Introduction In the realm of pharmaceuticals, the pursuit of excellence in product quality is a never-ending journey. Governments and private industries have diligently crafted recommendations and regulations over the years, evolving in response to the dynamic landscape of the pharmaceutical sector, particularly in the digital age. In this comprehensive paper, we delve into the fundamental […]
Introduction Cleanrooms in the Pharmaceutical industry are sanctuaries of precision, where the highest standards of cleanliness are not just expected but demanded. A key player in the sterilization arsenal of these cleanrooms is Vaporized Hydrogen Peroxide (VHP), a potent chemical used to disinfect surfaces and equipment. However, the nature of VHP, while highly effective at […]
Introduction Airborne particle counters play a crucial role in ensuring the environmental integrity of pharmaceutical, bio-pharmaceutical, and radiopharmaceutical facilities worldwide. In an increasingly globalized pharmaceutical industry, cooperation and harmonization have become the norm, driving the demand for continuous monitoring in these facilities as well as the drive for digital solutions to meet your Contamination Control Strategy. In this […]
Pharmaceutical injectable aseptic injections are essential medical products that are administered through injections, directly into the body. The manufacturing process for these injectable drugs is a meticulous endeavor, requiring stringent control measures to ensure they remain free from any microbial contamination or particles that could compromise patient safety. In this article, we’ll delve into the intricate process […]
Every revolution is, well, revolutionary. Processes and people massively change in a way that rocks the world to its core, in a way that makes it so the world is never the same again. We have witnessed these sorts of transcending changes throughout the last three industrial revolutions and, now, we are arguably experiencing the […]
ISPE’s Pharma 4.0 initiative points to everything the pharmaceutical industry could be if it embraced the same advancements of the fourth industrial revolution: digitization, empowerment, and automation. This is achieved through the integration of Industry 4.0 technology, originally spurred by the internet and now encompassing artificial intelligence, advanced robotics, and automation. Pharma 4.0 is sometimes […]
For years now, robots and automation have been making their way into pharmaceutical production. Lately, though, the power of Artificial Intelligence (AI) has taken the world by storm in the form of ChatGPT: a uniquely human AI bot that will have conversations with you, research for you, and adapt to what you ask it to […]
A lot has changed since the 1700s in the whole world, but especially in the pharmaceutical industry. Over the past 250 years, four industrial revolutions have swept the world, drastically changing the way we manufacture items and their availability – including pharmaceuticals. Industry 1.0 The first industrial revolution spanned from 1760 to 1830, with its […]
A PQ is a performance qualification which is conducted prior to a system becoming operational. The PQ tests the system to ensure it meets its operational objectives in a real world operational environment. It is the final step in equipment and systems qualification. A PQ should never be a re-execution of the vendor supplied Operational […]
Particle Counter management is a critical process in ensuring particle counter health and data integrity. The accuracy of the data from particle counters is critical in regulated industries. Particle Counters should be calibrated regularly based on their use. Manufacturers recommend that Particle Counters are calibrated at a minimum on an annual basis.
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