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Regulation and standards for “clean plants” have been increasing in recent years as China’s pharmaceutical R&D and production industry develops rapidly. EP & Clean Tech China 2019, hosted by CCCMHPI, UBM EMEA and UBM Sinoexpo, is an annual event of the pharma clean industry, that will blow a strong, new pharma clean wind in Hall N4 of Shanghai New International Expo Centre (SNIEC). Over 100 Chinese and overseas quality clean enterprises will gather on-site, to showcase the latest pharma cleanroom equipment and products, engineering technologies, and solutions, etc.
The Next Generation Greenhouse: AGT Unveils Cleanroom Technology, Energy Efficiency and Fast Build Times to Empower Growers
Sleek, modern structures full of patent-pending technologies such as Natural Earth Air System, oil bath fans and variable daylight control ushers in a new era for greenhouses
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.
ISPE International Society for Pharmaceutical Engineers ISPE delivers technical and operational solutions to support its Members across the global pharmaceutical and biopharmaceutical industry. ISPE positions itself as a center of excellence in the pharmaceutical...
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