Pharmacy500 Marketplace

Environmental Monitoring & Compliance

Leading Providers of Pharmacy Environmental Monitoring, Pharmacy Contamination Monitoring, Cleanroom Air Quality, Sterile Environment...

Aisle OVERVIEW

Controlled environment monitoring and validation refers to the systematic processes used to ensure that controlled environments within a pharmacy consistently meet the required standards for air quality, temperature, humidity, and contamination levels. These processes are critical for maintaining compliance with regulatory guidelines, such as USP <797> and USP <800>, and for safeguarding the integrity of compounded medications and the safety of personnel and patients. Monitoring and validation of controlled environments are essential for ensuring the sterility, safety, and efficacy of compounded medications and maintaining a safe working environment for pharmacy personnel.

Company Profiles

Environmental Monitoring by Primex

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OneVue Sense Environmental Monitoring by Primex is an enterprise-level automated monitoring solution that equips even the most complex, multilocation healthcare facilities with medical-grade devices and easy-to-use, flexible software. From onboarding through post-implementation, we focus on helping organizations improve efficiency, standardize operations, mitigate risks, and meet compliance requirements. Scalable to fit any-sized facility or hospital pharmacy, OneVue Sense provides real-time alerts for out-of-range conditions via text message, phone call, or email — giving you time to take corrective action. Plus, you’ll get access to the web-based OneVue Software platform to review historical data, manage monitored assets, and generate on-demand reports — invaluable during audit situations to prove compliance. The OneVue Sense portfolio offers an array of environmental monitoring solutions, including temperature, indoor air quality, differential pressure, water leak, and contact closure sensors. OneVue Sense features everything you need to proficiently manage environmental monitoring and compliance across your multilocation healthcare facility.

Particle Measuring Systems

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Protect Your Cleanroom. Strengthen Compliance.

Contamination Monitoring Solutions for 503A & 503B Facilities

For compounding pharmacies and outsourcing facilities, contamination control isn’t optional—it’s essential to patient safety, regulatory compliance, and operational efficiency.

Particle Measuring Systems (PMS) helps 503A and 503B facilities take control of their cleanroom environments with complete, integrated contamination monitoring solutions that support cGMP and USP <797> compliance.


Built for the Realities of Compounding Pharmacies

Whether you’re managing a single cleanroom or scaling a 503B operation, PMS solutions are designed to help you:

  • Maintain sterile compounding environments
  • Meet USP <797> environmental monitoring requirements
  • Support cGMP inspection readiness
  • Reduce risk of contamination events and batch loss
  • Simplify documentation for audits

Complete Environmental Monitoring—All from One Partner

PMS delivers end-to-end solutions for contamination control:

  • Particle monitoring (non-viable)
  • Microbial monitoring (viable)
  • Environmental monitoring systems (EMS)
  • Data management & compliance software

One integrated system, designed to support your entire environmental monitoring program


Particle Monitoring: Stay in Control of Air Quality

Airborne particles are the first indicator of risk in your cleanroom.

PMS particle monitoring solutions include:

  • Portable particle counters for:
    • Clean Room certification
    • Routine sampling
    • Investigations
  • Continuous particle monitoring for:
    • ISO 5 / critical areas
    • Real-time alerts and trending

What this means for your pharmacy:

  • Quickly identify contamination issues
  • Maintain ISO classifications required by USP <797>
  • Confidently document air quality for inspections

Microbial Monitoring: Verify Sterility Assurance

USP <797> requires ongoing evaluation of microbial contamination risk.

PMS microbial solutions include:

  • Portable microbial air samplers for routine EM programs
  • Remote/continuous samplers for critical environments

Key benefits:

  • Capture viable organisms accurately
  • Support trending and root-cause analysis
  • Strengthen sterility assurance programs

Continuous + Portable Monitoring = Smarter Compliance

Modern regulatory expectations are shifting toward continuous monitoring and data trending.

PMS supports both approaches:

  • Portable monitoring
    • Flexible, easy to deploy
    • Ideal for routine compliance sampling
  • Continuous monitoring
    • Real-time visibility into critical operations
    • Immediate detection of excursions
    • Supports proactive contamination control

Combine both to align with risk-based monitoring strategies


Environmental Monitoring Systems (EMS)

Move beyond disconnected data and manual tracking.

PMS EMS solutions provide:

  • Centralized monitoring across your facility
  • Real-time alarms for out-of-spec conditions
  • Automated data collection and reporting
  • Scalable systems—from small pharmacies to large 503Bs

Integrates with:

  • LIMS and internal reporting systems
  • Isolators and controlled environments
  • Facility automation platforms

Data Management Built for Audits

Documentation and data integrity are critical for compliance.

PMS software solutions help you:

  • Automate environmental monitoring records
  • Maintain 21 CFR Part 11-compliant data integrity
  • Generate audit-ready reports instantly
  • Reduce manual errors and paperwork

Result:

  • Faster batch release decisions
  • Reduced compliance risk
  • Confidence during inspections

Designed to Support cGMP & USP <797>

PMS solutions are trusted by compounding pharmacies to:

  • Monitor viable and non-viable contamination
  • Maintain controlled, ISO-classified environments
  • Ensure traceable, compliant data
  • Support continuous improvement in EM programs

Helping you meet cGMP expectations, including USP <797>, with confidence


Why Pharmacies Choose PMS

  • Proven expertise in sterile environments
  • Solutions designed specifically for compounding workflows
  • Flexible systems that grow with your facility
  • One partner for monitoring, data, and compliance

Take Control of Your Environmental Monitoring Program

Reduce risk. Simplify compliance. Protect patients.

Connect with a PMS expert to evaluate your current monitoring strategy and identify opportunities to strengthen compliance.

Health Care Logistics
Temperature Monitoring

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Temperature Monitoring

Find practical, proven solutions for Temperature Monitoring and management.
From medical-grade data loggers, temperature recorders and thermometers to portable refrigerators, medication warmers and more, HCL offers virtually everything imaginable to protect and secure temperature-sensitive medications throughout your facility.

Enjoy wireless convenience to recorded temperature information with DataPad, a handheld touch screen device that allows users of EL-USB data loggers to download data and view results on the spot. This convenient temperature monitoring tool eliminates the need to remove the logger from the refrigerator or freezer and take it to a computer to retrieve information. It also allows the full setup of loggers and configuration of units directly from the field.

Refrigerator Locking Boxes keep supplies safe and secure and enable users to control access to temperature sensitive drugs while keeping them stored at a regulated temperature. Achieve an additional layer of protection for refrigerated meds with Lockable Thermostat Covers that help control thermostat settings so only authorized personnel have access.

Visit our site to learn more about our full inventory of Temperature Monitoring solutions. If you don’t find what you’re looking for, our talented team of product experts is ready to help!

Rees Scientific

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At Rees, we understand the critical importance of maintaining precise environmental conditions for the success of pharmaceutical research, development, and manufacturing. Our Environmental Monitoring Systems meticulously oversee temperature, humidity, differential pressure, and other critical parameters across various storage conditions crucial for preserving sensitive materials. Tailored for stability chambers, room environments, refrigerators, freezers, and more, Rees plays a pivotal role in safeguarding the integrity of vaccines, medications, and sensitive research.

By using a Rees Environmental Monitoring System, organizations can ensure that they are following the best practices, minimizing risk, and upholding the highest standards of quality assurance. Rees’s advanced monitoring technologies provide real-time alerts and detailed audit trails, enabling Quality Assurance (QA) and Quality Control (QC) professionals to maintain stringent quality standards and adhere to regulatory requirements effortlessly. This level of control and documentation is crucial for navigating the complex regulatory landscape and upholding the highest standards of product quality and safety.

Our regional service teams are strategically positioned to offer localized support, ensuring that facilities have access to timely, expert assistance wherever they are located. This regional approach allows us to provide personalized service that understands and addresses the specific needs and challenges of each organization.

Furthermore, our comprehensive CQV offerings are designed to ensure that your environmental monitoring system is fully compliant with industry regulations. From installation qualification (IQ) to operational qualification (OQ) and performance qualification (PQ), our CQV services are thorough, covering every aspect of system performance to guarantee compliance with cGMP, GxP, ASHP, USP <800> and other regulatory standards. This process not only affirms the reliability and accuracy of your monitoring system but also prepares your facility to meet regulatory inspections with confidence.

As a testament to our commitment to excellence and reliability, Rees is proudly accredited under the ISO 9001 & 17025 standards. These accreditations reflect our ongoing dedication to continually refine our policies, procedures, and protocols. Such dedication ensures our systems are aligned with the latest regulatory requirements and best practices in today’s ever-evolving, highly regulated industries.
Rees is dedicated to empowering the pharmaceutical industry with EMS solutions that address the unique challenges and requirements of this dynamic field. Our dedication to precision, reliability, and compliance support makes us an invaluable partner to professionals worldwide.

Pharmacy500

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The Pharmacy500 is awarded to 500 pharmacy supply chain businesses and associations that significantly impacted dispensing pharmacies in the U.S. over the past year.

Pharmacy500 Benefits

The following are complimentary benefits extended to Pharmacy500 companies and associations (coming this spring!)

  1. Company listings in the Platinum Pages Buyer’s Guide, 20Ways publications, and RXinsider website
  2. Company inclusion in the 20Ways themed Buyer’s Guide
  3. Unlimited job postings in the Pharmacy500 Career Center *Unlimited through 2025
  4. Tradeshow promotional resources including Pharmacy500 floor stickers and lanyards
  5. Two posts (annually) in RXinsider’s Pharmacy Market BUZZ news feed

Who are the Pharmacy500 and what are the selection criteria?

The Pharmacy500 includes:

  1. Companies within the Pharmacy Supply Chain
  2. National Pharmacy Trade Associations

The Pharmacy500 Selection Committee applies the following criteria to determine the list of 500:

  • Offers and actively markets at least one product or service to dispensing pharmacies
  • Dispensing pharmacies comprise at least 25% of their customer base
  • Has an estimated annual revenue exceeding $500,000
  • Has five or more full-time employees, and has been in business for more than two years
  • Has a national presence
  • Exhibited at one of the following national conferences in the previous year: APhA; ASCP Annual Meeting & Exhibition; Asembia’s Summit; ASHP Midyear Clinical Meetings & Exhibition; Cardinal Health RBC; McKesson ideaShare; NACDS Total Store Expo; NASP Annual Meeting & Expo; NCPA Annual Convention and Expo; Pharmacy Futures (ASHP Summer); ThoughtSpot.

The following supply chain segments are critical to pharmacy operations and patient care, but are excluded from the Pharmacy500 simply due to volume:

  • Manufacturers and Merchandisers of Pharmaceuticals
  • Manufacturers and Merchandisers of Devices and OTC Products
  • Colleges of Pharmacy
  • State Associations
  • Government Agencies and State Boards of Pharmacy
  • Pharmacy Fraternities & Sororities
  • Dispensing Pharmacies, Health Systems, Chains, Payors, and PBMs

Product Highlight SHOWCASE

Subject Matter Expert & Thought Leader PROFILES

Owner/Microbiologist, Pure Microbiology

Abby Roth, founder of Pure Microbiology, has over 18 years of experience in supporting the testing and consulting needs of the pharmaceutical, medical device, and compounding industries. Her background in pharmaceutical microbiology includes extensive knowledge of environmental monitoring. Abby served as a USP Compounding EC member during the 2015-2020 cycle. She is an involved member of the Controlled Environment Testing Association (CETA), serving on the Board of Directors, speaking at its annual meetings, and chairing committees for the revision of four CETA Application Guides. Abby has been invited to speak for state boards of pharmacy and for national organizations.

Diane Gates

President, CenPharma, LLC

President and Principal Consultant at CenPharma, I’m a quality and validation leader with 20+ years in biologics, advanced therapies, and combination products. I’ve built and led teams of up to 40, driven global QA functions across multi-site operations, and stewarded clients through inspection readiness, remediation, and commercial scale-up. My expertise spans cGMP quality systems, supplier management, CAPA, batch release, and Annex 1 environmental programs, alongside process, cleaning, aseptic, method, and computer systems validation (including MES). I’ve guided tech transfers, scale-up, and comparability strategies for NDA/BLA support, grounding decisions in ASTM E2500, ISPE guidance, and FDA Process Validation principles. MS ChE (NC State); BS ChE, magna cum laude (Virginia Tech).

Resources & Awareness

The Pharmacy500 are the pharmacy operations supply chain businesses and associations that significantly impacted dispensing pharmacies over the past year. This report analyzes the Pharmacy500 logos and their visual elements to provide insight into branding trends.

The 2026 Pharmacy500 Companies Market Teardown report provides a concise snapshot of the 2026 companies, highlighting new additions, examining regional distributions, practice settings, supply chain categories, and key conferences attended.

RXinsider’s Pharmacy500 Careers Outlook report identifies key employment trends and workforce dynamics across Pharmacy500 companies. Check out this report to learn more about open position trends and the current state of the job market impacting the pharmacy supply chain!

Fortune Magazine’s annual Fortune 500 ranks the largest U.S. companies by revenue. Many leaders in healthcare and pharmaceuticals drive medication production, distribution, and patient access. This report highlights their impact on the pharmacy industry.

Eagle is an FDA-registered CGMP testing provider offering laboratory testing and validation support, including sterility testing and method validation, expert consulting for GAP audits and facility design, and cleanroom certifications. To learn more, visit the 20Ways Winter Hospital publication.

ISO-MED streamlines procurement with tailored supply plans, e-commerce ordering, and a range of testing and compounding supplies, including environmental monitoring tools, media fill kits, PPE, sterile compounding materials, and hazardous drug handling solutions. To learn more, visit the 20Ways Winter Hospital publication.

QI Medical supports compounding pharmacies with cost-effective, disposable USP <71> compliant testing products designed for aseptic validation, environmental monitoring, and sterility testing. To learn more, visit the 20Ways Winter Hospital publication.

In this case study, we take a look at how Dameron Hospital utilized Rees Scientific’s Zigbee Wireless and WiFi continuous monitoring system to automate temperature tracking, ensure regulatory compliance, and protect valuable medications and vaccines through data-driven environmental monitoring.

The Pharmacy500 Academy by RXinsider delivers in-depth training focused on environmental monitoring and environmental compliance, featuring detailed product comparisons and company insights. Visit the Pharmacy500 Academy to expand your expertise in contamination control.

Pharmacy500

CONTAMINATION CONTROL

Accu-Chart Plus Health Care Systems
Acute Care Pharmaceuticals (Hospeco Brands Group)
AirCare Automation
AirClean Systems
Allied Pharmacy Products
ARL Bio Pharma
Associates of Cape Cod, Inc
B. Braun Medical Inc.
BA Sciences
Baxter
Berkshire Corporation
Blue Thunder Technologies
Bureau Veritas
Cardinal Health
CenPharma LLC
Charles River Laboratories
ChemoGLO
CINTAS Corporation
Cleanetics
Cleanroom Connection
Contec, Inc.
DiNovo Cleanroom Supplies and Packaging Solutions
Dycem
Eagle Analytical Services
Ecolab
EMSL Analytical, Inc.
Esco
Eurofins Analytics
FG Clean Wipes
Fresenius Kabi Group
Germfree
Grifols
Hampshire Controls Corp.
Hardy Diagnostics
Health Care Logistics, Inc.
Infinity Laboratories
Integrated Medical Systems, Inc. (IMS)
InTemp Monitoring Solutions
International Medical Industries
Interphex
ISO-MED, Inc. (Hospeco Brands Group)
IsoTech Pharma
Labconco
Lakeland Industries, Inc.
LGM Pharma
Loop Robots
Maxpert Medical
Medi-Dose, Inc./EPS, Inc.
Medical Technology Associates, LLC
Medisca Inc.
MediZap
Modular Cleanrooms, Inc.
Modular Devices
NuAire, Inc.
Pace®
Parasol Medical, LLC
Particle Measuring Systems, Inc.
PCCA
Perfex Corporation
Pharmetric Laboratory
Primex Inc.
Prompt Praxis Laboratories
ProPharma Cleanrooms
Prudential Cleanroom Services
Q.I. Medical Inc
QleanAir Scandinavia
Quality Solutions
Quva
Rees Scientific
Shepard Medical Products | CareMates
Spectrum Pharmacy Products
Technical Safety Services
Teknipure
Texwipe (ITW)
The Baker Company
Total Pharmacy Supply, Inc.
Total-Shield PLUS (McGowan Industries, Inc.)
Travis CleanAir, Inc.
U.S. Micro-Solutions, Inc.
Unite Medical
Veltek Associates, Inc.
Vileda Professional
West Pharmaceutical Services, Inc.
Winfield Laboratories, Inc.
WorkingBuildings
Zebra Technologies Corp.

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