ABOUT US

LIGHTHOUSE offers complete solutions for headspace Oxygen Monitoring, Container Closure Integrity Testing, Moisture Determination and Microbial Contamination inspection of media vials. Our solutions include feasibility studies, process and packaging studies, method development, method validation protocols, automated or benchtop lease platforms, on-site trouble shooting and support.

Rapid, nondestructive, laser-based headspace analysis is suitable for applications specific to the sterile pharmaceutical industry. It is a useful analytical tool to generate statistical process and product data in all stages of the product life cycle, from Development to Manufacturing and Quality Control. LIGHTHOUSE Instruments is the leading provider and manufacturer of headspace analysis platforms and measurement services.

Contact us for a free demo, feasibility study, or other information.

SOLUTIONS AND SERVICES

Container Closure Integrity Testing Container Closure Integrity Testing

What is your Container Closure Integrity (CCI) strategy? Recent regulatory revisions have put emphasis on appropriately designed CCI studies and robust method validation. LIGHTHOUSE offers complete solutions for CCI testing throughout the product life cycle, from Development to Manufacturing and Quality Control. 

Oxygen Monitoring Of Sensitive Formulations Oxygen Monitoring Of Sensitive Formulations

The need to monitor headspace oxygen levels in parenteral containers arises from the requirement to ensure the stability and potency of oxygen-sensitive product. LIGHTHOUSE offers complete solutions for (in-process control) oxygen monitoring of oxygen-senstive formulations, from Development to Manufacturing and Quality Control. 

Moisture Determination Of Dry Product Moisture Determination Of Dry Product

Residual product moisture content is a critical parameter when considering the stability and shelf life of lyophilized pharmaceutical product, sterile powders, or solid dosage product. Lighthouse offers complete solution for moisture determination of dry product.

Media Fill Inspection Media Fill Inspection

Media Fill Inspection in the pharmaceutical industry has long been based on growth media culture methods. The general approach to media fill inspection is to incubate media filled vials for 14 days and then determine potential contamination with a visual inspection of the media sample. Over the last decade a number of Rapid Microbial Methods based on various analytical techniques have been implemented. These provide quicker, more sensitive, accurate, and reproducible test results when compared with conventional, growth-based methods. Recently, it has been demonstrated that laser-based headspace provides yet another alternative approach for detecting microbial contamination in sterile pharmaceutical product. 

(Lease) Bechtop Headspace Analysis systems (Lease) Bechtop Headspace Analysis systems

Rapid, nondestructive, laser-based headspace analysis enables determination of headspace Oxygen, Moisture/Pressure, Carbon Dioxide and Water Activity. Using laser absorption, light from a near-infrared laser is tuned to match an internal absorption frequency of various molecules and passed through a glass sample container in the headspace above the product. The amount of laser light absorbed is proportional to the concentration of the specified gas in the headspace.

Automated Headspace Analysis (Lease) platforms Automated Headspace Analysis (Lease) platforms

The PULSAR line of automated headspace inspection machines provides a reliable, compact, and flexible platform for 100% inspection of headspace oxygen, moisture, pressure, and carbon dioxide levels in sealed parenteral containers. Automated nondestructive, laser-based, headspace inspection enables robust process studies in development as well as 100% batch inspection to guarantee the quality of finished product. 

Measurement Services: Lab testing, Onsite testing, Lease Measurement Services: Lab testing, Onsite testing, Lease

Do you require rapid, nondestructive, headspace analysis, but are you limited by time and resources?

More Solutions

WEBINARS

Protecting Oxygen Sensitive Formulations Throughout The Product Life Cycle Protecting Oxygen Sensitive Formulations Throughout The Product Life Cycle

Many biopharmaceutical drug formulations have some degree of oxygen sensitivity. Topics for this webinar include how oxygen levels in finished parenteral drug containers can be determined for oxygen scavenger & stability studies, for determining inherent primary packaging integrity, and for optimizing & qualifying inert gas purging system during filling.

Using Positive Controls In Container Closure Integrity Studies Using Positive Controls In Container Closure Integrity Studies

This webinar describes the use of positive controls as an important element of CCI studies designed to validate packaging components for CCI or to qualify processes for producing good CCI.

Oxygen Permeation In Pre-Filled Syringes Oxygen Permeation In Pre-Filled Syringes

This webinar presents how to design and conduct studies to assess the total oxygen permeation rate of your pre-filled syringes, and how to determine if the permeation is primarily through the plunger or through the tip.  Protecting oxygen-sensitive formulations during filling will also be discussed. 

Non-destructive Moisture Analysis Of Freeze Dried Product Non-destructive Moisture Analysis Of Freeze Dried Product

This webinar describes how non-destructive headspace moisture analysis can be used for characterizing batch moisture distributions, for lyo cycle development and optimization, and for freeze dryer moisture mapping and validation.

Determining And Controlling Oxygen Levels In Sensitive Formulations Determining And Controlling Oxygen Levels In Sensitive Formulations

This webinar will review how oxygen levels in finished parenteral drug containers can be determined and controlled throughout the product life cycle by using laser-based headspace analysis.

Container Closure Integrity Testing Method Development Container Closure Integrity Testing Method Development

Recent regulatory revisions have also put emphasis on robust method validation for container closure Integrity test methods. This webinar covers approaches that can be used for method development for CCI testing in all phases of the product life cycle.

CCI Testing And Revisions To EU Annex 1 CCI Testing And Revisions To EU Annex 1

The new language in EU Annex 1 will likely have a significant impact on your CCI testing practices. In this webinar CCI testing strategies and the proposed revisions to EU Annex 1 are discussed.

New Guidelines For Container Closure Integrity Testing New Guidelines For Container Closure Integrity Testing

Increased regulatory scrutiny and exciting new analytical technologies have altered the landscape of container closure integrity testing. In order to provide guidance to this new environment the US Pharmacopoeia revised Chapter <1207> Sterile Product Package Integrity.  View this webinar recording to learn about the new guidelines and how they will impact your approach to sterile product package integrity.

APPLICATION NOTES

Non-Invasive Headspace Analysis For Automated Media Fill Microbial Inspection Non-Invasive Headspace Analysis For Automated Media Fill Microbial Inspection

Laser-based headspace provides yet another alternative approach for detecting microbial contamination in sterile pharmaceutical product allows for quicker, more sensitive, accurate, and reproducible test results when compared with conventional, growth-based methods.

Headspace Oxygen Monitoring On A Pre-filled Syringe Line Filling Oxygen-Sensitive Product Headspace Oxygen Monitoring On A Pre-filled Syringe Line Filling Oxygen-Sensitive Product

This application note describes how laser-based headspace analysis is used for the rapid non-destructive determination of headspace oxygen levels in pre-filled syringes. Data is presented demonstrating two major applications of this technique: 1) headspace oxygen monitoring on a pre-filled syringe line filling oxygen-sensitive product, and 2) container closure testing of pre-filled syringes.

Sterile Production Process Studies Using 100% Headspace Inspection Of Finished Product Sterile Production Process Studies Using 100% Headspace Inspection Of Finished Product

This Application Note describes the application of the PULSAR inspection platform to perform 100% headspace oxygen monitoring during the filling of oxygen-sensitive formulations, 100% container closure inspection of suspect batches, moisture inspection of freeze dried product, and automated media fill inspection.

Nitrogen Purge Optimization And Validation Of Sterile Liquid Filling Lines Nitrogen Purge Optimization And Validation Of Sterile Liquid Filling Lines

Large molecule biopharmaceuticals can be prone to oxidation and to prevent this from occurring, the headspace is often purged with an inert gas during filling to ensure a longer shelf life.

In-Process Monitoring Of Headspace Oxygen Levels In Parenteral Containers In-Process Monitoring Of Headspace Oxygen Levels In Parenteral Containers

Using a high sensitivity detection technique known as Frequency Modulation Spectroscopy (FMS), LIGHTHOUSE rapid non-destructive headspace oxygen inspection can help streamline the monitoring of purge performance on the filling line. This paper demonstrates the correlation of the FMS rapid non-destructive technique for analyzing headspace oxygen levels with the most commonly used conventional destructive techniques for headspace oxygen inspection.

Stopper 'Pop-Up' And The Effects On Container Closure Integrity Of Freeze Dried Vials Stopper 'Pop-Up' And The Effects On Container Closure Integrity Of Freeze Dried Vials

Stopper pop-up resulting in loss of container closure integrity is not uncommon and impacts the stability, sterility and reconstitution of lyophilized product. Non-destructive headspace analysis is a powerful method for monitoring container closure integrity in finished vials of freeze dried product and for building quality into the manufacturing operation.

Implementing FDA Guidance: CCI Testing In Lieu Of Sterility Testing Implementing FDA Guidance: CCI Testing In Lieu Of Sterility Testing

This application note details FDA released guidance titled “Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products."

Container Closure Integrity Of Sterile Vials During Deep Cold Storage Container Closure Integrity Of Sterile Vials During Deep Cold Storage

Learn how rapid, nondestructive laser-based headspace analysis can support with data generation to demonstrate the maintenance of seal integrity during deep cold storage and transport.

More Application Notes

CONTACT INFORMATION

Lighthouse Instruments

2030 Avon Court

Charlottesville, VA 22902

UNITED STATES

Phone: 434-293-3081

Contact: Sales

FEATURED APPLICATION NOTES

FEATURED CASE STUDIES

  • Headspace Oxygen Formulation Oxidation
    Headspace Oxygen Formulation Oxidation

    Application of the LIGHTHOUSE headspace method demonstrates how ability to quickly and accurately determine headspace oxygen levels saves time and enables deep insight into formulation stability. 

  • Lyo Chamber Moisture Mapping
    Lyo Chamber Moisture Mapping

    Rapid non-destructive headspace moisture analysis from LIGHTHOUSE enables fast moisture determination of statistical numbers of lyo samples.

  • Determination Of Moisture Permeation During Product Shelf Life
    Determination Of Moisture Permeation During Product Shelf Life

    How non-destructive headspace analysis information can be critical for QC groups performing stability studies, or for packaging development groups responsible for choosing the optimal primary packaging configuration.

  • Container Closure Integrity Testing For Sterile Vial Products In Deep Cold Storage
    Container Closure Integrity Testing For Sterile Vial Products In Deep Cold Storage

    A vaccine-focused biotechnology company approached LIGHTHOUSE to help investigate a phenomenon observed in liquid vaccine product stored at -80°C. During QC testing, a number of vials were found to have an overpressure. This phenomenon represented a serious safety risk and LIGHTHOUSE was asked to support an investigation to identify the root cause.

WHITE PAPERS

More White Papers

CASE STUDIES

  • Verifying Vacuum Maintenance While Preserving The Product Sample
    Verifying Vacuum Maintenance While Preserving The Product Sample

    Vacuum in finished sterile product containers is critical for certain pharmaceutical formulations to ensure proper reconstitution before administration to the patient, or to prevent interactions between the formulation and headspace gas. A loss of vacuum can be a clear indicator of a container closure integrity defect or an issue with the original sealing process. Using a LIGHTHOUSE headspace analysis platform for non-destructive headspace pressure determination verifies the maintenance of vacuum while preserving the product sample.

  • Container Closure Integrity Testing For Sterile Vial Products In Deep Cold Storage
    Container Closure Integrity Testing For Sterile Vial Products In Deep Cold Storage

    A vaccine-focused biotechnology company approached LIGHTHOUSE to help investigate a phenomenon observed in liquid vaccine product stored at -80°C. During QC testing, a number of vials were found to have an overpressure. This phenomenon represented a serious safety risk and LIGHTHOUSE was asked to support an investigation to identify the root cause.

  • Determination Of Moisture Permeation During Product Shelf Life
    Determination Of Moisture Permeation During Product Shelf Life

    How non-destructive headspace analysis information can be critical for QC groups performing stability studies, or for packaging development groups responsible for choosing the optimal primary packaging configuration.

  • Lyo Chamber Moisture Mapping
    Lyo Chamber Moisture Mapping

    Rapid non-destructive headspace moisture analysis from LIGHTHOUSE enables fast moisture determination of statistical numbers of lyo samples.

  • Root Cause Investigation Into A Possible Container Closure Integrity Failure
    Root Cause Investigation Into A Possible Container Closure Integrity Failure

    In cases where oxidation of the formulation causes discoloration and eventual degradation of the product, non-destructive headspace analysis tests can give deep insight into the root cause. Since the samples are not destroyed by the headspace analysis, further testing can be done to accurately correlate headspace conditions with other product characteristics.

  • Headspace Oxygen Formulation Oxidation
    Headspace Oxygen Formulation Oxidation

    Application of the LIGHTHOUSE headspace method demonstrates how ability to quickly and accurately determine headspace oxygen levels saves time and enables deep insight into formulation stability. 

  • 100% Container Closure Inspection Of Freeze Dried Drug Product In Quarantine
    100% Container Closure Inspection Of Freeze Dried Drug Product In Quarantine

    A leading contract manufacturer approached LIGHTHOUSE for help after a suspected raised stopper issue motivated the manufacturer to place several batches into quarantine. A decision was made to perform 100% container closure inspection of the product vials with the help of LIGHTHOUSE.

More Case Studies

FEATURED WEBINARS

  • New Guidelines For Container Closure Integrity Testing
    New Guidelines For Container Closure Integrity Testing

    Increased regulatory scrutiny and exciting new analytical technologies have altered the landscape of container closure integrity testing. In order to provide guidance to this new environment the US Pharmacopoeia revised Chapter <1207> Sterile Product Package Integrity.  View this webinar recording to learn about the new guidelines and how they will impact your approach to sterile product package integrity.

  • Oxygen Permeation In Pre-Filled Syringes
    Oxygen Permeation In Pre-Filled Syringes

    This webinar presents how to design and conduct studies to assess the total oxygen permeation rate of your pre-filled syringes, and how to determine if the permeation is primarily through the plunger or through the tip.  Protecting oxygen-sensitive formulations during filling will also be discussed. 

  • Determining And Controlling Oxygen Levels In Sensitive Formulations
    Determining And Controlling Oxygen Levels In Sensitive Formulations

    This webinar will review how oxygen levels in finished parenteral drug containers can be determined and controlled throughout the product life cycle by using laser-based headspace analysis.

  • Non-destructive Moisture Analysis Of Freeze Dried Product
    Non-destructive Moisture Analysis Of Freeze Dried Product

    This webinar describes how non-destructive headspace moisture analysis can be used for characterizing batch moisture distributions, for lyo cycle development and optimization, and for freeze dryer moisture mapping and validation.

  • Container Closure Integrity Testing Method Development
    Container Closure Integrity Testing Method Development

    Recent regulatory revisions have also put emphasis on robust method validation for container closure Integrity test methods. This webinar covers approaches that can be used for method development for CCI testing in all phases of the product life cycle.

  • CCI Testing And Revisions To EU Annex 1
    CCI Testing And Revisions To EU Annex 1

    The new language in EU Annex 1 will likely have a significant impact on your CCI testing practices. In this webinar CCI testing strategies and the proposed revisions to EU Annex 1 are discussed.