Leak Test App Model P Control | Standardized Package Testing

Model P · Standardized Package Testing

Leak Test App for Automated and Traceable Package Testing

The DVACI Leak Test App standardizes package leak-test execution through controlled recipes, automated cycles and structured result records on the Model P controller.

Operators select the appropriate product recipe and observe the package while the application controls vacuum, pressure and time according to the approved configuration.

Quick Technical Answer

What Is the Leak Test App?

It is a Model P application for configuring, selecting, executing and documenting package leak-test recipes. Administrators manage the test parameters; operators run the assigned recipe through a simplified workflow.

The available cycle functions depend on the connected chamber, pressure hardware, accessories and validated test procedure.

Recipe ControlStore product-specific vacuum, pressure and timing parameters.

Automated ExecutionRun the programmed sequence with less manual adjustment.

Traceable RecordsCapture test context and export structured result information.

Why manual testing creates risk

Reduce variation without removing operator observation.

When operators adjust vacuum and timing for every test, results can depend on individual setup and execution. Manual transcription also makes test history harder to review.

The application separates responsibilities: administrators define recipes and permissions, the system executes the cycle and the operator observes the package for the indication specified by the method.

Consistent test parameters
Controlled access by role
Repeatable cycle execution
Structured test documentation

CDV 4 packaging vacuum chamber equipped with the Model P Leak Test App — Leak Test App operation is integrated with the Model P control platform and the selected CDV chamber configuration.

Recipe management

Give each package its approved test configuration.

A recipe can define the test sequence and operating parameters required for a particular product or package format.

01 · PRODUCT

Create the recipe

Associate the package with its required method and parameter set.

02 · PARAMETERS

Define the cycle

Configure vacuum or pressure levels, timing and applicable repetitions.

03 · ACCESS

Control changes

Limit recipe editing to authorized administrative users.

04 · EXECUTION

Run consistently

Allow operators to select and execute the approved recipe.

Leak Test App recipe management interface on the DVACI Model P controller — **Recipe management**Save defined test conditions instead of re-entering parameters for every cycle.

Standardized Leak Test App recipe used to reduce package-testing variability — **Process standardization**Use the same approved configuration across operators, shifts and repeated evaluations.

Optional barcode workflow

Connect product identification with recipe selection.

A compatible barcode reader can be integrated so scanning the product calls the corresponding test recipe. This reduces reliance on manual searching and helps prevent selection of an unrelated configuration.

Barcode logic and recipe associations must be configured and verified as part of the user's controlled process.

Barcode scan automatically selecting the corresponding package recipe in Leak Test App — Barcode-based selection can connect the package identifier with its configured leak-test recipe.

Advanced test cycles

Build more than a single-level vacuum test.

Leak Test App can configure up to four vacuum levels in one recipe. With the appropriate Model P hardware, a sequence may also combine vacuum and pressure or repeat cycles to evaluate package behavior under changing conditions.

Once started, the system controls the programmed sequence so the operator can concentrate on the visual or procedural observation required by the method.

Leak Test App configuration with multiple vacuum levels in one package test cycle — Progressive levels and repetitions should be defined from the real package response and approved procedure.

SelectChoose the product recipe manually or through barcode identification.

ConfirmVerify package, method and test information before execution.

RunAllow the controller to execute vacuum, pressure and time stages.

RecordSave the test context and result for later review or export.

Leak Test App combining vacuum and positive-pressure stages in one package test recipe — Vacuum and pressure functions require a compatible chamber, connections and Model P hardware configuration.

Vacuum + pressure

Adapt the sequence to different package behaviors.

Some packages respond to external vacuum, while others require internal or external positive pressure. Appropriate configurations can incorporate both types of stages in the same programmed workflow.

The software does not determine the correct method automatically. The user must establish the test approach, limits and acceptance criteria for the package.

Visual leak-test methods

Automate the conditions while the operator evaluates the indication.

Leak Test App controlling an immersion bubble-emission test for flexible packaging — **Immersion testing**Apply the programmed vacuum while the operator observes the submerged package for a continuous bubble stream.

Leak Test App controlling a dry leak test on liquid-filled packaging — **Dry testing**Evaluate liquid-filled packages for visible product seepage without filling the chamber with water.

These are visual methods: automated pressure control improves consistency, but the result can still depend on observation, package behavior and the approved procedure.

Traceability and documentation

Connect each result with its test context.

The application can record information such as operator, date, time, lot number, selected recipe and test parameters for later review.

Leak Test App screen showing automatically recorded package test results — **Recorded test information**Preserve the context needed to review how and when a cycle was executed.

Leak Test App exporting package leak-test result data to Excel — **Result export**Export structured data for documentation, analysis or integration into the quality workflow.

Operator and timeAssociate execution with the user, date and time recorded by the system.

Product and lotConnect the test result with the relevant production or sample identifiers.

Recipe and parametersDocument the programmed conditions used during the cycle.

Protected reporting

Generate PDF reports with electronic verification.

The application can generate PDF reports with an electronic signature or seal. A later modification can invalidate that verification, helping reviewers identify that the exported document no longer matches the originally signed version.

This feature supports record integrity, but regulatory compliance depends on the complete system: validation, access controls, procedures, record retention, audit strategy and the user's quality system.

Review FDA guidance on electronic records and signatures →

Leak Test App PDF package test report with electronic signature verification — Electronic verification supports detection of changes to an exported report; it does not establish compliance by itself.

Regulatory note: Do not describe the application as “21 CFR Part 11 compliant” unless the supplied configuration, validation package and intended use have been formally assessed for the customer's regulated environment.

Automation standardizes how the cycle is executed. A reliable leak-testing process still depends on the correct recipe, trained observation, validated criteria and controlled data practices.

Frequently asked questions

Leak Test App FAQ

Which controller includes the Leak Test App?

The application is available on DVACI's Model P control platform. The final functionality depends on the connected chamber, hardware and selected options.

How many vacuum levels can one recipe contain?

The application can configure up to four vacuum levels within a single test cycle.

Can a barcode select the test recipe?

Yes, a compatible barcode workflow can be integrated to associate a product identifier with its corresponding recipe.

Does automation eliminate visual inspection?

No. For visual bubble-emission and dry-seepage methods, the application controls the cycle while the trained operator evaluates the required indication.

Are PDF reports automatically compliant with 21 CFR Part 11?

No. Electronic verification is one technical control. Compliance depends on the complete configured system, validation, procedures, user management and record lifecycle.

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