GAMP5 refers to the fifth publication of Good Automated Manufacturing Practices published by the International Society for Pharmaceutical Engineering (ISPE). GAMP5 is not a set of regulations, but instead a collection of guidelines developed through evidence-based decision making that reinforces the standards set by many regulations, including Annex 11 and 21CFR11. These guidelines outline a […]
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 […]
You will hopefully not be shocked to learn that data integrity is an integral part of a properly running cleanroom. If this does come as a surprise to you, we highly recommend you read on and take notes. But for many cleanroom or particle counter professionals, the term “data integrity” has been drilled into our […]
What is a foundational piece of your cleanroom contamination control strategy? Your gowning protocol. Humans, by far, produce the most particles in a cleanroom and your gowning protocol can limit that number. While we have a number of ways to improve your gowning protocol across the board, it is important to recognize that different ISO classifications require […]
An active air sampler is one of the tools you can use in your cleanroom to monitor contamination, but, specifically, it is the tool you can use to monitor viable contamination. These are live microbes, so they have the potential to grow, like mold or fungi. While a particle counter can tell if contamination is […]
Testing of compressed gases is a GMP requirement when such gases are used in cleanroom applications. It is critical for such testing to occur since product process zones in ISO 5 cleanrooms and zones require tight control on contamination and compressed gases used may also if not checked correctly be an avenue for particulate contamination […]
It is no mystery that cleanrooms need to be, well, clean. From the surfaces and tools to the air in the cleanroom, everything needs to remain at a certain level of cleanliness depending on the cleanroom’s classification and application. Those criteria extend to the compressed gasses used in cleanrooms, as well, like oxygen, hydrogen, methane, […]
Lighthouse offers an opportunity to sample the contamination level in compressed gases. In the electronics industry as well as the Pharma industry contamination control of compressed gas has been getting more important over the last few years.
If you use compressed gasses in your cleanroom, ISO 8573 is an important set of guidelines and regulations for your cleanroom, specifically ISO 8573-1:2010. This set of guidelines is maintained and governed by the International Organization for Standardization (ISO), an international, non-governmental organization dedicated to creating worldwide standards for a variety of industries. ISO standards […]
If you know us, then you know that clean air and water is our passion in life. But what happens when you cannot prove to the regulatory authorities that your air and water is clean? Cleanrooms and monitoring systems generate a lot of data. In an 8 hour shift, as many as 5,000 individual count […]
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 […]
Did you know we start to mitigate risk in our lives as early as 6 months old? That’s right: at 6 months old, an infant can recognize a stranger and knows – in their gut – that the unfamiliar person could pose a risk. The following cries are the baby’s form of risk mitigation. But […]
If you are working with a pharmaceutical or semiconductor manufacturing cleanroom, you most likely have seen ultrapure water in action. This water is used for water for injectables (WFI) in pharmaceuticals and as a chisel for semiconductors. While it has many other purposes, these are the primary two. And those two industries use a lot […]
Anyone who has used an N95 face mask knows that they are far from comfortable: they pinch in all the wrong places, they fail fit tests, and they limit your vision. As you have to fiddle with your face mask, its functionality and protection comes into question. As the world’s leading clean air experts for […]
What is the biggest villain in the contamination control and cleanroom world? Particles. Contamination. This contamination can cause yield and financial loss, delays, frustration, and physical threats to the end user. It is something that should be avoided wherever possible. To minimize contamination risk in your cleanroom, you first need to understand what contamination control […]
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