Cleanroom Standards

Get the latest cleanroom standards news and tips below. Cleanroom Connect brings you the latest cleanroom standards news from around the world, featuring current topics and news from cleanroom standards organizations and governing bodies.

Medical Device Single Audit Program – How Should You Prepare?

To streamline the oversight of manufacturers’ quality systems, and encourage improved product safety on a global scale, the International Medical Device Regulators Forum (IMDRF) has developed the Medical Device Single Audit Program (MDSAP) whereby recognized Auditing Organizations (AOs) conduct a single audit of a medical device manufacturer that satisfies the relevant requirements of various regulatory agencies.

New Modbus Flow Totalizer for Hazardous Applications

SignalFire Wireless Telemetry introduces the ModQ Sentry, a Modbus Flow Totalizer that interfaces with pulse-type inductive turbine (and other) flow meters to provide instantaneous flow rates, accumulated totals and status information. Units are configurable for volume and time settings and offer options to configure the K factor to match the turbine.

Aseptic Gowning for the Cleanroom

Correct aseptic gowning procedures are of utmost importance to ensure a safe and compliant operation in the cleanroom environment. Particulate is difficult to detect because it is invisible to the naked eye. Contamination is commonly introduced to the cleanroom environment through the people who enter the cleanroom.

Compounding Pharmacy Safety violations

In December, the Food and Drug Administration issued a thorough inspection report on PharMEDium’s Tennessee plant that resulted in a pause in pharmaceutical production, until otherwise permitted. PharMEDium, one of the nation’s largest compounding pharmacy companies, is owned by AmerisourceBergen. It supplies medications to about 77% of hospitals nationwide.

Single Pass Versus Recirculating Clean Rooms

The decision that will influence the design of a cleanroom air handling system determining the method to use should be made depending of the desired preciseness of your control. If you are controlling temperature and humidity very tightly, you want to use a recirculating system so that once you’ve conditioned that air, you are not letting the conditioned air escape.

USP 797 Cleanroom Performance

USP General Chapter <797> provides standards for compounding sterile preparations to promote patient safety and prevent harm. These standards help ensure patients receive quality preparations that are free from contaminants and are consistent in intended identity, strength and potency.

ASHRAE – American Society of Heating, Refrigerating and Air-Conditioning Engineers

ASHRAE, founded in 1894, is a global society advancing human well-being through sustainable technology for the built environment. The Society and its members focus on building systems, energy efficiency, indoor air quality, refrigeration and sustainability within the industry. Through research, standards writing, publishing and continuing education, ASHRAE shapes tomorrow’s built environment today. ASHRAE was formed as the American Society of

Cleanroom Standards

Cleanroom Standards News and Insights

cleanroom standards

cleanroom standards

Cleanroom standards news by industry leading cleanroom entities and governing organizations. The cleanroom standards area includes news and insights from various cleanroom standards agencies and/or governing bodies.

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