Industry Solutions
Pharmaceutical and medical packaging teams use package leak testing to evaluate container closure integrity and sealed-package performance in production.
Container closure integrity (CCI) and package-integrity testing can cover flexible bags and pouches, blister packs, sealed trays, vials, rigid containers and device packages. The product format, accessible ports, package behavior and quality plan determine the test approach.
Zaxis supplies production test instruments and fixtures. The manufacturer’s quality team owns acceptance criteria and method validation for the package and its intended use.
Request for QuotePackage-integrity work evaluates whether a sealed package or closure performs according to the manufacturer’s defined quality requirements. Some methods are nondestructive pneumatic measurements; destructive approaches such as bubble/internal pressurization may be used in a manufacturer’s validation program.
A chamber can assess a sealed package from outside the package when a direct connection is not practical. Rigid containers or devices with accessible ports can use a configured pressure-decay test.
Methods used
Match the package format, fixture, test access and validation plan to a suitable production method. A production decision is defined by the manufacturer’s quality team.
Vacuum decay evacuates a sealed package or part and measures movement back toward atmospheric pressure. Chamber testing evaluates a sealed product from outside the package when no direct port is available.
These pneumatic approaches can keep a product dry and may support nondestructive production measurements when the chamber, fixture and programmed conditions are defined.
Read about vacuum decay →Pressure decay applies pressure to a sealed container or device, isolates the source and measures pressure loss over a defined interval. A direct port and stable fixture are important to the setup.
It can support a repeatable air-based production decision for rigid containers or connected devices where the manufacturer has defined the test conditions and acceptance criteria.
Read about pressure decay →Bubble/internal pressurization can be used as a destructive method in a package-quality or method-validation program. The manufacturer’s quality team determines the applicable method, sampling and acceptance criteria.
A Zaxis production tester and fixture can provide a separate configured pneumatic measurement where that approach fits the package and production plan.
Explore chamber testing →Use chamber and vacuum-decay configurations for sealed-package work; route air-test applications by fixture, port count and automation needs.
VM3 and chamber testingVacuum/chamber testing configuration for sealed packages where an external chamber suits the package format.
Z5Compact multi-channel air tester for configured factory stations.
Z5LAir leak tester option for configured production applications.
Z8Modular air leak tester with up to four test ports for configured production testing.ASTM F2338 addresses vacuum-decay testing for nonporous packages. ASTM F2095 addresses pressure-decay package leak testing, and ASTM F2096 addresses bubble/internal pressurization. USP <1207> provides package-integrity evaluation guidance; ISO 11607 addresses sterile barrier packaging.
These references name method or packaging scope only. They do not indicate that a tester, package or process is certified, compliant or qualified. The manufacturer’s quality team owns acceptance criteria, method validation and the final production decision; Zaxis supplies production test instruments and fixtures.
Flexible packages can change shape under pressure or vacuum, so a chamber or fixture should control the package and leave a defined test volume. Rigid containers and connected devices may use a direct pressure connection and a fixture that stabilizes the product.
Fixture design, package behavior and programmed conditions are part of the manufacturer’s method-validation work. Zaxis provides the production test instrument and fixture configuration that the application calls for.
Package integrity testing and precision dispensing address distinct production tasks. Zaxis eVmP valveless metering pumps support controlled pharmaceutical dosing applications including reagents, hydrogels, pre-filled doses and soft-gel manufacturing.
For a pharmaceutical line, evaluate the package-integrity test and the fill or dispensing process as separate, configured stations.
A chamber or fixture can evaluate flexible bags, pouches and other sealed packages using a programmed pneumatic method selected around the package behavior and quality plan.
Rigid containers and connected devices can use a pressure-decay setup when a direct connection and stable fixture fit the package or device.
Chamber-based production testing can evaluate sealed package formats from outside the package when direct test access is impractical.
It covers package-integrity or container closure integrity evaluation for formats such as flexible bags and pouches, blister packs, sealed trays, vials, rigid containers, device packages and closure assemblies.
Vacuum decay, chamber testing and pressure decay can provide pneumatic production measurements without intentionally opening the package. Bubble/internal pressurization may be a destructive method in a manufacturer’s validation program.
A vacuum or chamber approach can be used for a sealed package when an external chamber suits the package format and a direct connection is impractical. The manufacturer defines the final method and acceptance criteria.
Pressure decay can be used for a rigid container or connected device when a direct port and stable fixture are available. The production conditions and acceptance criteria are set by the manufacturer’s quality team.
ASTM F2338 covers vacuum decay for nonporous packages; ASTM F2095 covers pressure-decay package leak testing; ASTM F2096 covers bubble/internal pressurization; USP <1207> gives package-integrity evaluation guidance; and ISO 11607 addresses sterile barrier packaging. These names describe scope, not certification or compliance.
The manufacturer’s quality team owns acceptance criteria, method validation and the final production decision. Zaxis supplies production test instruments and fixtures.
For sterile-barrier and package-integrity context, see ISO 11607 and ASTM F2338.
