Purification Workshop Design Standards and Industry Specifications_Industry Specifications_News_sz-pharma

A key factor in pharma clean room design is controlling the air change per hour (ACh), also known as the air change rate (ACR). This is the number of times per hour that outside air is filtered to replace the existing volume of a building or room. In an average home, a clean room has more than 10 to 600 air changes per hour. ACR must be painstakingly measured and controlled. In its ISO 14644 -. 1 In the appendix to the cleaning standard, the International Organization for Standardization deals only with applications in microelectronics facilities. (ISO Classes 6 to 8; Federal Standards 1000, 10000, and 100000.) There are no ACR standards in the appendix for pharmaceutical, healthcare, or biotechnology applications that may require higher ACR regulations. Using an ACR range (rather than a set of criteria) is a better guide for cleanliness classification based on current research, case studies and experiments. This is true because optimal ACR varies based on factors such as internal pharma machinery, staffing, and operational purpose. Everything depends on the level of pollutants outside trying to get into the facility and the level of pollutants generated inside. The breadth of these ranges reflects the impact of people and processes on cleanliness. The low-end numbers in each pollution category usually indicate airflow rates and air change requirements for built or stationary facilities—no people there and no pollution process in progress. When there are people and processes generating contaminants, more air changes are required to maintain optimal cleaning standards. For example, some manufacturers insist on changing the air as many as 720 times an hour to meet the Class 10 standard. Determining the appropriate amount of air change for a specific application requires careful evaluation of factors such as the number of personnel, the effectiveness of pharma machinery protocols, frequency of visits, and cleanliness of processing pharma machinery.
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