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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.
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...
ISO cleanroom standards offer international consistency and have been developed by a technical committee of controlled environment subject matter experts.
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, 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
American National Standards Institute Website As the voice of the U.S. standards and conformity assessment system, the American National Standards Institute (ANSI) empowers its members and constituents to strengthen the U.S. marketplace position in the global economy...
ABSA - American Biological Safety Association ABSA - American Biological Safety Association ABSA International (ABSA) was founded in 1984 to promote biosafety as a scientific discipline and serve the growing needs of biosafety professionals throughout the world. The...
What factors should you consider when evaluating clean room windows? When does provide visibility into a clean room operation without allowing people into the clean room operation. This promotes a cleanly environment and decreases the possibility of contamination.
The most important part of maintaining a clean environment as it corresponds to clean room windows, you want to ensure that there are minimal window ledges in the clean room environment. Ledges are a great place to collect contaminants that could set back your queen room operation.
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