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. 

What is a REST API and Why Should I Care? 

The awareness and utilization of APIs has exploded in recent years. Originally the domain of the software development community, these powerful interoperability enablers are now at the forefront of web, cloud-based and mobile device application development. 

Let’s face facts; manual monitoring of cleanroom particulate counts is costly, monotonous and highly error prone. Cleanroom managers are very aware that by far the greatest contamination threats come from individuals entering controlled spaces. Understandably, to reduce the number people accessing these critical environments, many companies are tasking the cleanroom operations staff already working within these spaces with the additional responsibility for manual environmental monitoring (EM). While this approach has obvious benefits, such as lower labor costs and reduced contamination risks, it also introduces significant new data integrity issues.  

Setra’s wide array of non-viable particle counters are used throughout critical environments to measure particle concentrations of various sizes; these counters use a long-life laser diode, light scattering, and photo detector to calculate particle size and quantities as the sampled air passes through. Particle counters are required for cleanroom certification but are also often used for continuous, sequential, or periodic monitoring of the space between certifications and to ensure that particle levels are maintained below critical thresholds during manufacturing. This post will look at Setra’s different particle counters and their differences to help you decide upon the correct unit(s) for your application.

Setra’s comprehensive range of particle counters and air quality monitors are the most advanced, high-performance instruments available. This industry-leading position has developed from an enduring, intense focus on innovation and original intellectual property creation.

Cleanrooms are specially constructed, highly regulated environments for controlling atmospheric conditions and eliminating dust particles. As such, these spaces require continuous monitoring of many environmental parameters. Without this continuous monitoring, the quality of manufactured product and safety of cleanroom personnel could be at risk.

For regulated spaces creating electronic records of environmental monitoring and other sensitive data, accuracy and security are of paramount concern. How data is handled in regulated environments like cleanrooms is crucial to both regulatory compliance and data security. Besides the damage a data breach can do to a company’s reputation, a company has a legal obligation to protect user and customer data.

An ISO 14644-1 classified cleanroom is a room or contained environment where it is crucial to keep particle counts low. Typically, these particles are dust, airborne microbes, aerosol particles, and chemical vapors. Beyond particle counts, cleanrooms often have controls for a number of other parameters like pressure, temperature, and humidity. Additionally, to be considered a cleanroom, the space needs High-Efficiency Particulate Air (HEPA) filters to remove particles from the air.