple preparation facilities.
Sterile Manufacturing Facilities: Outsourcing facilities (503B) operating under cGMP requirements use our surface sampling services for routine environmental monitoring, deviation investigations, and validation studies with laboratory analysis meeting FDA documentation expectations.
We also serve academic medical centers, veterinary compounding facilities, and other regulated operations where monthly surface sampling supports contamination control programs. [3] Our 50 years of experience includes facilities across pharmaceutical and healthcare sectors nationwide.
Why Facilities Choose Allometrics for Monthly Surface Sampling
Over 50 years serving regulated pharmaceutical environments gives us depth of knowledge that newer laboratories cannot match. Since 1976, we’ve focused on precision measurement and certification services for compounding pharmacies and cleanroom facilities—providing expertise specifically aligned with your environmental monitoring requirements.
Documentation that withstands regulatory scrutiny: Our laboratory analysis follows documented procedures producing detailed CFU count reports in the format state boards, FDA inspectors, and accreditation surveyors expect. Our quality management system ensures consistent processes from sample collection through final reporting.
Technical support when you need it: Our team understands USP compliance pressures and guides you through sampling location selection, timing requirements, and proper collection procedures. When questions arise during audits or internal reviews, you have access to professionals who can explain methodology and results.
Nationwide service with flexible delivery: Whether you operate a single-location independent pharmacy or manage sterile preparation across multiple facilities, we provide consistent service quality. Choose between onsite collection by certified technicians or self-collection programs—both designed to accommodate your operational needs and minimize workflow disruption.
Order Your Monthly Sampline 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!
Understanding Monthly Surface Sampling Requirements
What is Monthly Surface Sampling?
Monthly surface sampling detects viable microbial contamination on surfaces throughout classified compounding areas. Collected samples undergo laboratory incubation allowing any captured microorganisms to grow into visible colonies counted and reported as colony-forming units (CFU).
USP 797 requires facilities compounding Category 1 and Category 2 sterile preparations to perform surface sampling at least monthly. Facilities preparing Category 3 preparations must conduct surface sampling weekly, plus end-of-batch sampling within the PEC. Sampling must occur at the end of compounding activities, before cleaning and disinfection.
Benefits of Consistent Monthly Surface Sampling
Regular surface sampling provides verification your contamination control measures function effectively during operations:
Compliance documentation:
- Objective evidence meeting USP 797, 800, 825 and other environmental monitoring requirements
- Documented results that satisfy state board inspectors and accreditation surveyors
- CFU count records supporting internal quality reviews and management oversight
Operational insights:
- Early detection of cleaning protocol failures before contamination affects preparations
- Identification of high-touch surfaces requiring enhanced disinfection attention
- Baseline data supporting investigations when out-of-specification results occur
Self-collection programs provide added benefit of staff education—when personnel perform their own sampling, they develop stronger awareness of contamination sources and proper cleaning protocols.
Risks of Neglecting Monthly Surface Sampling
Missing required surface sampling creates compliance gaps that cannot be corrected retroactively. State boards reviewing environmental monitoring records will identify missing monthly sampling periods as documentation failures requiring corrective action and mandatory compliance plans.
Beyond regulatory consequences, inadequate surface sampling leaves contamination undetected between cleaning cycles. Equipment surfaces and frequently touched areas can harbor microorganisms compromising preparation sterility without visible evidence—potentially affecting multiple compounding sessions before detection through failed media fills or patient infections.
Professional liability insurance and accreditation status depend on documented environmental monitoring compliance. Gaps in monitoring records can trigger coverage reviews or accreditation restrictions affecting your ability to operate.
Schedule Your Monthly Surface Sampling Program
Call (281) 474-3329 to discuss your facility’s surface sampling requirements with our specialists. We’ll recommend the service delivery model that fits your operations—onsite technician collection or self-collection kits with comprehensive training—and coordinate your first sampling cycle.
Prefer email? Contact us with your facility information and we’ll respond within one business day with program details and pricing for both service options.
Getting started is straightforward:
- We help identify sampling locations based on your classified areas and equipment layout
- You choose onsite collection visits or self-collection kit delivery
- For self-collection, we provide comprehensive training on proper technique and timing
- Samples go to our A2LA-accredited laboratory for analysis
- You receive detailed CFU count reports for your environmental monitoring documentation
Monthly surface sampling documentation matters during your next inspection. State boards and accreditation surveyors expect consistent environmental monitoring records. Establish your program now rather than scrambling to address compliance gaps when audit notices arrive.
Ready to meet your USP surface sampling requirements? Contact Allometrics today.