Versatile Solutions for Sachet and Pouch Leak Testing

In pharmaceutical packaging, attention to detail matters. We’ve seen time and time again the impact efficient practices can have on an operation’s process. These non-destructive leak testers are designed to create less waste than the older leak detection methods and produce more reliable results for your packaging solutions.

Ascend Packaging Systems understands that every work environment is different and there are many different types of pouches and sachets on the market. This wide range in variety was taken into account when the MediScan and PakScan were designed.

Sepha MediScan Features and Benefits Technical Specifications CCI Testing Method Interface & Other Features

The Table-Top MediScan for Leak Testing Pouches and Sachets

The Sepha MediScan pouch leak tester detects leaks as small as 10 microns in pouches, sachets, and flexible bags. The test method is pre-programmed into the equipment to remove any trace of operator subjectivity, which permits easier validation.

The unit itself fits on a table top and is an excellent solution for R&D labs with limited space and where packs need to be changed regularly. The MediScan is designed and built to offer quick and easy operation to provide objective, validatable results.

Features and Benefits of the MediScan

There are several other features and benefits to MediScan non-destructive leak testing equipment.

Accuracy
Test one pack at a time

Simple
No tooling required

Space Saving
Compact tabletop design

Intuitive
Easy to operate

Speed
Fast test cycle

Memory
Storage of results

Validation
Full 21 CFR Part 11 validation package available

Technical Specifications of the MediScan Pouch Leak Testing Machine

Operation
Semi-automatic

Construction
304 Stainless Steel Casework

Pack type
Sachets & Pouches

Pack Dimensions
Up to 250mm (L) x 200mm (W) x 100mm (D)
(9.8- x 7.9- x 3.9 inches)

Operating speed
Up to 2 cycles per minute

Test Range
Down to 10 Micron

Software
Easy to use operator touchscreen interface

Machine dimensions
700mm (W) x 490mm(L) x 560mm (H) mm
(27.6- x 19.3- x 22 inches)

Machine weight
63 kg

Shipping weight
113 kg

Controls
PC with Touchscreen HMI

Approx tooling changeover
No tooling required

CCI Testing Method

The MediScan uses the force decay container closure integrity testing (CCIT) method to ensure pouches and sachets are leak-free. The force decay method works by placing the packaging within the machine’s tool set that includes a strain gauge load cell stored within a vacuum test chamber.

Then, the vacuum is applied to the test chamber, and the packaging responds to the vacuum force by expanding. Next, the strain gauge load cell measures the expansive force over time to determine if the package has a gross leak, micron leak, or no leaks.

If there’s a gross leak present, expansive force isn’t measured.
If there’s a micron leak, expansive force is initially measured but starts to reduce as the pack allows air to escape into the vacuum chamber.
If the packaging is leak-free, it expands under the vacuum and remains inflated, generating a constant force of measurement over time.

To ensure the integrity of the pack is not affected or doesn’t burst, a force reaction/restraining plate is used to prevent full expansion.

Interface & Other Features

The MediScan incorporates leak detection technology and software to leak test flexible packaging and ensure product packaging integrity. The machine’s interface software aligns with FDA 21 CFR Part 11 regulations, allowing manufacturers to store and export data for auditing, while protecting reports from being edited or deleted.

To meet 21 CFR Part 11 compliance, the MediScan is equipped with:

Secure user access through unique usernames and passwords
An audit trail of all operational records
Report protection and safe interactions with other systems
Assigned electronic signatures for individual users

Other features of the MediScan include:

No tooling required, making it highly flexible across several pack types and sizes
Capable of detecting weak seals, channel leaks and holes down to 10μm (pack dependent)
Table top device
Capable of handling non-porous packages up to 100mm x 200mm x 250mm
Easy operator use via touch screen interface and easy load chamber
Capable of storing multiple test methods for up to 30,000 product types
User-defined password protection ensuring multiple operator use
Fully validated system
Production of objective and repeatable results
Test results can be printed, exported via USB or integrated into local quality control system via Ethernet cable
Fast, efficient test speed
Active Directory and OPC connectivity available on request

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Sepha PakScan Features And Benefits Application Technical Specifications Interface

Sepha PakScan for Pouches and Sachets

The Sepha PakScan uses pressure, vacuum, and precision load cells to identify leaks as small as 10 microns. It has the capacity to test four large sachets simultaneously. The software supplies a clear result for each separate package in the batch. It leverages modern technology to make the process straightforward and simple for your operators.

Benefits of the PakScan’s CCI Testing Method

The PakScan also uses the force decay CCI testing method to ensure pouches and sachets are leak-free. The force decay method has a wide range of benefits:

The non-contact method is clean and dry, unlike destructive leak testing methods and doesn’t destroy test products or packaging.
Tested products can be retrieved from faulty packs and repackaged.
Packs that pass the leak test can be put back onto the production line.

The outcome of the for decay method is accurate, validated results for each pouch or sachet. This non-destructive leak testing method can detect holes as small as 10 microns. The PakScan also automatically stores product-specific data in pre-designated file locations and verifies the tested product before each cycle.

Other benefits of the PakScan’s CCI testing method include:

No operator intervention required to provide you with objective results
Pass or fail criteria can be set to the same micron level as your existing testing method
Result data is stored and can be printed or downloaded to other storage devices for further analysis

Quicker Troubleshooting for Line Set-Up To Reduce Rejects

Faster test cycles means that leak testing can be carried out more frequently.
Earlier detection of leaks allows line operators to investigate the cause of the failed seal more quickly, so fewer faulty packs are produced on the line.

Easy to Use

No special technical skills required
Touch screen operator interface
One minute product changeover

Features and Benefits of the PakScan Leak Tester

Accuracy
Tests up to 10 packs at once.

Simple
No tooling required.

Space Saving
Compact tabletop design

Intuitive
The pre-programmed test method removes operator subjectivity, permitting easier validation.

Speed
Fast test cycle. Up to 4 cycles per minute.

Memory
Storage of results.

Validation
Full 21 CFR Part 11 validation package available

Application

The Sepha PakScan is suitable for flexible packaging made from non-porous material including PVC, PVDC, Aclar, and Aluminium foils and laminates.

Drug Stability Testing in Labs

R&D departments test materials using the PakScan to ensure the correct materials are used to protect new products from contamination by moisture, air, and bacteria.

QA Testing of Packaging Processes

With the PakScan, you can build leak tests into the Quality Assurance procedures for your packaging line. The machine’s objective seal testing feature ensures the integrity of your packaging process.

Reduce Production Rejects

The PakScan allows you to minimize the amount of rejected pouches, sachets, and waste created in pharmaceutical production and packaging facilities by carrying out leak testing more frequently.
Earlier detection of a leak means your line operators can troubleshoot the cause of a leak before a large volume of faulty packages are produced.

Technical Specifications of the PakScan Flexible Package Tester

Operation
Semi-automatic

Construction
All product contact areas constructed from Stainless Steel (Grade 316)

Pack Type
Sachets, pouches, bags, MAPs – in flexible and non-porous materials

Maximum Pack Dimensions for 3Up Configurations
270 x 155 x 45mm (10.6 x 6.1 x 1.7″) per pack

Maximum Pack Dimensions for 4Up and 5Up Configurations
270 x 95 x 45mm (10.6 x 3.7 x 1.7″) per pack

Maximum Pack Dimensions for 6Up Configurations
130 x 155 x 45mm (5.1 x 6.1 x 1.7″) per pack

Maximum Pack Dimensions for 8Up and 10Up Configurations
130 x 95 x 45mm (5.1 x 3.7 x 1.7″) per pack

Test Cycle Time
From 20 seconds

Machine Dimensions
750mm (W)x 920mm (L)x 1740mm (H)
(29.2- x 36.2- x 68.5 inches)

Electrical
110/230 VAC, single phase

Air
6 Bar (approx 90 psi)

Measurement ranges
Down to hole size of 10 microns

Machine Dimensions
670mm (L) x 1042mm (W) x 1195mm (H) – including screen
(26 x 41″ x 47″)

Machine Weight/Shipping Weight
200 kg (440 lbs) / 260 kg (575 lbs)

Software
System can be run in compliance with 21 CFR Part 11

Tooling Changeover
Approximately 1 minute (A different product nest is required for each format size)

Interface

The PakScan can identify gross holes, leaks, and weak seals down to 10 microns in up to 10 packs simultaneously within 30 seconds. Its non-destructive test method provides deterministic and objective results that are visualized on the result screen with a pass or fail reading for each individual packet. The PakScan’s interface software was developed to align with FDA 21 CFR Part 11 regulations, which allows packaging manufacturers to store and export data for audit purposes, while protecting reports from being edited or deleted.

To meet 21 CFR Part 11 compliance, the PakScan is equipped with:

Secure user access through unique usernames and passwords
An audit trail of all operational records
Report protection and safe interactions with other systems
Assigned electronic signatures for individual users

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Packaging Leak Detection Is Vital

Why worry about the functionality of pouch leak testers? They are an integral part of the packaging and production line for countless pharmaceutical manufacturers. The team at Ascend Packaging Systems has accumulated a massive amount of knowledge about the pharmaceutical industry and what makes a difference for your customers. That is why we put so much focus into optimizing your processes and giving your facility the most versatile solutions.

Accurate Leak Detection Designed for Simplicity

While integrity testing needs to be rigorous, detailed and accurate, displaying the test results for the operator should be clear, concise and simple. Both the MediScan and PakScan have been designed with this simplicity in mind. The machines are performing a proven, scientific test method, but the results are displayed on the screen as an easy to ready PASS/FAIL for operators to quickly identify. This helps eliminate operator error and improves efficiency.

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