Usp 797 guidelines beyond use dating
In general, the CSP work environment is designed to have the cleanest work surfaces horizontal or vertical clean benches, biological safety cabinets, or isolators located in a buffer area, which is preceded by an anteroom that provides a clean area for donning personnel barriers, such as hair covers, gloves, gowns, or full clean-room attire.
Written procedures have to exist to ensure that storage conditions in the patient-care setting are suitable for the CSP-specific storage requirements. All cartoned supplies are decontaminated in the anteroom area by removing them from shipping cartons and wiping or spraying with a disinfecting agent, such as sterile IPA, while being transferred to a clean, sanitized cart or other conveyance for introduction into the buffer or clean area.
A critical site is any opening providing a direct pathway between a sterile product and the environment or any surface coming in direct contact with the product and the environment.
The effectiveness of steam sterilization is verified using appropriate biological indicators see Biological Indicators or other confirmation methods see Sterilization and Sterility Assurance of Compendial Articles or Sterility Tests Work surfaces should be constructed of smooth, impervious materials, such as stainless steel or molded plastic, so that they are readily cleanable and sanitizable.
For example, an ampul should not be opened unnecessarily in advance of use.
The plan must be adequate to evaluate the various controlled air environment areas LAFW, barrier isolator, buffer or clean area, and anteroom area of the sterile compounding facility. Specification of how results are to be reported and evaluated.
Compounding personnel who assign beyond-use dates to CSPs when lacking direct chemical assay results must critically interpret and evaluate the most appropriate available information sources to decide a conservative and safe beyond-use date. Written guidelines beyond use dating and procedures that address Sterile components.
A well-designed positive pressure barrier isolator, supported by adequate procedures for its maintenance, monitoring, and control, may offer an acceptable alternative to the use of conventional LAFWs in clean rooms for aseptic processing.
The USP Compounding Compendium contains the 5 essential compounding chapters, over 40 supporting general chapters, and more than compounded preparation monographs. A method not described in the USP may be used if verification results demonstrate that the alternative is at least as effective and reliable as the USP Membrane Filtration method or the USP Direct Inoculation of the Culture Medium method where the membrane types of dating in geology method is not feasible.
For the purposes of this chapter, CSPs include any of the following:. Consequently, hospital or institutional laboratories may be called upon to perform these quality assurance tests. Monitor for and detect occurrences of therapeutic complications such as infection, phlebitis, electrolyte imbalance, and catheter misplacement.
For a low-risk preparation, in the absence of passing a sterility test, the storage periods cannot exceed the following time periods: Filling of reservoirs of injection and infusion devices with volumes of sterile drug solutions that will be administered guideline beyond use dating several days at ambient temperatures between 25 and Compounding personnel must periodically review the delivery performance of couriers to ascertain that CSPs are being efficiently and properly transported.
Draw 25 mL of the medium into each of three mL sterile syringes. Whenever such items are brought into the room, they should first be cleaned and sanitized.
In addition, operations using nonsterile components require the use of a method of preparation designed to produce a sterile product. Evaluation of airborne microorganisms in the controlled air environments LAFW, barrier isolators, buffer or clean area, and anteroom area is performed by properly trained individuals using suitable electric air samplers or by exposing sterile nutrient agar plates for a suitable time frame.
Once begun, this test is completed without interruption. Compounding personnel ascertain that ingredients for CSPs are of the correct identity and appropriate quality using the following information: In addition, the pharmacy should adhere to appropriate procedures of all controlled storage spaces to ensure that such spaces are not subject to significantly prolonged temperature fluctuations as may occur, for example, by leaving a refrigerator door open too long.