Sterile preparations

In contrast, parenteral suspensions have relatively low solids contents, usually between 0.5 and 5%, with the exception of insoluble forms of penicillin in which concentrations of the antibiotic may exceed 30%. These sterile preparations are designed for intramuscular, intradermal, intralesional, intraarticular, or subcutaneous injection. Syringeability is an important factor to be taken into consideration with injectable dosage forms. The viscosity of a parenteral suspension should be sufficiently low to facilitate injection. Common suspending vehicles include preserved isotonic saline solution or a parenterally acceptable vegetable oil. Ophthalmic and optic suspensions that are instilled into the eye/ear must also be prepared in a sterile manner. The vehicles are essentially isotonic and aqueous in composition. The reader should refer to Chapter 12 for further discussion on parenteral products. 

Sterility testing is conducted on each lot of ophthalmic product by suitable procedures, as set forth in the appropriate pharmacopeia and validated in each manufacturer s laboratory. While the majority of ophthalmic preparations contain preservatives for multiple-dose use, sterile preparations in special containers for individual use on a single patient must be made available. This availability is especially critical for every hospital, office, or other installation where accidentally or surgically traumatized eyes are treated, as well as for patients intolerant to preservatives. 

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 ... 

If appropriate, because of the number of sterile preparations compoimded, products may be tested for sterility and the effectiveness of incorporated preservatives, if present. This may be done either at the pharmacy or in a contract laboratory. 

It is implicit in the use of parenteral products that a sterile preparation is required. Several methods of sterilization can be used including y-irradiation. However, the influence of y-irradiation on the physico-chemical properties of this poloxamer are not known. The work of Stafford (6) has shown that in the absence of oxygen, aqueous... 

Standard (IX) saline-citrate (0.15 MNaCl, 0.015 MNa3-citrate) (sterile)—Prepare as in the Appendix to Experiment 19. Autoclave (20 min at 105-110°C). Prepare about 250 ml of this reagent. 

Injection A sterile preparation intended for parenteral use five distinct classes of injections exist as defined by the USP. 

Injection, Solution, Concentrate A sterile preparation for parenteral use which, upon the addition of suitable solvents, yields a solution conforming in all respects to the requirements for injections. 

Liposomes are potentially valuable as ocular drug delivery systems due to their simplicity of preparation and versatility in physical characteristics. However, their use is limited by instability (due to hydrolysis of the phospholipids), limited drugloading capacity, technical difficulties in obtaining sterile preparations, and blurred vision due to their size and opacity [42],... 

Sterile preparation of yeast invertase (50 mL per team) pH 4.8 to 5 acetate buffer 1 M sodium hydroxide 3,5-dinitrosalicylate reagent solution 1 MHCl glucose-fructose standard solution sucrose. 

One of the primary methods used for protecting liquid and solid photolabile pharmaceuticals and preparations from photodegradation is to package them in colored glass or plastic. Colored/pigmented containers are also suitable for the photostabilization of sterile preparations, such as eye drops. 

The modern use of glass has been somewhat reduced by the advent of plastics. Despite the durability and cost-effectiveness of plastic containers, plastic has not permeated all pharmaceutical applications. Glass is still the most attractive packaging material where chemical inertness, very low moisture and gas permeability, and heat resistance are concerned. Modern uses of glass are typically restricted to injectable liquids for parenteral use ° and other sterile preparations. ... 

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-... 

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. 

The Florida soils tested were only weakly capable of degrading EDB under anaerobic conditions. A soil preparation from the 1 m depth from Polk county showed a 40% decrease of labeled and non-labeled EDB, after seven months. No C02 was produced and there was no more 14C-activity in the residual water after hexane extractions than for the sterile preparations. This indicates that the degradation product or products are volatile, such as ethylene. All other soils failed to degrade EDB under similar conditions over equally long incubation periods. This implies that either appropriate organism(s) are not present or the soils contained insufficient secondary carbon sources necessary to maintain cometabolism. 

These guidelines do not replace any of the sections in Parts One and Two but stress specific points for the manufacture of sterile preparations to minimize the risks of microbiological, particulate, and pyrogen contamination. 

The production of sterile preparations should be carried out in dean areas, entry to which should be through airlocks for personnel and/or for goods. Clean areas should be maintained to an appropriate standard of deanliness and supplied with air that has passed through filters of an appropriate efficiency. 

Any specific requirements for the manufacture of special groups, for example sterile preparations, are covered in the Supplementary Guidelines. 

High standards of personal hygiene and cleanliness are essential. Personnel involved in the manufacture of sterile preparations should be instructed to report any condition which may cause the shedding of abnormal numbers or types of contaminants periodic health checks for such conditions are desirable. Actions to be taken about personnel who could be introducing undue microbiological hazard should be decided by a designated competent person. 

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