BPS Sterile Compounding Exam with all Correct & 100% Verified Answers
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USP - (ANSWER)United States Pharmacopeia
USP 800 - (ANSWER)Hazardous Drugs - Handling in Healthcare Settings
USP 797 pertains purpose - (ANSWER)To prevent harm and death to patients treated with CSPs
USP 797 pertains to - (ANSWER)* preparation, storage and transport of CSPs, NOT administration
* types of preps according to their physical forms, sites & routs of
administration
Responsibility of Compounding Personnel - (ANSWER)Practices & quality assurances required to prepare,
store & transport CSPs that are sterile & acceptably accurate, pure and stable
LOW Risk CSP
Where are they prepared?
What are the requirements?
Frequency of media fill test? - (ANSWER)* ISO Class 5 environment
* No more than 3 sterile products including ingredients, packages,
components & devices (includes administration container/device)
* Only transferring, measuring & mixing
* No more than 2 entries into any one sterile container or package
,BPS Sterile Compounding Exam with all Correct & 100% Verified Answers
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(bag, vial) of sterile product or administration container/device
* Media fill test at least annually
- Incubate at 20-25 or 30-35 Celsius for 14 days
- Can incubate at both 7 days at each temp or total of 14 days
Manipulations of LOW Risk CSP - (ANSWER)* Aseptically opening ampules, penetrating vials with sterile
needles
and syringes
* Aseptically transferring sterile liquids in sterile syringes to sterile
administration devices, package containers of other sterile
products & containers for storage & dispensing
Storage Periods of LOW Risk CSPs in Absence of Sterility Tests
(cannot exceed this time period before administration) - (ANSWER)* Controlled Room Temp 48 hours
* Refrigerated (Cold) 14 days
* Frozen (-25 to -10 degrees C) 45 days
Requirements of LOW Risk Level CSPs with 12 hour BUD
Where can they be prepared?
What type of PEC?
What types of CSPs can be prepared?
,BPS Sterile Compounding Exam with all Correct & 100% Verified Answers
|Latest Version |Already Graded A+
What is BUD - (ANSWER)* PEC is a Compounding Aseptic Isolator (CAI)
* PEC is a Compounding Aseptic Containment Isolator (CACI)
* PEC is a laminar airflow workbench (LAFW) or a biological
safety cabinet (BSC) that cant be located in an ISO 7 buffer area
* Only LOW risk level & NON-Hazardous & radiopharmaceuticals
LOW Risk Level CSPs must meet 4 criteria - (ANSWER)1. *ISO 5 PEC: (LAFW, BSC, CAI, CACI)
* Located in a segregated compounding area (SCA)
* Restricted to sterile compounding activities
2. * SCA must have sealed windows
* SCA must not have doors that connect to outdoors or high
traffic flow
*SCA cannot be adjacent to construction sites, warehouse for
food preparation - not all inclusive
3. * Personnel must follow personnel cleansing/garbing , etc.
* No sinks allowed adjacent to ISO 5 area PEC or device
4. * Must follow proper cleaning/disinfection areas, personnel
training/evaluation of garbing, aseptic work practices,
cleaning/disinfection procedures, viable & non viable
environmental sampling
, BPS Sterile Compounding Exam with all Correct & 100% Verified Answers
|Latest Version |Already Graded A+
MEDIUM Risk Level CSPs
Where are they prepared?
What are the requirements?
Frequency of media fill?
Incubation and duration of media fill? - (ANSWER)* ISO Class 5 environment
* Multiple individual or small doses of sterile products combined or
pooled to prepare a CSP that will be administered to either to
multiple patients or to one patient on multiple occasions
* Prolonged & complex mixing and transfer (other than single
volume transfer)
* More than 3 sterile products & entries into any container
* Pooling ingredients from multiple sterile products to for multiple
CSPs
* Media fill test at least annually
- Incubate at 20-25 or 30-35 Celsius for 14 days
- Can incubate at both 7 days at each temp or total of 14 days
Storage Periods of MEDIUM Risk CSPs in Absence of Sterility Tests
|Latest Version |Already Graded A+
USP - (ANSWER)United States Pharmacopeia
USP 800 - (ANSWER)Hazardous Drugs - Handling in Healthcare Settings
USP 797 pertains purpose - (ANSWER)To prevent harm and death to patients treated with CSPs
USP 797 pertains to - (ANSWER)* preparation, storage and transport of CSPs, NOT administration
* types of preps according to their physical forms, sites & routs of
administration
Responsibility of Compounding Personnel - (ANSWER)Practices & quality assurances required to prepare,
store & transport CSPs that are sterile & acceptably accurate, pure and stable
LOW Risk CSP
Where are they prepared?
What are the requirements?
Frequency of media fill test? - (ANSWER)* ISO Class 5 environment
* No more than 3 sterile products including ingredients, packages,
components & devices (includes administration container/device)
* Only transferring, measuring & mixing
* No more than 2 entries into any one sterile container or package
,BPS Sterile Compounding Exam with all Correct & 100% Verified Answers
|Latest Version |Already Graded A+
(bag, vial) of sterile product or administration container/device
* Media fill test at least annually
- Incubate at 20-25 or 30-35 Celsius for 14 days
- Can incubate at both 7 days at each temp or total of 14 days
Manipulations of LOW Risk CSP - (ANSWER)* Aseptically opening ampules, penetrating vials with sterile
needles
and syringes
* Aseptically transferring sterile liquids in sterile syringes to sterile
administration devices, package containers of other sterile
products & containers for storage & dispensing
Storage Periods of LOW Risk CSPs in Absence of Sterility Tests
(cannot exceed this time period before administration) - (ANSWER)* Controlled Room Temp 48 hours
* Refrigerated (Cold) 14 days
* Frozen (-25 to -10 degrees C) 45 days
Requirements of LOW Risk Level CSPs with 12 hour BUD
Where can they be prepared?
What type of PEC?
What types of CSPs can be prepared?
,BPS Sterile Compounding Exam with all Correct & 100% Verified Answers
|Latest Version |Already Graded A+
What is BUD - (ANSWER)* PEC is a Compounding Aseptic Isolator (CAI)
* PEC is a Compounding Aseptic Containment Isolator (CACI)
* PEC is a laminar airflow workbench (LAFW) or a biological
safety cabinet (BSC) that cant be located in an ISO 7 buffer area
* Only LOW risk level & NON-Hazardous & radiopharmaceuticals
LOW Risk Level CSPs must meet 4 criteria - (ANSWER)1. *ISO 5 PEC: (LAFW, BSC, CAI, CACI)
* Located in a segregated compounding area (SCA)
* Restricted to sterile compounding activities
2. * SCA must have sealed windows
* SCA must not have doors that connect to outdoors or high
traffic flow
*SCA cannot be adjacent to construction sites, warehouse for
food preparation - not all inclusive
3. * Personnel must follow personnel cleansing/garbing , etc.
* No sinks allowed adjacent to ISO 5 area PEC or device
4. * Must follow proper cleaning/disinfection areas, personnel
training/evaluation of garbing, aseptic work practices,
cleaning/disinfection procedures, viable & non viable
environmental sampling
, BPS Sterile Compounding Exam with all Correct & 100% Verified Answers
|Latest Version |Already Graded A+
MEDIUM Risk Level CSPs
Where are they prepared?
What are the requirements?
Frequency of media fill?
Incubation and duration of media fill? - (ANSWER)* ISO Class 5 environment
* Multiple individual or small doses of sterile products combined or
pooled to prepare a CSP that will be administered to either to
multiple patients or to one patient on multiple occasions
* Prolonged & complex mixing and transfer (other than single
volume transfer)
* More than 3 sterile products & entries into any container
* Pooling ingredients from multiple sterile products to for multiple
CSPs
* Media fill test at least annually
- Incubate at 20-25 or 30-35 Celsius for 14 days
- Can incubate at both 7 days at each temp or total of 14 days
Storage Periods of MEDIUM Risk CSPs in Absence of Sterility Tests
