Setra Blog

Safety is Top Priority. Compliance is Essential. Will you be ready by November 2023?

Revised standards for USP General Chapter <797> for compounded sterile preparation (CSP) have been finalized and have an estimated effective date of Nov 1, 2023. These revisions will also affect USP <800> where hazardous drug (HD) compounding is applicable. Both standards include environmental monitoring and management requirements that were not previously enforced and must be met to achieve accreditation through local and national governing bodies come November 2023. Understanding the conditions and monitoring requirements is critical in ensuring compliance.

There are many major benefits to be gained from the implementation of a Setra Continuous Environmental Monitoring System (CEMS). The use cases shown below exemplify the ongoing value delivered through this secure, highly available, cloud-based, real-time environmental monitoring, alarming, reporting and data collection platform. 

Setra's latest product innovation of wireless transmitters builds on our over fifty years of experience delivering industry leading sensing technology. Our new wireless sensing product line can easily measure and monitor a variety of environmental parameters. Wireless transmitters are used throughout a number of applications, including but not limited to:

In the medical field, the primary HVAC standard is ASHRAE Standard 170. One of the vital duties of an HVAC system in this space is to filter and control the spread of airborne infectious particles. Infection control is a focus of the medical field as procedures continue to evolve with technology advancements. The medical field relies on HVAC technology not only to fulfill regulatory requirements, but also to reliably and accurately manage their environments to keep patients safe.

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.

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.