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 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.

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 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.

The R&D lab of a global pharmaceutical company has recently committed to replacing all of their humidity sensors with Setra’s SRH300 and SRH400. The customer’s team was thrilled to learn that the Setra high accuracy humidity and temperature sensors are enabled with BACnet MS/TP and will seamlessly connect to their current building automation system.

In hospitals, pharmaceutical compounding centers, and other sensitive healthcare environments, one of the biggest threats to patient health is the spread of pathogens. Exposure to viruses, bacteria, pollen, and fungi all pose hazards to patients and care providers and can compromise critical spaces like operating rooms and other procedure areas.

In most hospital pharmacy cleanrooms, standard operating procedure includes sampling of air quality for viable particles (i.e. particles that include or are composed of microorganisms). These tasks are traditionally executed with an air sampler containing agar strips or simply by placing agar contact plates on surfaces throughout the facility. These samples are then left to incubate and are then analyzed to determine the environment’s air quality.

Hospital pharmacies are unique because of the critical role they play in maintaining patient health and safety. Pharmacies that perform compounded sterile preparations (CSPs), in particular, must meet specific clean room standards to ensure sterile conditions are maintained. While there are many established environmental requirements in these spaces, some pharmacy managers are choosing to go the extra mile in exchange for added peace of mind.