Transcription of BRIEFING 797 Pharmaceutical Compounding—Sterile ...
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BRIEFING 797 Pharmaceutical Compounding—Sterile ...
BRIEFING 797 Pharmaceutical Compounding Sterile Preparations, USP 41 page 6554 and PF 41(6) [Nov. Dec. 2015]. Based on the number and significance of public comments received in response to the revision proposal published in PF 41(6), the USP Compounding Expert Committee is proposing to revise this chapter. The current proposed chapter in PF 44(5) [Sept. Oct. 2018] is posted online at with line numbers. Submit comments using the form available at The Expert Committee seeks stakeholder feedback on the proposed revisions to the chapter, including the following major changes: 1.
practices of aseptic manipulations and sterilization; environmental quality specifications and monitoring; and disinfection of gloves and surfaces of ISO Class 5 (see Table 1) sources. Table 1. ISO Classification of Particulate Matter in Room Air (limits are in particles of 0.5 µm and larger per cubic meter [current ISO] and cubic
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