Lighthouse Instruments B.V.

Science Park 408, 1098 XH Amsterdam
Netherlands

Telephone +31 6 42267380
euinfo@lighthouseinstruments.com

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interpack 2017 hall map (Hall 6): stand A15

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interpack 2017 fairground map: Hall 6

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04.05.2017

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Every day: LIGHTHOUSE application experts are available to discuss headspace analysis

Non-destructive Headspace Analysis

Lighthouse will display headspace equipment for a number of different packaging applications. An automated headspace inspection machine will be on display that can be configured for 100% headspace oxygen monitoring, container closure inspection for process studies, 100% moisture inspection of lyo product, and automated medial fill inspection. Headspace benchtop equipment will also be available for the demonstration of packaging applications such as container closure testing, syringe permeation studies, and non-destructive moisture determination of dry product.

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Our range of products

Product categories

  • 01  Packaging machines and devices
  • 01.05  Inspection and control
  • 01.05.02  Leackage test systems/devices

Our products

Product category: Leackage test systems/devices

FMS-Headspace Systems

Headspace Analyzer for Oxygen, Moisture/Pressure and Carbon dioxide

The FMS-Headspace Analyzer is a non-destructive gas analyzer for monitoring headspace oxygen, moisture/pressure and carbon dioxide in sealed parenteral containers. This compact benchtop instrument utilizes a patented laser absorption technique developed with funding from the Food and Drug Administration.

Light from a near-infrared diode laser is tuned to match an internal absorption frequency of the gas molecule of interest and passed through the empty container headspace above the product. The amount of laser light absorbed is proportional to the gas concentration in the headspace. The measurement method is rapid and non-destructive. These characteristics allow for multiple measurements on the same sample enabling the accurate monitoring of the headspace of a single sample over time. Because the sample is not destroyed there are no waste disposal issues and potentially valuable product can be saved for other tests.

The analyzer is a robust solid state device and is straightforward to use.  Operators do not require special expertise to run the system meaning the accuracy of the measurements does not depend on operator skill.

Applications

The benchtop headspace analyzer is used for development and QC laboratory applications as well as for at-line in-process control of headspace gas levels in production. Systems can be permanently situated in laboratories for product development, release testing, and QC investigations or mounted on carts and wheeled from line to line for in-process monitoring and troubleshooting activities.

Applications include:
• Leak detection
• Container closure integrity studies
• IPC monitoring of oxygen levels during the filling of oxygen-sensitive product
• Optimization and validation of purging systems on filling lines
• Oxygen degradation studies
• Stability trends, end-of-shelf life studies
• Moisture determination of lyo product
• Lyo chamber moisture mapping
• Water vapor permeation studies
• Moisture degradation studies
• IPC monitoring of carbon dioxide levels during the filling of product purged with carbon dioxide in the headspace
• Microbial growth detection in media vials

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Product category: Leackage test systems/devices

PULSAR Headspace Inspection System

100% inspection of pharmaceutical product

The PULSAR Headspace Inspection System is an automated 100% inspection machine designed to measure headspace oxygen, moisture, and carbon dioxide levels in sealed parenteral containers. PULSAR characterizes the physical headspace conditions of a container in a single compact and flexible platform. Aseptic manufacturing facilities implement various analytical systems and inspection processes to ensure the quality of finished product and to monitor production processes.

The PULSAR Headspace Inspection System has been designed to address the following applications:

  • Headspace oxygen monitoring during the filling of oxygen-sensitive formulations
  • 100% moisture inspection of freeze dried product
  • Automated media fill inspection
  • The PULSAR Headspace CCI Inspection Lease System is available for 100% Container Closure Integrity inspection
Headspace Laser Spectroscopy

The PULSAR Headspace Inspection System uses a patented laser-based detection method developed with funding from the Food and Drug Administration. Light from a near infrared laser is passed through a container in the region above the product and below the cap (headspace region). Diode laser sensors are designed to monitor the absorption wavelength of the target headspace molecules to determine headspace concentrations. Vials that do not meet the specified headspace conditions can then be identified and rejected.

LIGHTHOUSE Instruments introduced the laser headspace technology into the pharmaceutical industry more than 15 years ago and has the largest installed base of laser-based headspace systems worldwide.

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About us

Company details

Our Mission
To be the leading global provider of optical-based non-destructive headspace analysis systems that lower the cost and ensure the quality of parenteral products.

What We Do
Our product lines are comprised of series of systems that non-destructively monitor headspace oxygen, moisture, and pressure levels in sealed parenteral containers. Our systems have been designed specifically for the pharmaceutical industry and typical applications include 100% container closure integrity inspection, packaging developments container closure studies, at-line oxygen monitoring of oxygen-sensitive liquid products, formulation stability studies, and water activity measurements. In addition to manufacturing and marketing our headspace systems, we also provide Measurement Services which include the analysis of product sent to our analytical labs as well as providing lease headspace systems for on-site product inspection activities. As a science-based company, we provide our clients with knowledge and expertise gained from analyzing and inspecting millions of finished sterile drug samples from pharmaceutical facilities around the world.

The FMS-Series of benchtop headspace analyzers provide a portable and robust solution for development activities and at-line process monitoring. The VISTA In-Line Headspace Inspection machines enable 100% monitoring of headspace oxygen, moisture, and pressure (vacuum) in parenteral containers at production speeds. All LIGHTHOUSE headspace platforms employ a solid state laser technology called Frequency Modulation Spectroscopy (FMS) and proprietary signal processing to achieve sensitivity levels 10,000 times greater than traditional near-infrared (NIR) optical methods.

All of our systems are validated and registered with the FDA, EMA, and other national regulatory agencies for use in the US, Europe, and Asia. They are CE-certified and are CFR Part 11 compliant. Complete validation and FAT protocols are available for all FMS-Series and VISTA In-Line Inspection Systems. Our systems come complete with one or more sets of NIST-traceable calibration standards that are manufactured and certified by LIGHTHOUSE.

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Company data

Target groups

Pharmaceuticals