USP <797> Testing and Compliance Services
Core EM Lab works with individual compounding facilities, health systems, specialty pharmacies, home infusion services providers, and certification companies across the country to perform environmental testing in cleanrooms and other designated areas. Specializing in microbial identification, Core EM Lab offers reliable, cost-effective testing with quick turnaround times. Let us help you create custom solutions for your pharmacy!
Core EM Lab provides comprehensive viable surface testing that exceeds UPS <797> requirements. We also provide viable surface testing kits for your monthly testing requirements. Please contact us for more information.
Core EM Lab provides comprehensive viable air testing that exceeds UPS <797> requirements. We also provide viable air & surface testing kits for your semi-annual testing requirements. Please contact us for more information.
Core EM Lab provides comprehensive media fill testing to help our customers fulfill UPS <797> requirements. We provide Media Fill Testing kits that are designed to assess the proficiency and accuracy of your pharmacy personnel and staff members, ensuring compliance and quality in sterile compounding practices. These include the following options with Optical Density validation testing (optional):
-USP797 Media Fill Testing - Low Risk
-USP797 Media Fill Testing - Medium Risk (Basic)
-USP797 Media Fill Testing - Medium Risk (Comprehensive)
-USP797 Media Fill Testing - High Risk
Please contact us for more information.
Core EM Lab provides comprehensive gloved fingertip testing to help our customers fulfill UPS <797> requirements. We provide Gloved Fingertip Testing kits that are designed to assess the sterility practices of your pharmacy personnel and staff members, ensuring compliance and safety in your operations. Please contact us for more information.
Core EM Lab provides multiple sample collection kits to help you meet UPS <797> requirements. Below is a list of available kits. Kits can be set to auto-ship to your location on the cadence that works for you and your team - including your certifier. All kits come with everything needed to collect your samples, including a chain of custody form, bags for each sample (help eliminate cross-contamination), and a return next-day morning delivery shipping label. Please contact us for more information.
- Monthly Surface Kits
- Semiannual Air & Surface Kits
- Media Fill Kits - Low, Med (Basic & Comprehensive), High, and Custom
- Gloved Fingertip Kits
- Custom Kits based on your needs
In need of sample media in a rush? Core EM Lab can ship your required sample media overnight morning delivery with return shipping for sample processing.
Core EM Lab uses a state-of-the-art Mass Spectrometer for identification. Bruker's MALDI Biotyper® (Matrix-Assisted Laser Desorption/Ionization Time-Of-Flight Mass Spectrometry or MALDI-TOF MS) is considered the gold standard for microorganism identification. The MALDI Biotyper® has become the worldwide leading solution for clinical microbiology, as well as for food, pharmaceutical and water testing. Results are delivered in seconds with a scaled reliability rating that exceeds 99%.
Core EM Lab has worked with pharmacy professionals across the country to develop its reporting capabilities. Our reports exceed USP <797> standards and include pictures of your incubated plates, historical trending, a detailed identification glossary, a floor plan of your space with your sample ID locations, and more. We have also developed an optional Alert Level trigger (vs just the USP Action Level) for notification, identification, and reporting. Please reach out to us and we can share a sample report with you.
Part of our process is to review and document every plate at the halfway point during incubation. This allows us to notify you if we can already see that your sample is going to exceed a customer pre-set Alert Level or the USP Action Level guidelines. Early notification allows your team to take the steps necessary to ensure compliance as quickly as possible in your compounding space.
Have you completed a documented Risk Assessment for your space? If not, let us know and we can connect you with one of our network experts to complete this vital part of the Quality Management System for your space.
All customers receive access to a free portal that provides all historical reports and other documents.
Core EM Lab has a network of experts in the pharmacy space. If you need help with anything from building a new clean room to how to systematize your CAPA process, we have our network of experts to help you achieve your goals. Please reach out to us with any needs you may have.
Industrial Hygiene
Core EM Lab offers a variety of services to industrial hygienists, as they are often responsible for assessing and controlling environmental hazards in workplaces, especially in industries like manufacturing, healthcare, and construction.
Core EM Lab offers testing for airborne contaminants like mold spores, bacteria, or chemicals. We provide air sample incubation and identification services to detect microbial contamination or particulate matter in indoor air.
Core EM Lab offers testing for surfaces in workplaces for microbial contamination or chemical residues, particularly in settings like healthcare facilities, clean rooms, or industrial production environments.
Core EM Lab offers testing to assess the quality of water systems in workplaces for potential microbial growth (e.g., Legionella testing), including incubation and growth identification for waterborne pathogens.
Core EM Lab uses a state-of-the-art Mass Spectrometer for identification. Bruker's MALDI Biotyper® (Matrix-Assisted Laser Desorption/Ionization Time-Of-Flight Mass Spectrometry or MALDI-TOF MS) is considered the gold standard for microorganism identification. The MALDI Biotyper® has become the worldwide leading solution for clinical microbiology, as well as for food, pharmaceutical and water testing. Results are delivered in seconds with a scaled reliability rating that exceeds 99%.
Core EM Lab works with you to ensure workplaces are compliant with OSHA and EPA regulations regarding exposure limits for pathogens or environmental contaminants. We assist in documenting microbial contamination levels for compliance reporting.
Core EM Lab partners with industrial hygienists to offer periodic environmental testing (air, water, and surfaces) to help prevent occupational health issues by identifying hazardous biological agents early.
Beverage Industry
At Core EM Lab, we provide comprehensive environmental testing solutions for breweries, distilleries, and non-alcoholic beverage producers. Our services ensure product safety and regulatory compliance, including microbiological testing to prevent contamination and nutritional analysis for labeling. From fermentation monitoring to final product testing, we help you optimize processes and maintain consistency. Whether verifying alcohol content or assessing shelf-life, our expert team and advanced technology give you the data needed to deliver safe, high-quality beverages.
Microbiological method used to estimate the total number of viable aerobic bacteria present in a sample.
- Coliform Testing: Detects the presence of coliform bacteria, indicating potential fecal contamination.
- E. coli and Salmonella and Listeria Testing: Ensures the beverage is free from these harmful pathogens.
- Yeast and Mold Testing: Common for beverages susceptible to fermentation and spoilage.
- Total Plate Count (TPC): Measures overall microbial load.
- Testing for Saccharomyces cerevisiae (STA+):Testing for STA+ strains of Saccharomyces cerevisiae is crucial for optimizing fermentation processes in the beverage industry, ensuring product quality, and maintaining consistency. We provide Phenotypic Testing (Fermentation of Starch-based Media) + Iodine staining and MALDI-TOF-MS- Microbe Identification.
- Testing for Brettanomyces (Brett) Species: Brettanomyces (often referred to as Brett) species such as Brettanomyces bruxellensis, Brettanomyces claussenii, and others are often involved in spontaneous or mixed fermentation in certain beer styles (e.g., lambics, gueuze) but are considered spoilage organisms in other styles. MALDI-TOF-MS- Microbe Identification.
- Yeast and Mold Testing: Common for beverages susceptible to fermentation and spoilage.
- E. coli and Salmonella and Listeria Testing: Ensures the beverage is free from these harmful pathogens.
- Total Plate Count (TPC): Measures overall microbial load.
Measures acidity, which is important for flavor, preservation, and safety.
- pH Testing: Measures acidity of the water.
- Coliform Testing: Detects the presence of coliform bacteria, indicating potential fecal contamination.
- E. coli and Salmonella and Listeria Testing: Ensures the beverage is free from these harmful pathogens.
- Yeast and Mold Testing: Common for beverages susceptible to fermentation and spoilage.
- Total Plate Count (TPC): Measures overall microbial load.
- Coliform Testing: Detects the presence of coliform bacteria, indicating potential fecal contamination.
- E. coli and Salmonella and Listeria Testing: Ensures the beverage is free from these harmful pathogens.
- Yeast and Mold Testing: Common for beverages susceptible to fermentation and spoilage.
Customized EM Services
At Core EM Lab, we understand that every industry and facility has unique environmental monitoring needs. That’s why we offer fully customizable environmental monitoring (EM) solutions, tailored to fit your specific operational and regulatory requirements. Our team will work with you to design and implement a monitoring plan that addresses your critical control points, ensuring compliance and promoting safety. With advanced technologies and a flexible approach, Core EM Lab provides the tools you need to maintain clean, safe, and compliant environments.
