Newsletter | March 12, 2024

03.12.24 -- A Data-Derived Approach For Selecting Criticality Levels In FMECAs

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Webinar: The Increasing Demand For Sterile Filtration Of High Concentration Drugs

Industry experts share the current trends and challenges associated with the manufacture of high concentration drug products and provide an overview of their preferred approach to perform extensive filterability trials without the need to generate a high quantity of expensive product. Click here to learn more.

FEATURED EDITORIAL

A Data-Derived Approach For Selecting Criticality Levels In FMECAs For Cleaning Process Risk Analysis

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.

INDUSTRY INSIGHTS

The Cost Savings Of Blow/Fill/Seal: More Than A Million Reasons To Switch

Despite the benefits of B/F/S over glass, some pharmaceutical companies refuse to make the switch. Explore how an investment in B/F/S may yield incredible long-term savings.

Lyobeads Are The Hottest Thing In Freeze Drying For Pharma

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.

Selecting The Best Pharmaceutical Mixing Equipment For Your Operations

Finding the right mixing equipment isn’t as simple as selecting an item from a menu. Here is what you should consider when choosing pharmaceutical mixing equipment and vendors for a facility.

Correlating Laser-Based Headspace Analysis To Helium Leak Rate Testing

Laser-based headspace analysis is a nondestructive and rapid method for testing container closure integrity. We demonstrate that headspace analysis is equally as sensitive as helium leak rate testing.

Aqueous Cleaning Processes

What does the BATH-O-CARD acronym represent, and how can it help you during your aqueous cleaning process?

Remote Regulatory Assessments

Explore what remote regulatory assessments (RRAs) are and how updated guidance on these examinations could help clarify the consequences of noncompliance.

The Case For A Facility Monitoring System

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.

Mitigate Drug Shortage Risk With Improved Collaboration

Learn how to overcome the hurdles associated with traditional data management approaches and discover the key to reducing the risk of drug shortages in pharmaceutical manufacturing.

Predictive Validity: The Key To Improving The Drug Development Process

The drug development industry recognizes the importance of predictive validity, but Jack Scannell, the author of Eroom’s law, and a team of experts argue it is far more crucial than most believe it is.

Five Steps To Packaging Quality Assurance For Liquid Pharmaceuticals

Find solutions to five key challenges of quality assurance and information to help you identify which product inspection products can best support your application.

Improving Patient Access With Technology And Regulatory Frameworks

The pharmaceutical industry is shifting toward decentralized manufacturing models to improve patient access to life-changing therapies.

How Can You Ensure Successful Late-Phase Development And Launch?

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.

Ensuring The Efficacy Of Probiotic Products

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.

SOLUTIONS

Life Sciences Manufacturing Excellence Platform

Digital Backbone For Manufacturing And Process Quality Data

Premier European Product Launch And Packaging Solution

A Technology-Driven CDMO Delivering Integrated End-To-End Services

Cleanroom Mopping Systems

Genderless Sterile Connector

Polymer Processing Capabilities

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