REPASSA » Our Solutions » Non-destructive Leak Testing & Deblistering

Leak Testing

Non-destructive leak testing solutions for blister packs, induction sealed bottles, sachets, pouches and medical devices.

Sepha has developed innovative leak test machines that provide a non-destructive alternative to Blue Dye testing methods. We offer a range of non-destructive, deterministic leak testing systems, specially designed to rapidly test for leaks in a wide variety of pharmaceutical packaging. Unlike the industry standard destructive test methods like Blue Dye Methylene, our testing methods are non-destructive, allowing product that has been tested to be returned to the production line.
VisionScan 3D

VisionScan 3D is a non-destructive, tool-less blister leak test for all foil types.

  • Incorporates patented 3D technology that can detect leaks in individual blister pockets, channel leaks and weak seals down to a 5μm laser drilled pin hole (pack and material dependent)
  • Tool-less device making it ideal for production lines running multiple products
  • Large test area (297x210mm) provides high throughput
  • Rapid test time down to 60 seconds for micron holes and as low as 30 seconds for gross holes
  • Can form part of 21CFR part 11 compliant system
  • The test method is clean and dry, unlike other destructive leak testing methods (eg Methylene Blue Dye Test), and does not destroy test product or packaging.
APPLICATIONS

Drug stability testing in laboratories
R&D departments test materials to ensure the correct materials are used to protect new products from contamination by moisture, air and bacteria.

QA Testing of packaging processes
Build leak tests into Quality Assurance procedures for your blister packaging line. Objective seal testing maintains compliance and ensures the integrity of the packaging process. VisionScan 3D ensures protection from moisture, air and bacteria and allows investigation of atypical results.

Reduce production rejects
Minimise reject blisters and waste disposal created in pharmaceutical production and packaging facilities by carrying out leak testing more frequently. Earlier detection of a leak means line operators can troubleshoot the cause of a leak before large volumes of faulty blisters are produced.

PakScan

PakScan is a non-destructive, multi-product seal integrity tester for pouches, sachets and flexible packaging.

  • Non-destructive seal integrity and leak detection device that uses force decay technology to detect weak seals and holes down to 10µm
  • Can test up to 10 packs simultaneously (standard configurations: 3, 4, 5, 6, 8 & 10 packs)
  • Capable of handling dry, non-porous packages
  • User defined password protection ensuring multiple operator use
  • Easily validated system
  • Repeatable test with deterministic and objective pass/fail results
  • Test results can be printed, exported via USB (2x) or integrated into local quality control system via Ethernet cable
  • Active Directory and OPC connectivity available on request
  • System can be run in compliance with 21 CFR Part 11
APPLICATIONS

Drug stability testing in laboratories 

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

QA Testing of packaging processes 

Build leak tests into the Quality Assurance procedures for your packaging line. Objective seal testing ensures the integrity of the packaging process.

Reduce production rejects

Minimise reject pouches and sachets and waste disposal created in pharmaceutical production and packaging facilities by carrying out leak testing more frequently. Earlier detection of a leak means line operators can troubleshoot the cause of a leak before a large volume of faulty packages are produced.

VisionScan

VisionScan is a non-destructive, tool-less leak detection device for pharmaceutical blister packs.

  • Incorporates imaging technology that will detect leaks in individual blister pockets, channel leaks and weak seals equivalent to a 7μm (Pack and material dependent) laser drilled pin hole
  • Tool-less device making it ideal for production lines running multiple products
  • Can test multiple packs per test cycle
  • Rapid test time down to 10 seconds for micron holes and as low as 6 seconds for gross holes
  • Compact and lightweight, mobile table top device with improved environmental impac
  • The image scanning method is clean and dry, unlike other destructive leak testing methods (eg Methylene Blue Dye Test), and does not destroy test product or packaging.
  • Pass or fail criteria can be set to the same micron level as your existing Blue Dye Test.
  • Users of the Sepha VisionScan can expect a ROI of less than one year when replacing the methylene blue dye test
  • Touch screen operator interface. No special technical skills required.
APPLICATIONS
Drug stability testing in laboratories

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

QA Testing of packaging processes
Build leak tests into Quality Assurance procedures for your blister packaging line. Objective seal testing maintains compliance and ensures the integrity of the packaging process. VisionScan ensures protection from moisture, air and bacteria and allows investigation of atypical results.

Reduce production rejects
Minimise reject blisters and waste disposal created in pharmaceutical production and packaging facilities by carrying out leak testing more frequently. Earlier detection of a leak means line operators can troubleshoot the cause of a leak before large volumes of faulty blisters are produced.

MediScan

MediScan is a tool-less, non-destructive leak detection device for non-porous pouches, sachets and medical device packaging

  • 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*
  • Table top device
  • Capable of handling wet or dry 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 (x2) or integrated into local quality control system via Ethernet cable
  • Fast, efficient test speed
  • Audit data available and fully 21 CFR part 11 compliant.
APPLICATIONS
Drug stability testing in laboratories

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

QA Testing of packaging processes
Build leak tests into Quality Assurance procedures for your blister packaging line. Objective seal testing maintains compliance and ensures the integrity of the packaging process. VisionScan ensures protection from moisture, air and bacteria and allows investigation of atypical results.

Reduce production rejects
Minimise reject blisters and waste disposal created in pharmaceutical production and packaging facilities by carrying out leak testing more frequently. Earlier detection of a leak means line operators can troubleshoot the cause of a leak before large volumes of faulty blisters are produced.

BottleScan

BottleScan is a non-destructive, tool-less multi-bottle leak tester for induction-sealed pharmaceutical bottles

  • Detects defects in bottles and induction seals down to 15µm
  • Tests up to 4 bottles per test cycle in a test term of 30 – 90 seconds
  • Can run in compliance with 21 CFR Part 11
  • Operating system can store up to 30,000 product types
  • No tooling required so ideal for production lines with multiple products
  • Quick, repeatable test with objective pass/fail results
  • Can handle multiple bottle sizes
  • Configurable methods allow user to decide machine sensitivity
  • Simple operator use with minimal training required
  • Audit data available and can form part of 21 CFR Part 11 compliant system
  • Active Directory and OPC connectivity available on request
APPLICATIONS
Drug stability testing in laboratories

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

QA Testing of packaging processes
Build leak tests into Quality Assurance procedures for your blister packaging line. Objective seal testing maintains compliance and ensures the integrity of the packaging process. VisionScan ensures protection from moisture, air and bacteria and allows investigation of atypical results.

Reduce production rejects
Minimise reject blisters and waste disposal created in pharmaceutical production and packaging facilities by carrying out leak testing more frequently. Earlier detection of a leak means line operators can troubleshoot the cause of a leak before large volumes of faulty blisters are produced.

Multi-Q

Multi-Q is a multi-functional, non-destructive leak test system for rigid and flexible packaging including vials, pouches, sachets, bottles, bags and medical devices

  • In addition to Vacuum and Pressure Decay methods, the Multi-Q is also compatible with a Flexible Membrane, Ramp to Event, Ramp to Proof Pressure and Occlusion attachment, offering an all-in-one solution to test the integrity of all types of pharmaceutical containers including sachets, pouches, bags, trays, medical devices and modified atmospheric packaging (MAP).
  • 1. FLEXIBLE MEMBRANE
  • Non-destructive seal and leak detection device designed for flexible or semi-flexible packaging
  • Using hybrid membrane technology, the flexible head utilizes the ASTM F2338-09(2013) test method to perform the leak test
  • Can detect all defect types including channel leaks, weak seals and pin holes down to 15µm
  • Tool-less
  • Can test packages that contain tablets/capsules/devices/powders
  • Ideal for testing pouches, sachets and bags
  • 21 CFR Part 11 compliant
  • 2. VACUUM DECAY
  • Non-destructive, deterministic quantitative test method
  • Utilizes vacuum decay to identify leaks and channel leaks as low as 5µm
  • Ideal for testing bottles, ampoules, vials, BFS strips & bottles, medical devices, Pre-filled syringes, pouches and trays
  • Can test containers with a water based liquid, protein/glucose, lyo/powder content
  • Rapid test time as low as 10 seconds
  • Utilizes the ASTM F2338-09(2013) test method to perform the leak test
  • 21 CFR Part 11 compliant
  • 3. PRESSURE DECAY
  • Non-destructive, deterministic, quantitative test method
  • Utilizes pressure decay to identify leaks and channel leaks as low as 5µm
  • Ideal for testing vials, ampoules and bottles
  • Can test containers with a toxic product, oil based liquid, lyo/powder content
  • Rapid test time as low as 10 seconds
  • 21 CFR Part 11 compliant
  • 4. RAMP TO EVENT
  • Destructive, deterministic, quantitative test method
  • Utilizes pressure/vacuum to ramp to a failure event
  • Ideal for component testing to detect weak welds/seals etc.
  • 5. RAMP TO PROOF PRESSURE
  • Non-destructive, deterministic, quantitative test method
  • Utilizes pressure/vacuum to ramp to a target pressure
  • 6. OCCLUSION
  • Non-destructive, deterministic, quantitative test method
  • Utilizes pressure drop/time
  • Typically used to test parts that must remain open to function correctly

 

Deblistering

Blister packs can be rejected for several reasons including empty pockets, incorrect product, incorrect batch coding, leak test failure and inventory changes. When valuable tablets or capsules need to be recovered it is essential minimal pressure is used during deblistering to extract the product to ensure foil pieces do not detach from the blisters and product damage is prevented.

Sepha has developed a comprehensive range of automatic, semi-automatic and manual deblistering machines that offer speed, efficiency and safety in the recovery of valuable product from all types of rejected blister packs including push-through, child-resistant and peelable blisters.

PressOut Manual Wide

PressOut Manual Wide is a manual deblistering machine for recovering tablets and capsules from push-through blister packs.

  • Portable & flexible – can be adjusted quickly to suit any push-through blister pack
  • Fully cGMP compliant and easily cleaned
  • Handles thermoform/alu as well as coldform/alu blisters
  • The patented mechanism is adjustable for many different push-through blister formats.
  • There is no need to purchase a different set of change parts for every different blister pack.
  • Product recovered cleanly and hygienically
  • Ideal for small batches
APPLICATIONS

Pharmacy dispensing 

Ideal for deblistering of bulk-supplied blisters for dispensing drugs into monitored dosage systems (MDS) tailored for individual patients in hospitals, nursing homes or other managed care facilities. Perfect for assisting with refilling cartridges in automated dispensing systems.

Clinical trials in laboratories 

Enables deblistering of valuable clinical trial drugs from unused packs. Also, competitive products need to be deblistered and repacked for use in double blinded clinical trial studies.

Quality control testing

Testing packaging material characteristics.

Pharmaceutical production and packaging facilities 

Ideal to empty blisters which have been rejected from the packaging line because of empty pockets, poor seals, incorrect batch coding etc. The good product can then be re-packaged to increase yield and reduce wastage costs. Fluctuating market demands can be managed easily by deblistering surplus stocks of finished blister packs and re-packaging the contents in formats to suit the needs of other markets.

For waste disposal

When the product reaches the end of its shelf life it needs to be destroyed.  For reject blisters containing toxic product, there often is an expensive disposal process of the product is not separated from its packaging.

PressOut Universal

PressOut Universal is a high-speed automated deblistering machine that recovers tablets and capsules from rejected blister packs including child resistant and peelable packs

  • Automated, variable speed control & operation setting
  • Capable of removing product from child resistant packs
  • Automatic feed
  • Can deblister up to 50 blister packs per minute
  • Handles all pack formats
  • Integrated 316 Stainless Steel product collection bin
  • Zero contamination levels
  • Fully cGMP compliant
  • Temperature and humidity monitoring option
  • Easy access for fast cleaning and product changeover
  • Suitable for all types of blister pack including curved formats, peelable and heavy gauge alu/alu products
  • Up to 50 blisters per minute with automatic feed

 

PressOut Semi-Automatic

PressOut Semi-Automatic is a tool-less, portable, semi-automatic deblistering machine for recovering tablets and capsules from push-through blister packs.

  • Portable & flexible – can be adjusted quickly to suit any push-through blister pack
  • Fully cGMP compliant and easily cleaned
  • Handles thermoform/alu as well as coldform/alu blisters
  • The patented mechanism is adjustable for many different push-through blister formats.
  • The neoprene rollers come in different grades of hardness so that softer guide rollers can be used for more fragile products.
  • There is no need to purchase a different set of change parts for every different blister pack.
  • Product recovered cleanly and hygienically
  • Ideal for small batches

 

APPLICATIONS

Pharmacy dispensing 

Ideal for deblistering of bulk-supplied blisters for dispensing drugs into monitored dosage systems (MDS) tailored for individual patients in hospitals, nursing homes or other managed care facilities. Perfect for assisting with refilling cartridges in automated dispensing systems.

Clinical trials in laboratories 

Enables deblistering of valuable clinical trial drugs from unused packs. Also, competitive products need to be deblistered and repacked for use in double blinded clinical trial studies.

Quality control testing

Testing packaging material characteristics.

Pharmaceutical production and packaging facilities 

Ideal to empty blisters which have been rejected from the packaging line because of empty pockets, poor seals, incorrect batch coding etc. The good product can then be re-packaged to increase yield and reduce wastage costs. Fluctuating market demands can be managed easily by deblistering surplus stocks of finished blister packs and re-packaging the contents in formats to suit the needs of other markets.

For waste disposal

When the product reaches the end of its shelf life it needs to be destroyed.  For reject blisters containing toxic product, there often is an expensive disposal process of the product is not separated from its packaging.

PressOut Universal Mini

PressOut Universal Mini is a bench top, automated deblistering machine for recovering low volumes of pharmaceutical tablets and capsules including child resistant and peelable blister packs

  • Deblisters at a speed of up to 16 packs per minute
  • Bench top unit with small footprint
  • Capable of recovering tablets and capsules from peelable and child resistant blister packs
  • Automatic feed
  • Simple operation via Allen Bradley touchscreen HMI
  • Simple, fast tooling setup and changeover
  • Easy access for cleaning
  • Fully cGMP compliant
  • Low cost tooling
  • Mobile workstation available as an optional extra
  • Zero contamination levels

 

PressOut Automatic

PressOut Automatic is an automatic deblister machine for recovering tablets and capsules from push-through and multi-product blisters with in-line layouts

  • Automatic Feed and user interface with fault indicators
  • Fully cGMP compliant & easy to use
  • Variable speed up to 60 blisters per minute
  • Handles thermoform/alu as well as coldform/alu
  • No product or foil contamination
  • Pack counter
  • Sensor to prevent magazine operating when empty
  • The patented roller and guide system gently eases product out of the pocket so that minimal pressure is exerted on the tablets.
  • The neoprene rollers come in different grades of hardness so that softer guide rollers can be used for more fragile products
APPLICATIONS

Pharmacy dispensing 

Ideal for deblistering of bulk-supplied blisters for dispensing drugs into monitored dosage systems (MDS) tailored for individual patients in hospitals, nursing homes or other managed care facilities. Perfect for assisting with refilling cartridges in automated dispensing systems.

Clinical trials in laboratories 

Enables deblistering of valuable clinical trial drugs from unused packs. Also, competitive products need to be deblistered and repacked for use in double blinded clinical trial studies.

Quality control testing

Testing packaging material characteristics.

Pharmaceutical production and packaging facilities

Ideal to empty blisters which have been rejected from the packaging line because of empty pockets, poor seals, incorrect batch coding etc. The good product can then be re-packaged to increase yield and reduce wastage costs. Fluctuating market demands can be managed easily by deblistering surplus stocks of finished blister packs and re-packaging the contents in formats to suit the needs of other markets.

For waste disposal

When the product reaches the end of its shelf life it needs to be destroyed.  For reject blisters containing toxic product, there often is an expensive disposal process of the product is not separated from its packaging.

Clic-Open

Clic-Open is a safe and easy glass ampoule opener that reduces the risk of injuries

 

 

 

 

 

Clic-Open is a handy gadget which snaps off the top of glass ampoules without leaving jagged edges. It can be used by anyone who needs to administer liquid drugs supplied in ampoules, including:

  • Nurses
  • Doctors
  • Paramedics
  • Midwives
  • Ambulance staff
  • First Aiders
  • Patients

It is an instant hit with healthcare professionals and patients because it:

  • Prevents sharps injuries by protecting fingers from glass cuts
  • Is hygienic and reduces contamination
  • Is easy to use
  • Is durable – opens up to 200 ampoules
  • Is flexible – opens pre-stressed and “easy-open” ampoules

SAFETY GADGET

Why is Clic-Open better than opening ampoules by hand?

Ampoules are dangerous to break open by hand or using a file or protective gauze. When the ampoule head is snapped off, the glass often breaks leaving sharp jagged edges which can cut the user’s fingers. Slivers of glass or gauze fibres can also fall into the liquid drug.

PROMO TOOL

A safety gadget is an imaginative and ethical give-away for the medical industry to encourage brand re-enforcement and customer loyalty.

If you are a marketing or advertising professional working for a pharmaceutical company which sells drugs in ampoules, then the CLIC-OPEN ampoule opener is an ideal giveaway at hospital or pharmaceutical exhibitions and events. Medical sales staff can even use it as a novel gift.

  • Great brand exposure for medics!

Print the company or product logo on the side of Clic-Open so that the company’s brand is exposed every time an ampoule is used.

  • Include in patient injectable kits

Clic-Open is a great added value premium to include in patient kits for drugs that must be dispensed in glass ampoules.

OPERATION

Clic-Open uses a tiny tungsten carbide cutter to score the glass before snapping the ampoule open.

  1. Insert the ampoule head into the jaws of the CLIC-OPEN. Holding the ampoule steady, press only the upper jaw with the cutter onto the ampoule neck. Turn lightly to give a 1mm score.
  2. Without squeezing the jaws together, but using the lower jaw only as an anchor, break open the ampoule at the score line.
  3. Push in the plunger to eject the head of the ampoule into a waste container

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