Why Organizations Choose ATEK Over Mesa Laboratories
Mesa Laboratories has built a 40-year reputation around sterilization process validation and biological indicators—a critical, specialized capability in pharmaceutical and healthcare manufacturing. But sterilization validation and continuous environmental monitoring are two different problems. Mesa solves one; ATEK solves the other. For regulated facilities that need both—and most do—understanding how these solutions complement each other is essential to a complete compliance strategy.
Understanding Mesa Laboratories
Founded in 1982 in Lakewood, Colorado, and trading publicly on NASDAQ (ticker: MLAB), Mesa Laboratories brings deep domain expertise in sterilization and disinfection solutions. The company generates approximately $220 million in annual revenue across divisions focused on biological indicators (steam, EtO, hydrogen peroxide gas plasma sterilization), chemical indicators, calibration solutions (through the Bios brand), and clinical genomics. Mesa’s CheckPoint devices and DryCal flow calibrators serve pharmaceutical, medical device, and hospital environments globally.
Mesa Laboratories’s recognized strengths include:
- Sterilization Process Expertise — Four decades of focused specialization in biological indicators and sterilization monitoring. FDA and international regulators accept Mesa BIs as routine sterilization validation devices, and the company’s sterilization process knowledge is deep and respected.
- Publicly Traded Financial Stability — NASDAQ listing with audited financials, established customer relationships with major hospital systems and pharma manufacturers, and dedicated R&D investment in sterilization science.
- Regulatory Acceptance — Long track record of FDA approval for biological indicator performance claims, Health Canada recognition, and international regulatory acceptance across EU, Japan, and other major markets.
Common Challenges with Mesa Laboratories
Organizations using Mesa’s sterilization validation products frequently encounter these broader operational considerations:
- Sterilization-only focus: Mesa BIs and sterilization monitoring devices validate the sterilization process itself—the kill step. But regulatory compliance requires continuous monitoring of the environment (temperature, humidity, differential pressure) in cleanrooms, pharmacies, and biotech facilities where environmental conditions matter beyond just sterilization cycles. Mesa addresses one part of the compliance picture, not the full landscape.
- Recurring consumable costs accumulate: Biological indicators are single-use consumables. High-volume sterilization facilities—hospitals with multiple autoclaves running dozens of sterilization cycles daily—incur substantial recurring BI costs. Unlike a software subscription with transparent pricing, each BI is an independent purchase, making budget forecasting challenging as volumes scale.
- No continuous environmental data: Mesa’s portfolio does not include continuous monitoring for the environment between and outside sterilization cycles. Organizations need separate systems to monitor cleanroom conditions, pharmacy environments, and temperature-controlled storage during non-sterilization operational hours.
- Support model built for validation, not operations: Mesa’s support aligns with sterilization validation protocols and BI performance questions—important but episodic. Environmental monitoring requires 24/7 operational support because temperature excursions in a pharmacy or cleanroom can occur at any time, including nights, weekends, and holidays.
How ATEK Addresses These Needs
Continuous Environmental Monitoring Complements Sterilization Validation: Mesa’s BIs validate that a sterilization cycle worked. ATEK monitors whether the environment remains suitable for the products you sterilized. Think of Mesa as the validation layer and ATEK as the operational oversight layer. For a hospital pharmacy: Mesa validates that your autoclaved medications are genuinely sterilized; ATEK ensures the pharmacy environment stays compliant with temperature and humidity requirements 24/7. For a biotech cleanroom: Mesa monitors the sterilization of equipment; ATEK monitors the continuous environmental conditions during manufacturing. Explore how ATEK supports biotech and pharma compliance.
Cloud-Native Compliance Without Consumable Overhead: Where Mesa BIs require recurring purchases—each sterilization cycle consumes a BI—ATEK’s cloud platform operates on an all-inclusive per-monitoring-point model. One rate includes wireless sensor hardware, cloud dashboard, automated reporting, calibration, validation documentation, and 24/7 support. No per-cycle consumables, no hidden line items, no budget surprises as sterilization volumes fluctuate.
A2LA-Accredited Calibration Lab in Canada: Mesa relies on external or distributor-based calibration. ATEK’s in-house A2LA-accredited calibration lab in Canada handles calibration, traceability certificates, and NIST documentation directly—included with every monitoring point. For Canadian facilities, this eliminates cross-border shipping delays and keeps calibration on-schedule without waiting for US-based lab turnaround.
24/7 Support for Operational Emergencies: Environmental excursions don’t wait for business hours. When a pharmacy temperature alarm triggers at 3 AM Eastern, Mesa’s support structure is oriented toward sterilization protocol questions during normal operations. ATEK’s Montreal-based team answers the phone in 5 minutes, 24/7/365, with environmental monitoring specialists ready to guide immediate response. Bilingual support (English and French) serves Quebec facilities without translation delays.
Side-by-Side Comparison
| Factor | Mesa Laboratories | ATEK | Advantage |
|---|---|---|---|
| Sterilization process validation | Specialized expertise | Integrated with environmental data | Mesa |
| Biological indicators | Core product line | Not offered | Mesa |
| Continuous environmental monitoring | Not offered | Purpose-built | ATEK |
| Real-time cloud dashboard | Not available | Native | ATEK |
| FDA 21 CFR Part 11 compliance | Not applicable to BIs | Native platform compliance | ATEK |
| 24/7 support response | Business hours only | 5-minute guarantee, 24/7/365 | ATEK |
| A2LA-accredited calibration | External/distributor | In-house Canada-based | ATEK |
| Bilingual support (EN/FR) | Not available | Montreal team | ATEK |
| Consumable cost model | Recurring per-cycle | All-inclusive per point | ATEK |
Who Benefits Most from Switching
- Hospitals with central sterile processing departments that already validate sterilization with Mesa BIs but need continuous monitoring of pharmacy and sterile storage environments
- Pharma manufacturers using Mesa biological indicators for sterilization validation who recognize the need for separate environmental monitoring and want to consolidate all compliance data into one platform
- Canadian biotech and pharma facilities that appreciate Mesa’s sterilization expertise but require Canadian data hosting, A2LA calibration without cross-border shipping, and local bilingual support
Making the Transition
Switching to ATEK for environmental monitoring is designed to complement your existing Mesa sterilization validation program—not replace it. The systems work in tandem:
- Assessment & Integration Planning — We evaluate your facility layout, Mesa sterilization validation schedule, critical environmental monitoring points (pharmacy, cleanroom, cold storage), and compliance documentation workflows. Most facilities continue Mesa BI protocols unchanged while adding ATEK for environmental oversight.
- Parallel Deployment — ATEK wireless sensors install in environmental monitoring locations (not in sterilization chambers—that’s still Mesa’s role). The platform begins capturing data immediately while your Mesa sterilization program operates normally.
- Compliance Mapping — ATEK’s cloud dashboard becomes the unified record of your environmental compliance. We map your existing SOP references to ATEK’s reporting and ensure audit trails satisfy FDA 21 CFR Part 11 expectations.
- Operational Handoff — Your team transitions to managing environmental monitoring through ATEK’s mobile app and dashboard. 24/7 support is available from day one. Mesa continues handling sterilization validation—your sterilization team experiences no disruption.
When Mesa Laboratories May Be the Right Fit
Mesa Laboratories remains the essential choice for sterilization process validation. If your facility requires biological indicator monitoring, steam sterilizer validation, ethylene oxide process qualification, or hydrogen peroxide gas plasma sterilization monitoring, Mesa is the appropriate partner. Their sterilization expertise is specialized and deep—it is not something ATEK replaces. Mesa should be part of your compliance strategy for the validation layer.
When ATEK Is the Better Choice
Choose ATEK when you need:
- Continuous environmental monitoring for pharmacy, cleanroom, cold storage, and other non-sterilization spaces where temperature and humidity matter 24/7
- Cloud platform compliance with FDA 21 CFR Part 11 built-in, not bolted-on, so your environmental data is audit-trail-ready
- Operational support available at 3 AM when an environmental alarm requires immediate response from someone who knows environmental compliance (not a general help desk)
- Canadian infrastructure with PIPEDA-compliant data hosting, local A2LA calibration, and bilingual support for Quebec operations
- Consolidated compliance view where sterilization validation (Mesa) and environmental monitoring (ATEK) feed into unified reporting and audit documentation
Start with a free assessment to see how continuous environmental monitoring complements your Mesa sterilization validation program.
Frequently Asked Questions
Are Mesa BIs still needed if we use ATEK for environmental monitoring?
Yes. Mesa biological indicators validate that your sterilization process kills microorganisms—the kill step. ATEK monitors whether the environment where your sterilized products are stored and used remains compliant. These are two different requirements. A properly sterilized medication that sits in a pharmacy where temperature drifts into non-compliance hasn’t achieved regulatory compliance. Mesa + ATEK together fulfill the complete compliance picture: sterilization validation plus operational environmental monitoring.
Does ATEK replace Mesa for sterilization monitoring?
No. ATEK does not offer biological indicators or sterilization process validation. Mesa’s expertise in sterilization is specialized and remains essential. ATEK adds continuous environmental monitoring alongside your existing Mesa sterilization program—they are complementary solutions, not competitive ones.
How long does it take to add ATEK if we’re already using Mesa?
Installation is typically 1-2 weeks depending on facility size. Wireless sensors deploy to environmental monitoring locations (pharmacy, cleanroom, etc.), and your team accesses the cloud dashboard within days. Your Mesa sterilization program operates unchanged throughout. Unlike major platform migrations, adding ATEK is an additive process with zero disruption to existing Mesa workflows.
Is ATEK FDA 21 CFR Part 11 compliant for environmental monitoring data?
Yes. ATEK’s cloud platform provides native FDA 21 CFR Part 11 compliance including electronic signatures, complete audit trails, ALCOA+ data integrity, and automated compliance reporting. Environmental monitoring data stored in ATEK is audit-trail-ready. Mesa BIs typically do not require Part 11 compliance (they are physical validation devices), but if you need validated records of sterilization and environment together, ATEK captures the environmental component.
Can we integrate ATEK data with Mesa’s sterilization records?
ATEK can export environmental monitoring data in formats suitable for inclusion in your quality management system alongside Mesa’s sterilization records. While the systems don’t directly integrate, your compliance team can maintain unified documentation that includes both Mesa sterilization validation and ATEK environmental data. Many facilities maintain a combined compliance dossier with records from both platforms.
What if we need ATEK’s calibration lab to calibrate Mesa’s calibration equipment?
ATEK’s A2LA-accredited calibration lab can calibrate Mesa’s calibration devices (like DryCal flow calibrators and other reference equipment). However, this is a separate service—contact our compliance team to discuss calibration of specialized equipment. Most facilities use Mesa for sterilization BI traceability and ATEK for environmental sensor calibration, which are distinct services.