Exceeding Your Benchmark – Benchmark Products

Pharma Manufacturing: Meeting Annex I with Precision Machining for Safer Sterile Drug Production

precision machining

Pharmaceutical manufacturers are under increasing pressure to deliver sterile, high-quality medicines in smaller batches and faster cycles. As pharma manufacturing evolves, regulatory demands have intensified, especially following the 2023 revision of EU GMP Annex I, which places new emphasis on contamination control strategies, improved traceability, and minimizing human intervention throughout production. According to American…

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Benchmark Products
Sterile Compounding and Contamination Control with Abby Roth

In this episode of Exceeding Your Benchmark, host Michelle Dawn Mooney speaks with Abby Roth, founder of Pure Microbiology, about sterile compounding and contamination control. Abby shares her expertise in microbiology, sterile environments, and best practices in pharmaceutical compounding. The conversation begins with a distinction between traditional drug manufacturing and sterile compounding, highlighting the…

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Benchmark Products
One Year of The Exceeding Your Benchmark Podcast

Benchmark Products provides products for critical life science and pharma environments. In this podcast series Exceeding Your Benchmark, they interview leading experts on a variety of trending topics. In celebration of its first year, Exceeding Your Benchmark looks back at interviews with experts from life science and pharmaceutical manufacturing on timely topics from Annex…

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Exceeding Your Benchmark - Benchmark Products
Exploring the Fundamentals of Validation in Life Science Manufacturing

In the rapidly evolving domain of life science manufacturing, validation emerges as a cornerstone to ensure that products meet stipulated requirements concerning quality, safety, and efficacy. This pivotal aspect of manufacturing comes to focus as regulatory landscapes shift, mandating stringent compliance to ensure patient safety. In a recent episode of Exceeding Your Benchmark, a…

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Articles Healthcare
Pharmaceutical Manufacturing is Witnessing Major Transformation as New Demands for Sterility Assurance Reshape Healthcare

For an industry where precision and quality control are paramount, pharmaceutical manufacturing is witnessing an evolutionary leap in contamination control practices. Propelled by changes in regulatory environments, such as the EU’s Annex 1 update and ICH Q9 focusing on quality risk management, the sector is shifting from isolated, data-point-centric strategies towards a more holistic…

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Exceeding Your Benchmark - Benchmark Products
Connecting Data to Improve Your Contamination Control Strategies

Contamination control is absolutely critical in the pharmaceutical industry and includes particulate, microbial, product carryover, chemical, and viral aspects of contamination and often involves proactive, reactive, and supporting aspects. However, regulations, liabilities, and patient health added to the mix create data silos that often form multiple processes and make it difficult to create efficient and…

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Exceeding Your Benchmark - Benchmark Products
Revolutionizing the Audit Process: Advancements in Supplier Assessments Within the Pharmaceutical Sector

Pharmaceutical companies invest significant resources in research and development to discover new drugs and therapies and improve existing ones. This involves rigorous testing, clinical trials, and obtaining regulatory approval before a drug can be sold. Government agencies, such as the Food and Drug Administration (FDA) in the United States, oversee the approval process and conduct…

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rubber
How Precision Engineering and Regulatory Complexity Shape the Future of Rubber Manufacturing
April 9, 2026

In an era where precision manufacturing often hides behind the simplicity of everyday products, the world of rubber components offers a striking reminder that complexity frequently lives beneath the surface. What appears to be a modest gasket or sealing element is, in reality, the product of highly specialized engineering, rigorous testing, and an…

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tekniplex
Inside TekniPlex Gaggiano: How Specialized Manufacturing and Precision Engineering Define a True Center of Excellence
April 9, 2026

Manufacturing excellence today is less about scale alone and more about precision, control, and adaptability—especially in industries where even microscopic inconsistencies can have outsized consequences. As global supply chains grow more complex and regulatory standards tighten, facilities that invest in specialized processes and contamination control are quietly becoming the backbone of innovation. Segregated…

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materials
Tekniplex Showcases Sustainable Materials Innovation at Paris Packaging Week 2026
April 9, 2026

At Paris Packaging Week 2026, Tekniplex didn’t just exhibit—it staged an experience that reflected the evolving intersection of materials science and brand storytelling. The company’s modern booth, complete with a living wall and immersive digital displays, signaled a broader shift in how packaging innovators are choosing to engage a sustainability-conscious audience. Beneath the…

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Paris Packaging
Paris Packaging 2026: How Material Science and Global Innovation Are Reshaping the Future of Packaging
April 9, 2026

In an era where sustainability, performance, and consumer expectations are colliding, packaging has quietly become one of the most dynamic frontiers of innovation. What was once viewed as a functional afterthought is now a strategic lever—one that blends advanced science, manufacturing precision, and an increasingly human-centered understanding of market needs. Material science, in this…

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Other Exceeding Your Benchmark - Benchmark Products
How Life Science Manufacturing Facilities Can Successfully Adapt To Change
February 11, 2023

In this podcast episode of “Exceeding Your Benchmark,” host Gabrielle is joined by Ashley Harp, Lead Process Engineer at CRB. They discuss the challenges manufacturing facilities like Life Science Companies are facing as they adapt to new technologies and advancements in manufacturing, specifically in the area of combining highly potent active pharmaceutical ingredients (HPAPIs) and…

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How Cell and Gene Manufacturers Can Scale to Meet Demand
December 21, 2022

Between 2022 and 2030, the cell and gene therapy sector is expected to experience a compound annual growth rate (CAGR) of 39.42 percent, BioSpace said of a recent Vision Research Report. This is quite a large anticipated growth; how will startups and current manufacturing companies work to meet this growing demand? On today’s episode of…

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What Updated Annex 1 Regulations Mean for Sterile Manufacturing Companies in 2023
November 2, 2022

Over the summer new GMP Annex 1 regulations were released by the FDA and EMA, prompting new changes to become standard protocolin sterile manufacturing companies. By August 2023, the regulations will take effect and companies will have to ensure that they are in compliance with the guidelines set. Discussing this on a new podcast, host…

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