GMP contract testing laboratory · Allentown, Pennsylvania
Confidence in Every Result.
Microbiological and analytical testing, sterility, endotoxin, environmental monitoring, and water-system support for pharmaceutical, biotechnology, compounding, and medical-device teams.
Explore PlumGxP
Your next step starts here.
Find a test, see the science, or get ready to work with us. These tools put the next step within reach.
Find your test
Explore testing options by sample, service, or the question you need answered.
Tell us what you need
Select the services you’re interested in and send your request to our team.
See our technology
Explore the instruments and testing platforms behind our laboratory services.
Follow your sample
Walk through submission to reporting, with portal previews and real equipment videos.
Work with us
Meet the culture behind the science and join our future opportunities list.
Access your portal
Sign in to submit samples, follow testing progress, and access your reports.
Request PlumGxP documents
Start gathering the laboratory information your Quality team needs to qualify PlumGxP.
Inside the PlumGxP facility
Explore dedicated laboratory spaces, biometric access controls, and whole-facility generator backup that help protect your samples and testing.
Talk directly to a scientist
Schedule a meeting to discuss your testing needs, technical questions, or next project.
Find the testing you need.
Search by test, regulation, application, or program need — or start with what you’re trying to accomplish.
Microbial Identification
Autof MS 1000 MALDI-ToF
Rapid identification supporting environmental monitoring, contamination investigations, and routine quality control. Protein fingerprint matching supports efficient identification of prepared microbial isolates.
View Microbial Identification →Microbial Identification
MicroSEQ® DNA Sequencing
Sequence-based identification of bacteria, yeast, and mold. Curated reference libraries support routine identification and help resolve challenging or inconclusive isolates.
View Microbial Identification →Bacterial Endotoxin Testing
Sievers Eclipse & CRL Endosafe® PTS
Sensitive quantitative testing for raw materials, water, components, and finished products. Microfluidic and cartridge-based technologies support efficient testing across different sample volumes.
View Endotoxin Testing →Traditional Sterility Testing
Sartorius Sterisart® Universal Gen 4
Compendial sterility testing supporting final release of sterile products and components. Closed-system membrane filtration and direct inoculation options are selected according to product suitability.
Explore Traditional Sterility Testing →Rapid Sterility Testing
SCANRDI® Solid-Phase Cytometry
Non-growth-based microbial detection supporting validated sterility and product-release programs. Fluorescent labeling and laser scanning can detect viable organisms, including stressed and viable but non-culturable cells.
Explore SCANRDI Rapid Sterility Testing →Rapid Sterility Testing
Celsis Advance II™ & Celsis Adapt™
Growth-based rapid microbial testing supporting validated sterility and release programs. Amplified ATP bioluminescence detects contamination after enrichment, with sample concentration and interference removal for challenging matrices.
Explore Celsis Rapid Sterility Testing →Cleanroom Environmental Monitoring
Interscience Scan® 300
Viable and nonviable monitoring supporting routine cleanroom control, trending, and investigations. Automated, image-backed colony counting supports consistent enumeration of suitable plates with analyst review.
View Routine EM →Environmental Monitoring Performance Qualification — EMPQ
Interscience Scan® 300
Qualification support for new, modified, and requalified cleanrooms—from study planning and sampling to incubation, identification, and reporting. Image-backed automated colony counting supports reliable enumeration.
View EMPQ →Compressed Gas Testing
Compressed Gas Sampling System
Onsite testing of compressed air and process gases for microbial contamination, particulates, moisture, and oil, as applicable. Controlled pressure and flow support representative microbial sampling.
View Facility & Utility Testing →Aseptic Process Testing & Media Fills
Aseptic Process Simulation
Microbiological support for aseptic process simulations, including incubation, growth-promotion testing, environmental monitoring, and investigation support.
View Media-Fill Support →Gowning Validation & Verification
Personnel Monitoring & Surface Sampling
Personnel qualification, monitoring, and training support for aseptic gowning programs. Sampling helps evaluate gowning technique and contamination-control practices.
View Aseptic Process Support →Disinfectant Efficacy Testing
Surface Challenge & Recovery Studies
Evaluate disinfectants and sporicides against relevant microorganisms on representative facility surfaces. Studies support selection of agents, contact times, and cleaning-program conditions.
View Validation Support →Cleaning Validation & Verification
Sievers M9 TOC Analyzer
Testing and method validation supporting equipment cleaning programs. Total organic carbon analysis helps assess organic residues in suitable rinse and swab extracts.
View Cleaning Validation →Water System Testing & Qualification
Sievers M9 TOC Analyzer
Microbiological and chemical testing for water-system qualification and routine monitoring, including TOC, conductivity, pH, and endotoxins. Automated vial handling supports efficient TOC and conductivity analysis.
View Water-System Testing →Microbial Limits & Product Bioburden Testing
Dedicated Testing Suite for Nonsterile Products
Microbial enumeration, specified-organism testing, and method suitability for raw materials, nonsterile products, and in-process samples. Sample manipulations are performed within ISO Class 5 biological safety cabinets.
View Microbial Limits →Medical-Device Bioburden Testing
Enumeration & Recovery Validation
Microbial enumeration and recovery-efficiency studies supporting medical-device bioburden assessment, sterilization validation, and routine program control.
View Product Testing →Antimicrobial Effectiveness Testing
USP <51> Preservative Challenge
Challenge testing to evaluate preservative effectiveness in applicable formulations. Programs assess microbial reduction and control over the specified test period.
View Product Testing →Biological Indicator Analysis
Growth Detection & Population Verification
Biological indicator testing supporting sterilization-process studies and routine monitoring. Services include growth-based analysis and population verification, as appropriate to the indicator and program.
View Facility & Utility Testing →Not finding exactly what you need?
Testing programs do not always fit neatly into a test name. Start with the problem and we’ll help determine the right approach.
Talk to a Scientist →Start with the question, not the test.
Tell us what you’re trying to release, qualify, investigate, or validate. We’ll help determine the most practical testing strategy.
The complete overview
Take our capabilities with you.
A concise reference to PlumGxP testing, qualification, and onsite support.
Qualification concierge
Give Quality a clearer path to yes.
Build a tailored laboratory qualification request, identify the documents your quality unit needs, and connect directly with the right PlumGxP contact.
A laboratory relationship, redesigned
The result is only one part of the answer.
PlumGxP is built around the decisions that laboratory data must support. That means direct access to people who understand the work, flexible service models, controlled execution, and context that helps quality teams act with confidence.
Every sample tells a story.
We look beyond a number to the method, sample, process, environment, organism, trend, and decision connected to it.
See how we think →Scientists closer to the conversation.
Responsive access, thoughtful project coordination, and a laboratory partner that can adapt its level of support as your internal capability changes.
Explore the client experience →Support where the work happens.
Sampling, materials, equipment, transport, incubation, analysis, identification, reporting, and training can be combined around your program.
See flexible EM support →Designed for defensible work.
Quality systems, controlled documentation, traceability, and scientific review support the integrity of every result.
Review quality & compliance →Beyond the result
Because results are only part of the story.
Real-time sample tracking, responsive communication, and direct access to scientific experts connect the sample to the process, the result to the risk, and the data to the decision.
Confidence through partnership
Every laboratory generates results. The best build confidence.
Thoughtful scientific review and clear context help your team understand what a result means and decide what comes next.
The experience behind the result
One culture. Two experiences.
How scientists experience their workplace shapes how clients experience their laboratory. Explore both sides of the PlumGxP model.
Supported scientists do better science.
A collaborative workplace gives people the time, tools, trust, and voice to think critically—not simply move samples through a queue.
PlumGxP
Regulatory credentials & industry affiliations
Our registrations, local licensing, accreditation progress, and professional affiliations reflect a commitment to compliant operations, technical competence, and active engagement with the life-sciences community.
FDA Registered Laboratory
Registered with the U.S. Food and Drug Administration as a drug establishment supporting regulated laboratory testing.
Licensed in Allentown
Licensed to operate in Hanover Township and connected to the regional business community through the Greater Lehigh Valley Chamber of Commerce.
Life Sciences Pennsylvania
Member of Pennsylvania’s pharmaceutical, biotechnology, medical-device, and broader life-sciences community.
Industry Engagement
Team participation in PDA and ISPE supports continued learning in microbiology, sterile manufacturing, facilities, and quality systems.
DEA Controlled Substances
DEA controlled-substance registration for Schedules I–V early Q4 2026
ISO/IEC 17025:2017
Perry Johnson Laboratory Accreditation, Inc. (PJLA), Q4 2026.
View PJLA Pending Accreditation Letter (PDF) ↗Registration and authorization scope is limited to the activities and locations shown in applicable official records. Relevant documentation is available through the Qualification Concierge.
Bring us the test, the challenge, or the question behind it.
Tell PlumGxP what needs to move forward. We will help identify the right scientific service and a practical next step.