Setra Blog

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.

Flow rate is important to consider when selecting a particle counter for a critical environment. The flow rate of a particle counter is the rate at which a pump draws air through the sample chamber, measured in cubic feet per minute (cfm). Two common flow rates for particle counters are 1 cfm and 0.1 cfm. Depending on the application, each flow rate can be valuable.

Compliance with USP 797 and USP 800 are critical for maintaining a sterile cleanroom for CSPs. Proper environmental conditions, as outlined by USP 797 and USP 800, help to ensure the effectiveness and quality of medications.

USP 800 is the standard governing hazardous drugs and their handling during receipt, storage, compounding, dispensing, administration, and disposal of both sterile and nonsterile preparation. USP 800 is in place to protect personnel and environments from hazardous drugs compounds, such as those in chemotherapy drugs or radiopharmaceuticals. USP 800 focuses on the safe handling of hazardous drugs (HDs) to minimize the risk of exposure to healthcare personnel, patients, and the environment. A drug is considered hazardous if

USP 797 is the standard in place governing the sterile preparation of compounded pharmaceuticals. USP 797 covers the compounding of both hazardous and nonhazardous drugs with a focus on the protection of sterile compounds and environments from contamination. This standard is in place to ensure patient safety and reduce risks associated with compounding pharmaceuticals, including contamination, infection, and incorrect dosage. The standard helps to guarantee patients receive quality drugs free from contaminates. This standard applies to all pharmacies that produce compounded sterile preparations (CSPs); this includes pharmacies within hospitals, radio or nuclear pharmacies, chemo units, and operating rooms. The goal of the standard is to prevent harm to patients resulting from microbial contamination, bacterial endotoxins, variation in the strength of ingredients, and chemical and physical contaminates.

Introducing Setra’s new Power Meter! Available mid-2019, the new Power Meter is making its debut at AHR 2019.

Setra FLEX Environmental Monitor helps to ensure safe and energy-efficient indoor environmental and ventilation control conditions for pressurized critical spaces. Compliance with the standards and regulations for monitoring and control of critical environments requires highly reliable yet easy to use products, and FLEX was designed with compliance of these standards in mind. FLEX is the highest performing and most flexible room monitor and controller in the industry.

Setra’s latest innovation and addition to our extensive line of industrial pressure transducers is the Model AXD™ pressure sensor. The Model AXD is Setra’s most versatile pressure transducer yet. The Model AXD is for high performance applications where reliability and versatility are key, all at an affordable price.

Setra FLEX is a comprehensive environmental monitoring system for critical environments. Winner of the 2018 AHR Innovation Award in the Building Automation category, FLEX provides flexible room control and monitoring in a pre-configured, simple to use unit.

Relative humidity (%RH) is a measurement of how much water vapor is in the air compared to how much water vapor could be in the air. Monitoring relative humidity is important in a variety of environments, from office spaces to operating rooms to industrial manufacturing.