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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.
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 Doors Selection: What factors should you evaluate In this brief segment, told by a cleanroom door expert, learn the factors that should be analyzed when making a cleanroom doors selection. What factors should you consider when evaluating cleanroom doors...
From Pharmaceutical Cleanrooms to Aerospace Cleanrooms, modular wall systems provide a durable surface that is easy to clean and can be quickly adapted to resize or shape the cleanroom. Due to the wide range of cleanroom applications, you have several factors to consider when choosing your cleanroom’s modular wall systems and your Wall Panel Substrates. When scoping a cleanroom for your business, you have to take into account the following:
The cleanroom airflow system is one of the most critical components to achieving a clean environment. Parallel to the system design and selection, air change rates are an important factor in contamination control of a cleanroom and will help determine fan and motor...
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