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Enhancing Accuracy & Safety in Pharma Lab’s Workflows

June 19, 2025

In the pharmaceutical industry, precision and reproducibility aren’t just goals, they’re regulatory mandates. Every step in a pharmaceutical analytical workflow must meet strict guidelines for Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) compliance. When it comes to acid digestion and reagent dosing for trace metal analysis or quality control, manual workflows pose serious risks: variability, exposure to hazardous acids, and costly delays.

Enter the Milestone easyFILL, an automated, high-throughput reagent addition system that brings consistency, safety, and speed to pharmaceutical laboratories across Canada.

Sample Preparation Workflow

When dealing with a wide variety of matrices, from active pharmaceutical ingredients (APIs) to excipients, raw materials, and biologics, each may require different sample preparation methods before trace elemental analysis by ICP-MS or ICP-OES.

Traditionally, lab technicians manually:

  • Pipette acids under a fume hood
  • Track reagent volumes by hand
  • Transfer vessels between dosing, digestion, and dilution steps

This time-consuming and repetitive process increases operator exposure to corrosive reagents such as HNO₃, HCl, or HF. Even minor inconsistencies during manual handling can lead to out-of-spec results, triggering re-analysis, deviations, or regulatory scrutiny.

Milestone’s easyFILL addresses these challenges by automating the reagent addition process, significantly reducing operator contact with hazardous acids. Its built-in exhaust system further improves safety by directing acid vapors to the laboratory’s extraction system, ensuring a cleaner and safer working environment.

Precision Dosing for Consistent Results

Milestone’s easyFILL dispenses precise volumes of up to six reagents using calibrated, PTFE-lined tubing and a high-accuracy peristaltic pump. For pharmaceutical applications, this ensures:

  • Consistent acid-to-sample ratios
  • Reduced inter-batch variation
  • Better method validation and reproducibility

By automating this critical step, labs achieve tighter USP <232>/<233> and ICH Q3D compliance for elemental impurities testing.

Reduced Exposure to Hazardous Acids

Operator safety is critical in regulated environments. Milestone easyFILL performs all dosing inside a sealed, vented enclosure, with zero direct handling of corrosive acids. The automated rinsing of internal lines after each cycle further prevents cross-contamination, a major concern when running multi-compound studies or GMP batches.

Automated Dosing that Meets Regulatory Demands

Time is not just money, it’s regulatory pressure, data integrity and safety. The Milestone easyFILL delivers a fast, compliant, and reliable solution for sample prep, allowing labs to:

  • Boost throughput
  • Ensure consistent analytical quality
  • Minimize risk of human error
  • Improve operator safety
  • Meet international pharmaceutical regulations

Working together… providing solutions!

Milestone’s easyFILL delivers the accuracy and consistency researchers demand. ATS Scientific Inc., works closely with labs providing access to expert technical support and personalized service backed by decades of industry experience, ensuring smooth integration and ongoing success with your instruments.