Usp 41 chapter 1116 pdf

 

 

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USP 35. General Information / ?1116? Aseptic Processing Environments 697. Table 4. The guidance provided in this chapter and the monitoring. environments for aseptic and other cleanroom applications (to be covered in a separate chapter). The new chapter may be patterned after <1116>. ?1116? MICROBIOLOGICAL CONTROL AND MONITORING OF ASEPTIC PROCESSING ENVIRONMENTS Microbiologically controlled environments are used for a variety of purposesThe purpose of this informational chapter is to review the various issues that relate to aseptic processing of bulk drug substances, dosage forms,

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