China
Africa
Explore chapters and articles related to this topic
Design Considerations for a Radiopharmaceutical Production Facility
Published in Michael Ljungberg, Handbook of Nuclear Medicine and Molecular Imaging for Physicists, 2022
Generally, the production of radiopharmaceuticals for human administration is classified as aseptic manufacture. Since a terminal sterilization of products is rarely possible (e.g. autoclaving), special precautions must apply to ensure the quality of the radiopharmaceutical products. Guidance for the requirements for such activities can be found in, for example, The rules governing medicinal products in the European Union [2]. To protect products from contamination, cleanroom areas are required. The classification of cleanrooms is well established and applies for both pharmaceutical manufacture and in the electronic industry, where extremely clean air is also important. Cleanroom classification is based on the measurement of airborne particles. Table 5.1 gives the EU limits for the different grades of cleanrooms.
Introduction
Published in Sunipa Roy, Chandan Kumar Sarkar, MEMS and Nanotechnology for Gas Sensors, 2017
Sunipa Roy, Chandan Kumar Sarkar
Cleanroom technology is based upon three criteria:Cleanroom design and construction: It is essential to design and construct the room first. While designing, one must adopt the design standards, e.g. what type of design layout and construction materials can be used, and how requisite material would be supplied to the cleanroom.Second, the most important aspect, is the continuous monitoring after the cleanroom has been installed and operational; it must be examined properly to confirm that it is working as determined. In the long run, it should conform to the standards that are required.Finally, it is necessary to handle the cleanroom in a proper way to avoid contamination of the products. This includes proper checking of people’s access, entry of materials and garments used, strictly following cleanroom rules and regulations and maintaining cleanliness of the room.
Considerations for Development and Manufacture
Published in Richard J. LaPorte, Hydrophilic Polymer Coatings for Medical Devices, 2017
The majority of processes associated with the manufacture of medical devices are conducted in controlled environment or cleanroom facilities, the design and construction of which are quite intensive and extremely expensive. Cleanrooms are classified according to the concentration in air of particles 0.5 μm or greater in size that can be maintained continuously. For example, a class 10,000 cleanroom is one in which the concentration of particles that are ≥ 0.5 μm in size is no greater than 10,000 per cubic foot of air (Table 4.1). The class of cleanroom required for the manufacture of a particular product to be in compliance with quality norms is dictated by Federal Standard 209E, which combines both international and federal standard designations. To achieve and maintain required particle concentrations, cleanrooms rely on air filtration in conjunction with air recirculation.
Survey of particle production rates from process activities in pharmaceutical and biological cleanrooms
Published in Science and Technology for the Built Environment, 2019
Oluwaseyi T. Ogunsola, Junke Wang, Li Song
Cleanroom technology has evolved due to the convergent needs from several fields of manufacturing, healthcare, and the military (Holbrook 2010). The objective of cleanroom technology is the establishment and maintenance of a working environment that is devoid of particulate contamination (Schicht 1990). The strict cleanliness requirements and narrow humidity and temperature control bands make cleanroom design a challenging task. Cleanliness depends on the quality of the supply air, contamination sources within the cleanroom, and the design of the HVAC system. As in 1958, there is a lack of uniformity in cleanroom building, testing, and operations. There were challenges with maintaining the required level of cleanliness for nuclear weapon production facilities (Holbrook 2010). The unidirectional flow cleanroom configuration was developed to offer a solution to the cleanroom cleanliness problem. By the end of 1963, the Federal Standard 209 was made widely available. It classified cleanrooms based on the number of particles 0.5µm per cubic foot of air and above and 5µm per cubic foot of air and above. The “laminar” flow cleanroom was developed in response to the need for a self-cleaning cleanroom and is based upon a displacement method of contamination control (Whitfield 1963). Thus, it requires very high air flow rates. The resulting economic penalty led to the confinement of unidirectional flow to areas that are only critically required (Schicht 1990). As of 2000, the nine industry categories for which cleanroom technologies are crucial are: electronics, semiconductors, micromechanics, optics, biotechnology, pharmacy, medical devices, food and drink, and hospitals (Holbrook 2010). There are various processes and operations within those fields.