Chapter in Pharmaceutical Compounding — Sterile Preparations issued by the US Pharmacopeia describes the guidelines, procedures and compliance requirements for compounding sterile preparations and sets the standards that apply to all settings in which sterile preparations are compounded. The clean room must include an attached anteroom at the same air quality level ISO Class 8 for movement of personnel and materials in and out of the clean room. Building and operating a clean room can be an expensive and time-consuming proposition. Fortunately, pharmacies can also comply with requirements using a barrier isolator, also known as a glovebox. A glovebox isolator or barrier isolator provides a physical barrier between pharmacy personnel and the compounding activity. Traditional clean benches and biosafety cabinets have an open front access area, where there is the possibility that disruptions in the room airflow or poor aseptic technique by the operator will introduce contaminants to the work area. A glove box provides an additional level of protection, as the sterile product is never exposed to the room environment or to compounding personnel directly. When using a glovebox, materials are passed into the main working chamber through an enclosed pass-thru chamber, and accessed through glove ports to perform aseptic manipulations. Clean air is supplied to the work area through a HEPA filter, providing better than ISO Class 5 conditions under positive pressure within the glovebox. Gloveboxes offer the same or better air quality as a clean bench or biosafety cabinet located within a clean room, plus their design offers some significant advantages in both initial investment and ongoing operating expenses.
Using a Pharmacy Glove Box for Compounding Sterile Preparations
Beyond-use dates for CSPs are rarely based on preparation-specific chemical assay results, which are used with the Arrhenius equation to determine expiration dates see General Notices and Requirements for manufactured products. The majority of CSPs are aqueous solutions in which hydrolysis of dissolved ingredients is the most common chemical degradation reaction. The extent of hydrolysis and other heat-catalyzed degradation reactions at any particular time point in the life of a CSP represents the thermodynamic sum of exposure temperatures and durations.
Such lifetime stability exposure is represented in the mean kinetic temperature calculation see Pharmaceutical Calculations in Prescription Compounding Drug hydrolysis rates increase exponentially with arithmetic temperature increase; thus, exposure of a beta-lactam antibiotic solution for one day at controlled room temperature see General Notices and Requirements will have an equivalent effect on the extent of hydrolysis of approximately 3 to 5 days in cold temperatures see General Notices and Requirements.
Personnel who prepare, dispense, and administer CSPs must store them strictly in accordance with the conditions stated on the label of ingredient products and finished CSPs.
All pharmaceutical compounding standards, both sterile and nonsterile, shall be 36th Edition, Compounding Compendium, with the exception of USP Chapter.
Eric S. Kastango, M. Guidelines for adopting and successfully implementing the requirements of the United States Pharmacopeia USP chapter for compounding sterile preparations are presented. The quality of a compounded sterile preparation CSP is directly related to the methods used to ensure that the CSP achieves the desired goal of purity, potency, and sterility. A properly designed, constructed, and maintained cleanroom contributes to the quality of CSPs. Design criteria of a sample clean-room are supplied, as are a summary and comparison of the liquid disinfectants that can be used to clean and sanitize the facility and maintain environmental controls.
All activities associated with cleaning the cleanroom, including air and surface sampling, must be properly documented in logs, examples of which are provided.
Usp 797 beyond use dating chart
D uring the s, the practice of pharmacy began growing and evolving. In response to an increasing number of patient injuries due to medication delivery and sterile compounding, the industry began calling attention to safety. For the next 30 years, various pharmacy organizations published documents in an effort to establish a standard for the practice of compounding sterile preparations CSPs.
General chapter: pharmaceutical compounding — sterile preparations. USP Rockville, MD: USP; pp. 44, 47, 54, 16 Pharmacy Compounding.
Considerations for CSP. Verification of Compounding Accuracy and Sterility. Environmental Quality and Control. Suggested Standard Operating Procedures. Finished Preparation Release Checks and Tests. Storage and Beyond-Use Dating. Patient or Caregiver Training. Patient Monitoring and Adverse Events Reporting. Quality Assurance Program.
A primary responsibility of the pharmacist is to ensure safe sterile dosage form preparation. Compounding an accurate formulation free of microbial and particulate matter is an essential component of this process. As was described in Chapter 12 of this book, the USP is a private, nonprofit organization recognized by the federal government as the official group responsible for setting national standards for drug purity and safety.
Most recently, the USP has become involved with issuing standards on the pharmaceutical compounding of sterile preparations.
Update on USP Chapter
Consequently, the Board amended rule —8. On September 23, USP announced that the effective date of the published revisions to USP Chapters and would be delayed, and would no longer become effective on December 1, USP is considering the following appeal topics for USP Chapters and 1 beyond-use date BUD provisions in both chapters, 2 removal of the alternative technology provision from USP Chapter , and 3 the applicability of both chapters to veterinary practitioners.
In accordance with rules —
Sterile Compounding. Guidelines. 1. 6/14/ Why is chapter important to ambulatory surgery Beyond Use Dating (BUD)?.
Compounding personnel are responsible for ensuring that CSPs are accurately identified, measured, diluted, and mixed; and are correctly purified, sterilized, packaged, sealed, labeled, stored, dispensed, and distributed. These performance responsibilities include maintaining appropriate cleanliness conditions and providing labeling and supplementary instructions for the proper clinical administration of CSPs.
All CSPs are prepared in a manner that maintains sterility and minimizes the introduction of particulate matter. A written quality assurance procedure includes the following in-process checks that are applied, as is appropriate, to specific CSPs: accuracy and precision of measuring and weighing; the requirement for sterility; methods of sterilization and purification; safe limits and ranges for strength of ingredients, bacterial endotoxins, particulate matter, and pH; labeling accuracy and completeness; beyond-use date assignment; and packaging and storage requirements.
The dispenser shall, when appropriate and practicable, obtain and evaluate results of testing for identity, strength, purity, and sterility before a CSP is dispensed. Qualified licensed health care professionals who supervise compounding and dispensing of CSPs shall ensure that the following objectives are achieved. This chapter emphasizes the need to maintain high standards for the quality and control of processes, components, and environments; and for the skill and knowledge of personnel who prepare CSPs.
Iowa Board of Pharmacy Enforcement of USP Chapters 795, 797, and 800
This chapter provides procedures and requirements for compounding sterile preparations. Sterile compounding also requires cleaner facilities; specific training and testing of personnel in principles and practices of aseptic manipulations; air quality evaluation and maintenance; and sound knowledge of sterilization and solution stability principles and practices.
Aqueous injections for administration into the vascular and central nervous systems pose the greatest risk of harm to patients if there are issues of nonsterility and large errors in ingredients. The intent of this chapter is to prevent harm and fatality to patients that could result from microbial contamination nonsterility , excessive bacterial endotoxins, large content errors in the strength of correct ingredients, and incorrect ingredients in CSPs.
The quality control and testing for CSPs in this chapter are appropriate and necessary. The content of this chapter applies to health care institutions, pharmacies, physician practice facilities, and other facilities in which CSPs are prepared, stored, and dispensed.
The general guidelines for assigning beyond use dates have been laid out in USP chapter and will be changed with the revision that is.
It is conducted at least annually thereafter for low- and medium-risk compounding and semiannually for high-risk compounding. This test is performed because direct touch contamination is the most likely source of introducing microorganisms into CSPs. The gloved fingertip test is performed immediately after the compounding employee completes the hand hygiene and garbing procedures. This test must be performed on three separate occasions with absolutely no CFU growth within the required incubation period.
Retesting is required annually for those compounders mixing low- and medium-risk preparations and semiannually for high-risk preparations. For the retesting, the gloved fingertip test is performed following the media fill. A highly structured and monitored environment is critical to ensure that the compounding professional works competently and safely to compound sterile preparations.
Four pillars are used to ensure this outcome: When things go wrong with sterile compounding, it is often the results of inadequate attention to policy and procedures.
USP 797 Guidelines & Standards
Keywords: beyond use dating, BUD, stability, sterile compounding, USP. Beyond use date (BUD) is the date after which a compounded preparation shall.
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