Sepha showcasing pharmaceutical packaging and leak test innovations at Pack Expo 2022

Sepha showcasing pharmaceutical packaging and leak test innovations at

Pack Expo 2022

Belfast, UK, 13th October 2022: At Pack Expo International 2022, Sepha will showcase its latest
packaging and leak test innovations, including the VisionScan 3D, the Multi-Q HD and the EZ
Blister+. Pack Expo International will be the first time that many of Sepha’s North American
customers have the chance to see these new technologies on display together, as the company
debuts its own dedicated booth themed around quality, integrity and reliability.

For over 40 years Sepha has provided the pharmaceutical, medical device and healthcare
industries with solutions to accurately detect leaks in packaging, recover high-value products from
rejected blister packs and create high-quality blister packs. These specialised, high-quality
machines enable pharmaceutical manufacturers to improve quality assurance procedures, reduce
manufacturing costs and meet regulatory requirements.

Taking centre stage will be Sepha’s two key products from the leak testing range, the VisionScan
3D and Multi-Q HD. Both are non-destructive and reliable quality control systems to test the
integrity of pharmaceutical packaging including blister packs and parenterals. They are in line with
American Society for Testing and Materials (ASTM) standard test methods and United States
Pharmacopeial Convention (USP) 1207 guidelines that prefer deterministic methods. They also
can form part of a 21 Code of Federal Regulations (CFR) Part 11 compliant environment.
• VisionScan 3D – a blister leak test solution that is built around a new patented 3D
measurement technique to test the integrity of pharmaceutical blister packs. The 3D
technology is used in combination with differential pressure and vacuum and enables the
machine to detect leaks in individual blister pockets as low as 5μm (pack and material
dependent). The new technology can be applied to all foil types, matt or gloss. Different text
patterns can be tested with one test method, making it ideal for production lines with
multiple language print variations. The system is designed to allow for easy calibration,
quick set up times and a streamlined validation process across different foil types.
• Multi-Q HD – a non-destructive, deterministic and reliable Container Closure Integrity (CCI)
test system developed to detect leaks down to 1μm in parenteral containers. CCI testing is
critical for parenteral applications as they often contain drugs that have a short shelf life and
are highly sensitive to oxygen or moisture; even the smallest defect can affect sterility and
efficacy of the drug. As the content is injected directly into the tissue or bloodstream, any

compromised container can jeopardise patient safety. These applications often have a
lower Maximum Allowable Leakage Limits (MALL) and require a higher level of sensitivity to
demonstrate CCI.

In addition, Sepha will also bring its latest development the EZ Blister+ that has been
developed to answer calls from larger pharmaceutical manufacturers and Contract
Manufacturing Organisations (CMOs) for a small-scale blister packaging machine with 21 CFR
Part 11 capabilities. With the demand for small batches of pharmaceuticals and medical
devices, manufacturers are increasingly unable to accommodate requests for low volumes on
their high-speed blister lines. Most current benchtop machines are not intended for commercial
production, and although capable of fulfilling small orders, do not have the necessary software
architecture for demonstrating 21 CFR Part 11 compliance.
• EZ Blister+ 21 CFR Part 11 – a small blister pack machine that meets the need for
electronic data storage capabilities and digital connectivity. It provides the same proven
blister packaging performance, but with added software capabilities that enable the creation
of electronic signatures, batch reports, audit trails and other electronic documentation. The
EZ Blister+ offers a 3-in-1 manufacturing process including forming, sealing and
perforating/cutting.

The Sepha booth (#W-14019) will be part of the Healthcare Packaging Pavilion, located in the
West Building. With 70,000 square feet of exhibits, the Healthcare Packaging Pavilion will be the
central hub for solutions targeted to the life sciences industry such as pharmaceuticals, biologics,
nutraceuticals and medical devices.

Paul Smith, Managing Director of Sepha, says: “This is the first time that our customers in North
America will have the chance to see all three of our machines together, in person, and to do it at
such an iconic event such as Pack Expo is very exciting for us at Sepha. The show not only brings
together the latest and most innovative technologies available on the market, but also everyone
involved in the pharmaceutical packaging industry. We’re really looking forward to finally meeting
with everyone in person to gain more insight into their packaging and leak testing requirements.
Our expert team will be on hand to give live demonstrations and show how Sepha’s solutions can
help solve industry wide problems.”
To see the innovative technologies in person, stop by Sepha’s booth in the West Hall, #W-14019,
or to book a meeting slot with one of the team, click here.

ENDS

For further information: Media contact:
Gabine McKeegan, Marketing Manager Izzy Turnock, The Scott Partnership
gabine.mckeegan@sepha.com sepha@scottpr.com
+44(0)28 9048 4848 +44(0)1477 539539
About Sepha
Founded in 1980, Sepha provides innovative, non-destructive leak testing solutions, lab scale
packaging solutions and deblistering machines for recovery of high value product. The company
has established a strong global sales customer service and support network in all major
pharmaceutical manufacturing markets. The company works with most of the world’s top
pharmaceutical companies helping them to improve quality assurance procedures and to reduce
manufacturing costs, enabling clients to efficiently meet the stringent regulatory requirements of
the industry.