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Foil pouches packaging solution for various industries, including pharmaceuticals and medical devices. Ensuring the integrity of these pouches is crucial to maintain product quality and safety. Helium leak detection systems such as SIMS 1915+ helium-based technology play a vital role in this process. By identifying potential leaks early on these systems help prevent product contamination, extend shelf life, and safeguard customer health.

Foil pouches offer a straightforward and effective solution for sterile barrier packaging, particularly well-suited for medical equipment and pharmaceuticals. Ensuring the integrity of these pouches is crucial to maintain product quality and safety. SIMS 1915+ helps in safeguarding product integrity. The integrity of foil pouches is crucial to maintain product quality and safety. Pouch defects can compromise product quality and introduce contamination risks, potentially leading to product degradation and health hazards for patients. Consequently, rigorous testing of foil pouches is essential to ensure package quality and reliability.

Why are foil pouches used in pharmaceutical industry

Foil pouches are lightweight, flexible, and cost-effective, making them easy to store and transport. Foil pouches can be resealed, extending product shelf life and preventing contamination. Package property of foil pouches help protect sensitive medications from moisture, oxygen, and light, ensuring product integrity. Foil pouches are also compatible with various sterilization methods, making them suitable for sterile product. It can be customized to accommodate different product sizes and shapes, offering versatility in packaging design. By using leak detection systems like SIMS 1915+, manufacturers can further enhance the quality and safety of foil pouch packaging, ensuring medications reach consumers in pristine condition.

Foil pouches package integrity testing using SIMS 1915+

The SIMS 1915+ is a helium leak detection system specifically designed for the pharmaceutical and medical device industries. It utilizes helium as a tracer gas to accurately detect leaks in a variety of packaging formats, including foil pouches, bottles, vials, blister cards, syringes, and cartridges. Unlike traditional methods like vacuum bubble and dye penetration tests, SIMS 1915+ provides quantitative measurements, ensuring a higher level of precision. This advanced system offers numerous applications, including package design validation, tooling certification, manufacturing line setup, and ongoing quality control. Its oil-free pump, detector, and integrated power system are tailored to the specific needs of the industry, enabling the detection of leaks as small as 1 x 10-10 mbar L/s at room temperature. Each SIMS 1915+ device can be customized to meet the unique requirements of individual clients, providing a flexible and reliable solution for maintaining product integrity.

Applications of SIMS 1915+ include:

• Pre-filled syringes
• Bottles
• Blister packs
• Foil pouches
• Vials
• Combination products (cartridges)

Benefits of SIMS 1915+ in foil pouches

• Detects microscopic defects invisible to the eye, ensuring product integrity.
• Provides precise leak rate measurements for rigorous quality control.
• Offers rapid testing cycles for efficient production.
• Adapts to diverse foil pouch configurations.
• Ensures adherence to regulatory standards and industry best practices.

EGG HARBOR TOWNSHIP, N.J. (PRWEB)

Leak Detection Associates (LDA), the world’s premier manufacturer of custom built, helium-based leak testing instruments for the Pharmaceutical, Biotechnology, Medical Device and Food Packaging Industries is excited to announce the launch of its newest and most advanced helium leak detection system, the SIMS Model 1915. The SIMS 1915+ unit is engineered incorporating industry-leading Agilent Technologies components and is custom designed to meet the stringent requirements of clients in FDA-regulated industries. The new unit will replace the SIMS 1284+, marketed by LDA for the past 12+ years, and represents the most advanced and sensitive system available worldwide. With a revised interface and corresponding pump configuration specifically intended for pharma/biotech package testing, clients will see an improvement in instrument performance with more intuitive operation. Notably, the launch of the system coincides with the release of the all-new 21 CFR Part 11 compliant software package developed by the Leak Detection Associates software development team.

“While the SIMS 1284+ has proven to be a workhorse with a global client installation base for over 12 years, advancements in vacuum and helium-based technology have enabled our engineering team to improve component configuration and system performance, yielding the most advanced helium leak testing system for pharmaceutical and biotechnology applications. I am confident our clients will appreciate the new features, capabilities, and usability the SIMS 1915+ will offer”, commented Jeff Morrow Lucas Director of Engineering for Leak Detection Associates.

Key features and benefits of the new SIMS 1915+ model include:
• Base Helium Leak Detector powered by Agilent Technologies, globally recognized as a leader in the regulated market industries for laboratory equipment
• An IDP-15 Dry vacuum pump (oil free) rated for 15m3/hour (9 cfm) and a Patented dual pump design for fast clean up and background suppression
• Improved power-off process keeps spectrometer under vacuum and protects the turbomolecular pump, reducing operator dependency and increasing filament longevity
• Maximum Test Port Pressure of 13 mbar (10 Torr, 1333 Pa) and 200 mbar (150 Torr, 2000 Pa) in Gross Leak Mode

The new SIMS Model 1915+ model is available for immediate order and based upon an improved supplier relationship with Agilent Technologies, lead times for custom-built orders will decrease from the previous 12-14 weeks to as short as 4 weeks. As clients have come to expect, each new SIMS Model 1915+ will be customized to client’s specific testing needs whether testing vials, blister cards, cartridges, or pre-filled syringes. Each SIMS 1915+ can be complimented with Leak Detection Associates’ robust service and contract offerings to provide end-to-end leak testing solutions.

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EGG HARBOR TOWNSHIP, N.J. (PRWEB) DECEMBER 27, 2019

Leak Detection Associates (LDA), the world’s premier manufacturer of custom built, helium-based leak testing instruments for the Pharmaceutical, Biotechnology, Medical Device and Food Packaging Industries is excited to celebrate the completion of its first calendar year under new management. Following acquisition by CLJ Holdings in February, 2019, a comprehensive and aggressive reorganization plan was implemented by CEO Brian Mulhall, intended expand and improve product and service offerings to a global market. Multiple major milestones were achieved over the course of 2019, including opening a new company headquarters, strategic partnerships for global distribution and support, new product offerings including the Agilent-based SIMS 1915+ and low temperature (-80°C) testing systems, and the launch of newly developed Part-11 compliant SIMS software.

“Entering 2019, we outlined ambitious goals that, if accomplished, would reaffirm LDA’s position as the premier manufacturer of helium leak test instruments specifically tailored to the regulated life sciences industries” commented Alan Weiss, Chief Financial Officer of LDA. “As 2019 comes to a close, we are proud of our new facility and fresh product line which a platform for continued success in providing solutions for our clients worldwide.”

While helium leak detection has a longstanding history of use in pharmaceutical packaging operations, with ASTM F2391-05 being written by LDA founder Dr. Darrell Morrow, recent industry guidelines such as USP 1207 and the proposed revision to EU Annex 1 continue to drive adoption of more sensitive and deterministic leak tests worldwide. To better connect with this market, LDA launched a redesigned website in 2019 and has made a commitment to participating in industry events, such as Interphex and Parenteral Drug Association (PDA) Workshops on CCIT. To better cater to LDA’s client base with global site networks, newly established strategic partnerships were forged, including an agreement with IPP for instrument distribution and support across the UK and Ireland.

Critical to the 2020 product line, Director of Engineering Jeff Morrow-Lucas and his team created two new hardware offerings in 2019; notably the SIMS 1915+ Helium Leak Detection System packaged with LDA’s newly released, Part-11 compliant SIMS software. Incorporating Agilent Technologies components, the new system, completely redesigned, marks improvements in instrument performance, intuitive operation, and access to Agilent’s global maintenance and service network, while the newly developed SIMS software ensures data integrity. In addition, the newly released LT80 add-on system enables testing of pharmaceutical package systems at temperatures as low as -80°C, critical for many biologics, cell and gene therapies, which require storage or shipment at aggressive temperatures that can cause leakage.

As clients have come to expect, each new SIMS 1915+ will be customized to client’s specific testing needs, whether testing vials, blister cards, cartridges, or pre-filled syringes. Each SIMS 1915+ can be complimented with Leak Detection Associates’ robust and ever-expanding catalog of accessories, service, and contract offerings to provide end-to-end leak testing solutions.

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