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) MAY 22, 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 that a formal partnership agreement with Industrial Production Processes (IPP) Ltd has been signed. The agreement will grant exclusive rights for IPP group to represent LDA in the countries of England and Ireland. With locations in Cork, Ireland and Worcestershire, UK, IPP is well positioned in both locations to meet the needs of LDA clients who are in need of helium-based leak testing instruments and systems and the ancillary services that go with them. IPP maintains of staff of 24 service and sales engineers that will be in the ready to serve existing and new clients. As a leading package system instrument and service provider in these geographic areas, IPP has the local knowledge and experience to enhance the already strong Leak Detection Associates’ brand.

“Global expansion is a key initiative of the new Leak Detection Associates management team and we are excited to partner with IPP to make this possible in Ireland and the UK,” commented Brian Mulhall, CEO of Leak Detection Associates. “I have known and worked with Jack Daly and the IPP group in previous settings and the team always brings a high level of knowledge, experience and client care to their work. They are a leading provider of package equipment and laboratory instruments in these countries and we are happy they will be our partners.”

Commented IPP Managing Director Jack Daly, “Partnering with LDA was an easy and natural decision as we are already well established in the relevant packaging instrument field and their technology allows the IPP team to better serve our client base with a broader product and service offering.”

IPP will serve as the exclusive product and service provider for Leak Detections Associates complete line of products and services. The current model SIMS 1284+ helium leak detection instrument is the only custom designed and manufactured helium leak testing instrument that meets the regulatory requirements of the pharma, biotech and medical device industries. In addition, LDA and IPP will offer a full suite of support services that will include custom designed change parts to address various container and package configurations, system parts and add-on options as well as local service, repair and qualification programs.

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EGG HARBOR TOWNSHIP, N.J. (PRWEB) MAY 13, 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 the go-live of a completely new Heliumleak.com company website. The redesigned website aims to improve LDA’s ability to communicate directly with the marketplace; serving as a destination to learn LDA’s product and service offerings, news and events, but also as a knowledge center for those interested in helium leak detection applications and CCIT in general.

“For those first exploring any topic, whether it be CCI or unrelated, the first step will be to seek information online.” commented Brian Mulhall, CEO of Leak Detection Associates. “In redesigning LDA’s Heliumleak.com, this was kept in mind. In addition to more detailed descriptions of products, services, and applications of helium to specific package systems, the Resource Center will serve as an industry-leading destination for up-to-date information on all aspects of CCI. Blogs and Whitepapers will routinely be released discussing unique applications of helium leak detection and CCI in general, and an entire section is dedicated to topics such as FDA, EMA, USP, and ASTM guidance.”

The Products section now includes more detail about LDA’s flagship detector, the SIMS 1284+, but also will serve to highlight current and future complimentary offerings, such as LDA’s proprietary vial filling kit and Headspace Analyzing Module (HSAM), which allow for testing of pre-sealed vials. The redesigned services section now clearly highlights LDA’s 20+ years of experience in qualification, calibration, but also consultation, feasibility, and method development services. Uniquely, an entirely new section was added for Applications, which discusses helium-leak approaches for specific package systems, such as vials, pre-filled syringes, combination products, blisters, and more.

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