Lighthouse Solutions
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Automated Media Fill Microbial Inspection
7/16/2024
Opportunities for improving and streamlining the media fill process are interesting for aseptic filling operations. In particular, the manual visual inspection process used to inspect media vials for signs of contamination after incubation is considered to be tedious and time-consuming.
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Pharmaceutical Automated Sample Handling System For Headspace Testing
7/16/2024
This collaborative automated sample handler eliminates manual sample handling enabling testing of large sample sets and collection of statistically significant data, while freeing analyst’s time. The FMS Automation Module has a sample capacity of hundreds of vials and can complete headspace testing with a throughput as high as 300 samples per hour.
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Pharmaceutical Headspace Inspection System: Pulsar
7/16/2024
The PULSAR Headspace Inspection System can provide automated, 100% inspection of headspace oxygen, pressure, and carbon dioxide levels in sealed parenteral containers, while our PULSAR Headspace CCI Inspection Lease System offers a small footprint, fast delivery solution for the 100% CCI inspection of pharmaceutical product on a per project basis.
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Interactive Lab Experience For The Pharmaceutical Industry
5/23/2023
Explore a development lab and the various areas where headspace analysis can be used to generate robust, science-based data on packages and processes in this self-guided, virtual tour.
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Pharmaceutical CCIT Systems To Meet EU Annex 1 Requirements
12/14/2022
The revised EU Annex 1 contains new requirements for ensuring the container closure integrity (CCI) of sterile pharmaceutical products, causing pharmaceutical companies to reassess their CCI policies for compliance.
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Container Closure Integrity Testing
1/2/2019
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.
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Oxygen Monitoring Of Sensitive Formulations
1/2/2019
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-sensitive formulations, from Development to Manufacturing and Quality Control.
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Moisture Determination Of Dry Product
1/2/2019
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.
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Media Fill Inspection
1/2/2019
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.
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(Lease) Benchtop Headspace Analysis systems
1/2/2019
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.