Newsletter | June 13, 2025

06.13.25 -- Proper Care And Handling Of Coupons Used For Swab And Rinse Recovery Studies For Total Organic Carbon Analysis

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Webinar: The Pathway to Operational Readiness

Join CAI for a webinar on accelerating operational readiness and reducing risk from Day One. Explore a proven framework built on six pillars and five maturity phases to align people, processes, and systems. Gain actionable strategies to overcome silos, ensure compliance, and drive long-term success in life sciences and mission-critical industries. Learn how to close readiness gaps and improve outcomes. Click here to learn more.

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5 Steps To Design A Microbiological Performance Qualification For Facilities

Explore five steps to design an EMPQ for sterile manufacturing: classification, protocol drafting, cleaning evaluation, disinfectant efficacy testing, and continuous improvement.

Establishing Effective Visual Residue Limits In Cleaning Validation

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Fundamentals Of Real-Time Viable Particle Monitoring: How Does It Work?

Real-time viable particle monitoring instruments have been available for over a decade. Examine in detail about this technology and how it is used to detect viable particles in real time.

Aseptic Filling And Processing Considerations For Biosimilars

One of the most intriguing, high-stakes aspects of R&D is the realm of biosimilars. Uncover the challenges of biosimilar production as well as aseptic processing considerations for biosimilars.

Enabling CDMOs To Focus On Core Priorities

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Rare Disease Launches In The Era Of EU Health Technology Assessment

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The Role Of IV Bag Inspection In Drug Manufacturing

Advanced IV bag inspection technologies ensure patient safety and regulatory compliance in drug manufacturing. Gain insight into automated leak detection and quality control innovations.

The Future Of Compliance, Efficiency, And Data Integrity

Read how eValidation revolutionizes the pharmaceutical industry by enhancing compliance, efficiency, and data integrity, as well as its indispensable role in modernizing traditional validation methods.

Small Molecule API Production: Unveiling The Impact Of Fermentation

Technological developments have led to growth in the suitability of fermentation. Experience the impact of the evolution of synthetic biology and supporting technologies on modern fermentation practice.

Transforming A Liquid Protein Solution Into A Solid Oral Dosage Form

Unlocking the potential of oral protein therapeutics requires innovative formulation and manufacturing strategies to overcome stability, absorption, and bioavailability challenges.

Five Considerations For PUPSIT Implementation

Pre-use, post-sterilization integrity testing is vital for contamination control to ensure the integrity of sterilized equipment before use. Find out how PUPSIT can enhance safety and quality in your protocols.

Solid Form Screening Of Active Pharmaceutical Ingredients

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Discover how a biodegradable polymer platform, easily applied with hot melt processing, enables processing at a relatively low temperature while preserving the potency of temperature-sensitive APIs.

The Golden Tool For Container Closure Integrity Testing

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Webinar: Fixing the Fixed: Unlocking Efficiency in Large-Scale Microbial Manufacturing

Commercial biomanufacturing isn't static—it's an evolving process. This webinar shares real-world case studies from Lonza’s microbial manufacturing facility, highlighting how continuous improvement is achieved through data-driven yield optimization, process refinement, and deviation analysis. Attendees will learn how to maintain agility, apply Six Sigma tools, and build resilience into operations to enhance efficiency, quality, and performance. Click here to learn more.

FEATURED EDITORIAL

Proper Care And Handling Of Coupons Used For Swab And Rinse Recovery Studies For Total Organic Carbon Analysis

Surrogate surfaces, or “coupons”, are used to simulate pharmaceutical manufacturing surfaces or medical devices for the performance of swab and rinse recovery studies. Experts from The Center for Pharmaceutical Cleaning Innovation provide insights for proper care and handling.

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