A lab built around your compliance.
Core QC Labs is an environmental monitoring laboratory in Harrisburg, Pennsylvania. We partner with compounding pharmacies, health systems and manufacturers to make microbial testing fast, reliable and genuinely useful.
Make the invisible accountable.
Specializing in microbial identification, Core QC Lab offers reliable, cost-effective testing with quick turnaround times for individual compounding facilities, health systems, specialty pharmacies, home-infusion providers and certification companies across the country.
We don't just hand back a number. We identify the organism, map where it came from, trend it over time, and help you create custom solutions for your pharmacy.
Gold-standard ID
Bruker MALDI Biotyper® mass spectrometry for genus & species.
21 CFR Part 11
Compliant electronic records and reporting.
Free portal access
Historical reports, certificates and trending for every client.
PJLA accredited
Independently accredited testing you can rely on.
Compendial testing
Growth promotion, sterility, bioburden, microbial limits and stability.
ISO/IEC 17025:2017 Accredited.
Achieving accreditation is a rigorous, thorough process that demands dedication and precision. As a lab established in 2023, we committed ourselves to the highest standards — and we are proud to be ISO/IEC 17025:2017 Accredited as of Nov 1, 2024 through the Perry Johnson Laboratory Accreditation (PJLA).
FDA Applicant.
Core QC Labs has submitted its FDA establishment registration and is operating to cGMP and Good Documentation Practice while the application is processed. Your data is generated to the same standard either way — under our ISO/IEC 17025:2017 scope, with 21 CFR Part 11 compliant records.
Establishment registration submitted — FEI pending. We say applicant rather than registered because the establishment identifier has not been issued yet — when FDA issues it, this page will carry the number so you can verify it yourself.
Three things we never compromise on.
Accuracy first
MALDI-TOF identification and accredited methods — results you can defend in an audit.
Speed that matters
7-day standard turnaround, overnight media delivery, and early growth alerts.
Partnership
Custom plans, a network of cleanroom experts, and support beyond the report.