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.
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.
How to Wash Cleanroom Garments
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.
New Medical Devices Industry Handbook
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 Engineering
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 Committee
ISO cleanroom standards offer international consistency and have been developed by a technical committee of controlled environment subject matter experts.
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
ANSI American National Standards Institute
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 - 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...
Clean Room Windows Selection
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.
Air Flow Systems in Clean Room Design
What are the different air flow systems used in a clean room design? There are three types of Air Flow Systems in a Cleanroom: Pressurized Plenum Ducted supply and ducted return Ducted supply and open return Pressurize Plenum Air Flow System A clean room design...
Cleanroom Standards
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