at-rest
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condition of the cleanroom is complete with equipment installed and
operating in a manner agreed upon, but with no personnel present.
How many air changes per hour for ISO 8 Class Rooms?
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The total HEPA-filtered air change rate must be adequate to maintain ISO
Class 8 under dynamic operating conditions considering the factors listed
above
At least 15 ACPH of the total air change rate in a room must come from the
HVAC through HEPA filters located in the ceiling
, Rooms where activity levels are high may require more HEPA-filtered ACPH
to maintain ISO Class 8 air quality under dynamic operating conditions
The total ACPH must be documented on the certification report
Describe an HD sterile compounding setup
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Iso Class 7 buffer room with an iso class 7 ante room, C-PEC (externally
vented) BSC Class II OR A CACI, C-SEC is externally vented, 30 ACPH,
negative pressure 0.01 to 0.03.
DPA
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Direct Processing Area - Radio
Closed System Vial transfer device
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They must be used in an ISO Class 5 BSC or CACI
Who at the facilities is responsible for ensuring that each area related to CSP
preparations meets the classified air quality standard appropriate for the activities to
,be conducted in that area?
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Designated Person
Where can the sink be placed for hand hygiene in a clean room suite?
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inside or outside of the anteroom.
It can be on the clean side or the dirty side of the anteroom
What are requirements of a C-SEC
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externally vented, be physically separated, have appropriate acph, must
have a negative pressure between negative 0.01 and 0.03 inches of water
column relative to adjacent areas
Air sample conversion if less thant 1000 Liters
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Raw Countx1000/sample size taken
, Placement of RABS
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If used to prepare only Category 1 CSPs, the ISO Class 5 environment may
be achieved by placing the RABS in an unclassified SCA. If used to prepare
Category 2 or Category 3 CSPs, the RABS must be located within a
cleanroom suite with an ISO Class 7 or better buffer room with an ISO
Class 8 or better anteroom. For placement of a CACI used for the
preparation of antineoplastic and/or API HDs, see á800ñ
CAG 002:2008
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CAG for testing compounding isolators
Media Fill Testing Procedure
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Simulate compounding activities if sterile to sterile use soybean-casein
digest media, if non sterile use commerically available nonsterile soybean-
casein digest powder to make a 3% non-sterile solution. Preparer at least 1
container as a positive control.
Once compounding simulations are completed perform gloved fingertip
and thumb sampling on each hand and surface sample of DCA inside the
PEC. Take samples prior to disinfecting.
Incubate 20-25 and 30-35 for a minimum of 7 days at each temperature.
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condition of the cleanroom is complete with equipment installed and
operating in a manner agreed upon, but with no personnel present.
How many air changes per hour for ISO 8 Class Rooms?
Give this one a try later!
The total HEPA-filtered air change rate must be adequate to maintain ISO
Class 8 under dynamic operating conditions considering the factors listed
above
At least 15 ACPH of the total air change rate in a room must come from the
HVAC through HEPA filters located in the ceiling
, Rooms where activity levels are high may require more HEPA-filtered ACPH
to maintain ISO Class 8 air quality under dynamic operating conditions
The total ACPH must be documented on the certification report
Describe an HD sterile compounding setup
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Iso Class 7 buffer room with an iso class 7 ante room, C-PEC (externally
vented) BSC Class II OR A CACI, C-SEC is externally vented, 30 ACPH,
negative pressure 0.01 to 0.03.
DPA
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Direct Processing Area - Radio
Closed System Vial transfer device
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They must be used in an ISO Class 5 BSC or CACI
Who at the facilities is responsible for ensuring that each area related to CSP
preparations meets the classified air quality standard appropriate for the activities to
,be conducted in that area?
Give this one a try later!
Designated Person
Where can the sink be placed for hand hygiene in a clean room suite?
Give this one a try later!
inside or outside of the anteroom.
It can be on the clean side or the dirty side of the anteroom
What are requirements of a C-SEC
Give this one a try later!
externally vented, be physically separated, have appropriate acph, must
have a negative pressure between negative 0.01 and 0.03 inches of water
column relative to adjacent areas
Air sample conversion if less thant 1000 Liters
Give this one a try later!
Raw Countx1000/sample size taken
, Placement of RABS
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If used to prepare only Category 1 CSPs, the ISO Class 5 environment may
be achieved by placing the RABS in an unclassified SCA. If used to prepare
Category 2 or Category 3 CSPs, the RABS must be located within a
cleanroom suite with an ISO Class 7 or better buffer room with an ISO
Class 8 or better anteroom. For placement of a CACI used for the
preparation of antineoplastic and/or API HDs, see á800ñ
CAG 002:2008
Give this one a try later!
CAG for testing compounding isolators
Media Fill Testing Procedure
Give this one a try later!
Simulate compounding activities if sterile to sterile use soybean-casein
digest media, if non sterile use commerically available nonsterile soybean-
casein digest powder to make a 3% non-sterile solution. Preparer at least 1
container as a positive control.
Once compounding simulations are completed perform gloved fingertip
and thumb sampling on each hand and surface sample of DCA inside the
PEC. Take samples prior to disinfecting.
Incubate 20-25 and 30-35 for a minimum of 7 days at each temperature.
