Podcasts
Core2Write – Eliminate Particulates & Fibers in the Core
July 30th 2021GMP firms have a constant struggle with the task of reducing fibers, particulates, and microorganisms within classified areas. A main source of this problem is paper products used to document operations. Veltek Associates, Inc. has developed an innovative way to address and solve problems surrounding particulate and fiber shedding from cleanroom documentation with our CleanPrint 10® synthetic writing substrate, Core2Write® customized documentation, and Core2Print® HEPA filtered cleanroom printing system.
Using AI for CAPA Root Cause Investigation with Sue Marchant
June 18th 2021Sue Marchant, director of product at MasterControl, will discuss how AI technology is helping pharmaceutical companies address CAPA and root cause investigations. The CAPA process has historically been more corrective than preventive, hard to track and implemented without context. During the podcast, we will be discussing the options available today to connect quality data and subsequently what problems can be solved using AI. These technologies will turn the tables making CAPA more preventive than corrective with the ability to track process in real time and understand the contributing factors and considerations surrounding an event. Additionally, Marchant will explain how AI combines and analyzes data, pinpoints relationships, and provides valuable process improvement. Companies should not be intimidated or hesitant about implementing AI technology. Today’s technology has AI capabilities embedded in the software to accelerate AI development. Companies no longer need specialists to get started and take advantage of the benefits.
Screening Permeability as a Tool in Formulation Selection
May 5th 2021The bioavailability of insoluble compounds remains one of the biggest challenges to drug delivery. While there are strategies that can be applied at lower dosage levels, it is particularly difficult to formulate for improved bioavailability at high dosage levels. Improving bioavailability can be crucial to creating a dosage form that is easy to use and meets requirements for patient compliance. CoreRx tackles bioavailability challenges for molecules by leveraging our membrane flux in vitro technology. Today, we will discuss how using this technology enabled CoreRx to discern which factors were most important for bioavailability of a model Class IV compound, and led to development of a formulation with ~70% increase in bioavailability.
Aseptic Sterile Fill/Finish Support for Clinical Supplies
April 2nd 2021Eurofins BioPharma Product Testing highlights how it overcomes the challenges faced in sterile fill finish manufacturing in the bio/pharmaceutical industry at our San Diego, CA facility. With state-of-the-art facilities and a vial filler, Eurofins provides a solution for small batches of sterile GMP or GLP products for use in Toxicology Studies, as well as Phase I or Phase II clinical trials by eliminating human error and other associated risks.
Challenges with Extractables and Leachables in Medical Devices
March 23rd 2021Understand challenges posed by updated E&L guidance for medical devices (ISO 10990-18) Insight into considerations for analytical setup that impact regulatory compliance Overview of materials E&L risk profiles and testing requirements
Migration to Prefabricated Cleanrooms
February 22nd 2021In nearly all industries, there has been a general shift away from on-site construction to prefabricated solutions. Specifically, the requirement in the biopharmaceutical industry to address speed to market and lower the total cost of ownership for facilities has accelerated this movement. More recently, the impact of COVID on our society has placed a strain on how we operate while also creating an immense need for additional capacity.
Core2Scan - Process Tracking & Compliance Support with RFID
February 17th 2021Core2Scan® is a complete RFID tracking solution designed for the pharmaceutical and biotech industry. Core2Scan® can track assets, people, raw material, and inventory. The asset tracking piece incorporates asset management tools for monitoring equipment calibration, PM, and service requests. This solution can also be used for process improvement, allowing you to track asset and personnel flow throughout your facility. Compliance support is built into Core2Scan®. The system provides a history of all asset movement, giving users a thorough and documented audit trail. Core2Scan® includes hardware, software, and RFID tags that can all be used in and out of the cleanroom. With software that supports 21 CFR Part 11 compliance, you will have a tool that meets your needs.
The Age of Big Q: A Full Organization Obsession with Customer Success
January 14th 2021Quality is one of the most important components of products in pharmaceuticals. Traditionally, the onus was on the manufacturing function to deliver quality. But what if every single member of the organization was completely focused on customer needs? Big Q, or Quality culture, ensures that quality is up to everyone. DuPont expert will discuss more about how its excipient platform is taking customer cues to implement this total quality focus.
