01
Nov 2020

Leak Detection Associates Announces New and Updated Helium Leak Detection System

2019 PDA Container Closure Integrity Testing Workshop Presentation

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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280
24
Jun 2020

Leak Detection Associates Announces New SIMS 1915+ Low Temperature -80C Helium Leak Testing System

Leak Detection Associates Announces New SIMS 21 CFR Part 11 Compliant System Software

EGG HARBOR TOWNSHIP, N.J. (PRWEB) DECEMBER 12, 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 announce its second major product launch of 2019. The new LDA LT80 (LOW TEMPERATURE -80C) helium leak testing system is designed for testing containers at temperatures as low as -80°C. Incorporating an SP Corporation Chiller, LDA’s LT80 system allows for concurrent temperature conditioning, temperature monitoring, and helium leak testing of packages. The LT80 is available as an upgrade to existing LDA SIMS units in the field, or as a complete package, the LDA SIMS 1915+ LT80, incorporating the recently released features of the industry-leading, Agilent Technologies-based SIMS 1915+ with 21 CFR Part 11 compliant SIMS Software. The LDA SIMS 1915+ LT80 package represents the first time a ready to order, off the shelf, Part 11 compliant helium leak testing system specifically configured for low temperature testing down to -80°C has been available in the marketplace.

“Many innovative biopharmaceutical products coming to market today feature proteins that typically degrade at room temperature. Companies continue to drive toward deeper cold storage to support these products, and are in need of developing container and package systems that can maintain container closure integrity at these challenging conditions and throughout the product lifecycle, as set forth by USP 1207,” commented Jeff Morrow Lucas Director of Engineering for Leak Detection Associates. “Based on expressed needs of the marketplace, the SIMS 1915+ LT80 unit is designed for this specific application – testing packages while at cold conditions down to -80C – and provides an easy to implement solution to this evolving need for analysis.”

The key objective of any CCI program is to ensure that the container closure system maintains integrity throughout its lifecycle by preventing ingress of elements detrimental to a product’s efficacy and sterility, such as microbes or reactive gases, or egress of product or package headspace. The freeze/thaw cycle that is common with biologically-based products frequently require extremely low storage and shipment temperatures. When exposed to deep-cold or ultra-cold temperatures, physical changes to elastomeric components in particular can occur as materials reach or exceed their glass transition state, creating leaks at low temperatures that would otherwise not be observed while at room temperature. This type of leakage is typically observed at primary seal areas, such as that between an elastomeric closure and glass vial being used below -60C. This is of particular relevance for those shipping on dry ice, which reaches temperatures down to approximately -78C. Having a means to test container closure integrity while at these low temperatures enables manufacturers to gain insight into optimal package choice and design, as well as assembly parameters, to minimize leakage and demonstrate robust understanding of a package system’s performance in accordance with USP 1207.

The new SIMS Model 1915+ LT80 model is available for immediate order and will be customized to client’s specific testing needs. Each SIMS 1915+ LT80 can be complimented with Leak Detection Associates’ robust service and contract offerings, custom test fixtures, and change parts to provide end-to-end leak testing solutions.

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104
30
Dec 2019

Leak Detection Associates Announces New SIMS 21 CFR Part 11 Compliant System Software

Leak Detection Associates Announces New SIMS 21 CFR Part 11 Compliant System Software

EGG HARBOR TOWNSHIP, N.J. (PRWEB) DECEMBER 30, 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 pleased to announce the release of its new SIMS Version 1.11.19 21 CFR Part 11 compliant software program specific to the custom-built helium leak testing systems it designs and manufactures. The new program, which was developed to support both existing SIMS 1284+ models and the new SIMS 1915+ units, makes LDA the sole marketplace supplier of helium-based leak testing systems that meet all of the 21 CFR Part 11 software requirements as dictated by the Food & Drug Administration (FDA).

“Meeting the strict regulatory demands now in place for any computer-driven analytical instrument is a critical factor in terms of quality system compliance. Dedicating the time and resources to development of a complete Part 11 compliant instrument operation program allows us to stand as a leader in the marketplace and deliver a solution to exceed client expectations, ” commented Alan Weiss, Chief Financial Officer of LDA.

Over the past twenty years, with the increasing use of computer systems and electronic records, the FDA has issued a number of guidance documents and directives that outline specific requirement for electronic data management. Systems must account for multiple level login of users, application of electronic signature and approval, secure data management that prevents alteration of existing results and an electronic audit trail that records all relevant events in a time and date stamped pattern. Contracting with a development team that specializes in development of instrument operation software programs and with extensive experience in the Part 11 area, LDA was able to design a robust and comprehensive program specific to helium leak testing on our custom-designed and manufactured systems, while improving functionality and usability compared to existing software options.

For existing SIMS units in the marketplace, LDA is offering a system software upgrade program for easy installation performed onsite for a client’s existing install base. All new instruments ordered, inclusive of new models – the SIMS 1915+ and SIMS 1915+ LT – will come with the new 21 CFR Part 11 program.

TO READ FULL PRWEB PRESS RELEASE PLEASE CLICK HERE

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helium-based leak testing instruments, SIMS 1915+, SIMS 1915+ LT
100
27
Dec 2019

Leak Detection Associates Celebrates Major 2019 Milestones

Leak Detection Associates Announces New SIMS 21 CFR Part 11 Compliant System Software

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.

TO READ ENTIRE PRWEB PRESS RELEASE PLEASE CLICK HERE

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sims 1915+, helium leak detection system, low temperature testing systems
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