Blogs

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.

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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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