Sterile preparations, compounding

Documents of special importance in providing guidelines and standards for pharmaceutical compounding include the National Association of Boards of Pharmacy s "Good Compounding Practices Applicable to State Licensed Pharmacies " the USP 27/NF 22 Chapter 795, "Pharmacy Compounding — Nonsterile Preparations " and Chapter 797, "Pharmacy Compounding — Sterile Preparations " as well as numerous other portions of the USP/NF. 

The following are summaries of the lengthy Chapter 795, "Pharmacy Compounding — Nonsterile Preparations," and Chapter 797, "Pharmacy Compounding — Sterile Preparations, in the USP/NF."... 

USP Chapter 797 Pharmacy Compounding — Sterile Preparations is divided into the following fen categories ... 

CAA crystalline amino acid CEAA conditionally essential amino acid CPN central parenteral nutrition CSP compounded sterile preparations EFAD essential fatty acid deficiency... 

USP General Information Chapter. Pharmaceutical Compounding Sterile Preparations (797). USP 27/NF 22. Rockville, MD, United States Pharmacopeia Convention, 2003. 

USP Chapter <797> classifies compounded sterile preparations (CSP) or pharmaceuticals into low-risk, medium-risk, and high-risk level categories based on the potential chemical, microbial, and endotoxin contamination. Radiopharmaceuticals including PET radiopharmaceuticals belong to the low-risk level group. 

USP <797> Pharmaceutical Compounding-Steiile Preparations - Storage and Beyond-Use Dating. .. quantitative stability-indicating assays, such as high performance liquid chromatographic (HPLC) assays, would be more appropriate for certain Compounded Sterile Preparations... 

Pharmaceutical compounding - sterile preparations. United States Pharmacopoiea USP 37/The National Formulary 32. United States Pharmacopoeial Convention. Rockville 2014... 

USP Chapter <797> Pharmaceutical compounding -Sterile preparations describes the conditions and practices for all sterile preparations in compounding pharmacies in the United States [6]. The so-called compounded sterile preparations (CSPs) are divided into low-risk level, medium-risk level and high-risk level. Low- and medium-risk levels use closed systems and cover aseptic handling in controlled environments. 

The United States Pharmacopeia USP 35 (2012) The United States Pharmacopeial Convention. Rockville. <797 > Pharmaceutical compounding - sterile preparations... 

ASHP (2014) Guidelines on compounding sterile preparations. Am J Health-Syst Pharm 71 145-166... 

The USP Chapter 797 details the procedmes and reqnirements for compounding all sterile preparations inclnding PN formnlations. These standards will apply to aU health care settings in which sterile preparations are componnded and will be nsed by boards of pharmacy, the FDA, and accreditation organizations snch as the Joint Commission on Accreditation of Healthcare Organizations. Componnded sterile preparations (CSP) are defined by risk level (high, medinm, low) based on the probabihty of microbial, chemical, or physical contami-... 

Risk level classification under USP Chapter <797> is done in general terms except for compounded sterile products prepared from... 

Multiple individual or small doses of sterile products combined or pooled to prepare a compounded sterile product for administration to either multiple patients or to one patient on multiple occasions. 

I. Health care institutions where compounded sterile products are prepared, stored, or dispensed. 

By contrast with the elusive though isolable HOF, the history of HOCl goes back over two centuries to the earliest experiments of C. W. Scheele with CI2 in 1774 (p. 792), and the bleaching and sterilizing action of hypochlorites have long been used both industrially and domestically. HOCl, HOBr and HOI are all highly reactive, relatively unstable compounds that are known primarily in aqueous solutions. The most convenient preparation of such solutions is by perturbing the hydrolytic disproportionation equilibrium (p. 856) ... 

Mineral-basal media may be sterilized by autoclaving, but for almost all organic compounds that are used as sources of C, N, S, or P, it is probably better to prepare concentrated stock solutions and sterilize these by filtration, generally using 0.2 pm cellulose nitrate or cellulose acetate filters. The same applies to solutions of vitamins, and to solutions of bicarbonate and sulfide that are components of many media used for anaerobic bacteria. 

Most proteins are not sufficiently stable in aqueous solution to allow formulation as a sterile solution. Instead, the protein is freeze-dried and reconstituted before use. Development of a freeze-dried protein formulation often requires special attention to the details of the freezing process (potential pH shifts and ionic strength increase with freezing) as well as to potential loss of activity with drying. Formulation additives, such as sugars and polyhydroxy compounds, are often useful as cryoprotectants and lyoprotectants. Residual moisture may also be critical to the stability of the dried preparation [33],... 

Several guidelines are available in the literature for the pharmacist who must extemporaneously prepare an ophthalmic solution. The USP contains a section on ophthalmic solutions, as do other compendia and several standard textbooks. Since the pharmacist does not have the facilities to test the product, he or she should dispense only small quantities, with an expiration date of no more than 30 days. Refrigeration of the product should also be required as a precautionary measure. To reduce the largest potential source of microbial contamination, only sterile purified water should be used in compounding ophthalmic solutions. Sterile water for injection, USP, from unopened IV bottles or vials is the highest-quality water available to the pharmacist. Prepackaged sterile water with bacteriostatic agents should not be used. 

Purified water (PW) is used for cleaning and preparation of nonsterile drug compounds whereas water-for-injection (WFI) is used for the final rinse and preparation of sterile materials. Refer to Section 9.6.1. 

The culture medium was prepared by dissolving all the compounds for the culture medium except L-threonine in an Erlenmeyer flask containing 5 L of water. The pH was adjusted to 5.5 with NaOH and then sterilized for 20 min at 120 °C. L-Threonine was filtered (syringe sterile filter Sartorius Minisart 0.2 pm) and was added to the sterilized culture medium. 

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