The chapter was to have become official on December 1, , but USP-NF announced on September 23, , that appeals were pending on provisions of the chapter regarding beyond-use dating, use of alternative technologies proven equivalent to those described in the chapter, and applicability of the chapter to veterinary practitioners. This notice and content of this program will be ated as events occur. Compounding has been a fundamental ct of providing medicines to patients for centuries. Physicians, chemists, and pharmacists manipulated naturally derived products including those of plant, mineral, and animal origin into medicines. They did this through mixing, grinding, filtering, percolating, heating, and distilling, which led to preparations of vinegars, extracts, infusions, elixirs, syrups, tinctures, ointments, and pills.
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Other considerations for facilities include design, air handling, sink placement, and finishes. Facilities must be designed to minimize contamination of surfaces, to promote effective cleaning, to limit unnecessary personnel and materials traffic, and to include only furniture and equipment that is necessary for compounding. A key component is airflow and control of particulate matter.
This is achieved using HEPA filtering and air handling systems that are designed to meet ISO classification standards, sweep away the particles from the compounding area and the compounders, and maintain the required facility pressure differentials. Water sources sinks and drains may not be placed in the buffer area.
Finishes on ceiling, wall, and floor surfaces must be easily cleaned and disinfected, smooth, and impervious. Training and monitoring of compounding personnel are critical components for safe and effective sterile compounding.
Sterile Drug Production Practices: USP > vs. CGMPs Ian Deveau, Ph.D. Branch Chief. Office of Manufacturing Quality/Office of Compliance. CDER/FDA. November ,
Training must be conducted by expert sterile compounding personnel and must be documented. As with any personnel training, documentation of the training is crucial for recordkeeping purposes and certification.
Media fill testing shows that a compounder can aseptically mix a CSP at the facility using sterile fluid culture media. The media fill test is completed before personnel are allowed to compound independently. It must then be conducted at least every 6 months.
Initially, it must be passed before personnel are allowed to compound independently. Direct touch contamination is the most likely source of introducing microorganisms into CSPs. The initial 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. Compounding personnel must requalify every 6 months.
For the retesting, the gloved fingertip test is performed following the media fill inside the PEC. A skilled compounder must also observe proper garbing and hand hygiene of personnel every 6 months.
These simulation tests are critical in determining that personnel are garbed to compound aseptically. 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: following policies and procedures, using appropriate BUDs, wearing personal protective equipment PPEand the proper cleaning of the cleanroom suite and SCA. When things go wrong with sterile compounding, it is often the results of inadequate attention to policy and procedures.
This includes monitoring and documenting daily temperature, humidity and pressure differentials; equipment e. Note that BUDs do not include the infusion time. Naturally, the pharmacist must ensure that the stability of the CSP is retained throughout the intended administration period; this is not the same as the BUD.
-Requires maintaining of sterility when compounding exclusively with sterile ingredients and components. Beyond Use Dating Chemical Stability or from appropriate literature sources or direct testing.-Lack justification than follow USP >.-SOP should have how the BUD was determined. Beyond Use Dating Microbial Stability-BUD is limited. USP > Course 2: Handling CSPs (Competency Only - No CE) (Pre) Based on the popular ASHP training video and workbook, this second course provides information on beyond-use dating, offers guidelines for compounding sterile preparations inside and outside of a sterile area, and discusses the labeling, checking, and storing of. Sep 15, Developing USP General Chapter > USP is a not-for-profit, science-driven organization that has an established process for convening independent experts in the development and maintenance of healthcare quality standards. The process is public health focused, leveraging current science and technology, and draws on the expertise of scientists and healthcare practitioners while .
Docking and activation of a single proprietary bag and vial system for a single patient, for immediate administration according to the product labeling, is not considered compounding. Along with hand hygiene, garb helps prevent microbial contamination.
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Garb includes gloves, gowns, hair covers, face masks, and shoe covers. Compounders need to use a laminate gown intended for use with chemotherapy drugs when compounding HDs unless allowed in the Assessment of Risk.
Apr 24, General Chapters > Pharmaceutical Compounding - Sterile Preparations Type of Posting Revision Bulletin Posting Date Apr- Official Date May- Expert Committee Compounding Reason for Revision Compliance - Appeals Panel Decision In accordance with the Rules and Procedures of the - Council of Experts, USP is ating the. ? Pharmaceutical Compounding - Sterile Preparations. Revision Bulletin. level for air, surface, and personnel gear are not exceeded for a specified cleanliness class. Compounding Aseptic Containment Isolator (CACI) -A compounding aseptic isolator File Size: 1MB. Jul 24, USP Chapter sets compounding risk levels based on the likelihood of contaminating a compounded sterile preparation (CSP) with microorganisms, spores, endotoxins or other foreign material. Knowing the level of risk corresponding to each compounded preparation is important because different rules apply to the compounding process depending on.
The placement of garb and PPE and the order in which it is donned is determined by the facility design. Currently, two types of CSTDs are on the market: physical barrier systems and air-cleaning systems.
Cleaning and disinfecting practices and frequencies differ for areas used for compounding nonhazardous and HDs. Cleaning and disinfecting includes multiple steps that must be outlined in policies and procedures.
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The area must then be cleaned with a detergent. Only compounding personnel can clean PECs, but others who are appropriately trained and have documented competency can clean the floors. Appropriate cleaning and disinfecting solutions and dilutions must be used. Ready-to-use solutions are preferred, since they eliminate the need to mix different concentrations. Sterile alcohol is used since it has been filtered and irradiated to remove spores.
EM programs include testing for viable microbial airborne particles and surface sampling. EM testing must be performed by a qualified person, such as a member of the pharmacy staff, a microbiologist, or a certifier.
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Viable testing includes sampling of surfaces and other areas that might be contaminated through touching in the primary and secondary engineering control areas, as well as electronic air sampling. Viable air testing must be performed at least every 6 months using an impaction device that captures a measured volume of air within the ISO classified areas.
The device includes an agar plate. If microbial contamination is present, it will be captured on the plate, which is then incubated by a laboratory that performs environmental testing.
If any growth is found, it must be addressed and corrected. The area is then retested to ensure the correction. Some experts recommend having the outside certifier perform the tests every 6 months and the pharmacy personnel perform the tests in the intervening months.
Sterile Gloves and fingertip testing
This way, two different laboratories review the data, which enables a system of checks and balances. If any growth is found, it must be remediated. Documentation and records-keeping of these EM records is critical.
Certification of the sterile compounding facility hoods and rooms by an independent certifier is required every 6 months. The certifier issues a report that should clearly indicate which areas pass, fail, or need attention.
CETA Guidelines include all existing regulations and standards in a document designed for certification. The certification report must document airflow testing, HEPA filter integrity testing, total particle count testing, and for PECs, a dynamic airflow smoke pattern test. Sterile compounding facilities should be ready to simulate compounding or perform cleaning to simulate the work environment for the certification process.
Once certifiers have completed assessments, they provide written reports of the findings and the areas that need improvement for review with pharmacy management and leadership or other pertinent staff. The boxes include procedures for:. A lot of time, effort, and resources are needed to achieve and maintain compliance in a compounding facility with sterile compounding. Certain areas such as facilities, personnel training, aseptic techniques, and EM can be challenging in meeting requirements.
Several gap analysis tools Table 3 are available to help with this process, as well as many consultants in the field who can help. USP is a not-for-profit, science-driven organization that has an established process for convening independent experts in the development and maintenance of healthcare quality standards.
Review their work plan and past meeting summaries. Your participation is integral to the standard setting process.
BEYOND USE DATING FOR STERILE COMPOUNDING Beyond Use Date (BUD) is very different from expiration date. USP Chapter defines BUD as the date or time after which a compounded sterile preparation (CSP) may not be stored or transported and is calculated from the date or time of compounding. Expiration date is aFile Size: KB. In , USP revised the chapter, which became a general chapter devoted specifically to sterile compounding, > Pharmaceutical Compounding-Sterile Preparations (General Chapter > or >). > was revised twice: once in and the pending revision in . BUDs in USP > Pharmaceutical Compounding - Sterile Preparations New factors for consideration when establishing BUDs The revised chapter changed the categorization of Compounded Sterile Preparations (CSPs) from microbial contamination risk levels (i.e. low-, medium-, and high-risk level) to Category 1 and Category 2 doursim.com Size: KB.
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