Working with an international team of experts from universities on the forefront of air quality monitoring research, RESET® will be releasing a new air quality standard aimed at providing a framework for qualifying airborne particulate sensors – specifically optical particle counters – used for indoor and outdoor air quality monitoring.
Cleanroom Standards Articles
It’s the cleanest room in a hospital, but most of us will never step foot in it. Pharmacies and compounding laboratories are a hot topic in the health care world as the US Pharmacopeial Convention’s (USP) revised guidelines necessitate new pharmacy design to meet USP 797 and USP 800 compliance.
TSI introduces a new range of AeroTrak®+ Remote Airborne Particle Counters (APCs) for monitoring manufacturing cleanrooms. TSI is so confident about the performance of the new laser technology inside, that all models are covered by an industry-exclusive standard 5 year laser warranty.
QuantumClean & ChemTrace will demonstrate how its ultra-high purity chamber tool part cleaning, proprietary coatings and microcontamination analytical testing can help reduce wafer fabrication Cost-of-Ownership (CoO). Solutions’ information is available during show hours at SEMICON Europa at the Messe München Exhibition Center in Munich, Germany from November 13 — 16, 2018 (booth A4510).
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.
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.
NexLogic Technologies, Inc. has announced the completion of its International Standards Organization (ISO) 14644-1 Class 4/10,000 and the equivalent Federal Standard 209E (FS209E) Class 10 clean room as an integral part of its new microelectronics services and manufacturing capability.
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.
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.
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.
In this video, you can learn how to properly wash your clean room garments. When doing so, there are two factors that must be taken into account: water and detergent. Valutek offers this video to inform you on how to extend the life expectancy of your clean room garments.
he medical devices industry is one of the most highly regulated sectors in the world. Significant quality systems and product requirements must be satisfied to ensure the medical devices produced are fit for their intended purpose.