Container Closure Integrity Testing of Prefilled Syringes and Vials

In the pharmaceutical packaging industry, the container closure integrity testing of prefilled syringes (CCIT) is critical to ensure that syringes and other pharmaceutical products remain safe and effective.

Other pharmaceuticals that require a CCI test before shipment include:

Vials
Cartridges
Auto-injectors

At Ascend Packaging Systems, we know that CCI testing is crucial to ensure your packaging is free of leaks that could contaminate your product.

CCI Testing Methods

There are two types of leak testing methods for packaging: destructive and non-destructive. Some pharmaceutical manufacturers test packaging for leaks by placing them in water or blue dye baths. Then, the test administrator observes if liquid makes its way into the packaging. If the packaging passes, it still has to be destroyed because it was used in a test, making this traditional CCI testing destructive and expensive.

Using a non-destructive testing (NDT) method allows the examined packaging to survive the test unharmed, saving you money and resources.

Vacuum Decay Leak Test

The vacuum decay test is used to ensure CCI for vials and pre-filled syringes. Designed to identify gross defects and micron leaks in packaging down to 1 micron, the vacuum decay leak test is the perfect NDT method for pharmaceuticals and medical devices.

Pressure Decay Leak Test

Used to identify leaks and micron holes in vials filled with liquid or powder, the pressure decay leak test is a common NDT method for containers filled with toxic products. Pressure decay leak testing is commonly used on products that can’t be tested using the vacuum decay method.

Force Decay Leak Test

The force decay leak test confirms flexible packaging integrity for solid or dry products. It’s an ideal NDT method to identify leaks or weak seals in nonporous, sealed packaging, such as pouches, sachets, bags, and stick packs.

Vacuum Deflection Leak Test

An ideal testing method for pharmaceutical blister packs and packaging with multiple cavities or pockets, the vacuum deflection leak test is an NDT method that uses a 3D volumetric scanner to measure blister pack deflection surfaces in response to an applied vacuum. The test’s 3D scanning technology offers sensitive results, detecting leaks as low as 5 microns depending on the pack type and material used.

Taking CCI Testing Down to 1 Micron

The Sepha Multi-Q HD is designed to detect packaging leaks down to 1 micron. A perfect CCI testing solution for vials and pre-filled syringes, the Sepha Multi-Q HD uses the vacuum decay ASTM F2338-09 testing standard, a consensus recognized by the FDA for non-destructive leak detection in packages using vacuum decay. With the Sepha Multi-Q HD, you’re getting a non-destructive leak detection method that offers reliable and repeatable results.

Features and Benefits Technical Specifications

Features and Benefits of the Sepha Multi-Q HD

Non-destructive, deterministic, and quantitative test method
Identifies defects down to 1 μm
Ideal for testing vials, ampoules, bottles, pre-filled syringes, and BFS strips containing water-based liquid
Unlimited data storage
Uses the ASTM F2338-09 standard test method
In line with USP 1207
21 CFR Part 11 compliant
OPC connectivity
Active directory

Technical Specifications for Sepha Multi-Q HD

Container Type
Ampoules, vials, pre-filled syringes, bottles, blow fill seal strips, medical devices

Measurement Range
Down to 1 µm*

Test Cycle Time
From 10 seconds

Operation
Fixed tooling attachable to top of unit or via test port

Data Storage Capacity
Unlimited

ASTM Standard
ASTM F2338-09

Machine Dimensions
377mm (L) x 366mm (W) x 288mm (H)

User HMI
10.1” PCAP touchscreen

Connectivity
Active directory, network printing, central network storage, custom data MES/OPC connectors available

Utilities
Electrical: 24V 5A | Air Supply: Min. 200L/min at 0.6 MPa {ISO8573-1:2010 Class 2} or vacuum pump

Features
Flexible reports, 3x USB, 2x ethernet port, external calibrated leak port

Ready To Enhance Your CCI Testing?

With Ascend Packaging’s CCI testing solutions, you can take your NDT methods to the next level.

Get Started Today

A Next-Generation Syringe Leak Testing Machine

A next-generation blister packaging leak detection machine that takes syringe leak testing to the next level, the Sepha VisionScan 3D is built with an innovative, patented 3D scanning technology that uses vacuum deflection to test the integrity of pharmaceutical blister packs.

By using the latest technology, the VisionScan 3D gives you a clear pass or fail result for each package and provides the leak’s location. When you use the VisionScan 3D for your leak detection, you get an NDT method that saves you money and time and gives you a more modern, reliable leak detection process.

Features and Benefits Technical Specifications

Features and Benefits of the Sepha VisionScan 3D

Simple operator use with a touchscreen interface
Uses a vacuum deflection test method according to ASTM standard F3169-16
Innovative, tool-less features for production lines running multiple products
Rapid test time down to 60 seconds for micron holes and 30 seconds for gross holes
Patented 3D measurement technology combined with differential vacuum and pressure

Technical Specifications for Sepha VisionScan 3D

Operation
Semi-automatic

Construction
Anodized Aluminum, Acrylic, and Polyurethane Case

Test Area
297 mm x 210 mm

Measurement Range
Detect defects as small as 5 microns *pack and material dependent

Operating Speed
As low as 60 seconds for micron holes and 30 seconds for gross holes

Machine Dimensions
691 mm (W) x 489 mm (D) x 701 mm (H)

Control Hardware
18.5” Full HD, 1080 x 1920 pixels with PCAP touch screen, 4 x USB ports, 1 x Ethernet port

Audit Compliance
21 CFR Part 11 compliant

Machine Weight
68 kg

Shipping Weight
110 kg

Shipping weight
80 kg

Count on Ascend for Your CCI Testing Needs

When you count on Ascend for your CCI testing needs, you get targeted results and product details for leak detection, resulting in a reliable test that meets regulatory standards. We know leak detection, and our machinery is the most innovative of its kind available today. Our team combines the reach of global manufacturers with the personal attention of local service providers. Contact us today to learn more about our leak detection solutions for blister packages.

Put Our Years of Experience to Work for Your Business.

We’re prepared to support our customers with all their packaging equipment needs.