Successfully reported this slideshow.
We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. You can change your ad preferences anytime.
Topics2
Chapter 2
The Sterile Compounding
Environment
2012 Paradigm Publishing
Topics3
Learning Objectives
 Identify the origin of the pharmacy clean room and procedures
for sterile compounding.
 Des...
Topics4
Topics
 Learning Objectives
 Introduction
 Anteroom Setup and Characteristics
 Clean Room Setup and Characteri...
Topics55
Introduction
 Some changes necessitated by USP Chapter <797>
have required pharmacies to undergo extensive and
c...
Topics66
Anteroom Setup and Characteristics
 The anteroom, which may also be called the
transition area or ante-area, pro...
Topics77
Anteroom Setup and
Characteristics…/2
 Most sterile compounding
pharmacies have an
anteroom that is separate
fro...
Topics88
Anteroom Setup and
Characteristics…/3
 Most sterile compounding pharmacies secure a
sticky mat to the floor at t...
Topics99
Anteroom Setup and
Characteristics…/4
 Limit storage items to materials that are directly
required for sterile c...
Topics1010
Anteroom Setup and
Characteristics…/5
2012 Paradigm Publishing
Topics1111
Clean Room Setup and
Characteristics
 The clean room is the innermost room
also referred to as the IV room or...
Topics1212
Clean Room Setup and
Characteristics…/2
 A pharmacy-designated HVAC system should pump
HEPA-filtered air into ...
Topics1313
Clean Room Setup and
Characteristics…/3
 PECs, such as horizontal laminar airflow hoods, should
be placed with...
Topics1414
Cleaning of the Anteroom and Clean
Room
 USP Chapter <797> provides clear guidelines for the
cleaning of the p...
Topics1515
Maximum Particle Count
ISO Class Name (in particles of 0.5 micron and larger per cubic meter of
air)
3 35.2
4 3...
Topics1616
Cleaning of the Anteroom and Clean
Room…/3
 The International Organization for Standardization
(ISO) creates w...
Topics1717
Cleaning of the Anteroom and Clean
Room…/4
 In general, the particulate matter contained in
regular room air w...
Topics1818
Cleaning of the Anteroom and Clean
Room…/5
 You must record the same information about the
clean-room-cleaning...
Topics1919
Cleaning of the Anteroom and Clean
Room…/6
2012 Paradigm Publishing
Topics2020
Cleaning of the Anteroom and Clean
Room…/7
2012 Paradigm Publishing
Topics21
Your Turn
2012 Paradigm Publishing
1) This a place where sterile compounding personnel can garb and
perform asep...
Topics2222
Types of Hoods Required
for Sterile Compounding
 All of the different hood types may be referred to as
primary...
Topics2323
Types of Hoods Required
for Sterile Compounding…/2
 The most widely used
sterile compounding
hood in the pharm...
Topics2424
Types of Hoods Required
for Sterile Compounding…/3
 CAI and CACI Hoods
most useful in sterile compounding
env...
Topics2525
Types of Hoods Required
for Sterile Compounding…/4
 Advantages of the CAI and CACI Hoods
two primary advantag...
Topics2626
Types of Hoods Required
for Sterile Compounding…/5
 BSC Hood
special hood for preparing
hazardous compounds s...
Topics2727
USP Chapter <797> Guidelines for
Hoods
 Most hoods share a
common design such that
room air enters the cabinet...
Topics2828
USP Chapter <797> Guidelines for
Hoods…/2
2012 Paradigm Publishing
Topics2929
USP Chapter <797> Guidelines for
Hoods…/3
 Each hood should have its
own, separate checklist
 Keep the checkl...
Topics3030
Risk Levels in Sterile Compounding
 USP Chapter <797> defines four microbial
contamination risk levels associa...
Topics3131
Risk Levels in Sterile
Compounding…/2
 Low-Risk CSPs
involves the mixing of no more than three commercially
p...
Topics3232
Risk Levels in Sterile
Compounding…/3
 Medium-Risk CSPs
meets all of the conditions associated with low-risk ...
Topics3333
Risk Levels in Sterile
Compounding…/4
 High-Risk CSPs
meet all of the conditions of the low- and medium-risk
...
Topics3434
Risk Levels in Sterile
Compounding…/5
 Immediate-Use CSPs
according to the USP <797> Guidebook, are “intended...
Topics3535
Risk Levels in Sterile
Compounding…/6
 Potential Contaminants in the Sterile Compounding
Environment
pathogen...
Topics3636
Risk Levels in Sterile
Compounding…/7
2012 Paradigm Publishing
Topics3737
Risk Levels in Sterile
Compounding…/8
 Potential Contaminants in the Sterile Compounding
Environment…continued...
Topics3838
Risk Levels in Sterile
Compounding…/9
 Excellent aseptic technique is the foundation of
sterile parenteral pro...
Topics39
Your Turn
2012 Paradigm Publishing
3) All of the different hood types may be referred to as
a. primary engineeri...
The Sterile Compounding Environment
Upcoming SlideShare
Loading in …5
×

The Sterile Compounding Environment

3,844 views

Published on

Chapter 2

Published in: Health & Medicine

The Sterile Compounding Environment

  1. 1. Topics2 Chapter 2 The Sterile Compounding Environment 2012 Paradigm Publishing
  2. 2. Topics3 Learning Objectives  Identify the 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
  3. 3. 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.
  4. 4. Topics55 Introduction  Some changes necessitated 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
  5. 5. Topics66 Anteroom Setup and Characteristics  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
  6. 6. 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
  7. 7. 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
  8. 8. 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
  9. 9. Topics1010 Anteroom Setup and Characteristics…/5 2012 Paradigm Publishing
  10. 10. Topics1111 Clean Room Setup and 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
  11. 11. Topics1212 Clean Room Setup and 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
  12. 12. Topics1313 Clean Room Setup and 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
  13. 13. Topics1414 Cleaning of the Anteroom 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
  14. 14. Topics1515 Maximum Particle Count ISO Class 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.”
  15. 15. Topics1616 Cleaning of the Anteroom 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
  16. 16. Topics1717 Cleaning of the Anteroom 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
  17. 17. Topics1818 Cleaning of the Anteroom 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
  18. 18. Topics1919 Cleaning of the Anteroom and Clean Room…/6 2012 Paradigm Publishing
  19. 19. Topics2020 Cleaning of the Anteroom and Clean Room…/7 2012 Paradigm Publishing
  20. 20. Topics21 Your Turn 2012 Paradigm Publishing 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.
  21. 21. Topics2222 Types of Hoods Required 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
  22. 22. Topics2323 Types of Hoods Required for Sterile Compounding…/2  The most widely used sterile compounding hood in the pharmacy is the horizontal LAFW 2012 Paradigm Publishing
  23. 23. Topics2424 Types of Hoods Required 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
  24. 24. Topics2525 Types of Hoods Required 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
  25. 25. Topics2626 Types of Hoods Required 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
  26. 26. 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
  27. 27. Topics2828 USP Chapter <797> Guidelines for Hoods…/2 2012 Paradigm Publishing
  28. 28. 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
  29. 29. Topics3030 Risk Levels in Sterile 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
  30. 30. Topics3131 Risk Levels in Sterile 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
  31. 31. Topics3232 Risk Levels in Sterile 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
  32. 32. Topics3333 Risk Levels in Sterile 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
  33. 33. Topics3434 Risk Levels in Sterile 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
  34. 34. Topics3535 Risk Levels in Sterile 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
  35. 35. Topics3636 Risk Levels in Sterile Compounding…/7 2012 Paradigm Publishing
  36. 36. Topics3737 Risk Levels in Sterile 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
  37. 37. Topics3838 Risk Levels in Sterile 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
  38. 38. Topics39 Your Turn 2012 Paradigm Publishing 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.

×