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

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. 

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. 

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 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. 

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.

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. 

WEBINARS

Learn about the advantages and disadvantages of CCI testing methods, how the revised EU Annex 1 may impact your strategy for ensuring CCI of sterile pharmaceutical products, and more.

Gain insight on the technical and regulatory justification to add water activity measurements into pharmaceutical stability protocols.

Gain insight into the risk to container closure integrity (CCI) during deep cold storage and identify appropriate analytical tools, to generate robust data to characterize and mitigate the risk to CCI.

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

Recent regulatory guidance has triggered changes in industry best practices in the area of container closure integrity (CCI) testing. A more science-based holistic approach that includes robust design & qualification of the process and the implementation of appropriate process controls is required. This webinar will describe a framework to enable such a holistic approach to CCI that assures both the primary packaging and the process contribute to good CCI of sterile injectable vial product.

When working on live viral vaccines, gene therapies or product that contains active cells cold storage is often required to maintain stability and/or activity. Deep cold storage, at dry ice (-80°C) or even cryogenic (-196 °C) temperatures, poses a significant challenge to packaging components and can result in CCI failures. Watch this webinar for a detailed presentation on this topic.

Water activity determination is increasingly being used in the pharmaceutical industry as evidenced by a newly drafted USP <922&GT Chapter for Water Activity measurement. This webcast presents how a water activity measurement can be implemented to give insight into the impact of moisture on critical product quality attributes including stability, dissolution rate, and physical properties of tablets, pills, capsules, and other solid pharmaceutical material.

Imagine a blue dye test, but replace the dye with a tracer gas. Headspace Gas Ingress Testing is a robust detection method of critical leaks. It is a rapid, non-destructive, analytical measurement and can be scientifically validated. Are you considering to upgrade your blue dye test, and do you want to learn more about this approach? Watch this webinar.

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.

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. 

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.

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.

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.

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.

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

This article describes how rapid non-destructive headspace moisture determination enables the generation of insightful data for product life cycle activities.

If CCI is lost during -80°C storage, non-sterile, cold, dense gas from the storage environment (i.e. air from a -80°C freezer or carbon dioxide from dry ice) can leak into the stored vial. It is therefore critical that robust development work is done to understand the CCI performance of any primary packaging components used for product needing deep cold storage and transport temperatures.

Pharmaceutical formulations, especially delicate large molecule biopharmaceuticals, may have some level of oxygen-sensitivity leading to degradation of the active pharmaceutical ingredient. Laser-based headspace oxygen analysis enables accurate, efficient determination of oxygen consumption curves. Accurate measurement of the oxidation rate supports the determination of headspace oxygen specifications and end-of-shelf life stability.

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.

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.

This app 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.

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.

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.

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.

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."

CONTACT INFORMATION

Lighthouse Instruments

2030 Avon Court

Charlottesville, VA 22902

UNITED STATES

Phone: 434-293-3081

Contact: Sales

FEATURED APPLICATION NOTES

FEATURED CASE STUDIES

WHITE PAPERS

CASE STUDIES

  • Here, we investigate possible primary packaging solutions for therapies requiring even colder storage temperatures down to cryogenic levels (-150°C to -180°C).

  • A new biological product, in pre-filled glass syringes, had demonstrated oxygen sensitivity in stability studies. Therefore, the headspace was purged with nitrogen during filling, and the client wanted to validate the batch production process and assess the nitrogen purge efficiency. In this study we demonstrate by performing a 100% inspection on the engineering batches using non-destructive headspace oxygen analysis you could gather the data needed before a commercial launch.

  • The accurate determination of oxygen concentration as a critical quality parameter for oxygen-sensitive products is important across the product life cycle activities. Traditional methods for determining headspace oxygen levels in parenteral containers, such as electrochemical methods or gas chromatography, are slow and destructive. This article describes several case studies comparing non-destructive laser-based oxygen headspace analysis with electrochemical oxygen analysis and gas chromatography.

  • This case study describes how packaging development and process study data of a pharmaceutical vial product requiring deep cold storage can be combined in a holistic approach.

  • With the application of non-destructive headspace moisture analysis, small-scale proof of concept studies can minimize project risk and the number of full-scale runs in the freeze-drying validation process.

  • A gene therapy clinical trial was halted due to CCI issues in deep cold storage. A CCI test method was developed that enabled non-destructive CCI testing of product vials at these cold temperatures. 

  • A manufacturer of a syringe product received complaints about discolored product that was nearing the end of shelf life. A root cause investigation was started and product syringes were put on stability. The headspace oxygen levels were monitored over time. The laser-based headspace analysis proved to be a useful tool to check package integrity and for the presence of reactive headspace gases that can degrade the formulation.

  • A client had an existing filling line and wanted to optimize the nitrogen purge process to decrease headspace oxygen levels to 2%. In addition, frequent line stoppages resulted in a need to identify and reject high oxygen vials that had lost the nitrogen headspace during the stoppage. A purging process qualification study was performed using rapid non-destructive headspace oxygen analysis in an at-line set-up with samples being measured immediately from the line.

  • Regulators are paying closer attention to the proper design of robust Container Closure Integrity (CCI) studies and the validation of CCI test methods. 

  • 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.

  • During QC testing, a number of vials of liquid vaccine product stored at -80°C were found to have an overpressure, representing a serious safety risk and they needed to identify the root cause.

  • 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 packaging.

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

  • 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.

  • 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.

FEATURED WEBINARS

  • 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.

  • 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. 

  • 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.

  • 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.

  • 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.

  • 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.