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Sterile Compounding:Facility Metrics
Copyright © 2008-2014 ClinicalIQ, LLC® - All Rights ReservedCopyright © 2008-2014 ClinicalIQ, LLC® - All Rights Reserved
Sterile Compounding:Facility Metrics
Eric S. KastangoOctober 9, 2013
Important Inspector Evaluation Metrics
Facility MetricsSelected Work Practices Inspector Evaluation Metrics
Primary and Secondary EngineeringControls
• Facility Maintenance PnP• Certification Documents
• Airflows (ACPH)• Non-viable particle counts (dynamic operating
conditions)• Viable air sampling results (dynamic operating
conditions)• Segregation (pressure/velocity)• Smoke Testing (dynamic operating conditions)
• Environmental Sampling Plan• Pressure/Velocity Differential Logs• Temperature/Humidity Logs
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• Facility Maintenance PnP• Certification Documents
• Airflows (ACPH)• Non-viable particle counts (dynamic operating
conditions)• Viable air sampling results (dynamic operating
conditions)• Segregation (pressure/velocity)• Smoke Testing (dynamic operating conditions)
• Environmental Sampling Plan• Pressure/Velocity Differential Logs• Temperature/Humidity Logs
Cleaning and Disinfecting onControlled Sterile CompoundingEnvironments
• Written Policy and Procedure• Employee Training• Written Competency Verification• Cleaning Logs
Polling Question
A LAFW (laminar airflow workbench) is an example ofa secondary engineering control?
1. True2. False
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What are Primary Engineering Controls (PECs)?
• There are 5 types of PECs designed to eliminate particles throughdelivery of unidirectional HEPA filtered air to the directcompounding area (DCA):
– Laminar Airflow Workbench (LAFW)
– Vertical Cleanbench (VCB)
– Compounding Aseptic Isolator (CAI)
– Biological Safety Cabinet (BSC)
– Compounding Aseptic Containment Isolator (CACI)
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• There are 5 types of PECs designed to eliminate particles throughdelivery of unidirectional HEPA filtered air to the directcompounding area (DCA):
– Laminar Airflow Workbench (LAFW)
– Vertical Cleanbench (VCB)
– Compounding Aseptic Isolator (CAI)
– Biological Safety Cabinet (BSC)
– Compounding Aseptic Containment Isolator (CACI)
What are Secondary Engineering Controls?
• Secondary Engineering Controlsare designed to reduce particlesthrough the delivery of HEPAfiltered air to the room tofacilitate the operation of theprimary engineering controls.
• The Buffer Area commonlyreferred to as a cleanroom– This room is where the PECs are
placed– <797> requires it to attain ISO
Class 7 air cleanliness or better
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• Secondary Engineering Controlsare designed to reduce particlesthrough the delivery of HEPAfiltered air to the room tofacilitate the operation of theprimary engineering controls.
• The Buffer Area commonlyreferred to as a cleanroom– This room is where the PECs are
placed– <797> requires it to attain ISO
Class 7 air cleanliness or better
What are Secondary Engineering Controls?
• The Ante-area (anteroom) is theroom directly outside the bufferarea– This room is to perform hand
hygiene, garbing and stagecomponents for entry to the bufferarea
– Anterooms must maintain ISOClass 8 air if they serve only abuffer area in which nonhazardous compounding isperformed
– If the anteroom also serves an HDbuffer room, then the anteroom isrequired to maintain ISO Class 7 air
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• The Ante-area (anteroom) is theroom directly outside the bufferarea– This room is to perform hand
hygiene, garbing and stagecomponents for entry to the bufferarea
– Anterooms must maintain ISOClass 8 air if they serve only abuffer area in which nonhazardous compounding isperformed
– If the anteroom also serves an HDbuffer room, then the anteroom isrequired to maintain ISO Class 7 air
Facility Design “Shalls”
• Line of demarcation in anteroom or SCA• Furniture, equipment and physical plant
surfaces nonporous, smooth and cleanable• Climate conducive to comfort (68°F)• Materials limited to what is essential for
compounding• Ceiling: hydrophobic panels caulked around
perimeter• Floors: cleanable with coved molding• Walls: solid or locking panels impervious,
cleanable and non-shedding• Sink: hands-free water and soap
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• Line of demarcation in anteroom or SCA• Furniture, equipment and physical plant
surfaces nonporous, smooth and cleanable• Climate conducive to comfort (68°F)• Materials limited to what is essential for
compounding• Ceiling: hydrophobic panels caulked around
perimeter• Floors: cleanable with coved molding• Walls: solid or locking panels impervious,
cleanable and non-shedding• Sink: hands-free water and soap
Polling Question
If an anteroom serves both a non hazardous buffer area and ahazardous drug buffer area, it must be which ISO aircleanliness classification?
1. Class 72. Class 83. Class 54. No Class
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1. Class 72. Class 83. Class 54. No Class
Facility Design “Shalls”
• Temperature of incubators conform torequirements
• Controlled room, cold and frozenenvironments are monitored and conform toUSP requirements
• Evidence that temperatures in all controlledareas are monitored at least daily anddocumented
• Evidence of effective mechanisms to– report excursions
– repair defects
– protect CSPs
– document actions
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• Temperature of incubators conform torequirements
• Controlled room, cold and frozenenvironments are monitored and conform toUSP requirements
• Evidence that temperatures in all controlledareas are monitored at least daily anddocumented
• Evidence of effective mechanisms to– report excursions
– repair defects
– protect CSPs
– document actions
Equipment Related “Shalls”
• ACDs used for TPN/dialysis tested weekly forvolumetric/gravimetric accuracy
• Written PnP details maintenance, calibration andcleaning of all equipment and documented
• Equipment used for compounding or monitorcontrolled environments (e.g., ACDs, temperatureand humidity monitors, isolators, volumetric airsamplers, freezers, refrigerators, etc.)
– Cleaned
– Maintained
– Calibrated
• Personnel who used equipment have receivedtraining and demonstrated ability touse/troubleshoot
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• ACDs used for TPN/dialysis tested weekly forvolumetric/gravimetric accuracy
• Written PnP details maintenance, calibration andcleaning of all equipment and documented
• Equipment used for compounding or monitorcontrolled environments (e.g., ACDs, temperatureand humidity monitors, isolators, volumetric airsamplers, freezers, refrigerators, etc.)
– Cleaned
– Maintained
– Calibrated
• Personnel who used equipment have receivedtraining and demonstrated ability touse/troubleshoot
Primary/Secondary Engineering Control “Shalls”
• If differential pressure design, then pressure gaugesinstalled and monitored at least daily:– Buffer anteroom (0.02” w.c. positive or 0.01”
negative)– Anteroomnon-classed (0.02” w.c. positive)
• If open concept (air displacement design):– Velocity across entire opening maintains 40
feet/minute and verified by smoke– Not allowed if HD compounding
• Air Cleanliness– Buffer ISO Class 7– Anteroom ISO Class 7/8
• Air Exchanges– Buffer room: at least 30 ACPH with 15 of those from
HEPA filtered air supplied to room– Ante-area: no requirement but at least 20 ACPH
common
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• If differential pressure design, then pressure gaugesinstalled and monitored at least daily:– Buffer anteroom (0.02” w.c. positive or 0.01”
negative)– Anteroomnon-classed (0.02” w.c. positive)
• If open concept (air displacement design):– Velocity across entire opening maintains 40
feet/minute and verified by smoke– Not allowed if HD compounding
• Air Cleanliness– Buffer ISO Class 7– Anteroom ISO Class 7/8
• Air Exchanges– Buffer room: at least 30 ACPH with 15 of those from
HEPA filtered air supplied to room– Ante-area: no requirement but at least 20 ACPH
common
Primary/Secondary Engineering Control “Shalls”
• Once PECs are placed, smokestudies were conducted to verifyunidirectional airflow in DCA
• PECs certified according to CETAguidelines (CAG-003-2006) orsimilar– BSCs: NSF/ANSI 49
• If LAFWs or BSCs not placed inISO Class 7, then compounding islimited to low risk level CSPs with12 hour BUD (non hazardous)
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• Once PECs are placed, smokestudies were conducted to verifyunidirectional airflow in DCA
• PECs certified according to CETAguidelines (CAG-003-2006) orsimilar– BSCs: NSF/ANSI 49
• If LAFWs or BSCs not placed inISO Class 7, then compounding islimited to low risk level CSPs with12 hour BUD (non hazardous)
Primary/Secondary Engineering Control “Shalls”
• Isolators not placed in ISO Class 7 must meetall of the following:– Maintain ISO Class 5 conditions during
dynamic operating conditions including duringtransfer of components and compounding
– Particle counts remain ISO Class 5 duringcompounding
– Not > 3250 particles 0.5μm and larger per m3
are counting during material transfer (withcounter probe nearest possible to transferdoor)
• Recovery time to achieve ISO Class 5 andwritten compounding procedures ensureadequate recovery time after materialtransfer and compounding.
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• Isolators not placed in ISO Class 7 must meetall of the following:– Maintain ISO Class 5 conditions during
dynamic operating conditions including duringtransfer of components and compounding
– Particle counts remain ISO Class 5 duringcompounding
– Not > 3250 particles 0.5μm and larger per m3
are counting during material transfer (withcounter probe nearest possible to transferdoor)
• Recovery time to achieve ISO Class 5 andwritten compounding procedures ensureadequate recovery time after materialtransfer and compounding.
Secondary Engineering ControlsTest Non Haz Buffer Anteroom HD Buffer
Airflow 30 ACPH (at least 15 ACPH fromoutside the room)
Not specified but 20 ACPH isdesirable 30 ACPH; 12 ACPH if CACI is used
RoomSegregation
Minimum differential pressure of0.02” w.c. + from cleanroom to
anteroom and all adjacent spaces
Minimum differential pressure of0.02” w.c. + from anteroom to all
adjacent spaces
Minimum differential pressure of0.01” w.c. - from the HD
cleanroom to the anteroom.
If displacement airflow, then velocity of 40 feet/minute fromcleanroom to the anteroom across the entire opening
Not allowed in HD compounding
HEPA FilterLeak Test
All HEPA filters in the secondary engineering controls are tested at each certification.Maximum allowable leakage is 0.01% of the upstream aerosol concentration.
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HEPA FilterLeak Test
All HEPA filters in the secondary engineering controls are tested at each certification.Maximum allowable leakage is 0.01% of the upstream aerosol concentration.
SmokePatternTesting
Buffer rooms must be segregated from the ante-area and all other adjacent spaces with the doors closeusing smoke to observe airflow under dynamic operating conditions (with pharmacy staff compounding).
Non-ViableParticleCounts
ISO Class 7 ISO Class 8 unless it serves HDbuffer then ISO Class 7 ISO Class 7
Airborne particle counter used to samples particle levels in all locationsunder dynamic operating conditions.
Temperature No specific requirement other than comfortable typically a temperature of 68°F
Humidity Not a mandatory test but Relative Humidity between 35% and 60% is recommended
Adapted from CETA Certification Matrix for Sterile Compounding Facilities CAG-008-2010.
Traditional Primary Engineering Controls
TEST LAFW BSC(NSF International Criteria)
Placement of PrimaryEngineering Control
Placed in ISO Class 7 cleanroom; 0.2”w.c. or SCA
Placed in ISO Class 7 Cleanroom, 0.1”negative w.c. to anteroom
Airflow Velocity Velocity 80 to 100 feet/minute 6-12”from the filter
Downflow Velocity Profile and FaceVelocity Tests
HEPA Filter Leak TestHEPA filters must be certified to be
free from leaks > 0.01% of upstreamaerosol concentration
HEPA filters must be certified to be freefrom leaks > 0.01% of upstream aerosol
concentration or aerosol penetration not> 0.005% of upstream concentration
Verifies LAFW is free from unsealedconstruction joints & particles notbeing introduced into critical work
area
In BSCs, this test is called the PressureDecay/Soap Bubble Test and verifies thatthe cabinet is not leaking to the exterior
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Backstreaming TestVerifies LAFW is free from unsealedconstruction joints & particles notbeing introduced into critical work
area
In BSCs, this test is called the PressureDecay/Soap Bubble Test and verifies thatthe cabinet is not leaking to the exterior
Airflow patterns smoke testAn observation using smoke to visualize airflow under dynamic operating
conditions (with pharmacy staff compounding) to confirm laminarity of the air isundisturbed
Site Installation AssessmentTests
Verifies that the BSC is properlyintegrated into the facility testing airflowand sash alarms; interlocks and exhaustsystem performance
Non-Viable Particle Counts Particles counters capable of detecting particles 0.5 μm are used to verify ISOClass 5 air conditions
Adapted from CETA Certification Guide for Sterile Compounding Facilities. CAG-003-2006-11 and NSF/ANSI 49-2012.
Unidirectional IsolatorsTest CAI CACI
Placement of PEC Preferably room/area devotedto compounding
Room certified to have at least 12 ACPH and be 0.1” w.c.negative to adjacent room
Airflow Velocity Measurement of actual airflow to manufacturer’s design intent. The main chamber is expressed asa range of feet/min with a designated % uniformity.
Chamber Pressure Test Determines that pass-through and main chamber pressures adequate to provide isolator separationbetween main chamber and ambient spaces. Pressure range determined by manufacturer.
Site Installation AssessmentTests
Tests to verify proper alarm function; pass-through door interlock function; and proper canopy orexhaust connection performance.
HEPA Filter IntegrityLeak Test
All HEPA filters in the secondary engineering controls are tested at each certification.Maximum allowable leakage is 0.01% of the upstream aerosol concentration.
Particle Containment andEnclosure Leak Test
Test determines particle integrity of the cabinet at points ofpotential leakage; leaks detected do not exceed ISO Class 5 air
cleanliness.
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Particle Containment andEnclosure Leak Test N/A
Test determines particle integrity of the cabinet at points ofpotential leakage; leaks detected do not exceed ISO Class 5 air
cleanliness.
Volatile HD ContainmentTest N/A Verifies that CACI is properly connected to exhaust and provides
personnel protection from volatilized HDs
Hazardous ParticleContainment Test N/A Verifies that CACI provides worker protection from the escape of
HD particles during compounding.
Airflow Smoke PatternTest
An observation using smoke to visualize airflow under dynamic operating conditions (withpharmacy staff compounding) to confirm laminarity of the air is undisturbed
Preparation Ingress andEgress Test
Determine if the pass-through system is capable of supporting material transfer while maintainingthe designated cleanliness classification during the transfer.
Non-Viable Particle Counts Particles counters capable of detecting particles 0.5 μm are used to verify ISO Class 5 air conditionsboth at rest and during dynamic operating conditions.
Adapted from CETA Compounding Isolator Testing Guide. CAG-002-2006.
General Environmental Sampling “Shalls”
• Detailed written PnP on all aspects ofenvironmental sampling
• Sampling occurs in all ISO areas from cleanest todirtiest ISO 5 ISO 7 ISO 8
• CFU Action Levels established
• Evidence of logical plan of action in the eventsampling exceeds Action Levels
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• Detailed written PnP on all aspects ofenvironmental sampling
• Sampling occurs in all ISO areas from cleanest todirtiest ISO 5 ISO 7 ISO 8
• CFU Action Levels established
• Evidence of logical plan of action in the eventsampling exceeds Action Levels
CFU/m3 air/plate(1000 liters) If < 1000 liters air sampled, convert to equivalent AL (e.g., 400 liter sample in ISO Class 7 then AL = >4 CFU/plate)
ClassificationVolumetricAir SampleRequired*
ISO Class 5 > 1ISO Class 7 > 10ISO Class 8 > 100
Table 2 in Chapter <797>
Viable Air Sampling “Shalls”
• Viable air sampling performed:– at time of initial certification of PECs/SEC– every 6 months in association with physical
plant recertification– after major service or device relocation
• Air sampling performed with volumetricsampler (not settling plates or paddles)
• Air sampling volume at each location is 400 to1000 liters
• General growth medium and fungal specificmedium
• Evidence that if Action Level is exceeded, areais cleaned and resampled
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• Viable air sampling performed:– at time of initial certification of PECs/SEC– every 6 months in association with physical
plant recertification– after major service or device relocation
• Air sampling performed with volumetricsampler (not settling plates or paddles)
• Air sampling volume at each location is 400 to1000 liters
• General growth medium and fungal specificmedium
• Evidence that if Action Level is exceeded, areais cleaned and resampled
Growth Media
• Soybean Casein Digest Media(Trypticase Soy Broth/Agar) to supportthe growth of bacteria
• Malt Extract Agar or other media thatsupports the growth of fungi
• Must use plates with lecithin andpolysorbate 80 which are chemicalsthat neutralize cleaning agents whenperforming:– Surface sampling
– Personnel glove sampling associatedwith MFUs
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• Soybean Casein Digest Media(Trypticase Soy Broth/Agar) to supportthe growth of bacteria
• Malt Extract Agar or other media thatsupports the growth of fungi
• Must use plates with lecithin andpolysorbate 80 which are chemicalsthat neutralize cleaning agents whenperforming:– Surface sampling
– Personnel glove sampling associatedwith MFUs
Sampling for Air Viable Organisms
• Volumetric air sampling isrequired– Predefined amounts of air
• Settling Plates cannot be theonly method of evaluating airviable organisms– Not qualitative– Settling of particles influenced
by size of particle and airmovement
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• Settling Plates cannot be theonly method of evaluating airviable organisms– Not qualitative– Settling of particles influenced
by size of particle and airmovement
Courtesy of MSI, Inc. Houston, TX(www.microbiologyspecialists.com)
Actions to Take When Action Levels Exceeded
• An investigation into the sourceof the contamination must beconducted.
• Sources:– HVAC systems: changes externally
– Damaged HEPA filters
– Changes in personnel garbinghabits
– Changes in work practices
– Failure to follow PnP
– New employees
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• An investigation into the sourceof the contamination must beconducted.
• Sources:– HVAC systems: changes externally
– Damaged HEPA filters
– Changes in personnel garbinghabits
– Changes in work practices
– Failure to follow PnP
– New employees
CFU Identification and Sources
Microorganisms IndicationStaphylococcus/ Micrococcus • Personnel habits or gowning problems
Gram negative rods • Water condensation, leaking, aerosols
Bacillus species • Dust, dirt, floor traffic, possible air handling
Molds • Influx of unfiltered air, mold from streetclothing or mold-contaminated cardboard,water reservoir, i.e. incubator humidificationsystem
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• Influx of unfiltered air, mold from streetclothing or mold-contaminated cardboard,water reservoir, i.e. incubator humidificationsystem
Yeast • Possible outdoor air influx; clothing-borne,especially in late summer/ fall; possiblehuman contaminant
Diptheroids/ coryneforms • Poor air conditioning (leading to sweating andpersonnel discharge from gowns)
Source: Azzur Labs (www.azzurlabs.com)
Facility Inspector Evaluation Metrics
EnvironmentalSampling
Required Frequency in USPChapter <797>
Suggested Best PracticeFrequency
Gloved FingertipSampling(personnel metric)
• Initially during garbing x 3• During MFT every 6 months for
high risk• During MFT annually for
low/medium risk
• Initially during garbing x 3• During MFT weekly for high risk• During MFTs monthly for
low/medium risk
Surface Sampling(personnel metric)
• “Periodic”• SOPs define when, where and
how SS is performed
• Weekly for high risk• Monthly for low/medium risk
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Surface Sampling(personnel metric)
• “Periodic”• SOPs define when, where and
how SS is performed
• Weekly for high risk• Monthly for low/medium risk
Non ViableParticle Counts(facility metric)
• Initial facility commissioning• Every 6 months during recert of
facility and engineering controlsin compounding areas
• As required
Viable VolumetricAir Sampling(facility metric)
• Every 6 months • Weekly for high risk• Monthly for low/medium
Facility Inspector Evaluation Metrics
• Facility Maintenance PnP
• Certification Documents
• Environmental Sampling Plan
• Documentation– Temperature– Pressure/Velocity– Daily ACD Calibration– Annual testing other equipment such as freezers, incubators,
refrigerators, etc according to NIST standards
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• Facility Maintenance PnP
• Certification Documents
• Environmental Sampling Plan
• Documentation– Temperature– Pressure/Velocity– Daily ACD Calibration– Annual testing other equipment such as freezers, incubators,
refrigerators, etc according to NIST standards
Facility Inspector Certification Report Metrics
• Does report reference CETA guidelines?
• Were particle counts performed under dynamic operating conditions?
• Was smoke testing ever performed and if so, was it performed underdynamic operating conditions?
• Was viable air sampling performed in all ISO classed areas?
• Was viable air sampling performed under dynamic operating conditions?
• Was viable air sampling performed based on the pharmacy’sEnvironmental Sampling Plan?
• If viable air sampling was performed, was any growth speciated to thegenus level?
• Is there any evidence that the pharmacy reviewed the VAS results andspeciation and took appropriate actions, if any?
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• Does report reference CETA guidelines?
• Were particle counts performed under dynamic operating conditions?
• Was smoke testing ever performed and if so, was it performed underdynamic operating conditions?
• Was viable air sampling performed in all ISO classed areas?
• Was viable air sampling performed under dynamic operating conditions?
• Was viable air sampling performed based on the pharmacy’sEnvironmental Sampling Plan?
• If viable air sampling was performed, was any growth speciated to thegenus level?
• Is there any evidence that the pharmacy reviewed the VAS results andspeciation and took appropriate actions, if any?
Polling Question
Daily cleaning of a non hazardous primary engineering control(LAFW or CAI) begins with which of these?
1. Sterile 70% IPA2. Germicidal detergent diluted
with tap water3. Germicidal detergent diluted
with SWFIrrig4. Any of these
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1. Sterile 70% IPA2. Germicidal detergent diluted
with tap water3. Germicidal detergent diluted
with SWFIrrig4. Any of these
Polling Question
Daily decontamination and cleaning of a primary engineeringcontrol used for HD compounding (BSC or CACI) begins withwhich of these?
1. Germicidal detergent dilutedwith SWFIrrig
2. Germicidal detergent dilutedwith tap water
3. Dilute bleach or sodiumthiosulfate
4. Sterile 70% IPA
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1. Germicidal detergent dilutedwith SWFIrrig
2. Germicidal detergent dilutedwith tap water
3. Dilute bleach or sodiumthiosulfate
4. Sterile 70% IPA
Cleaning and Disinfection "Shalls”
• Written PnP detailing cleaning agents, non-shedding wipes, mop materials, procedure,frequency and documentation.
• Personnel who perform cleaningsuccessfully complete– Hand hygiene and garbing competency
– Cleaning and Disinfection competency
• Floors and easily cleanable horizontalsurfaces in the buffer area, anteroom andSCA are cleaned daily with designatedcleaning agent
• Walls, ceilings, empty shelving, supply binsare cleanedmonthly with designatedcleaning agent
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• Written PnP detailing cleaning agents, non-shedding wipes, mop materials, procedure,frequency and documentation.
• Personnel who perform cleaningsuccessfully complete– Hand hygiene and garbing competency
– Cleaning and Disinfection competency
• Floors and easily cleanable horizontalsurfaces in the buffer area, anteroom andSCA are cleaned daily with designatedcleaning agent
• Walls, ceilings, empty shelving, supply binsare cleanedmonthly with designatedcleaning agent
Cleaning and Disinfection "Shalls”
• Only trained compounding personnel cleaninside of the ISO Class 5 areas
• ISO Class 5 critical work area disinfected:– Beginning of each work shift
– Between batches
– Every 30 minutes continuous compounding
– After spills
– Anytime contamination is suspected
• Sterile 70% IPA (sIPA) remains in contactwith the surface being disinfected for 10-30seconds and allowed to dry beforecompounding is started
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• Only trained compounding personnel cleaninside of the ISO Class 5 areas
• ISO Class 5 critical work area disinfected:– Beginning of each work shift
– Between batches
– Every 30 minutes continuous compounding
– After spills
– Anytime contamination is suspected
• Sterile 70% IPA (sIPA) remains in contactwith the surface being disinfected for 10-30seconds and allowed to dry beforecompounding is started
Cleaning and Disinfection "Shalls”
• Equipment that is reused is labeled anddedicated according to area of use
• Mops, wipes, etc. are non-shedding
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Polling Question
Where is a germicidal detergent used in daily cleaning?
1. Floors and easilycleanable horizontalsurfaces in buffer area,anterooms and SCAs
2. Floors only in buffer area,anteroom and SCAs
3. All floors, easily cleanablehorizontal surfaces andinside ISO Class 5 spaces
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1. Floors and easilycleanable horizontalsurfaces in buffer area,anterooms and SCAs
2. Floors only in buffer area,anteroom and SCAs
3. All floors, easily cleanablehorizontal surfaces andinside ISO Class 5 spaces
Use of Disinfectants
• Must be germicidal detergent• Dilution of agent is critical to its efficacy• Contact time• Storage conditions: light or temperature sensitive• Follow manufacturer instructions
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Resistance and Rotation of Cleaning Agents
“The development of microbial resistanceto disinfectants is less likely, asdisinfectants are more powerful biocidalagents than antibiotics and are applied inhigh concentrations against lowpopulations of microorganisms usually notgrowing actively, so the selective pressurefor the development of resistance is lessprofound.”“It is prudent to augment the daily use of abactericidal disinfectant with weekly (ormonthly) use of a sporicidal agent.”
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“The development of microbial resistanceto disinfectants is less likely, asdisinfectants are more powerful biocidalagents than antibiotics and are applied inhigh concentrations against lowpopulations of microorganisms usually notgrowing actively, so the selective pressurefor the development of resistance is lessprofound.”“It is prudent to augment the daily use of abactericidal disinfectant with weekly (ormonthly) use of a sporicidal agent.”
Excerpted from USP Chapter <1072> Disinfectants and Antiseptics
Polling Question
USP <797> requires use of sterile water to dilute cleaningagents inside of primary engineering controls?
1. True2. False
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When to use Sterile Water?
• Sterile water (SWInj or SWIrrig) should be usedto dilute disinfectant solutions used inside ofthe ISO Class 5 areas
• Though these areas and cleaning supplies arenot sterile, use of sterile water reducespyrogens and potential bioburden
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• Sterile water (SWInj or SWIrrig) should be usedto dilute disinfectant solutions used inside ofthe ISO Class 5 areas
• Though these areas and cleaning supplies arenot sterile, use of sterile water reducespyrogens and potential bioburden
Type Water CFU/mL* Pyrogens*
Tap Water 500 100 EU/mL
Purified Water 100 0.25 EU/mL
Water for Injection < 10 < 0.25 EU/mL*Sources: USP NF defines standards for Purified water and Water for Injection; US EPA definesdrinking water standards
Establishing a Program
• Work with Infection Controldepartment
• If building new facility, design forcleaning
• Important to understand designand materials of construction– Determine required
materials/equipment– Assess compatibility of agents
• Develop procedure– What, when, where and how– Agent rotation– Consider existing organizational
policies or procedures
• Train personnel to procedure• Document cleaning activities
performed• Monitor adequacy of program
– Environmental sampling– Observation
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• Work with Infection Controldepartment
• If building new facility, design forcleaning
• Important to understand designand materials of construction– Determine required
materials/equipment– Assess compatibility of agents
• Develop procedure– What, when, where and how– Agent rotation– Consider existing organizational
policies or procedures
• Train personnel to procedure• Document cleaning activities
performed• Monitor adequacy of program
– Environmental sampling– Observation
More than Daily* Daily MonthlyISO Class 5 PEC & worksurfaces• Beginning of day/shift• Prior to each batch• Every 30 min• When visibly soiled• As spills occur• Suspect contaminationEmpty trash as needed
Empty trashISO Class 5 PEC**Easily cleanable horizontalsurfaces in ante andcleanrooms (including pass-through counter)Restock daily supply cartFloors from furthestlocation in cleanroom outthru anteroom (includingpass-through floor)
Empty trashCeilingWalls, Pass-throughsEvery surface• Outside of PECs• All carts (top, bottom,
wheels, etc.)• Supply bins• Doors, handles, ventsISO Class 5 PEC**Restock supply cartFloors (same as daily)Clean refrigerators, freezers,incubators, etc.
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ISO Class 5 PEC & worksurfaces• Beginning of day/shift• Prior to each batch• Every 30 min• When visibly soiled• As spills occur• Suspect contaminationEmpty trash as needed
Empty trashISO Class 5 PEC**Easily cleanable horizontalsurfaces in ante andcleanrooms (including pass-through counter)Restock daily supply cartFloors from furthestlocation in cleanroom outthru anteroom (includingpass-through floor)
Empty trashCeilingWalls, Pass-throughsEvery surface• Outside of PECs• All carts (top, bottom,
wheels, etc.)• Supply bins• Doors, handles, ventsISO Class 5 PEC**Restock supply cartFloors (same as daily)Clean refrigerators, freezers,incubators, etc.
* Clean PEC with sterile 70% IPA** Clean with germicidal detergent diluted with SWf Irrigation followed by sterile 70% IPA; use decontamination first agent if HD PECRed represents best practice recommendation; Black indicates 797 required
What’s the same? What’s different?1. Complete hand hygiene & garbing
appropriate to compounding area
2. Cleaning solution is germicidal detergent;sporicidal may be rotated in weekly/monthly
3. Cleaning solution prepared in containerdedicated for use in ISO Class 5 areas &documented
4. All surfaces cleaned with cleaning agentdiluted with sterile water
5. Use low-linting wipes and/or tools dedicatedto ISO Class 5 areas
6. Disinfect all surfaces with sIPA after cleaning
7. Order of cleaning with cleaning agent andIPA:
Ceiling
Back
Sides, IV bar and hooks
Anything in PEC
Deck
LAFW: SameIntegrated VLF: Same except
Surfaces need to be reached with mop Clean/disinfect inside surface of Lexan®
CAI: Same except Surfaces may need to be reached with isolator tool (preferable to
open CAI if in controlled space) Surfaces of ante-chamber are decontaminated and cleaned before
the main chamber and in same order
BSC: If used for HD, same except Add 1st step: deactivate HD residue on all surfaces with appropriate
agent followed by cleaning agent and sIPA Additional surface to decontaminate/clean (inside of the sash view
screen) PPE/trash from decontamination discarded in black RCRA bag; rest
discarded in yellow HD trace trash.
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1. Complete hand hygiene & garbingappropriate to compounding area
2. Cleaning solution is germicidal detergent;sporicidal may be rotated in weekly/monthly
3. Cleaning solution prepared in containerdedicated for use in ISO Class 5 areas &documented
4. All surfaces cleaned with cleaning agentdiluted with sterile water
5. Use low-linting wipes and/or tools dedicatedto ISO Class 5 areas
6. Disinfect all surfaces with sIPA after cleaning
7. Order of cleaning with cleaning agent andIPA:
Ceiling
Back
Sides, IV bar and hooks
Anything in PEC
Deck
BSC: If used for HD, same except Add 1st step: deactivate HD residue on all surfaces with appropriate
agent followed by cleaning agent and sIPA Additional surface to decontaminate/clean (inside of the sash view
screen) PPE/trash from decontamination discarded in black RCRA bag; rest
discarded in yellow HD trace trash.
CACI: If used for HD same except Add 1st step: deactivate HD residue on all surfaces with appropriate
agent followed by cleaning agent and sIPA Surfaces may need to be reached with isolator tool (preferable to
open CACI if in controlled space) Surfaces of ante-chamber are decontaminated and cleaned before
the main chamber and in same order Additional surface to decontaminate/clean (inside of the sash view
screen) PPE/trash from decontamination discarded in black RCRA bag; rest
discarded in yellow HD trace trash.
Inspector Evaluation Metrics: Competency
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Inspector Evaluation Metrics: Cleaning
• Observe staff performing daily clean (if possible)• When you are in the controlled environments check the following:
– Returns– Storage of cleaning agents, supplies and equipment– Inside supply bins– Behind and on sides of hoods
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No roomto clean
Cleaning Logs
• Do forms reflect written policy andprocedure?
• Are written SOPs and forms sufficientlydetailed?
• Are staff trained on PnP?• Are forms complete?• Is monthly cleaning performed at
approximately the same time of month?
• Do forms reflect written policy andprocedure?
• Are written SOPs and forms sufficientlydetailed?
• Are staff trained on PnP?• Are forms complete?• Is monthly cleaning performed at
approximately the same time of month?
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• Do forms reflect written policy andprocedure?
• Are written SOPs and forms sufficientlydetailed?
• Are staff trained on PnP?• Are forms complete?• Is monthly cleaning performed at
approximately the same time of month?
• Do forms reflect written policy andprocedure?
• Are written SOPs and forms sufficientlydetailed?
• Are staff trained on PnP?• Are forms complete?• Is monthly cleaning performed at
approximately the same time of month?
Summary
• Building a compliant facility isn’t enough!• Maintaining the facility and regularly measuring and
adjusting its performance during regular service fromCertification professionals is necessary.
• Vigilance and adherence to proper cleaning and otherwork practices are required to maintain a state ofcontrol.
• Environmental Sampling provides the ongoing evidenceof the effectiveness of the facility, cleaning and workpractices in achieving an environment that is suitablefor compounding sterile preparations.
Copyright © 2008-2014 ClinicalIQ, LLC® - All Rights Reserved
• Building a compliant facility isn’t enough!• Maintaining the facility and regularly measuring and
adjusting its performance during regular service fromCertification professionals is necessary.
• Vigilance and adherence to proper cleaning and otherwork practices are required to maintain a state ofcontrol.
• Environmental Sampling provides the ongoing evidenceof the effectiveness of the facility, cleaning and workpractices in achieving an environment that is suitablefor compounding sterile preparations.
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