Which is an example of a low risk level CSP? Low-risk compounding includes using sterile needles and syringes to transfer sterile liquids from manufacturer-sealed ampules or vials to sterile devices or other sterile packages. It also covers manually mixing and measuring up to three manufactured products to create a CSP or nutritional solution.
What is a low-risk CSP?
In other words, the safe storage limit to ensure reasonable sterility of a CSP under certain conditions – without performing a sterility test. Compounding with aseptic manipulations using only sterile ingredients, products and devices in ISO Class 5 or higher air quality will generally fall in a low-risk category.
What is the appropriate risk level for a CSP?
The appropriate risk level—low, medium, or high—is assigned according to the corresponding probability of contaminating a CSP with (1) microbial contamination (e.g., microbial organisms, spores, endotoxins) and (2) chemical and physical contamination (e.g., foreign chemicals, physical matter).
What are the disadvantages of high-risk CSPs?
Large deviations from usual or expected chemical and physical properties of CSPs (e.g., water-miscible alcohols) may cause undetectable damage to filter integrity and shrinkage of microorganisms to sizes smaller than filter nominal pore size. STERILIZATION OF HIGH-RISK LEVEL CSPs BY STEAM
What is an ISO 18 low risk CSP?
LOW-RISK CSPs 18. Low-Risk Level CSPs with 12-Hour or Less BUD— PECs (LAFWs, BSCs, CAIs, CACIs,) shall be ISO Class 5 Compounding area is segregated from non-compounding areas. Personnel shall follow the procedures described in Personnel Cleansing and Garbing and Additional Personnel Requirements prior to compounding.
What is low risk level CSP?
Low-Risk Level CSPs. CSPs compounded under all of the following conditions are at a low risk of contamination. Low-Risk Conditions— The CSPs are compounded with aseptic manipulations entirely within ISO Class 5 (see Table 1) or better air quality using only sterile ingredients, products, components, and devices.
What is low risk level?
Low Risk This is the second lowest level of risk. Although marginally more serious than Minimal Risk encounters, Low Risk patients are generally quite healthy.
What is low risk level compounded sterile preparations?
Low Risk Level Compounding: Sterile compounds that are compounded with aseptic manipulations entirely within a ISO Class 5 or better air quality device, usually within an ISO Class 7 environment, using sterile products, components, and devices.
What is a Category 1 CSP?
Category 1 CSPs are defined as “CSP that is assigned a BUD of 12 hours or less at controlled room temperature or 24 hours or less refrigerated that is compounded in accordance with all applicable requirements for Category 1 CSPs in this chapter.” Category 1 CSPs may be prepared in an unclassified Segregated Compounding ...
Which option is an example of a low risk investment?
Treasury securities, including Treasury bonds, bills, and notes, are all considered low-risk investments. Fixed annuities are considered a low-risk investment because the insurance company issuing the policy guarantees a fixed interest rate.
What is an example of a low risk food?
Low-risk foods are ambient-stable such as; bread, biscuits, cereals, crisps and cakes (not cream cakes). Such foods are unlikely to be implicated in food poisoning.
What is a Category 3 CSP?
Category 3 CSPs are those that may be assigned longer BUDs than the limits for Category 1 or Category 2 CSPs, up to 180 days, if additional requirements are met. Added a maximum batch size of 250 final yield units for all CSPs requiring sterility testing.
How are compounded sterile preparations CSP risk levels determined quizlet?
CSP(Compounded Sterile Preparations) risk levels are determined by compounding setting; physical, chemical, or microbial contamination potential; and the overall process required. Steam autoclave is the oldest, safest, and most cost effective method of sterilization in the medical equipment industry.
What are the risk levels for USP 797?
USP 797 assigns each CSP one of five potential contamination risk levels: immediate use, low, low with 12 hours or less beyond use date (BUD), medium, high. The risk level depends on the CSPs compounding environment; its potential for microbial, chemical, and physical contamination; the nature of production of the CSP.
What is category CSP?
CSP stands for “Commercial Statistical Plan.” The four-digit CSP Classification Code identifies the type of business conducted by the building's occupants. These risks are grouped into categories based on statistics, including losses, occupant types, premiums, exposures and many other factors.
What is Category I and Category II CSPs?
Category 1 CSPs are compounded in an ISO 5 primary engineering control (such as a laminar-airflow workstation) that is located in a segregated compounding area. Category 2 CSPs are compounded in an ISO 5 primary engineering control that is located in an ISO 7 buffer area.
What is the difference in BUDs between Category I and Category II?
Category 1: CSPs are typically prepared in an unclassified Segregated Compounding Area (SCA) and have shorter BUDs. Category 2: CSPs are prepared in a cleanroom suite and have longer BUDs.
What is low risk compounding?
Low-risk compounding includes using sterile needles and syringes to transfer sterile liquids from manufacturer-sealed ampules or vials to sterile devices or other sterile packages. It also covers manually mixing and measuring up to three manufactured products to create a CSP or nutritional solution.
What is a high risk level compound?
High Risk Level Compounding: Sterile products compounded from non-sterile ingredients and/or compounded using any non-sterile devices, containers, or equipment. Products prepared from sterile ingredients, containers, devices, or equipment that are exposed to less than ISO Class 5 air.
What are the most common microorganisms in contaminated cleanrooms?
Weissfeld and Vance: The most common microorganisms in contaminated cleanrooms or CSPs are Bacillus species . This is frequently seen in hospital pharmacies that do a lot of their cleaning with 70% sterile alcohol; pharmacy staff often do not realize that Bacillus species can survive in 70% alcohol.
What are the different types of CSPs?
Four specific categories of CSPs are described in this chapter: low-risk level, medium-risk level, and high-risk level, and immediate use. Sterile compounding differs from nonsterile compounding (see
What are quality standards for CSPs?
quality standards for CSPs of drugs and nutrients based on current scientific information and best sterile compounding practices. The use of technologies, techniques, materials, and procedures other than those described in this chapter is not prohibited so long as they have been proven to be equivalent or superior with statistical significance to those described herein. The standards in this chapter do not pertain to the
What are the three contamination categories for CSPs?
The three contamination categories for CSPs described in this section are assigned primarily according to the potential for microbial contamination during the compounding of low-risk level CSPs and medium-risk level CSPs or the potential for not sterilizing high-risk level CSPs, any of which would subject patients to risk of harm, including death. High-risk level CSPs must be sterilized before being administered to patients. The appropriate risk level—low, medium, or high—is assigned according to the corresponding probability of contaminating a CSP with (1) microbial contamination (e.g., microbial organisms, spores, endotoxins) and (2) chemical and physical contamination (e.g., foreign chemicals, physical matter). Potential sources of contamination include, but are not limited to, solid and liquid matter from compounding personnel and objects; non-sterile components employed and incorporated before terminal sterilization; inappropriate conditions within the restricted compounding environment; prolonged presterilization procedures with aqueous preparations; and nonsterile dosage forms used to compound CSPs.
What is not exceeded for a specified cleanliness class?
level for air, surface, and personnel gear are not exceeded for a specified cleanliness class.
Can CSPs be redispensed?
The compounding facility shall have the sole au-thority to determine when unopened, returned CSPs may be redispensed. Returned CSPs may be redispensed only when personnel responsible for sterile compounding can ensure that such CSPs are sterile, pure, and stable (contain labeled strength of ingredients). The following may provide such as-surance: the CSPs were maintained under continu-ous refrigeration and protected from light, if re-quired, and no evidence of tampering or any readying for use outside the compounding facility exists. Assignment of new storage times and BUDs that exceed the original dates for returned CSPs is permitted only when there is supporting evidence from sterility testing and quantitative as-say of ingredients. Thus, initial preparation and thaw times should be documented and reliable measures should have been taken to prevent and detect tampering. Compliance with all procedures associated with maintaining product quality is es-sential. The CSPs shall not be redispensed if there is not adequate assurance that preparation quality and packaging integrity (including the connections of devices, where applicable) were continuously maintained between the time the CSPs left and the time they were returned. Additionally, CSPs shall not be redispensed if redispensing cannot be sup-ported by the originally assigned BUD.
What is a low risk level compound?
Low-risk level compounding occurs in an ISO Class 5 environment and involves only a few basic, steps. It could apply in reconstituting single-dose vials of antibiotics, simple transfers of sterile products or preparing hydration solutions. There is also a subsection of low risk designed for facilities with no ISO 7 secondary control clean room the low-risk level with 12 hour or less Beyond Use Date (BUD). This category is for those products that are low risk and will be administered within 12 hours of compounding.
What is a medium risk level?
Medium-Risk Level occurs in an ISO Class 5 environment and involves complex procedures, like bulk compounding, which could occur over an extended period. It also includes using pooled sterile commercial products for multiple patients or for one patient multiple times, as in Chemotherapy or pain management administered by an infusion device
What is the risk level of USP 797?
USP 797 assigns each CSP one of five potential contamination risk levels: immediate use, low, low with 12 hours or less beyond use date (BUD), medium, high. The risk level depends on the CSPs compounding environment; its potential for microbial, chemical, and physical contamination; the nature of production of the CSP.
What is the purpose of USP 797?
Pharmacopeia (USP) 797 is to provide the practice standards to help ensure that compounded sterile preparations are of high quality, and is for the pre-administration phase of sterile preparations. It describes the CSP requirements (guidelines, USP 797 procedures and compliance) for CSPs and sets the standards that apply to all settings in which sterile preparations are compounded. Adherence to 797 will reduce the potential for contamination caused by unclean environment, pharmacist error, lack of quality control, incorrect beyond-use dating and other factors. The standard applies to anyone who prepares CSPs and all places where they are prepared. CSPs include drugs, nutrients, biologics, diagnostics and radiopharmaceuticals. The guideline requires environmental controls to include a separate area for compounding that meets a definite level of cleanliness, and monitoring to guarantee that control is maintained.
When compounding hazardous drugs, a biological safety cabinet (BSC) or compounding aseptic containment iso?
All hazardous drugs must be stored and prepared in a negative pressure ISO 7 with an ISO 7 ante area. BSCs or CACIs should be vented to the outside. Of course, waste disposal should be according to state and federal regulations.
Is there an exception for CAIs related to providing isolation from the room?
There is an exception for CAIs related to providing isolation from the room, if secondary engineering control ISO 7 not available.
Can pharmacists be disciplined for not following USP 797?
While the Board cannot definitely say that pharmacists will face disciplinary action for the failure to follow USP 797, the possibility does exist.”. USP 797 has been accepted and adopted by several states. It is under review by numerous others.
General Principles of Compounding Risk Level
Low-Risk Compounding Conditions
- Compounding with aseptic manipulations using only sterile ingredients, products and devices in ISO Class 5 or higher air quality will generally fall in a low-risk category. Low-risk compounding includes using sterile needles and syringes to transfer sterile liquids from manufacturer-sealed ampules or vials to sterile devices or other sterile packag...
High-Risk Compounding Conditions
- Use of non-sterile ingredients or non-sterile devices usually creates a high-risk condition, as there is inherently greater risk of contamination from non-sterile products. Additional conditions resulting in high-risk level state include: 1. Exposing sterile ingredients and devices to air quality below ISO Class 5 2. Storage of opened or partially-used products that lack antimicrobial preser…