Utility Testing & Qualification

Ensuring Compliance, Reliability, and Readiness for GMP Environments

In regulated pharmaceutical and biotech environments, the facility environment and the utilities that serve them are the backbone of product quality and patient safety. Every system, from purified water and clean steam to compressed gases, must perform consistently within defined parameters. At Gillson Sciences, we offer comprehensive utility testing, qualification, and ongoing monitoring services that meet the standards of the FDA, EMA, USP, and ISO.

Our team supports clients through every phase of utility qualification, from installation verification (IQ) to operational and performance qualification (OQ/PQ). Ensuring systems are not only compliant but optimized for long-term reliability. Using validated analytical methods and GMP-trained field specialists, we help pharmaceutical manufacturers, CDMOs, and medical device organizations maintain confidence in their clean utilities and environmental systems.

Whether you are commissioning a new facility, expanding production, or preparing for inspection, our data-driven approach and industry expertise help you demonstrate control, compliance, and readiness so your utilities perform as cleanly and dependably as your science demands.

Qualification & Verification Services

At Gillson Sciences, our Steam Quality Testing services are designed to ensure your clean steam systems meet regulatory expectations for pharmaceutical-grade applications. Our team performs comprehensive analyses of clean steam and includes testing for non-condensable gases, dryness, Superheat, as well as purity testing for conductivity, resistivity, nitrate, pH, endotoxin, microbial and TOC to verify that your steam system delivers clean steam every time.

Our GMP-qualified field specialists perform testing onsite at your facility using calibrated instrumentation and methods aligned with global regulatory standards. Each assessment includes detailed documentation suitable for IQ/OQ/PQ and audit support, ensuring your utilities meet the highest standards and withstand any inspection.

With precise data, defensible reports, and decades of experience supporting sterile manufacturing environments, Gillson Sciences helps you confirm that your steam systems are performing as designed, safely, efficiently, and in compliance.

In pharmaceutical manufacturing, water is a regulated raw material, not just a utility. From Purified Water (PW) and Water for Injection (WFI) to Highly Purified Water (HPW) and clean steam condensate, every grade must meet defined microbial, chemical, and endotoxin specifications to protect product quality and patient safety.

At Gillson Sciences, we provide end to end pharmaceutical water system qualification and Verification Testing in accordance with USP <1231>, USP <643>, USP <645>, USP <85>, and EP/JP/ISO standards. Our comprehensive program supports all phases of your system lifecycle, including Operational and Performance Qualification (OQ/PQ), ensuring each point of use consistently delivers compliant water.

Our team performs routine sampling, trending, and system verification for all USP and EUPh grade water.

Using calibrated instrumentation and validated analytical methods, we evaluate

Heterotrophic plate counts (TAMC, TCYM) and screens for specified organisms- USP <1231>, USP <61> & <62>

  • Total Organic Carbon Testing (TOC) USP <643> JP, EUPh
  • Bacterial Endotoxin Testing (BET) USP <85>
  • Screen for Fluorescent Pseudomonad Group and Coliforms
  • Nitrate Testing EUPh
  • Conductivity USP <645> All Stages
  • Resistivity
  • pH

providing traceable documentation suitable for regulatory submission or audit defense.

Recovery Efficiency Testing is required on the first microbial sample. Water testing supplies can be provided by Gillson Sciences.

With deep GMP expertise and rapid, defensible reporting, Gillson Sciences ensures your water systems perform as designed, pure, reliable, and compliant across every use point

Compressed gases play a vital role across pharmaceutical, biotech, and medical device manufacturing, from supporting aseptic filling operations to driving instrumentation and environmental controls. Because these gases often come into direct or indirect contact with products, components, or cleanroom environments, their purity and microbial quality are critical to ensuring compliance and patient safety.

At Gillson Sciences, our compressed gas testing services verify that your gases meet the rigorous standards outlined in ISPE, FDA GMP for Medical Gases, ISO 8573-1, and EU GMP Annex 1. Our qualified scientists perform onsite sampling and laboratory analysis for particulates, moisture, hydrocarbons, purity, and microbial contamination, confirming your gas systems are operating within validated specifications.

All testing is performed using traceable, calibrated equipment, and results are provided with full documentation suitable for qualification (IQ/OQ/PQ) and ongoing GMP compliance. Whether your system delivers compressed air, nitrogen, oxygen, carbon dioxide, or other process gases, Gillson ensures each meets the purity expectations for its intended use.

With our combination of field expertise, rapid turnaround, and regulatory precision, Gillson Sciences helps you demonstrate that your compressed gas systems are not just operational but controlled, compliant, and audit ready.

We perform testing for food-grade air, a critical control point in food manufacturing quality systems.

Our testing supports Hazard Analysis & Critical Control Points (HACCP) compliance and covers:

  • Particle Classes 1–9
  • Water Classes 1–6
  • Oil Classes 1–4
  • Gas purity
  • Total microbial count

 

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