FAQ

  • Leak Testing
  • Packaging Solutions
  • Deblistering

What kind of container types can you test?

Our range of leak test solutions can test most container types used in the pharmaceutical industry including blister packs, medical device trays, vials, ampoules, bottles, pre-filled syringes, blow filled seal, bags, sachets and stick packs.

What technologies and test principles are utilised by your technologies?

Depending on container type and content, our machines utilise different technologies. Blister packs for example are leak tested using vacuum decay, while flexible packaging is tested by force decay or a flexible membrane in combination with vacuum decay. We also offer CCIT solutions for parenterals including vacuum decay and pressure decay. And have developed method to perform ramp to event, ramp to proof or occlusion.

Are your leak test solutions non-destructive?

Yes, our range of leak test machines conduct non-destructive tests. Unlike traditional methods, for example blue dye, Sepha’s machines are non-destructive and reduce unnecessary, costly waste often associated with these test methods. Packs that have passed the test, can be returned to the production line.

How sensitive are your leak test solutions?

The sensitivity that can be achieved differs for each test method. Depending on container type and content, the Multi-Q vacuum and pressure decay methods can identify leaks as low as 5µm, while the VisionScan can test for micron holes in blister packs as low as 7µm. The sensitivity is often not determined by our machines, but by our customers’ requirements to demonstrate package integrity to protect the product inside.

Do you offer CCIT solutions?

Yes, the Sepha Multi-Q is multi-functional leak test machine developed to test Container Closure Integrity of parenterals including vials, ampoules, pre-filled syringes, bottles, BFS and liquid filled flexible packaging. The machine can be used in combination with different technologies including vacuum decay (ASTM F2338-09(2013)) and pressure decay.

Can you test packaging used in other industries like food & beverage, nutraceutical or diagnostics?

Yes, our leak test solutions can be used across different industries. While most of our projects are related to pharmaceutical packaging, in recent years we have worked with many different companies in other industries and have tested product including lenses, perfume bottles, dog treats, wet wipes, laundry tablets etc.    

Are your tests ASTM compliant?

Yes, they comply with ASTM standard F2338-09(2013)

Do you offer in-line leak test solutions?

All our standard leak test solutions are off-line, that can be used in lab environments or next to a large packaging line. While we don't offer standard in-line solutions, our technologies are adaptable. We have worked on different projects where our technologies have been integrated to provide in-line solutions.

What materials can your blister packaging machines pack?

The EZ range of blister packaging machines can package a wide variety of materials including PVC, PVdC, Tyvek, Aclar®, AluAlu and Peelables

How are the thermoformed trays filled with tablets or capsules?

Using the EZ range of blister packaging machines, the thermoformed trays are filled manually between the forming and sealing cycles. This is a quick and easy process.

Can you add print or coding to the blister packs?

Our packaging machines do not have the facility to print text or images onto a blister pack, but they do have the ability to emboss coding digits onto the sealed pack. For example, expiry dates and batch codes.

What materials can the EZ Blister AutoFeed use?

The Autofeed option can be used for both thermoform and coldform packaging requirements. Material must be minimum of 130mm and maximum of 170mm width.

Can you supply a separate cutting machine, instead of a complete EZ Blister (AutoFeed)?

Currently we do not have an off the shelf cutting machine that is separate to the EZ Blister or EZ Blister AutoFeed.

What documents do you provide?

We can provide a full suite of documents, including but not limited to, specification documents (FDS, URS) User Manual (Including declaration of conformity, material certificates, spares & parts list, pneumatic & electrical drawings) and validation documents (IQ/OQ)

What is the main reason for deblistering product from blister packs?

There are different reasons to deblister tablets or capsules from blister packs. Pharmacies for example deblister blister packs for dispensing purposes, while for pharmaceutical manufacturers it is key to recover valuable product from rejected blister packs. We will discuss the most common reasons below. Read more...

What types of blister packs can be deblistered?

Different types of blister packs can be deblistered ranging from peelable child-resistant packs to alu/alu push-through packs to staggered multi-product packs. An overview of the different blister pack types that can be deblistered per machine is available on the page What types of blister packs can be deblistered?

Can your machines deblister child-resistant packs?

Yes, the PressOut Universal and PressOut Universal Mini include a sophisticated cutting technology that is suitable for all types of blister packs including curved formats, peelables and heavy gauge alu/alu or child-resistant blister packs. The machines provide a gentle operation where the foil around the pockets is partially cut before pressing-out the product. This minimises pressure on fragile or valuable products and prevents foil contamination as the foil remains attached to the waste blister pack during emptying.

How many blister packs can be deblistered per minute?

The deblister rate per hour varies per machine, ranging from from 16 up to 60 packs per minute depending on blister pack type. PressOut Manual Wide (up to 20/minute), PressOut Semi-Automatic (up to 30, minute), PressOut Automatic (up to 60/minute), PressOut Universal (up to 50/minute), PressOut Universal Mini (up to 16/minute).

Are your machines suitable to deblister packs that contain fragile or valuable tablets or capsules?

Yes, all models in the PressOut range use minimal pressure to extract tablets and capsules to prevent product damage during the deblistering process. This also ensures foil pieces do not detach from the blisters to prevent foil contamination. The PressOut Universal range has been developed for those products that need extra protection. The process features a cutting technology that partially cuts around the pocket, minimizing the pressure required to push out fragile or valuable products.

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