15
Sep 2022

SIMS 1915+ Helium Leak Detection System and its Applications

SIMS 1915+ Helium Leak Detection System and its Applications

USP <1207> Package Integrity Evaluation of Sterile Products provides an overview of relevant and authorized test procedures that may be utilized to achieve certification criteria. Developing a basic knowledge of these methodologies will allow you to make an informed decision on the most effective test methodology for a specific container and package system. Various CCI test methods are available today. Among them, helium leak testing has proven to be the most chosen method due to its extreme test sensitivity.

Why Use SIMS 1915+ for Leak Detection?

Seal Integrity Monitoring System (SIMS) 1915+ is the perfect choice for a helium-based leak detection system. Using helium as the tracer gas, packages may be quantitatively analyzed to levels much above the vacuum bubble and dye penetration test processes. This quantitative technique supports the entire lifetime by providing direct comparison across numerous packing materials and types, production line settings, and stable storage conditions. SIMS 1915+ can be used for package design, tooling qualification, manufacturing line setup, and continuous product quality monitoring. Each SIMS 1915+ helium leak testing equipment is built to the customer's specifications. SIMS 1915+ can do quantitative CCI analyses on packages with sensitivity as low as 1 x 10 -10 mbar L/s.

What are the Applications of SIMS 1915+?

  • Vials
  • Vials composed of glass and polymer are the most widely used package systems tested using helium leak detection. Vials are provided with a variety of capping to fulfill specific storage or handling needs. Vials are commonly used to store drugs or laboratory samples. Micro leaks in vials that carry sensitive drugs cannot be detected with a visual inspection. Helium leak testing is an ideal method for component qualification for empty components as well as a product-filled vial.

  • Pre-filled syringes
  • The use of pre-filled syringes has increased significantly in the pharmaceutical industry. CCI analyses of pre-filled syringes are more complicated, but they are much more important in ensuring entire system integrity. Helium leak testing for leak detection of pre-filled syringes has proven to be an effective method for evaluating the CCI of pre-filled syringes.

  • Bottles
  • Bottles made of glass or plastic are cost-effective traditional dosage forms ideal for the oral administration of syrups, solutions, and suspensions. Helium leak testing offered by LDA, a PTI company, quickly and effectively tests bottles for leaks and thereby defective bottles can be removed from the production line easily.

  • Blister packs
  • Due to the extreme sensitivity offered, the helium-based test method for evaluating the integrity of a blister card containing solid dose pharmaceutical drugs has been proven to be the most effective approach. Helium remains an ideal test method for qualifying the material components of CFF blister cards.

  • Foil pouches
  • Pharma manufacturers typically use foil pouches when a drug product requires multi-layered packaging. Helium leak testing of foil pouches is a viable and highly sensitive approach to meet strict regulatory requirements.

  • Combination products
  • These are multi-chamber systems that require unique test requirements. Helium Leak Detection as per ASTM F2391 is a well-established and widely used method for testing combination products. Testing combination products using helium leak testing ensure all components meet the strict leak rate requirements.

LDA’s (a PTI company) Seal Integrity Monitoring System (SIMS) 1915+ is an efficient method for a wide range of package types such as pre-filled syringes, cold form blister cards, foil pouches, parenteral vials, and unique medical devices. Seal Integrity Monitoring System (SIMS) Model 1915+ Helium Based Leak Testing System is designed specifically for the needs of the pharmaceutical and medical device industries.

Readmore...
helium leak testing equipment, helium leak detection, helium leak testing, helium leak detector, lda
136

Popular Blogs

Tags

Leak Detection Associates Celebrates Major 2019 Milestones

Dec 27, 2019   |   5256

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.

The Advantages of Using Helium for Leak Testing

May 13, 2020   |   4657

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.

An Overview of 21 CFR Part 11 Compliance Requirements

Nov 02, 2020   |   3798

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

Applications of HeLD to Cartridge Package Development and Validation

Nov 04, 2020   |   3634

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

Leak Detection Associates Announces New and Updated Helium Leak Detection System

Nov 01, 2020   |   2648

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