cleanroom gowning protocal
Nov 10, 2022

10 Ways To Improve Your Cleanroom’s Gowning Protocols

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 […]

Nov 9, 2022

8 Features To Look For In An Active Air Sampler

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 […]

Nov 3, 2022

Indoor Air Quality And Its Impact On Our Health And How To Improve It

Oct 13, 2022

How to Gas Sample Using a Particle Counter

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 […]

Gas Sampling in a cleanroom
Oct 8, 2022

The Basics Of Gas Sampling In A Cleanroom

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, […]

Oct 6, 2022

Gas Sampling Applications

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. 

Cleanroom gas sampling basics instructions
Oct 5, 2022

Basics Of ISO 8573

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 […]

Sep 22, 2022

Cleanroom Validation from URS to PQ; ISPE GAMP5 2022 Edition & V Scheme Application for Cleanroom Monitoring Systems

Data_Integrity_Blog
Sep 21, 2022

The Basics Of 21CFR11 And GAMP5 For Data Integrity In A Cleanroom

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 […]

Sep 9, 2022

Performance Quality Testing And Environmental Monitoring

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 […]

mitigate risk management
Sep 7, 2022

5 Ways To Mitigate Risk In A Cleanroom

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 […]

Pharma 4.0
Aug 3, 2022

Cleanroom Basics: What Is Ultrapure Water?

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 […]

shield 95 medi mask
Aug 3, 2022

Introducing The New “Fit Test Champion”: SHIELD-95-MEDI Surgical N95 Respirator

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 […]

Jul 13, 2022

Basics On Minimizing Contamination Risk In Your Cleanroom

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 […]

Jun 8, 2022

Lighthouse Active Air Sampler Technology and d50

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. […]

Jun 3, 2022

Lighthouse Apex Particle Counters compatibility with Vaporized Hydrogen Peroxide

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, […]

May 27, 2022

The Selection of the right Air Sampling Equipment for Your Process and Quality Assurance

May 25, 2022

Good Automated Manufacturing Practices 5 (GAMP5) And Your Cleanroom

The Good Automated Manufacturing Practices (GAMP) were developed by the International Society for Pharmaceutical Engineering (ISPE) for pharmaceutical cleanrooms. The ISPE remains the governing body for GAMP. According to ISPE, GAMP is, “A system for producing quality equipment using the concept of prospective validation following a life cycle model. Specifically designed to aid suppliers and users […]

May 18, 2022

Fill the “GAP” Good Application Practice “How to Test HEPA Filters ”

May 18, 2022

4 Cleanroom Particle Filtration Techniques

How many times have you heard us say, “your cleanroom filtration is critical”? Probably more than once if you’ve spent any time interacting with us. But not all filtration is the same! Depending on your filter and application, there are different cleanroom particle filtration techniques. Today, we’ll be covering 4 of them. Straining/Sieving This technique is […]