Environmental monitoring, especially particle counting, in cleanrooms is used to show that said cleanroom operates within its set parameters before and during manufacturing processes. The safety and quality of products can be affected if too many particles enter the manufacturing space or process. However, this monitoring is commonly still a manual process in many cleanrooms instead of routine or continuous particle counting. Cleanrooms are highly regulated environments that require the utmost attention to air quality and cleanliness.
September 26, 2019
To continue operating, a critical environment must meet many safety standards to keep their space free of harmful particles. If an environment is not monitored, it can be easily contaminated by harmful particles such as mold. Air sampling is one of the most common ways to monitor for - and thus prevent - mold. Viable and non-viable air sampling can be employed in detecting mold and other harmful particles in the air. Not monitoring for those particles can lead to disaster.
September 18, 2019
USP 797 revisions were published on June 1, 2019. The clarity and readability of documentation is a concern for all facilities and significantly impacts those who compound both hazardous and non-hazardous drugs or those who administer CSPs. The revisions to USP 797 reflect new science and evidence based on updated guidance documents, best practices, and new learnings.
July 11, 2019
OEM and mechanical parts suppliers adopting ISO Standards is increasingly common throughout the US, driven by a spike in industry demand for components manufactured in ISO compliant factories. In addition to existing and increasing demand for ISO compliance in clean rooms, healthcare spaces, and laboratories, manufacturing facilities like automotive, electronics, loT, and industrial are now adapting to observe these standards. To be ISO compliant, all of these spaces need highly accurate, reliable, and NIST-traceable sensors for monitoring.
When selecting a particle counter, it is necessary to consider what building automation network it can communicate with. Examining the available options helps to ensure the particle counter will connect to your existing network.
Nosocomial infections (also known as Hospital-Acquired Infections, Healthcare-Associated Infections, or HAIs) can result in otherwise avoidable extended hospital stays, readmittance, follow-up treatments, and even death. HAIs can often spread via airborne transmission, which emphasizes the need for proper room pressurization to contain hazardous particles. Operating rooms (ORs) are an area where patients are especially at risk for contracting infections. 2.5µm particles are an important leading indicator of the potential presence of contaminants that could put the patient at risk. The best opportunity to manage the risk of infections is by limiting 2.5µm particles in a space.
Inhaling airborne particles can put both critical patients and healthcare staff at risk for detrimental health issues. Controlling these particles is necessary for protecting both staff and occupants of nearby rooms from exposure to infectious particles. To maintain safety in a hospital, it is crucial to monitor both differential pressure and particle counts in anterooms.
March 28, 2019
Requirements and regulations are becoming ever more stringent for critical environments, making finding the right products for a space increasingly difficult. Not only must the specs of the product be considered, but the supplier must be taken into account as well. Shopping around with the intent to purchase from a variety of vendors takes a significant amount of time and effort. In addition to wasted time and effort, buying from multiple vendors comes associated with a number of risks and drawbacks, including:
- Incompatible hardware
- Incompatible software
- Minimal or disjointed tech support
- Inability to integrate products
- Installation and operational issues
February 22, 2019
1. Recognize the difference between BACnet options
BACnet has a multitude of protocols available, but Setra products typically only operate on one of two options.
February 12, 2019
Twice a year, many critical environments - such as compounding pharmacies and cleanrooms - undergo particle certification. To obtain room certification, either a minimum sample volume (as written in the EC GMP Annex 1) should be taken, or the sequential sampling technique (as identified in both FS209E and ISO 14644-1) should be used. However, since this particle certification usually occurs only every six months, many critical environments are unaware of their particle counts during the remainder of the year.