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The Sterile Compounding Environment
- 2. Topics2 Chapter 2 The SterileCompounding Environment 2012 Paradigm Publishing
- 3. Topics3 Learning Objectives Identifythe origin of the pharmacy clean room and procedures for sterile compounding. Describe anteroom and clean room setup and characteristics. Understand the various ISO levels that are appropriate for sterile compounding. Identify the different types of hoods used for sterile compounding. Classify the four sterile compounding risk levels. Recognize potential contaminants in the sterile compounding environment. 2012 Paradigm Publishing
- 4. Topics4 Topics Learning Objectives Introduction Anteroom Setup and Characteristics Clean Room Setup and Characteristics Cleaning of the Anteroom and Clean Room Types of Hoods Required for Sterile Compounding USP Chapter <797> Guidelines for Hoods Risk Levels in Sterile Compounding Chapter Summary 2012 Paradigm Publishing In Slide Show view, click the desired topic to the left to link directly to the related slide. To return to this slide at any point in the presentation, click the Topics button below.
- 5. Topics55 Introduction Some changesnecessitated by USP Chapter <797> have required pharmacies to undergo extensive and costly renovations Specialized HVAC equipment, clean rooms constructed of nonporous materials, and strictly regulated air pressure and humidity control serve to create appropriate anteroom and clean-room environments that are low in particulate matter 2012 Paradigm Publishing
- 6. Topics66 Anteroom Setup andCharacteristics The anteroom, which may also be called the transition area or ante-area, provides a space where sterile compounding personnel can garb and perform aseptic hand washing a place to stage components and supplies prior to entering the clean room serves as a transition area that helps to maintain required air pressure levels 2012 Paradigm Publishing
- 7. Topics77 Anteroom Setup and Characteristics…/2 Most sterile compounding pharmacies have an anteroom that is separate from the clean room small facilities that perform only low- or medium-risk sterile compounding may create an ante-area that is separated from the clean room by a simple line of demarcation 2012 Paradigm Publishing
- 8. Topics88 Anteroom Setup and Characteristics…/3 Most sterile compounding pharmacies secure a sticky mat to the floor at the doorway leading into the clean room placed on the less sterile side of that doorway intended to help compounders avoid tracking dirt into the sterile compounding area At a designated frequency, you must remove the top layer of the mat to expose a fresh sticky surface refer to your pharmacy’s Policy and Procedure (P&P) manual 2012 Paradigm Publishing
- 9. Topics99 Anteroom Setup and Characteristics…/4 Limit storage items to materials that are directly required for sterile compound preparation syringes, needles, vials, and supplies used in aseptic hand washing or hood cleaning procedures Avoid storing compounding supplies long-term Never store materials with a high potential for shedding Wipe down all supplies with sterile 70% isopropyl alcohol (IPA) prior to transporting them 2012 Paradigm Publishing
- 10. Topics1010 Anteroom Setup and Characteristics…/5 2012Paradigm Publishing
- 11. Topics1111 Clean Room Setupand Characteristics The clean room is the innermost room also referred to as the IV room or the buffer area Access is restricted to properly trained and garbed personnel Bring only those supplies needed Do not locate computers, printers, or other devices into the clean room Surfaces must be smooth, nonporous, and easy to clean. 2012 Paradigm Publishing
- 12. Topics1212 Clean Room Setupand Characteristics…/2 A pharmacy-designated HVAC system should pump HEPA-filtered air into the clean room to create a positive-pressure environment ensures that the airflow moves from the clean room outward, through the anteroom, and continuing in the direction of the outer pharmacy area helps to minimize the travel of dust, spores, and other particles from the outer rooms into the clean room 2012 Paradigm Publishing
- 13. Topics1313 Clean Room Setupand Characteristics…/3 PECs, such as horizontal laminar airflow hoods, should be placed within the clean room within each airflow hood, the area closest to the hood’s HEPA filter is called the direct compounding area (DCA) and also referred to as “first air” you perform sterile compounding procedures in the DCA To avoid disrupting the airflow from the HEPA filter, personnel working in the hood should minimize their movements 2012 Paradigm Publishing
- 14. Topics1414 Cleaning of theAnteroom and Clean Room USP Chapter <797> provides clear guidelines for the cleaning of the pharmacy’s anteroom and clean room disinfect countertops and other surfaces mop floors with a nonshedding mop designate cleaning supplies wipe down the walls, ceilings, and storage bins 2012 Paradigm Publishing
- 15. Topics1515 Maximum Particle Count ISOClass Name (in particles of 0.5 micron and larger per cubic meter of air) 3 35.2 4 352 5* 3520 6 35,200 7 352,000 8 3,520,000 2012 Paradigm Publishing Cleaning of the Anteroom and Clean Room…/2 *The ISO Class 5 rating is synonymous with “Class 100.”
- 16. Topics1616 Cleaning of theAnteroom and Clean Room…/3 The International Organization for Standardization (ISO) creates worldwide industrial and commercial standards that often become law USP Chapter <797> identifies several ISO categories, or classes, that classify the amount of particulate matter in room air numbered from Class 3 to Class 8, with a higher number designating a greater allowance for particulate matter 2012 Paradigm Publishing
- 17. Topics1717 Cleaning of theAnteroom and Clean Room…/4 In general, the particulate matter contained in regular room air within a pharmacy should be at or above the ISO Class 8 range At the next level of stringency, the particulate matter in the pharmacy anteroom must be no greater than ISO Class 8 Stricter still, the particulate matter in the clean room should be no more than ISO Class 7 The air within the DCA of a hood must be ISO Class 5 2012 Paradigm Publishing
- 18. Topics1818 Cleaning of theAnteroom and Clean Room…/5 You must record the same information about the clean-room-cleaning procedures as you record about anteroom-cleaning procedures do so on separate clean-room-cleaning log sheets 2012 Paradigm Publishing
- 19. Topics1919 Cleaning of theAnteroom and Clean Room…/6 2012 Paradigm Publishing
- 20. Topics2020 Cleaning of theAnteroom and Clean Room…/7 2012 Paradigm Publishing
- 21. Topics21 Your Turn 2012 ParadigmPublishing 1) This a place where sterile compounding personnel can garb and perform aseptic hand washing. a. clean room b. employee lounge c. anteroom d. supply room 2) The particulate matter in the clean room should be no more than a. ISO Class 4. b. ISO Class 5. c. ISO Class 6. d. ISO Class 7. In Slide Show view, click here to see the answer to Question 1. Then click again to advance to Question 2. In Slide Show view, click here to see the answer to Question 2.
- 22. Topics2222 Types of HoodsRequired for Sterile Compounding All of the different hood types may be referred to as primary engineering control (PEC) Sterile compounding personnel perform their work in the following hood types: the compounding aseptic isolator (CAI), the compounding aseptic containment isolator (CACI), the biological safety cabinet (BSC), and the laminar airflow workbench (LAFW) the hoods’ design, function, and operation differ in a number of important ways 2012 Paradigm Publishing
- 23. Topics2323 Types of HoodsRequired for Sterile Compounding…/2 The most widely used sterile compounding hood in the pharmacy is the horizontal LAFW 2012 Paradigm Publishing
- 24. Topics2424 Types of HoodsRequired for Sterile Compounding…/3 CAI and CACI Hoods most useful in sterile compounding environments where relatively few preparations are made each day may also be called a barrier isolator or an isolator cabinet personnel place their hands inside the gloves and reach through the inner pass-through window CACI provides greater protection for the worker 2012 Paradigm Publishing
- 25. Topics2525 Types of HoodsRequired for Sterile Compounding…/4 Advantages of the CAI and CACI Hoods two primary advantages: offers a safer environment for the worker, and it is not mandatory to place them in an ISO Class 7 environment Disadvantages of the CAI and CACI Hoods limited capacity, increased demand on the worker’s time, and logistical issues or costs associated with proper venting 2012 Paradigm Publishing
- 26. Topics2626 Types of HoodsRequired for Sterile Compounding…/5 BSC Hood special hood for preparing hazardous compounds such as antineoplastic drugs and other chemotherapy medications the worker stands behind the shield and places the hands into the cabinet to manipulate the sterile compound 2012 Paradigm Publishing
- 27. Topics2727 USP Chapter <797>Guidelines for Hoods Most hoods share a common design such that room air enters the cabinet through a prefilter that filters out large particles that might damage the HEPA filter keep the prefilter- replacement checklist in a plastic sheet protector in the anteroom 2012 Paradigm Publishing
- 28. Topics2828 USP Chapter <797>Guidelines for Hoods…/2 2012 Paradigm Publishing
- 29. Topics2929 USP Chapter <797>Guidelines for Hoods…/3 Each hood should have its own, separate checklist Keep the checklists inside a plastic sleeve or sheet protector that can be wiped down to prevent dust buildup Always place the checklists in the same designated location in the anteroom 2012 Paradigm Publishing
- 30. Topics3030 Risk Levels inSterile Compounding USP Chapter <797> defines four microbial contamination risk levels associated with the creation of CSPs The risk levels are provided as a guide for sterile compounding personnel to determine the potential for contamination in various compounding scenarios The pharmacy supervisor is responsible for determining the risk level of CSPs 2012 Paradigm Publishing
- 31. Topics3131 Risk Levels inSterile Compounding…/2 Low-Risk CSPs involves the mixing of no more than three commercially packaged sterile products, and no more than two separate injections into the sterile container, all done aseptically, within an ISO Class 5 workbench many low-risk CSPs are prepared daily in every IV room 2012 Paradigm Publishing
- 32. Topics3232 Risk Levels inSterile Compounding…/3 Medium-Risk CSPs meets all of the conditions associated with low-risk sterile product preparation and also involve other, more complex, sterile compounding procedures the preparation of a total parenteral nutrition (TPN) solution is a medium-risk activity because it involves multiple injections of several medications into an IV bag that is designed to be administered over a 24-hour period 2012 Paradigm Publishing
- 33. Topics3333 Risk Levels inSterile Compounding…/4 High-Risk CSPs meet all of the conditions of the low- and medium-risk groups and also involve the preparation of medications wherein one or more of the products being prepared is not sterile or the product is prepared in an environment that is less stringently controlled, or more risky, than ISO Class 5 the two most common sterilization methods include filtration sterilization, which is accomplished by passing the liquid medication through a 0.2-micron filter, or heat sterilization, which is achieved by autoclaving the compounded solution 2012 Paradigm Publishing
- 34. Topics3434 Risk Levels inSterile Compounding…/5 Immediate-Use CSPs according to the USP <797> Guidebook, are “intended only for those situations where there is a need for emergency, or immediate, patient administration of a CSP must be administered within one hour of preparation 2012 Paradigm Publishing
- 35. Topics3535 Risk Levels inSterile Compounding…/6 Potential Contaminants in the Sterile Compounding Environment pathogenic contaminants may include bacteria, viruses, fungi, hair, dander, or particulate matter touch contamination carries the potential for serious harm to the patient shadowing is caused by incorrect technique the area immediately behind an item within the hood is a zone of turbulence and is considered to be contaminated 2012 Paradigm Publishing
- 36. Topics3636 Risk Levels inSterile Compounding…/7 2012 Paradigm Publishing
- 37. Topics3737 Risk Levels inSterile Compounding…/8 Potential Contaminants in the Sterile Compounding Environment…continued the six-inch band along the outer edge of the hood is a poor environment for preparing sterile products you may hear this area referred to as the six-inch zone or the contamination zone of the hood inspect all parenteral preparations for precipitates and particulate matter incorrect needle insertion can lead to coring additives that are incompatible might form a precipitate or show other evidence of incompatibility 2012 Paradigm Publishing
- 38. Topics3838 Risk Levels inSterile Compounding…/9 Excellent aseptic technique is the foundation of sterile parenteral product preparation As an IV technician, you must ensure that all policies and procedures are followed at all times Failure to follow aseptic technique guidelines may lead to contaminated parenteral products that could transfer pathogens to patients Appropriate conduct in the clean room, combined with correct technique and careful inspection of final products, will help to guarantee the sterility of CSPs 2012 Paradigm Publishing
- 39. Topics39 Your Turn 2012 ParadigmPublishing 3) All of the different hood types may be referred to as a. primary engineering control. b. secondary engineering control. c. primary engineering class. d. secondary engineering class. 4) This is caused by incorrectly placing objects within the hood. a. shadowing b. touch contamination c. zone of turbulence d. pathogenic contaminants In Slide Show view, click here to see the answer to Question 3. Then click again to advance to Question 4. In Slide Show view, click here to see the answer to Question 4.
Editor's Notes
- #31 compounded sterile preparations (CSPs)