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 […]
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 […]
Air Sampler impaction technology has been around for decades. However the d50 is a little know aspect of air sampler technology design and it plays a critical role in air sample capture. Aerosol Impaction is the process in which particles are removed from an air stream by forcing the gases to make a sharp bend. […]
Vaporized Hydrogen Peroxide (VHP) is a powerful chemical used to sterilize surfaces andequipment in the cleanroom, specifically in the medical equipment and pharmaceuticalindustries. It can cause deterioration and breakdown of equipment. Due to the nature of theindustries in which it is used, VHP is often used to sterilize equipment while the cleanroomis in use. Thus, […]
Cleanrooms require air filters in order to trap contaminants from entering the cleanrooms air supply through its HVAC system. Cleanrooms are controlled environments where the control of temperature/humidity, pressure and particles are essential for optimum operational performance.
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.