Insights On Pharmaceutical Inspection
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Ensuring IV Bag Sterility With Container Closure Integrity Testing Systems
6/7/2022
Learn how USP 1207, the reference standard for container closure integrity testing (CCIT), applies to the CCIT inspection method of intravenous (IV) bags.
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Extractables And Leachables: Risk Management And Analytical Solutions
10/11/2023
Partnering with a CDMO that offers comprehensive and robust E&L studies can help facilitate a smooth product launch by ensuring minimal impact from impurities, all while mitigating risks.
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Choosing The Right Primary Container And Troubleshooting Issues
8/25/2023
Selecting the right primary container for an injectable drug product is critical. Discover how to identify relevant testing to de-risk your product development – and quickly uncover causes of failures.
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The Container Closure Integrity Requirements In The Revised EU Annex 1
11/21/2022
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.
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Container Closure Integrity Of Product Requiring Deep Cold Storage
8/26/2022
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.
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A High Sensitivity Solution For Pharma CCIT
10/26/2022
Experience a comprehensive CCIT solution completely adapted to the needs of pharma customers. The software features intuitive menus, simple navigation, 21 CFR part 11 compliance, traceability, and data storage.
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Oral Solid Dosage Products: Water Activity And Primary Packaging Selection
7/17/2022
Every individual oral solid dosage (OSD) product has different water activity initially and over time. Learn about USP <922> water activity and primary packaging selection of OSD products.
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Effects Of X-Ray Inspection On Pharmaceutical Products
3/7/2023
Some manufacturers still have reservations about adopting X-ray inspection as a safe method of product inspection. Explore the potential effects of X-ray inspection on pharmaceutical products and more.
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The Golden Tool For Container Closure Integrity Testing
8/17/2023
Discover the power of headspace gas ingress in ensuring product quality. Dr. Derek Duncan, Director of Product Lines, Lighthouse Instruments, reveals the golden tool for container closure integrity testing.
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Correlating Laser-Based Headspace Analysis To Helium Leak Rate Testing
5/22/2023
Laser-based headspace analysis is a non-destructive and rapid method for testing container closure integrity. We demonstrate that headspace analysis is equally as sensitive as helium leak rate testing.