the pharmacy clean room
TRANSCRIPT
The Structure and Equipment of the Controlled Environment
CLICK TO BEGIN
The Pharmacy Clean Room II: A Closer Look
Aseptic Preparation of Sterile Pharmaceuticals: Procedures and Conduct In the Controlled
Environment
Lesson Objectives
• Define four key terms that describe the characteristics of a pharmacy controlled environment
• Describe basic structural components that commonly comprise a clean room
• List 3 criteria that must be met by all clean room furniture and apparatus in order to be used in controlled areas
• Identify various types of clean room furniture and commonly used apparatus
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The Pharmacy Controlled Environment
The pharmacy environment is quite unlike other areas within a hospital or institution. There are special storage and security considerations that must be addressed on a daily basis in order to meet local, federal, and credentialing requirements.
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The Pharmacy Controlled Environment
• Every pharmacy area shares in the responsibility of ensuring safe, effective and appropriate use of drugs and devices. Further, any area in which sterile products are prepared must utilize additional measures to reduce the risk of contamination of the environment and all compounded products .
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The Pharmacy Controlled Environment
Let’s start by reviewing key terminology that will describe areas within a pharmacy controlled work environment.
If, at any point, you would like to review any of the terminology which will be noted specifically in this lesson, click on the “Glossary” bubble at the bottom left of each screen.
• Here are 4 key definitions:
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GLOSSARYGLOSSARY
The Pharmacy Controlled Environment—Key
Definitions• Clean Room:
A room in which the concentration of airborne particles is controlled; is constructed and used in a manner to minimize the introduction, generation and retention of particles inside the room. Other relevant parameters, such as temperature, humidity and pressure are also controlled as necessary. To ensure proper temperature range for drug storage, clean room temperature should be maintained within the range of 59 to 86° Fahrenheit.
• Clean Zone:A defined space in which the concentration of airborne particles is controlled to meet a specified airborne particulate cleanliness class. (You may recall that we discussed the ISO classes in Lesson 2 for LAFW’s)
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GLOSSARYGLOSSARY
The Pharmacy Controlled Environment—Key
Definitions• Controlled Area:
Area designated for preparing sterile pharmaceuticals. By USP definition, is also called the “buffer room”.
• Critical Areas:
Any area in the controlled area where products or containers are exposed to the environment, such as in the Laminar Airflow Workbench.
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GLOSSARYGLOSSARY
Aside from particle counts, which of the following is NOT one of the parameters to be measured and controlled in the clean room environment? Click on the best answer!
• Temperature• Humidity• CO2 Levels
Quick Review:
Aside from particle counts, which of the following is NOT one of the general parameters to be measured and controlled in the clean room environment? Click on the best answer!
• Temperature• Humidity• CO2 Levels
Actually, temperature is a parameter that must be measured and controlled in the clean room! This will be discussed further in a future lesson regarding environmental monitoring.
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Aside from particle counts, which of the following is NOT one of the parameters to be measured and controlled in the clean room environment? Click on the best answer!
• Temperature• Humidity• CO2 Levels
No—actually, humidity is measured and controlled in the clean room. We will discuss this further in an upcoming lesson regarding environmental monitoring.
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Aside from particle counts, which of the following is NOT one of the parameters to be measured and controlled in the clean room environment? Click on the best answer!
• Temperature• Humidity• CO2 Levels
• Correct! While air pressure is monitored, carbon dioxide levels are not specifically measured in the clean room.
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The Clean Room
• As with any other pharmacy area, the clean room must be arranged in a clean and orderly fashion , with all equipment in good operating condition. Measures must also be taken to limit the introduction and generation of airborne particles, within the clean room as a whole as well as within critical areas.
americancleanrooms.com
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GLOSSARYGLOSSARY
The Clean Room
• As the diagram at right indicates, there are several specifications that must be considered to create a USP Chapter 797 compliant clean room. Let’s look at a few key components!
Abtk.com
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The Four (Five or Six…!)Walls
• Per standards set by USP (United States Pharmacopoeia), a clean room must be constructed with non-particle generating materials, that are easy to clean and maintain, and do not provide successful breeding grounds for bacteria or other contaminants. americancleanrooms.com
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How’s the Air Up There?
• A controlled environment environment must be equipped with fan powered HEPA (High Efficiency Particulate Air) filters that filter all outside air before entry into the controlled areas.
Modularcleanrooms.com
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GLOSSARYGLOSSARY
Under Pressure!
• Clean room air filtration must be established and maintained in such a way as to create positive pressure, (clean room air pressure higher than outside air pressure) which helps prevent outside air from entering the inner controlled areas.
Terrauniversal.com
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GLOSSARYGLOSSARY
Finish this phrase: Clean room air filtration must be maintained to create____________pressure, which will help prevent outside air from entering the controlled areas.
• Positive
• Negative
Quick Review:
Finish this phrase: Clean room air filtration must be maintained to create____________pressure, which will help prevent outside air from entering the controlled areas.
• Positive
• Negative• That is correct! This
positive pressure helps keep potentially contaminating particles from entering the clean room.
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Finish this phrase: Clean room air filtration must be maintained to create____________pressure, which will help prevent outside air from entering the controlled areas.
• Positive
• NegativeSorry, the correct answer is POSITIVE. Positive pressure pushes inside clean room air outside of the room, which helps to prevent outside air, particles and contaminants from entering the clean room.
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Within the Four Walls
• Now that we have examined the structure, let’s look at specifically designated spaces within the clean room.
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Within the Four Walls
• In order to meet USP standards, a clean room must be equipped with:
• an anteroom: area used for handling of non sterile products or materials and for handwashing and donning of sterile garb
• demarked or
physically separated controlled area, where sterile products are compounded.
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GLOSSARYGLOSSARY
Within the Four Walls
• Whether in the anteroom, buffer room or one of the laminar airflow hoods, ASHP and USP standards regulate clean room air cleanliness. americancleanrooms.com
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GLOSSARYGLOSSARY
Within the Four Walls
Two critical factors upon which these standards are based are:
• Air particle counts • Drug compounding
risk levelsamericancleanrooms.com
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GLOSSARYGLOSSARY
Particle Counts
Per USP standards, a clean room, or buffer room, must meet ISO Class 8 standards (no more than 3,520,000 particles 0.5 microns or larger per cubic meter of air). The laminar airflow hood environment must meet ISO 5 standards.
Class Name Particle Size
ISO Class US Federal Standards
ISO, m 3 U.S. Federal Standards, ft 3
3 Class 1 35.2 1
4 Class 10 352 10
5 Class 100 3520 100
6 Class 1000 35,200 1000
7 Class 10,000 352,000 10,000
8 Class 100,000
3,520,000
100,000
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GLOSSARYGLOSSARY
Risk Levels
Both ASHP and USP have established risk levels for sterile compounding areas, based on the sterility, stability and storage requirements of compounded drugs.
Click here to see USP and ASHP facility and equipment requirements by Risk Level.
americancleanrooms.com
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GLOSSARYGLOSSARY
Risk Levels
Based on the risk level, ASHP and USP have established guidelines for controlled areas in which drugs are compounded.
Risk levels determine standards of practice for aseptic admixture and many other activities in the clean room. We will discuss this further in a future lesson about quality control in the clean room environment.
americancleanrooms.com
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GLOSSARYGLOSSARY
ASHP Guidelines USP GuidelinesRisk Level 1:Controlled area separate from other areasClean, well lighted and sufficient sizeClass 100 LAFW environment
Low Risk:Appropriate solid surfacesLimited to necessary furniture, fixtures, etcAnteroom area (demarked or physically separate)Buffer zone ISO Class 8
Risk Level 2:All Risk 1 level requirementsControlled area must meet class 10,000 standardsAnteroom desirable
Medium Risk:Same as low-risk level.
Risk Level 3:All Risk Level 2 requirementsAnteroom should be Class 100,000.
High Risk:Same as low-risk levelAnteroom must be physically separate from buffer room.
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The anteroom is the area of the clean room where:
• Sterile products are compounded
• Non-sterile products are handled
Quick Review:
The anteroom is the area of the clean room where:
• Sterile products are compounded
• Non-sterile products are handled
Sorry, that is incorrect. The anteroom is the area where non-sterile products are handled, as well as where personnel perform aseptic handwashing and donning of required clean room attire.
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The anteroom is the area of the clean room where:
• Sterile products are compounded
• Non-sterile products are handled
• That is Correct! Only the buffer room, or demarked areas of the clean room are designated for preparing sterile products. Only non-sterile items may be handled in the anteroom.
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Clean Room Equipment
• There is a variety of equipment that is used in conjunction with the process of IV admixture. Personnel require various pieces of clean room furniture, as well as some approved apparatus to assist in their processes.
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GLOSSARYGLOSSARY
Clean Room Equipment
• Any equipment approved to be used within a clean room must meet specified criteria:– Ability to be cleaned– Mobility– Constructed of non-
particle generating material
• Let’s examine a several pieces of equipment commonly found in a clean room.
americancleanrooms.com
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GLOSSARYGLOSSARY
Laminar Airflow Workbenches (LAFW's)
• In the critical area, air should meet ISO 5 conditions (no more than 3,520 particles of 0.5 microns or larger in size per cubic meter of air). A Laminar airflow workbench is a cost effective, efficient way to provide this environment.
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GLOSSARYGLOSSARY
Laminar Airflow Workbenches (LAFW's)
• A LAFW includes a high efficiency particulate air (HEPA) filter, which traps and contains microorganisms and particles, greatly reducing the chances of airborne particulates contaminating a sterile product.
Nuair.com
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GLOSSARYGLOSSARY
Horizontal LAFW
• Shown at right, is most commonly used as it does not require expensive venting of exhaust air and can be moved to various locations within the clean room.
Nuair.com
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GLOSSARYGLOSSARY
Vertical LAFW
Because horizontal air flow blows towards the user, the vertical laminar airflow hood is more appropriate for use with hazardous drugs. Vertical LAFW’s, or Biological Safety Cabinets, are classified according to their mechanism of air exchange and external exhaust systems.
Click here for more information regarding various classes of Biological Safety Cabinets.
Nuair.com
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GLOSSARYGLOSSARY
Biological Safety Cabinet Classifications
HOOD CLASS CLASS II, TYPE
A
CLASS II, TYPE B1
CLASS II, TYPE B2 CLASS II, TYPE B3
Filters inward air flow and exhaust Air
YES YES YES YES
% Recirculated air in controlled area
70 70 0All down flow
air drawn thru HEPA filter from controlled area, not
re-circulated from the cabinet
70
Exhausts to Room
YES YES NO YES
Exhausts Outside
NO YES, IF EXHAUST
DUCT CONNECTION
YES YES, IF EXHAUST
DUCT CONNECTION
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GLOSSARYGLOSSARY
Which of the two laminar airflow work benches is the most cost effective?
• Horizontal
• Vertical
Quick Review:
Which of the two laminar airflow work benches is the most cost effective?
• Horizontal
• Vertical
• Correct! Unlike the vertical LAFW, the horizontal LAFW does not require any exhaust venting as air is re-circulated back into the clean room.
BACK TO LESSON
Which of the two laminar airflow work benches is the most cost effective?
• Horizontal
• Vertical
Sorry that is not correct. Due to the hazardous substances compounded in a vertical LAFW, contained air must be filtered before exhausted out of the hood: some types of BSC’s may also require venting out of the clean room area, which can be costly.
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Pharmaceutical Refrigerators
It is critical that drug potency and stability be maintained at all times. Those drugs requiring refrigeration must be stored in a pharmaceutical refrigerator at a regularly monitored [at least daily] temperature range.
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GLOSSARYGLOSSARY
Pharmaceutical Refrigerators
The USP defines a [pharmaceutical] refrigerator as a “cold place in which the temperature is maintained thermostatically between 2 and 8 degrees centigrade (36 to 46 degrees Fahrenheit)”.
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Refrigerator Location
Refrigerators, due to their ventilation motors, may potentially disrupt air flow within a clean room. Therefore, they must be positioned as far away from LAFW’s as possible and outside of the demarcated clean zone.
Sanyobiomedical.com
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GLOSSARYGLOSSARY
What is the acceptable temperature range in Fahrenheit for a pharmaceutical refrigerator?
• 36 - 46°
• 46 - 59°
• 59 - 86°
Quick Review:
What is the acceptable temperature range in Fahrenheit for a pharmaceutical refrigerator?
• 36 - 46°
• 46 - 59°
• 59 - 86°• Correct! It is vital that this
temperature range be maintained for the stability of all refrigerated products.
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What is the acceptable temperature range in Fahrenheit for a pharmaceutical refrigerator?
• 36 - 46°
• 46 - 59°
• 59 - 86°• Incorrect—while this is a cool
temperature range, the approved range is 36 - 46° F
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What is the acceptable temperature range in Fahrenheit for a pharmaceutical refrigerator?
• 36 - 46°
• 46 - 59°
• 59 - 86°• Incorrect, that is the
temperature range for room temperature. The correct range is 36 - 46° F
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Clean Room Furniture and Storage
• In order to aid in reduced particle counts and surface area where bacteria may grow, furniture should be limited only to that which is necessary. All equipment must be constructed of non-particle generating materials that may be easily cleaned on a regular basis.
• Limited quantities of drugs and IV solutions may be stored in the clean room. No bulk storage is allowed.
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GLOSSARYGLOSSARY
Clean Room Shelving
• In order to minimize surface area where dust particles may settle, storage and shelving should be kept at a minimum in a controlled area.
• Due to the amount of particulate that it generates, NO cardboard may be stored at any time in the clean room!
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Rdm-ind.com
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Clean Room Shelving
• Shelving for plastic bags and glass containers should be easy to clean.
• Stainless steel wire shelving units, as shown, are ideal, particularly those with wheels so they can be moved for cleaning.
Rdm-ind.com
Rdm-ind.com
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Tables and Chairs
• As stated, stainless steel furniture is the most ideal as it will not generate particles and is easy to clean.
• Chairs may also be padded with a non-porous material, such as vinyl.
• Both should be equipped with wheels so that they can be easily moved for cleaning of both their surfaces as well as the floor beneath them.
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Tdiinternational.com
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Transport/Storage Carts
• Stainless steel is recommended. Carts should be mobile on wheels and castors.
• For USP 797 compliance, any carts used in the clean room must remain in the controlled areas at all times.
Cleanairproducts.com
Healthcarelogistics.com
Gotopac.biz
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GLOSSARYGLOSSARY
What type of material may clean room chairs be padded with?
• Leather
• Vinyl
• No padding is allowed
Quick Review:
What type of material may clean room chairs be padded with?
• Leather
• Vinyl
• No padding is allowedLeather is great, but not in a clean room! In order to reduce surface areas that may trap contaminants, only non-porous material, such as vinyl, may be used to pad chairs stored in a clean room.
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What type of material may clean room chairs be padded with?
• Leather
• Vinyl
• No padding is allowedYou are Correct! Vinyl is non-porous, so no contaminants will be trap in the padding of the chair.
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What type of material may clean room chairs be padded with?
• Leather
• Vinyl
• No padding is allowedOuch! Thank goodness that isn’t true! Chairs may be padded, but only with a non porous material, such as Vinyl.
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Other Equipment and Fixtures
Now let’s take a look at a few key apparatus that are used in the clean room on a regular basis. As with other equipment, all apparatus must be:
• constructed of non-particle generating materials
• mobile • easy to clean on a regular
basis.
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GLOSSARYGLOSSARY
Other Equipment and Fixtures
• Tacky mats are multiple plastic sheets coated with adhesives that trap particulate from shoe soles when stepped on.
• As dirt will collect quickly, the topmost sheet should be peeled off frequently so there is always a fresh tacky surface.
Healthcarelogistics.com
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GLOSSARYGLOSSARY
Other Equipment and Fixtures
• Repeater pumps are used for batch preparation.
• Tubing connects a large volume source to smaller volume bags or syringes.
• Pump may be operated manually or programmed to draw a defined volumes at timed intervals.
Healthmark.com
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GLOSSARYGLOSSARY
Other Equipment and Fixtures
• TPN compounding machines are used to mix large volumes of TPN (total parenteral nutrition).
• Is programmed to draw defined volumes of IV solutions and various drugs into a central collection IV bag.
• Electronic scales are used to measure the quantity of drug to be added to an IV or irrigation solution.
**Since this is considered high risk compounding, care must be taken not to contaminate the surface of the scale or drugs being weighed.**
Healthcarelogistics.com
Healthmark.com
Baxa.com
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GLOSSARYGLOSSARY
Other Equipment and Fixtures
• The sink is more important than you think! This is where aseptic procedures begin: with proper handwashing. Sinks , which must be located in the anteroom or outside of the clean room, must be stainless steel; fixtures are often “touchless” in today’s more modern clean rooms.
• Pass-throughs are used to pass products from the clean room to the outside environment.
• Reduces the frequency of staff exiting the controlled area and potentially introducing airborne contaminants into controlled areas.
• Only one side of the pass through will open at a time, so little or no air exchange takes place.
Terrauniversal.com
Americancleanrooms.com
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GLOSSARYGLOSSARY
Name one of the three key characteristics that clean room material must possess:
• Easy to clean
• Stationary
• Hard-wood construction
Quick Review:
Name one of the three key characteristics that clean room material must possess:
• Easy to clean
• Stationary
• Hard-wood construction• Yes, that’s right! Clean room
equipment must also be mobile and constructed of non-particle generating material. Excellent!
BACK TO LESSON
Name one of the three key characteristics that clean room material must possess:
• Easy to clean
• Stationary
• Hard-wood construction
That is not correct: clean room equipment must be mobile, so that the item itself, as well as the floor or counter surface beneath it, may be cleaned regularly. Equipment must also be constructed of non-particle generating materials.
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Name one of the three key characteristics that clean room material must possess:
• Easy to clean
• Stationary
• Hard-wood construction
I’m afraid not! All clean room equipment must be constructed of non-particle generating materials, and hardwood does not qualify. Materials must also be mobile and easy to clean.
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Lesson Review and Summary
We’ve taken a hard look at the clean room environment, inside and out! Let’s take a moment to review what you’ve learned in this lesson…
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Lesson Review and Summary
4 key terms defining clean room areas (see glossary):
• Clean room • Clean zone• Controlled area• Critical area
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Lesson Review and Summary
A clean room must be constructed of materials that are:
• Non particle generating• Easy to clean and do not
provide good breeding ground for infecting agents
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Lesson Review and Summary
A clean room must be equipped with:
• Fan powered HEPA filter, that will also create and maintain room positive pressure to help prevent introduction of airborne contaminants into controlled areas.
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GLOSSARYGLOSSARY
Lesson Review and Summary
There are two main areas that comprise a clean room:
• Anteroom: non-sterile supplies handled, handwashing, donning of protective gear
• Controlled area: or buffer room where sterile products are compounded.
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GLOSSARYGLOSSARY
Lesson Review and Summary
Air cleanliness standards for particle counts and compounding risk factors have been set by both ASHP and USP: clean rooms must meet ISO 8 (NMT 3,520,000 particles 0.5 microns or larger per cubic meter of air). LAFW’s must meet ISO class 5 standards.
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GLOSSARYGLOSSARY
Lesson Review and Summary
USP Risk levels:
Low: limit clean room furniture, demarked or separate anteroom
Medium: Same as Low risk
High Risk: Same as low risk, but anteroom must be physically separated and buffer room must meet ISO Class 8 standards
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GLOSSARYGLOSSARY
Lesson Review and Summary
Clean Room furniture and equipment must meet 3 specified criteria:
• Easy to clean• Mobility• Constructed of non-
particle generating materials
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GLOSSARYGLOSSARY
Lesson Review and Summary
Clean room Furniture:
• Laminar Airflow Workbenches: horizontal or vertical. Horizontal more cost effective as they are more mobile and do not require external venting
• Storage racks/shelves, and rolling carts (stainless steel ideal material)
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GLOSSARYGLOSSARY
Lesson Review and Summary
Clean room furniture:
• Pharmaceutical Refrigerators: must be stored a distance from LAFW’s, maintained at a temperature range of 36 - 46° F.
• Tables and chairs: Constructed of stainless steel, chairs padded with non-porous material like vinyl.
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GLOSSARYGLOSSARY
Lesson Review and Summary
Clean room apparatus
• Tacky mats: trap large particles on shoes, must peel to expose new surface
• Repeater pumps: used for batch preparation, pumps manually or pre-programmed volume of IV solutions from large volume source to small volume IV bags or syringes
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GLOSSARYGLOSSARY
Lesson Review and Summary
Clean room apparatus
• TPN compounder: Programmed to mix IV solutions and several drugs into central IV bag for Total Parenteral Nutrition
• Electronic Scales: Used to measure non-sterile drug to add to IV or irrigation solutions. Must use caution to avoid contamination during this High Risk Compounding
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GLOSSARYGLOSSARY
Lesson Review and Summary
Clean room apparatus
• Sink: Stainless steel construction, vital for aseptic handwashing
• Pass-Through: Used to transfer products between the clean room and external areas; door releases one way only, allows for little or no air exchange to prevent introduction of airborne contamination into clean zone
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GLOSSARYGLOSSARY
Congratulations, you have just completed the 3rd lesson of Module One!
You may now close this lesson and return to your BLN Lesson Plan to begin your test.Remember, in order to ensure that you have gained the important knowledge that you will need to begin developing your aseptic technique skills, you will need to score at least an 80% to proceed to the next lesson. Before closing this lesson, click on the scroll above to open and print the practice exercise. Please check your hands on training schedule for the dates/times to complete your experiential training on this lesson.
Practice Exercise
References
• E. Clyde Buchanan, M.S., Philip J. Schneider, M.S. Compounding Sterile Preparations, 2nd Edition American Society of Health-System Pharmacists, 2005. Chapter 3: Equipment for Compounding Sterile Preparations; Chapter 17: Sterile Preparation Facilities and Equipment.
• Liz Johnson Wilroy B.H.S., CphT., and Daniel E. Garcia PharmD., RPh. Pharmacy Sterile Products Training Manual. Pharmacy Education Resources, Inc. Revised 2002. Chapter 8: Pharmacy Controlled Environment and Conduct.