BatchCheck

Non-destructive batch testing for packaged products

What is BatchCheck?

BatchCheck is a laboratory service that enables manufacturers and laboratories to verify batch quality and packaging integrity without investing in capital equipment or destroying saleable products.

Customers submit a full batch or a statistically representative sample selection to Gasporox laboratories for analysis. Testing is performed at a single, defined time point using non-destructive gas and pressure measurement to verify headspace gas composition and or package pressure against customer-defined requirements.

Measurements can include oxygen, carbon dioxide, and total or partial pressure, individually or in combination. Testing is performed using laser-based headspace analysis and container integrity verification with Gasporox sensors and instruments.

All measurements are non-destructive. Containers remain intact throughout testing, allowing samples to be returned to the customer after analysis. Tested units can therefore be sold, stored, or used for further evaluation without product loss.

BatchCheck provides clear, batch-specific results that support quality assurance and batch release decisions, while lowering the barrier to advanced headspace analysis and CCIT by removing the need for in-house testing capability or capital equipment investment.

BatchCheck provides clear, batch-specific results that support quality assurance and batch release decisions, without requiring in-house testing capability or capital equipment investment.

What is measured?

BatchCheck offers configurable headspace measurements, allowing customers to select the parameters required for batch verification.

Available measurements

Customers can select one or more of the following measurement options:

  • Oxygen concentration (O₂) – Measurement of residual or ingress-related oxygen levels in sealed packages.
  • Carbon dioxide concentration (CO₂) – Measurement of carbon dioxide levels in sealed packages, including modified atmosphere applications.
  • Total- and partial-pressure – Measurement of total package pressure and calculation of individual gas partial pressures within the sealed container.

Combined measurements

For broader verification needs, measurement options can be combined within the same test cycle as an additional service:

  • Oxygen and carbon dioxide
  • Oxygen with total and partial pressure
  • Carbon dioxide with total and partial pressure
  • Oxygen, carbon dioxide, and total and partial pressure

Measurement principles

  • Al measurements are performed without opening the package
  • No consumables are required during testing
  • Results are repeatable and traceable, supporting quality assurance and audit requirements

Common uses

BatchCheck is typically used to verify that a production batch meets defined headspace specifications at a single, controlled time point. It is especially relevant when testing is required at short notice or on an occasional basis. Typical use cases include:

Batch release verification

Confirmation that headspace gas composition and or total and partial pressures are within defined acceptance limits prior to batch release.

Verification of gas concentration control

Demonstration that target oxygen, carbon dioxide, or tracer gas levels have been consistently achieved across a production batch.

Non-destructive batch screening for integrity risk

Identification of containers with abnormal gas composition or pressure values that may indicate potential leakage, without performing formal CCIT studies.

Verification after process changes

Confirmation of batch compliance following adjustments to filling, flushing, or sealing parameters, or after maintenance and tooling changes.

Quality assurance and audit support

Generation of batch-specific, traceable datasets to support internal QA requirements and external audits.

Assessment of batch consistency

Evaluation of container-to-container variability to identify outliers that may indicate process deviations or handling issues.

Benefits of non-destructive testing

BatchCheck is based on non-destructive, non-intrusive headspace testing, providing direct and practical benefits for batch verification and quality assurance.

Why it matters

  • Samples remain intact – Containers are not punctured, opened, or altered during testing.
  • No product waste – Package integrity is preserved, avoiding loss of product and reduction in commercial yield.
  • Samples can be reused – Tested units can be returned to the customer and sold, stored, or used for further evaluation or testing.

Limitations of destructive testing approaches

Many traditional headspace and package testing methods require puncturing or opening the container to access the internal atmosphere. This results in:

  • Permanent destruction of tested units
  • Reduced available sample size
  • Increased cost per test, particularly for high-value products
  • Practical limits on the number of units that can be tested from a batch

Additional technical advantages

  • No consumables required -Testing is performed without needles, septa, or reagents consumed per test.
  • Deterministic measurement results – Measurements are based on defined physical principles, providing repeatable quantitative results rather than probabilistic pass or fail outcomes.
  • Regulatory alignment – The testing approach is aligned with Annex 1 recommendations for non-destructive and deterministic container closure integrity and headspace verification.

Who BatchCheck is for?

BatchCheck is designed for organisations that require reliable, non-destructive batch-level verification of headspace conditions without investing in in-house testing capability.

Pharmaceutical manufacturers and Laboratories

Food producers and contract manufacturers

Beverage manufacturers, bottlers, and co-packers

Types of organisations

The BatchCheck is suitable for:

  • Producers requiring batch release or quality verification
  • Laboratories supporting testing, qualification, or investigation activities
  • Contract manufacturers and packers requiring independent batch verification

Production stages

A BatchCheck can be applied across multiple production contexts:

  • Final manufacturing batches prior to release
  • Sample production and pilot runs
  • Laboratory and development batches

This flexibility allows BatchCheck to support both routine quality needs and early-stage development work using the same non-destructive testing approach.

What’s included

BatchCheck provides clearly defined outputs focused on batch-level verification and traceable results. As a results of a BatchCheck you will receive:

  • Written test report – A structured report summarising the tested batch or sample group, measurement setup, and results.
  • Batch or sample group results – Clearly presented measurement data for the selected parameters, reported per batch or statistically defined sample set.
  • Measurement values – Quantitative results for oxygen concentration, carbon dioxide concentration, and or total and partial pressure, depending on the selected service scope.
  • Compliance indication – Where acceptance limits are provided by the customer, the report includes a clear indication of whether results are within defined limits.
  • Defined sample scope – Batch size and sampling strategy are agreed in advance in collaboration with Gasporox sales and laboratory teams.
  • Return of samples – Tested samples are returned to the customer after analysis, with containers remaining intact.
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Technology

The AutoMAP™ Pharma optical gas sensors are built on more than 25 years of development and refinement in industrial laser-based gas measurement. The system uses Tunable Diode Laser Absorption Spectroscopy (TDLAS), a highly reliable and precise method for non-destructive headspace gas analysis.

Developed by Gasporox in collaboration with its technology partners, this laser sensor technology is widely used in demanding industries such as pharmaceuticals, petrochemicals, and energy.

Gasporox’s laser-based headspace analysis has been successfully deployed for over a decade in pharmaceutical manufacturing. It is integrated into fully automated inspection systems and benchtop instruments for 100% in-line and laboratory testing of vials, ampoules, and other parenteral packaging formats. The performance and robustness of the system have been validated through extensive real-world use.