CDV Pharma · Vacuum & Pressure Leak Testing

CDV Pharma Advanced Vacuum Chamber for Leak Detection Testing

CDV Pharma leak testing combines controlled vacuum and pressure-based methods with recipe management, traceable results and pharmaceutical-focused reporting.

It is designed to help manufacturers move beyond simply applying vacuum and visually observing a result—especially in methylene blue testing workflows that require greater control, repeatability and data integrity.

Quick Technical Answer

What Is CDV Pharma?

CDV Pharma is a pharmaceutical package-integrity test platform that combines a purpose-built chamber, an independent control module, Orion controls and application-specific software.

The V&P configuration—Vacuum and Pressure—can support vacuum procedures, internal pressurization, methylene blue tests and pressure-differential transport simulations from one platform.

Multiple MethodsVacuum, positive pressure, dye immersion and altitude simulation.
Traceable WorkflowRecipes, identification and protected PDF test reports.
Pharma-FocusedA reduced-height chamber for compact pharmaceutical packages.
Pharmaceutical package integrity

More control for methylene blue and pressure-based testing

Pharmaceutical quality teams need to know which recipe was used, whether the programmed parameters were followed and how the result was documented.

CDV Pharma brings these elements into one workflow so tests can be performed more consistently across products, operators and batches.

  • Controlled vacuum and pressure recipes
  • Repeatable test execution
  • Result and sample traceability
  • Adaptable reporting workflow
CDV Pharma advanced vacuum and pressure chamber for pharmaceutical package leak testing
CDV Pharma combines the chamber, control hardware and application software in one testing platform.
One controlled platform

Run multiple package-integrity test approaches.

The CDV Pharma V&P hardware expands testing possibilities without requiring a separate platform for every methodology.

01 · VACUUM

External vacuum

Apply defined vacuum levels and times for bubble emission, dye immersion and other vacuum-based procedures.

02 · PRESSURE

Internal pressurization

Introduce controlled positive pressure when the package format and test procedure require it.

03 · DYE

Methylene blue

Control the pressure cycle used to help reveal a potential leak pathway with a visible tracer.

04 · ALTITUDE

Transport simulation

Reproduce pressure differentials that packages may experience during distribution or high-altitude transport.

CDV Pharma platform showing vacuum, pressure, dye immersion and transport simulation test methods
Available methods depend on the package, accessories and the approved test procedure.
Data integrity workflow

Control the recipe. Identify the test. Preserve the result.

Orion and the CDV Pharma application support a more repeatable sequence from recipe selection through report generation.

  • Repeatable test recipes
  • Operator and sample identification
  • Controlled result documentation
  • Adaptable database or system integration
Pharmaceutical vials and containers prepared for CDV Pharma leak testing
Choose the pressure mode and procedure according to the package configuration and target defect.
Vacuum + positive pressure

Increase the options available during method development.

Some leak pathways may respond differently under vacuum and positive pressure. The V&P configuration adds controlled positive pressure so the technical team can evaluate defects that may be difficult to reveal with a vacuum-only approach.

This does not replace method validation: sensitivity must be established for the actual package, defect, product and acceptance criteria.

Purpose-built chamber

Designed around smaller pharmaceutical packages.

The chamber's reduced internal height helps accommodate vials, ampoules, bottles, blisters and other compact configurations while limiting unnecessary methylene blue volume during immersion procedures.

  • Rigid and semi-rigid containers
  • Blisters and flexible packages
  • Closures and sealed systems
  • Small-format pharmaceutical products
CDV Pharma chamber performing a methylene blue dye immersion leak test
A 150 mm internal chamber height supports compact samples and can reduce dye consumption.
CDV Pharma V&P at a glance

Key system characteristics

45 × 30 × 15 cmInternal chamber dimensions
−900 mbarMaximum vacuum
2 barMaximum external pressure
500 mbarMaximum internal pressure

Confirm the final configuration, pressure ranges and accessories with DVACI for your package and user requirement specification (URS).

Methods can be developed with reference to applicable standards and compendial guidance.

  • USP <1207.2>
  • USP <381> / JP 7.03
  • ASTM D3078
  • ASTM F2096
  • ASTM D4991
  • ASTM D6653
  • European Pharmacopoeia 3.2.9
  • MGA 0486 FEUM

The applicable standard and validation strategy depend on the package system and intended use. See official publications from USP and ASTM International.

Frequently asked questions

CDV Pharma leak testing FAQ

What tests can the CDV Pharma V&P perform?

Depending on its configuration and accessories, it can support vacuum tests, internal pressurization, methylene blue procedures and pressure-differential transport simulations.

Why combine vacuum and positive pressure?

Package formats and defects do not all behave the same way. Having both modes gives the method-development team more ways to establish a detectable and repeatable response.

Does the system create traceable reports?

The CDV Pharma application can generate PDF reports with an electronic seal and can be adapted for integration with a customer's information system or database.

Does CDV Pharma automatically make a test compliant?

No. Equipment supports the workflow, but compliance also depends on the approved procedure, qualification, method validation, user controls and the quality system in which it is operated.

Review your application

Improve or standardize your pharmaceutical leak-test process.

Share your package format, test objective and URS with the DVACI technical team.

Request a demonstration →