02
Dec 2021

A Guide to SIMS 21CFR Part 11 Compliant System Software

A-Guide-to-SIMS-21CFR-Part-11-Compliant-System-Software

LDA, the global leader in helium-based leak detection systems for the pharmaceutical and medical devices industries. Helium leak testing is a technique for locating and identifying leaks in a closed vessel using a tracer gas, helium. The method of helium leak testing is often used to evaluate system performance. Helium gas is commonly employed as a leak testing medium because of its ability to detect and quantify leak rates at extremely low levels.

SIMS Version 1.11.19 21 CFR Part 11 compliant software program

SIMS Version 1.11.19 21 CFR Part 11 is a compliance software application particularly created and manufactured for custom-built helium leak testing equipment. The application was created to support SIMS 1915+ units and makes LDA the only helium-based leak testing system provider on the market that meets all the FDA's (Food & Drug Administration’s) 21 CFR Part 11 data integrity software criteria.

With the growing usage of computer systems and electronic records over the last two decades, the FDA has published a number of guidance documents and directives outlining particular requirements for electronic data management. Users must be able to log in at different levels, utilize electronic signatures and approvals, have secure data management that prohibits changes to current results, and have an electronic audit trail that captures all relevant activities in a time and date stamped pattern.

LDA was able to build a robust and thorough helium leak testing procedure on our custom-designed and built systems. This improves functionality and usability compared to existing software options, by contracting with a development team that specializes in the development of instrument operation software programs and has extensive experience in the Part 11 area. LDA is offering a system software update program for current SIMS devices in the market for quick onsite installation for a client's existing installation base. The 21 CFR Part 11 program consists of all the instruments, including SIMS 1915+ and SIMS 1915+ LT low temperature add-on units.

Leak Detection Associates has been the major provider of custom helium leak detection equipment to the pharmaceutical, and medical device industry for over 20 years. Based on intended usage and target package system configuration, each test system is developed to meet regulated quality system requirements as well as the particular client's specifications. The LDA team creates custom add-on components for clients that need a flexible leak detection system that can be used with a variety of package types and configurations. This ensures flexibility in reaching particular research goals.

Readmore...
helium-based leak detection systems, helium leak testing, helium leak detection, helium mass spectrometry, sims 1915+
143
08
Sep 2021

An Overview of Helium Leak Detection Technologies

An-Overview-of-Helium-Leak-Detection-Technologies

Helium leak detection technology is used to identify tiny leaks in a contained system. Other detection techniques may not be applicable due to operating limitations or if the leaks are so small that other techniques cannot find them. Due to its tiny size and inert nature, helium is an excellent choice for testing purposes. It has no effect on the materials in the item to be tested. Because of a variety of factors, helium is a preferable option as a tracer gas.

  • Non-toxic, inert, and non-flammable
  • The tiny atomic size makes it easy to pass through leaks

Helium is detected with a mass spectrometer or helium sniffer, however, it is also possible to utilize a residual gas analyzer. In comparison to other methods of finding leaks, helium testing is a thousand times more sensitive.

Various technologies

  • SIMS 1915+
  • SIMS 1915+ is the ideal option for helium leak detection in pharmaceutical and medical device packaging systems. Vials, syringes, cartridges, and blister cards are some of the most common applications. Helium is commonly used to test the rubber stopper on a vial or the plunger on a syringe or cartridge assembly for leaks in parenteral goods. Sensitivity level as low as 1 x 10-10 mbar/L/sec may be measured with SIMS 1915+, which offers useful data sets instead of a basic pass/fail condition while allowing testing to be done at ambient temperature. It is important to note that each SIMS 1915+ Helium Leak Testing device is custom-built to meet client-specific requirements and package specifications.

  • Cold storage package test systems
  • In an effort to retain product quality features, pharmaceutical and biologic firms continue to push for extended cold storage. In addition to requiring storage at temperatures below -20°C, many of these goods also require dry ice (-78.5°C) or liquid nitrogen (-200°C) for storage and delivery. However, many of the materials utilized in these package systems and responsible for preserving package integrity are not routinely evaluated at these temperatures. The glass transition state of elastomeric materials can be reached or exceeded at deep-cold or ultra-cold temperatures, causing leaks at low temperatures that would not otherwise be detected at room temperature.

  • HSAM and Vial Filler
  • When it comes to helium-based leak testing systems, the Head Space Analyzer Module (HSAM) with vial filling assemble is a key component. As part of the HSAM, a probe measures the helium content in the headspace of a container system. With the optional vial filling assembly, previously sealed vials may be prepared for testing by replacing the headspace gas with 100 percent helium before the test is performed. After capping, this module can be used to prepare samples for testing or to prepare samples that have been kept for some time before testing. They may be used in conjunction with the VM-2 to get precise readings that can be included in flexible research designs.

  • Sniffer Probe
  • This simple technique of tracer gas leak detection employs a sniffer probe to detect the gas's presence and locate the location of the leak. The tracer gas is initially applied to the part or system. With the sniffer probe, the operator then conducts a systematic search for probable leak spots. When it comes to finding micro leaks, sniff leak locating is quite successful. It is best used for examining smaller quantities of items. While the cost of sniffer testing depends on the kind of tracer gas utilized, it is a proven option for leak detection and localization.

  • Package Test Fixtures
  • Outside the box, no leak testing is possible using a Helium Leak Detector. An HLD is only one component of a matrix that makes a useable system, just like a display is part of a computer system. Checking for quality packing material and sealing is a part of testing a package. By squeezing and holding it underwater, an operator checks for bubbles in a package using the manual leak testing method. The package retains atmospheric pressure when there are leaks.

  • Calibrated Leak Standards
  • To support everyday usage, daily performance verification or system suitability tests, as well as planned certifications, LDA supplies full sets of calibrated helium leak standards. Each SIMS 1915+ has an inbuilt helium leak standard. Using a given leak rate, this technique releases a certain concentration of Helium. On each day of usage, it is utilized automatically by the instrument, or on-demand for autocalibration prior to analysis. Each external helium leak standard by LDA releases helium at a defined leak rate, similar to the internal leak standards. But instead of living inside the instrument, they attach to the test port in the same manner that a sample fixture would be installed in the system.

Some basic applications

  • Glass Vials
  • Pre-filled Syringes
  • Bottles
  • Blister Packs
  • Foil Pouches
  • Combination Products
Readmore...
helium leak detection, helium leak test, helium detector, helium mass spectrometer leak detector, sims 1915+
343
15
Jul 2021

Why is SIMS 1915+ an Ideal Choice for Helium Based Leak Detection?

Why-is-SIMS-1915-an-Ideal-Choice-for-Helium-Based-Leak-Detection

Leak testing may be understood as a form of non-destructive quality control procedure used to determine if an object, product, or system functions within a specified leak limit. When a gas or liquid escapes through a manufacturing defect such as a hole, crack or weak seal, it is considered a leak. Since such a leak can compromise quality of the product, appropriate leak testing is an important quality control criteria for manufacturers.

Overview of helium leak testing?

Helium leak testing is considered as one of the most sensitive Container Closure Integrity test methods. In simple terms, it can be understood as the process of using helium mass spectrometry for finding leaks in some type of enclosed or sealed system using helium as a “tracer” gas and measuring its concentration as it escapes due to leakage. This technique is widely used for evaluating integrity of critical parenteral or injectable products. Helium is used as a tracer gas because it is non-toxic, non- flammable, non-condensable and its presence in the atmosphere is not more than 5ppm. The small atomic size of helium makes it easier to pass through leaks. Since helium does not react with other materials, it is safe to use. Additionally, compared to other tracer gases helium is less expensive and is available in multiple cylinder sizes.

Helium leak detection using SIMS 1915+

LDA's Seal Integrity Monitoring System (SIMS) 1915+ is a helium-based leak detection technique proven to be effective for a variety of pharmaceutical and medical device product package systems. Using helium as the tracer gas, packages can be quantitatively tested to levels far exceeding the vacuum bubble and dye penetration test methods. This technique is applicable across a wide range of pharmaceutical and parenteral products including vials, syringes, cartridges and blister cards.

SIMS 1915+ enable quantitative analysis of packages at a sensitivity level as low as 1 x 10-10 mbar/L/sec. and provides relevant data sets in place of a simple pass/fail criteria while enabling testing to be performed at ambient temperature as well as cryo storage conditions. Each SIMS 1915+ Helium Leak Testing instrument is custom built to client specific standards and package configurations. We specialize in the engineering and development of custom test fixtures tailored to the component to be tested, which ensures precision and accuracy to meet your study goals, package configurations and quality monitoring needs.

SIMS 1915+ Options:

  • LT 80 and LT 150 Low Temperature Add-on Systems for ultra-cold CCI testing using helium leak methodology.
  • Various sizes of Vacuum Test Fixtures to accommodate all package types and sizes.
  • Custom Test Fixtures to allow Helium leak testing for non-vacuum chamber applications.
  • Additional External Helium Leak standards in various leak rate ranges.
  • Helium Sniffer probe – for site specific determination of leak sites.
Readmore...
helium leak testing, sims 1915+, helium mass spectrometry
447
19
Mar 2021

Ensuring Integrity of Glass Vials with Helium Leak Testing

Ensuring Integrity of Glass Vials with Helium Leak Testing

Container closure integrity plays an integral role in maintaining the stability of sterile pharmaceutical products. Most often, defects that cause vials to leak cannot be detected by a visual inspection process. Examples of such defects include microscopic cracks & scratches in the glass or temporary defects such as stopper pop-up that result in temporary container leakage. In such situations, helium leak testing ensures high sensitivity leak detection, which cannot be attained by many other leak test methods.

Overview of helium leak testing

Helium leak testing refers to the process of finding leaks in some type of enclosed or sealed system using helium as a “tracer” gas and measuring its concentration as it escapes due to leakage. It is an effective container closure integrity test method, aimed at evaluating the integrity of pharmaceutical and parenteral products. Helium leak detection works in the following way: Initially, the package is helium filled and subjected to vacuum. Then using a helium leak detector, the amount of helium escaping the package is quantitatively measured and stated as a leak rate. Apart from analyzing container closure integrity, helium leak testing is also applicable in product design, product quality analyses, failure analyses and validation. Helium leak testing is a flexible method that can be used with or without a test chamber in order to test "in-leakage" or "out-leakage", as well as leak location.

Why use helium as a tracer gas?

Helium is considered as an ideal choice of tracer gas because of the following reasons:

  • Helium is non-toxic, non-condensable, non-flammable.
  • It is inert, making it safe for use as it will not interact with the components being tested.
  • The atom size of helium is really small, allowing it to breach pathways reliably and easily.
  • Compared to other tracer gases, helium is less expensive and readily available.
  • Its presence in the atmosphere is not more than ppm.

Glass vial leak testing using SIMS 1915+

Seal Integrity Monitoring System (SIMS) 1915+ is an ideal choice for helium-based leak detection of vials, blister cards, syringes, and cartridge systems. Compared to conventional vacuum bubble and dye penetration test methods, packages can be quantitatively tested using helium as the tracer gas that ensures higher levels of accuracy. Proven to be an affective leak detection method, SIMS1915+ can also be used for package design, tooling qualification, production line setup and on-going product quality monitoring. Designed specifically for the needs of pharmaceutical and medical device industries, SIMS1915+features an oil-free pump, detector and integrated power system that ensures quantitative analysis of package systems at sensitivity levels as low as 1 x 10 -10 cc/s at room temperature. Based on the client’s specific requirement, each SIMS 1915+ Helium Leak Testing instrument manufactured by Leak Detection Associates can be customized. Given below is a list of SIMS 1915+ Leak Detection System specifications along with add-on components.

  • Helium Leak Detector Module (HLDM): Oil Free, Production version in Console Frame Assembly, with Stainless Steel working surface and Dual Test Port Manifold (allows concurrent use of VTFM & HSAM on HLDM unit).
  • Vacuum Test Fixture Model (VTFM) – custom designed for use in testing of vial container samples
  • Head Space Analyzer Module (HSAM) – Model VM-2 that includes three (3) Puncture Probes (two spares) for determination of Helium Concentration in the headspace of vial containers.
  • Integral Calibration Chamber (w/ Calibrant Gas Flow Meter/Controller) provided for HSAM Calibration and a Universal Holder to be used for various vial diameters.
  • Helium Filling Device specific for vial testing sample prep to enable vials to be filled with helium
  • LT Low Temperature Add on units specifically designed for testing products under ultra-cold storage testing down to –140 °C.
Readmore...
Helium leak testing, helium leak detection, glass vials leak testing, sims 1915+, head space analyzer module
679
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.

READ ENTIRE PRESS RELEASE ON PRWEB

Readmore...
helium leak testing, SIMS 1915+, helium leak detection system, benefits of SIMS 1915+
1646
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.

TO READ ENTIRE PRWEB PRESS RELEASE PLEASE CLICK HERE

Readmore...
USP 1207, SIMS 1915+, CCI program
651
19
Jun 2020

Leak Detection Associates Names Key Executives to Leadership Roles

Leak Detection Associates Names Key Executives to Leadership Roles

EGG HARBOR, N.J. (PRWEB) FEBRUARY 14, 2019

Leak Detection Associates (LDA), the world’s leading provider of helium based leak testing systems for the pharmaceutical, biotechnology and food industries, formally announced today the appointment of two key leadership executives to guide the company moving forward. Brian Mulhall has been named Chief Executive Officer and will oversee all aspects of the company’s operations, including product development, manufacturing, client services, sales and marketing. He will also be charged with leading the company’s global expansion plans going forward. Alan Weiss has been named Chief Financial Officer and will take charge of all financial aspects of the company’s operations. Mr. Mulhall and Mr. Weiss form an experienced team, working together with proven success for well over twenty years. Most recently, the pair served in the same roles for Whitehouse Analytical Laboratories, a company they founded in 2002 and ultimately sold to AMRI in December of 2015.

Commented Mr. Mulhall, “I am excited about this opportunity, as I know Dr. Morrow and his team have been on the leading edge of helium leak testing systems for over 20 years. The foundation is in place for us to assemble a team of leaders dedicated to vastly improving and expanding the LDA program, and I look forward to taking part in our future plans for success.”

“I share Brian’s excitement and enthusiasm, and we are looking forward to a bright future for LDA. They possess a truly unique approach and solution to leak testing systems, especially as it relates to key industries like pharma and biotech. The experience and commitment the current LDA team brings gives us a strong platform on which to build,” added Alan Weiss.

A number of formal plans and announcements will be forthcoming in the next few months. Concurrently, LDA’s lead product, a helium leak test system called the SIMS 1284+ combines the latest in helium leak detection technology with its proprietary SIMS software for data collection and analysis of various package systems. When using helium as a tracer gas, package leakage can be quantitatively measured to levels far exceeding the sensitivity of traditional bubble and dye penetration tests, as well as modern technologies with other unique applications, such as pressure decay, mass extraction, and high voltage leak detection. The LDA system is a plug-and-play solution for analysis by ASTM F2391-05, a method authored by LDA’s founder, Dr. Darrell Morrow, and is fundamentally represented in guidance documents such as the USP 1207 general chapter.

Using uniquely designed test fixtures, quantitative leak rate data as garnered by the LDA SIMS1284+ has supported a full range of package systems, including cold form aluminum blisters, foil pouches, vials, syringes, and cartridges requiring a higher level of seal and closure integrity to provide gas permeation or microbial ingress protection and security. While the instrument provides options for pass/fail package seal quality and container closure integrity testing, tailored applications allow evaluation of unique and specific study goals, such as a direct comparison of various packaging materials and forms, production line settings, or stability storage conditions. Flexible in its use, the technology and equipment can be used across a product lifecycle; in package design, tooling qualification, production line setup and package quality monitoring.

READ THE FULL PRWEB PRESS RELEASE

 

Readmore...
SIMS 1915+, packaging seal integrity testing, ASTM F2391-05, helium based leak testing system
625
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

Readmore...
helium-based leak testing instruments, SIMS 1915+, SIMS 1915+ LT
549
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

Readmore...
sims 1915+, helium leak detection system, low temperature testing systems
2587

Popular Blogs

Tags

The Advantages of Using Helium for Leak Testing

May 13, 2020   |   3544

The use of helium gas as a medium for leak testing dates back to the 1940’s.Using helium as the “tracer” gas enables the user to discover and measure extremely small leaks.

Applications of HeLD to Cartridge Package Development and Validation

Nov 04, 2020   |   3209

A study on the applications of helium leak detection for cartridges, which are frequently used as part of a device delivery system in pharmaceutical industry

An Overview of 21 CFR Part 11 Compliance Requirements

Nov 02, 2020   |   2815

A review of some simple and direct questions regarding Part 11 compliance to help you to understand its requirements and implementation.

Leak Detection Associates Celebrates Major 2019 Milestones

Dec 27, 2019   |   2587

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.

Leak Detection Associates Announces New and Updated Helium Leak Detection System

Nov 01, 2020   |   1646

Leak Detection Associates (LDA), the world’s premier manufacturer of custom built, helium-based leak testing instruments is excited to announce the launch of its newest and most advanced helium leak detection system, the SIMS Model 1915 that is engineered incorporating industry-leading Agilent Technologies components and is custom designed to meet the stringent requirements of clients in FDA-regulated industries.
COPYRIGHT 2020, LDA, ALL RIGHTS RESERVED PRIVACY AND COOKIES
Popup