Compounding Pharmacies
Transform your sterile compounding compliance with comprehensive environmental monitoring that puts patient safety first. Our expert services streamline USP 797 requirements while freeing your staff to focus on core compounding activities. Backed by specialized expertise and full-service monitoring, we deliver the quality assurance you need.
What are Compounding Pharmacies at Element?
Sterile compounding facilities require rigorous environmental monitoring and testing to maintain safety and compliance with USP standards and state pharmacy board requirements. At Element, we provide comprehensive monitoring services, from air and surface sampling to sterility testing, supporting both 503A sterile compounders and 503B outsourcing facilities with expert guidance and reliable results.
What Can Element Offer You For Compounding Pharmacies?
Products and materials we test
Products and materials we test
Our accredited laboratory services cover all critical aspects of sterile compounding environments, from air quality and surface contamination to personnel hygiene monitoring and finished product testing. We support both human and veterinary compounding facilities with comprehensive environmental and product analysis, delivering results you can trust for informed decision-making.
Key tests offered
Key tests offered
We deliver a complete range of testing services essential for maintaining sterile compounding compliance and quality. Our ISO 17025-accredited testing capabilities include environmental monitoring, sterility testing, and endotoxin analysis, providing you with reliable data to support your quality control program and meet the requirements of your state pharmacy board and regulatory auditing bodies.
Our comprehensive testing services include:
- USP <71> Sterility testing via Membrane Filtration or Direct Inoculation
- USP <85> Kinetic Chromogenic and Turbidimetric endotoxin testing
- Total airborne particle sampling
- Viable air and surface monitoring
- Media-fill testing
- Gloved fingertip and thumb sampling
Sterility & Endotoxin Testing:
If you’re compounding under Category 2 or Category 3 and/or meet the conditions to require product testing, we can offer USP <71> Sterility testing via Membrane Filtration or Direct Inoculation. For endotoxin testing, we offer USP <85> Kinetic Chromogenic and Turbidimetric methods.
Methods and solutions offered
Methods and solutions offered
Our comprehensive approach combines expert technical support with full-service monitoring solutions. We provide technical assistance in establishing an Environmental Monitoring plan, perform sample collection, offer remediation assistance, and provide data trending services to deliver end-to-end support that helps maintain your facility's compliance and operational efficiency. We provide:
- Full-service on-site environmental monitoring
- Aseptic Manipulation Competency assessment
- Hand Hygiene and Garbing Competency evaluation
- EM Performance Qualification services
- Cleanroom certification
- Investigational sampling
- Electronic Certificates of Analysis
Our range of related services:
- Full service on-site EM from gown-qualified and train technicians:
- Aseptic Manipulation Competency
- Hand Hygiene and Garbing Competency
- Total Airborne Particle Sampling
- Viable air and surface sampling
- Investigational sampling
- EM Performance Qualification (PQ) services (where applicable)
- Cleanroom certification via our third-party partner
- ISO 17025 accredited microbiology services:
- Incubation, enumeration, and genus-level identification
- Growth promotion testing of media
- USP <1072> Disinfectant Efficacy Testing (where applicable)
- USP <71> Sterility Testing (where applicable)
- Electronic Certificates of Analysis
Which labs offer this service
Which labs offer this service
Our team operates from Life Sciences hubs across the world, providing global access to our expert capabilities. Find your nearest Life Sciences hub on our Locations Page.
Technical expertise that drives results
Technical expertise that drives results
Our team of specialized microbiologists provides ongoing technical support, helping you establish effective monitoring plans, address contamination issues, and maintain regulatory compliance. This expertise, combined with our comprehensive testing capabilities, delivers the support you need to optimize your sterile compounding operations and focus on your core competency: patient care.
Standards we test to and products we test
- USP <797>
- USP <71>
- USP <85>
- USP <1072>
- ISO 17025
- Environmental air samples
- Surface samples
- Personnel monitoring samples
- Sterile compounds
- Growth media
- Disinfectant efficacy (where applicable)
- Media growth promotion
- Aseptic technique validation materials
Your Challenges, Our Solutions
Compliance excellence achieved
Resources optimized; efficiency maximized
Quality control strengthened; risks minimized
Technical expertise delivered; solutions implemented
Why Choose Element
Industry-leading expertise
Comprehensive solutions
Dedicated support
Cost-effective partnership
But don't just take our word for it
See what others want to say about partnering with Element
Explore our global network of labs and find your nearest location
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