ARTICLES BY HERMAN & ERICH BOZENHARDT
Huh? Where Did That Environmental Monitoring Hit Come From?2/16/2024
After decades of helping to rescue biotech and pharma companies from environmental monitoring excursions, Herman and Erich Bozenhardt bring this discussion about specific problems you should avoid.
Help! The Particle Count Is Overwhelming Us!12/12/2022
Contamination issues can challenge any facility, especially legacy facilities and those with intense operational demands, financial pressure. Let's look at some of the most common particle origins and some solutions.
Key Considerations For Decarbonizing Your Biotech Facility5/4/2022
Biopharmaceutical manufacturing processes do not directly utilize fossil fuels, but fossil fuels are used in the generation of raw materials, consumables, packaging, and in supplying energy to building systems and manufacturing equipment. This article looks at key facility decarbonizing considerations using a case study with quantification of estimated costs.
Facilities Remediation, Renovation & Reconstruction: When Does It End?2/7/2022
We sit at the beginning of 2022 amid the industry’s frantic and hurried effort to acquire, expand, and prepare more aseptic plant capacity — and to make it useable, compliant, and productive. This article provides a deep-dive on planning and design for your project, including walls, floors, ceilings, interstitial and mechanical spaces.
Bioprocess Facility Design — Layout Rules And Configurations12/9/2021
The adoption of single-use systems (SUS) is allowing for a shift to smaller and more flexible facilities. This article explores modern facility design options and configurations, and best practices for building a facility around SUS process technology.
An Introduction To Biopharma Facility Design & Layout10/11/2021
This article explores modern facility design principles that make use of the most flexible new technologies and provide a platform to rein in costs, reduce schedules, and deliver products compliantly and within business risk tolerance.
Expansion Options For Adherent Cell Therapy8/4/2021
While the stirred tank bioreactor is the workhorse of the biopharmaceutical industry, there are applications for which cells can’t be effectively cultured in suspension. Beyond the petri dish and the T-flask, many in our business have not had interactions with the numerous and sometimes niche solutions for adherent cell culture. This article discusses our options in this field.
PIC/S Annex Update: What Is Your ATMP Control Strategy?6/30/2021
Recently, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) revised Annex 2 of its GMP guide addressing the manufacturing of advanced therapy medicinal products (ATMPs). While this guide is not an FDA or EMA guidance, it represents the consensus thoughts of a group that those regulators participate in.