In regulated laboratories, failure rarely comes from obvious mistakes. More often, it stems from small, overlooked variables that quietly undermine results over time. One of the most underestimated? Gas quality.

While instruments, methods, and operators are meticulously controlled, gas supply is often treated as a background utility assumed to be “good enough.” In reality, inconsistent or poorly controlled gas quality can introduce risk at every stage of analysis, from data integrity to audit outcomes.

1. When Gas Quality Becomes a Compliance Risk

Regulatory frameworks such as GMP, GLP, and ISO demand consistency, traceability, and reproducibility. Gas plays a direct role in all three.

Impurities moisture, oxygen, hydrocarbons can lead to:

• Baseline drift and increased noise

• Reduced sensitivity and detection limits

• Inconsistent retention times

• Failed system suitability tests

These issues don’t always present as clear failures. They often surface as unexplained variability the most difficult kind of problem to defend during inspection.

2. The Cost of “Unexplained” Results

When results cannot be reproduced, the investigation rarely stops at the instrument. Entire workflows are questioned.

This leads to:

• Repeat testing and delayed batch release

• Deviation reports and corrective actions

• Lost confidence in analytical data

• Increased scrutiny during audits

In many cases, the root cause is not the method or the analyst but unstable or undocumented gas supply.

3. Cylinders Introduce Variability by Design

Traditional cylinder-based gas supply carries inherent risks:

• Batch-to-batch variation

• Pressure changes during use

• Contamination during handling and changeover

• Limited visibility into purity consistency over time

Even when nominal purity specifications are met, the lack of continuous control makes it difficult to demonstrate long-term stability, a key expectation in regulated environments.

4. Why Auditors Care About Gas

During inspections, auditors assess the full analytical chain. Gas is not exempt.

Common audit questions include:

• How is gas purity defined and verified?

• How is consistency maintained between runs?

• What controls exist to prevent contamination?

• How are deviations investigated if gas quality is suspected?

Without clear answers and documentation, gas supply becomes an avoidable audit vulnerability.

5. Controlling the Input Protects the Outcome

On-site gas generation allows laboratories to move from assumption to control.

Benefits include:

• Continuous purity monitoring

• Stable flow and pressure aligned to instrument requirements

• Reduced handling and contamination risk

• Simplified documentation within QA systems

By controlling gas at the source, laboratories reduce variability, strengthen compliance, and protect the credibility of their results.

In regulated science, small variables create big risks.

Eliminate uncertainty by taking control of gas quality

Protect compliance, data integrity, and audit confidence with on-site gas generation.

Learn more at https://lemaninstruments.ch