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The pharmaceutical industry demands absolute precision, unwavering compliance, and uncompromising quality assurance. At International Process Solutions, we proudly delivered a full-spectrum setup and calibration solution for a leading pharmaceutical laboratory, ensuring their facility met and exceeded industry standards from day one. Our team of experts executed every phase of the project—from equipment installation to GMP-compliant calibration—with unmatched attention to detail and adherence to FDA and ISO requirements.
Our involvement began with a strategic consultation to align on the lab’s operational requirements, compliance mandates, and performance goals. Working in collaboration with project managers and quality teams, we designed and implemented a turnkey equipment setup, incorporating critical pharmaceutical lab instrumentation and systems, including:
Each piece of equipment was installed with meticulous precision, in accordance with manufacturer specifications and pharmaceutical environmental guidelines. Our technicians ensured proper spatial alignment, electrical connectivity, and environmental controls were fully optimized to support validated performance.
Post-installation, we conducted a complete calibration of all installed instrumentation. Utilizing NIST-traceable standards, our technicians ensured that every device functioned within acceptable tolerances, delivering accurate and reliable readings critical for pharmaceutical production and research.
All data was logged into the laboratory’s quality management system (QMS) to maintain audit-ready documentation and ensure traceability for future regulatory inspections.
A major component of the project included cleanroom calibration services, essential for maintaining USP <797>, USP <800>, and ISO Class 5–8 cleanroom classifications. We installed and calibrated a continuous environmental monitoring system (EMS) integrated with:
Through our integration, the lab achieved automated real-time alerts, compliance with 21 CFR Part 11, and ongoing data acquisition that supports cGMP practices and FDA readiness.
International Process Solutions provided a full installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) protocol for every critical system deployed. These qualifications were meticulously executed, documented, and approved by quality assurance teams, enabling the client to achieve:
We developed customized validation protocols specific to the client’s applications, utilizing a risk-based approach aligned with ISPE GAMP 5 guidance.
Our team performed the entire setup and calibration process on-site, allowing for immediate system verification and minimal operational disruption. Using mobile calibration labs and portable metrology equipment, we delivered the same precision and reliability as off-site services while eliminating shipping delays or environmental exposure.
We calibrated a full range of lab instrumentation, including:
Each calibration was verified for linearity, accuracy, repeatability, and responsiveness across the full operational range of each device.
All calibration and validation data was securely captured using digitally validated systems, ensuring data integrity, ALCOA+ compliance, and 21 CFR Part 11 compatibility. Our processes supported:
These measures empower the client to remain inspection-ready at all times and ensure that all quality data meets or exceeds global regulatory expectations.
Beyond setup and calibration, we implemented a custom preventive maintenance and re-calibration schedule aligned with the lab’s operational cycles and risk profiles. This schedule includes:
By offering multi-year service contracts, International Process Solutions ensures uninterrupted compliance and optimal equipment performance well into the future.
Our team has decades of experience supporting pharmaceutical manufacturing, R&D laboratories, clinical trial labs, and sterile compounding facilities. For this project, we brought in specialists certified in:
We combine technical proficiency with regulatory expertise, offering our clients unmatched confidence in every installation and calibration we perform.
The result of this full-scale project was a fully operational, inspection-ready pharmaceutical laboratory, launched on schedule and with zero deviation. Thanks to our integrated approach, the lab was able to:
This seamless execution allowed the client to meet critical deadlines, optimize productivity, and maintain an unwavering commitment to product quality and patient safety.
At International Process Solutions, we don’t just calibrate instruments—we engineer confidence. Whether you’re launching a new lab, expanding facilities, or upgrading systems, our turnkey setup and calibration services are tailored to your environment, regulatory framework, and business objectives.
Partner with us to ensure your pharmaceutical operations are precise, compliant, and built to perform.
Contact our team today to schedule a consultation and discover how International Process Solutions can elevate your laboratory infrastructure.
Email, call, fax, or fill out our form – whatever works best for you. We’re here to serve, and to help. Reach out now – we’d love nothing more than to connect.
Southern California Calibration Services
tel: 310-432-0665
Northern California Calibration Services
tel: 650-595-7890
fax: 650-595-7899
About International Process Solutions
The story behind the formation of IPS.
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