Material Handling Featured Articles
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EMA's Revised GMP Annex 1 Addresses Common Global Challenges For Sterile Products
1/18/2023
The new EMA GMP Annex 1, “Manufacture of Sterile Medicinal Products," is in line with other international regulations, e.g., ICH and PIC/S. FDA involvement in its writing is a clear indication that the contents will be the FDA position in general terms. Fortunately, the annex contains many checklists to help you assess and remedy your systems.
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ICH Final Q13 Guideline For Continuous Manufacturing: What It Means
12/16/2022
The International Council for Harmonisation released the final draft of its Q13 guideline for continuous manufacturing. It's yet another signal that global regulators see tremendous potential in CM. Here are the key takeaways.
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Cleanroom Gowning Programs Compliant With EU GMP Annex 1
12/15/2022
Part 1 of this article series provided an overview of cleanroom gowning per the revised EU GMP Annex 1. This article focuses on establishing an aseptic personnel gowning program compliant with the Annex.
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Pharma Process Validation: Initial Conclusions Are Often Deceptive
9/26/2022
As a pharmaceutical consultant, this author has observed many pharma process validation outcomes. In this article, he provides insights into two recent process validation problems that could have been avoided with an enhanced developmental approach and a greater understanding of the impact of CMAs and CPPs.
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A CTO’s Journey Into Continuous Biomanufacturing
8/24/2022
At a recent Evaluating BioPharma virtual event, moderator John Bonham-Carter asked Chris Hwang, chief technology officer at Transcenta Holding Ltd., about Chris’ journey and experiences with continuous bioprocessing thus far in his career.
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The Process Map To Ensure Biopharma Raw Materials Supply
8/16/2022
In new product introduction, there is often a lack of a basic data package for a product being scaled up for clinical or launch supplies. This can lead to several issues, e.g., capacity and lead time restrictions, oversupply, and more. A stepwise process can be used as a guideline for introducing a material to support new drug substance manufacture.
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Troubleshooting Tablet And Tooling Issues Involving Magnesium Oxide
7/7/2022
Magnesium Oxide formulation is abrasive and alkaline which can be reactive to tool steels. Learn the warning signs of tooling issues and preventative measures that will make your tooling last longer.
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Tablet Tooling Considerations For Scale Up And Post-Approval Changes
7/7/2022
Understand how determining if tablet weight consistency or integrity plays the more dominant role in your tableting process directly impacts your production output rates.
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Tablet Tooling Selection Guide For OSD Manufacturers
7/7/2022
Learn how choosing the right tooling can increase tablet output, decrease waste, and ultimately determine the success of a product launch.
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Increasing Dwell Time In Pharmaceutical Tablet Manufacturing
7/6/2022
Many types of punches and dies are available to help compress difficult drug products. Explore the benefits as well as some drawbacks of using extended head flats.