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By Andrew Walsh, Thomas Altmann, Joshua Anthes, et al. | The ASTM E55 Cleaning Team, in collaboration with F04 Medical Device Committee members, felt the three-level criticality system was inadequate for use in a science- and risk-based standard for cleaning process development, validation, and monitoring. Learn about how science-based and data-driven criticality levels were derived, the meaning of each level, and how they can guide the selection of risk reduction and control measures. |
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| Lyobeads Are The Hottest Thing In Freeze Drying For Pharma | Article | By Brandon Cole, ATS Life Sciences Scientific Products | If the lyophilization process is applied to a single droplet of liquid, it creates a lyo ‘bead’ rather than a lyo 'cake.' Discover the potential of lyobeads and why they are an excellent alternative. |
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| Aqueous Cleaning Processes | e-book | By Michael Moussourakis, Jeff Phillips, Stacy Silverstein, and Malcolm McLaughlin, Alconox Inc. | What does the BATH-O-CARD acronym represent, and how can it help you during your aqueous cleaning process? |
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| Remote Regulatory Assessments | Article | By Emily Purchase, CAI | Explore what remote regulatory assessments (RRAs) are and how updated guidance on these examinations could help clarify the consequences of noncompliance. |
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| The Case For A Facility Monitoring System | White Paper | By Tim Russell, TSI Incorporated | Facility monitoring software with OPC UA client/server functionality makes great business sense. Learn how monitoring leads to reduced waste, improved yield, higher quality, and increased profits. |
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| How Can You Ensure Successful Late-Phase Development And Launch? | Article | By Dr. Claudia Muller, Dr. Heiko Nalenz, and Dr. Roman Mathaes, Lonza | It is important to consider several factors in the overall development approach during the early phases in order to de-risk the late-phase development of your biologic drug product. |
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| Ensuring The Efficacy Of Probiotic Products | Article | Ropack Pharma Solutions | Without proper handling and packaging, the efficacy of probiotics can be compromised at any point in the packaging, storage, and transportation process, impacting shelf life and effectiveness. |
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