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USP35-NF30 Chapter 797

'USP35-NF30 Chapter 797 '
USP–NF General Chapter Pharmaceutical Compounding— Sterile Preparations Copyright ©2011 The United States Pharmacopeial Convention USP 35 NF 30 2 0 1 2 USP 35Physical Tests / ?797? Pharmaceutical Compounding–Sterile 1 Table 1. ISO Classification of Particulate Matter in Room Air (limits are in particles of 0.5 µm and larger per cubic meter [current ?797? PHARMACEUTICALISO] and cubic feet [former Federal Standard No. 209E, FS 209E])* Class NameParticle Count COMPOUNDING–STERILE FS 209E, ISO ClassU.S. FS 209EISO, m3ft3 PREPARATIONS 3Class 135.21 4Class 1035210 5Class 1003,520100 6Class 1,00035,2001,000 INTRODUCTION 7Class 10,000352,00010,000 8Class 100,0003,520,000100,000 The objective of this chapter is to describe conditions and *Adapted from former Federal Standard No. 209E, General Services practices to prevent harm, including death, to patients that Administration, Washington, DC, 20407 (September 11, 1992) and could result from (1) microbial contamination (nonsterility), ISO 14644-1:1999, Cleanrooms and associated controlled environ- (2) excessive bacterial endotoxins, (3) variability in the in- ments—Part 1: Classification of air cleanliness. For example, 3,520 tended strength of correct ingredients that exceeds either particles of 0.5 µm per m3 or larger (ISO Class 5) is equivalent to monograph limits for official articles (see “official” and “arti- 100 particles per ft3 (Class 100) (1 m3 = 35.2 ft3). cle” in the General Notices and Requirements) or 10% for nonofficial articles, (4) unintended chemical and physical The standards in this chapter are intended to apply to all contaminants, and (5) ingredients of inappropriate quality in persons who prepare CSPs and all places where CSPs are compounded sterile preparations (CSPs). Contaminated prepared (e.g., hospitals and other healthcare institutions, CSPs are potentially most hazardous to patients when ad- patient treatment clinics, pharmacies, physicians’ practice fa- ministered into body cavities, central nervous and vascular cilities, and other locations and facilities in which CSPs are systems, eyes, and joints, and when used as baths for live prepared, stored, and transported). Persons who perform organs and tissues. When CSPs contain excessive bacterial sterile compounding include pharmacists, nurses, pharmacy endotoxins (see Bacterial Endotoxins Test ?85?), they are po- technicians, and physicians. These terms recognize that tentially most hazardous to patients when administered into most sterile compounding is performed by or under the su- the central nervous system. pervision of pharmacists in pharmacies and also that this Despite the extensive attention in this chapter to the pro- chapter applies to all healthcare personnel who prepare, vision, maintenance, and evaluation of air quality, the avoid- store, and transport CSPs. For the purposes of this chapter, ance of direct or physical contact contamination is para- CSPs include any of the following: mount. It is generally acknowle
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USP35-NF30Chapter797
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