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MPJE > USP 797 and 800 > Flashcards

USP 797 and 800 Flashcards

1
Q

What does USP 797 cover?

A

This chapter covers STERILE compounding.

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2
Q

What does USP 795 cover?

A

NON-STERILE compounding

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3
Q

What does USP 800 cover?

A

HAZARDOUS materials

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4
Q

What are some examples of engineering controls?

A

Compounding hoods and cleanrooms that maintain air quality standards in order to safely compound sterile products.

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5
Q

What does CSP stand for?

A

Compounding Sterile Preparation (ex. an IV antibiotic prepared in a hospital pharmacy

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6
Q

What’s a PEC?

A

Primary Engineering Control. A PEC is a device or room that provides an ISO Class 5 environment for compounding CSPs. For example, “the hood” or “the bench” where sterile compounding takes place.

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7
Q

What’s a SEC?

A

It stands for Secondary Engineering Control. A SEC provides clean air around a PEC. This is another layer of protection to keep the product being compounded clean.

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8
Q

What are some examples of SECs?

A

Buffer area: this is the clean room that the PEC (the hood) is placed in. Also called the buffer room
Ante area: this is the area in front of the buffer area also called the ante room

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9
Q

What is the ante room used for?

A

Handwashing, garbing, product decontamination

Provides another layer of protection for the buffer room

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10
Q

What is the buffer room used for?

A

This is where the actual compounding takes place. The PEC is inside the buffer room.

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11
Q

Can you have sinks or floor drains in the buffer area?

A

No

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12
Q

What’s the difference between “open architecture” and “closed architecture”?

A

Open has openings between the buffer and ante areas, for example separations shown only by markings on the floor. Closed architecture has walls and doors, no open spaces. Certain types of low-risk and medium-risk compounding of non-hazardous drugs may be done in open architecture. But hazardous drugs always must be compounded in a space with closed architecture.

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13
Q

What’s the difference between a C-PEC and a PEC? Between a C-SEC and a SEC?

A

The C stands for “containment” the purpose is to protect workers from hazardous drugs. Sterile compounding containing hazardous drugs are prepared in a C-PEC within a C-SEC. Sterile non-hazardous drugs are compounded in a PEC within a SEC.

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14
Q

What is the ISO classification system for air quality in clean rooms?

A

There are a total of 9 ISO classes. ISO class 1 is the “cleanest” and ISO Class 9 is the “dirtiest.”

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15
Q

What are some important ISO Classes for pharmacists to know?

A
  1. ISO Class 5 - hoods (PECs and C-PECs)
  2. ISO Class 7 - buffer rooms (and ante rooms for hazardous drugs)
  3. ISO Class 8 - ante rooms for non-hazardous drugs (SECs)
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16
Q

When testing compounding areas, what are three things that the testing company needs to test to determine if the room is meeting air quality standards?

A
  1. non-viable airborne particles
  2. viable airborne particles
  3. viable surface particles
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17
Q

How does a testing company test for non-viable airborne particles?

A

with electronic air samplers

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18
Q

How does a testing company test for viable airborne particles?

A

They set out agar plates and then incubates the plates to see if colonies of bacteria form

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19
Q

How does a testing company test for viable surface particles?

A

They take swab samples from surfaces where compounding occurs and from the buffer area and the ante room. They swab these samples onto petri dishes and wait to see if colonies form.

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20
Q

What are some examples of PECs?

A
  1. LAFW - laminar airflow workbench
  2. BSC - biological safety cabinet
  3. CAI - compounding aseptic isolator
  4. CACI - compounding aseptic containment isolator
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21
Q

What are conventional PECs that must always be used within a Class 7 buffer room?

A

LAFW - laminar airflow workbench and BSC- biological safety cabinet

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22
Q

What is the difference in a LAFW and a BSC?

A

LAFW keeps the compounded product clean but doesn’t protect the worker. Air is flowing across the product so particles of a HD may reach the person compounding. A BSC has a barrier between the worker and the product to reduce exposure to HD.

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23
Q

What types of isolators can be used outside of the buffer room if they are clean enough? What are the requirements for using outside?

A

CAI- compounding aseptic isolator
CACI - compounding aseptic containment isolator
Requirements are it has to maintain ISO class 5 air quality at all times, including when products are transferred into and out of the box.

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24
Q

What’s the difference in a CAI and a CACI?

A

The extra C stands for containment. HD has to be compounded in a CACI instead of a CAI.

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25
Q

Is there any other way to do sterile compounding without a buffer room?

A

Yes, you can use a PEC within a Segregated Compounding Area for low-risk compounding of non-hazardous drugs. This setup is sometimes used at small hospitals or clinics. These compounds expire quickly - their expiration date is only 12 hours after compounding.

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26
Q

What is “negative pressure”? Give some examples.

A

Lower pressure than surrounding areas. Negative pressure rooms are vented to the outside. Air flows into a negative pressure area. Examples that should be negative pressure:

  1. A receiving area where HD are unpacked
  2. A storage area for HD
  3. a C-SEC for HD (the clean room where compounding of HD takes place)
    * *** HD must be handled in negative pressure areas
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27
Q

What is “positive pressure”?

A

Higher pressure than the surrounding areas.
Examples:
1. a SEC (cleanroom where non-HD are compounded)
2. the ante room in front of the C-SEC where HDs are compounded

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28
Q

What is the purpose of positive pressure?

A

Positive pressure protects the product! Air flows out of the space, taking particles with it. Particles from the outside don’t get in.

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29
Q

What is the purpose of negative pressure?

A

Negative pressure keeps hazardous drugs contained. Air flows into the space, so hazardous particles can’t spill out into the surrounding areas.

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30
Q

Should a buffer room be positive or negative?

A

Positive if it is used for non-HD

Negative if it is used for HD

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31
Q

How often do you need to clean an ISO Class 5 PEC?

A
  1. at the beginning of every shift
  2. before every batch
  3. every 30 minutes while compounding
  4. after spills
  5. when surface contamination is known or suspected
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32
Q

How often do you clean the counters, surfaces and floors?

A

daily

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33
Q

How often do you need to clean the walls, ceilings and storage shelving?

A

monthly

34
Q

To prevent contamination of CSPs, the compounding environment needs to be routinely monitored. What elements of the environment need to be monitored? How often does environmental monitoring need to happen?

A
  1. viable and nonviable air particles
  2. viable and nonviable surface particles
  3. positive and negative air pressure
  4. temperature

When a new facility opens, and every 6 months thereafter.

35
Q

What needs to be monitored daily?

A

Temperature and pressure differential

36
Q

How often do you have to test the facility?

A

Every 6 months, usually hospitals have a testing company come in and do this

37
Q

What is acceptable pressure for a positive pressure room?

A

At least 5 Pa

38
Q

What is acceptable pressure for a negative pressure room?

A

USP 800: 0.01-0.03 in of water column

USP 797: no less than 2.5 Pa

39
Q

Describe compounding conditions for a low-risk CSP

A
    • CSPs are prepared using sterile technique in an ISO Class 5 PEC
    • The PEC is an ISO Class 7 buffer area (SEC), with class 8 or better ante room
    • Everything is clean - aseptic technique, disinfected containers, sterile needles and syringes
    • Each container is only entered TWICE max, including the final container!!
40
Q

Describe compounding conditions for a low-risk CSP with a 12 hour BUD.

A

Same as for regular low-risk compounds except the PEC is located in a segregated compounding area instead of a class 7 buffer area.

41
Q

Describe the compounding conditions for a medium-risk CSP.

A

Medium risk CSPs are made in the same sterile conditions as low-risk CSPs, however medium risk CSPs are more complicated. Examples:

    • Multiple doses, to be used by multiple patients
    • Multiple doses, to be used by one patient on multiple occasions
    • More than three sterile products are used to produce the compound
    • More complex compounding processes such as TPN
42
Q

Describe compounding conditions for a high-risk CSP

A

High risk is rare. Before administering a high-risk preparation to a patient, it MUST be terminally sterilzed by heat or filtration.

43
Q

What is an immediate use CSP?

A

This is a special category for products compounded immediately before use. These products are only used in situations where following the usual low-risk compounding procedures would delay patient care.

44
Q

What does an immediate-use CSP need to be labeled with?

A
  1. ingredients
  2. patient’s name
  3. 1 hr BUD
45
Q

After a pharmacy bulk package is opened how long is it good for?

A

6 hours, within an ISO class 5 environment

46
Q

After a multiple-dose vial is opened, how long is it good for?

A

28 days

47
Q

How long after making a batch of high-risk CSPs do you need to sterilize them?

A

– no more than 6 hrs, if they are kept at room temp
– no more than 12 hrs if refrigerated
If you wait longer than this, you need to sterilize them AND conduct sterility testing

48
Q

What are the steps in hand hygiene?

A
  1. washing - up to elbows and under fingernails
  2. drying
  3. sanitizing with an alcohol based hand rub
49
Q

What are the steps in garbing?

A

HINT: it goes “dirtiest” to “cleanest”

  1. Shoe covers, hair and beard covers and mask
  2. Hand hygiene
  3. Gown
  4. Sanitize hands
  5. Enter buffer area
  6. gloves
  7. sanitize gloves w/70% isopropyl alcohol and let dry
50
Q

How do you make sure items are clean before putting them in the PEC (hood) for compounding?

A

Items in foil or plastic overwrap are unwrapped right before putting them in the PEC. Items that are not wrapped are decontaminated (alcohol wipes) prior to putting them in the PEC.

51
Q

What is required to be on the label of a CSP?

A
  1. amount and concentration of active ingredients
  2. BUD, including time
  3. Storage requirements
  4. Responsible compounding personnel (for example, the tech who made it and pharmD who checked it)
52
Q

What additional information needs to be on the label of a batch-prepared CSP?

A
  1. control or lot number
  2. appropriate auxiliary labeling
  3. device-specific instructions where appropriate
53
Q

If a CSP is prepared for a patient, then not used, can it be redispensed to another patient?

A

Yes, but this can only be done by a compounding personnel.

54
Q

To avoid contamination, compounding personnel need to demonstrate competency regularly. How often should compounding personnel be tested?

A
  • for low and medium-risk compounding, every 12 months
  • for high risk compounding every 6 months
  • all compounding personnel are also tested when they are first hired
55
Q

USP 797 requires two assessments to test compounding personnel’s sterile technique. What are these two tests?

A
  1. Media- Fill testing: mimics the most challenging compounds made at the facility. the final product is incubated to see if anything grows, if there is growth it means the person doing compounding accidentally contaminated the product.
  2. Glove fingertip testing: The person being tested performs hand hygiene and garbing procedures except for the last step. They press their gloved fingers and thumbs onto agar plates, if anything grows they did not pass.
56
Q

How often do personnel need to pass a glove fingertip test?

A

three times when they are first hired.

57
Q

How often does a pharmacy need to review its list of HDs?

A

at least once a year

58
Q

Hazardous drug safety is promoted using a combination of facilities controls and engineering controls. What are some examples of facilities controls?

A
  1. signs posted indicating where HD handling areas are
  2. separate area for receiving, storing and compounding HDs
  3. restricted access to areas where HDs are handled
  4. negative pressure areas
59
Q

What is a CSTD?

A

Closed System Transfer Device : supplementary control that helps to keep HD contained while they are being manipulated in order to protect pharmacy personnel

60
Q

What are the requirements for HD storage areas?

A

negative pressure, externally vented and at least 12 ACPH (air changes per hour)

61
Q

Can you store HD in the sterile compounding area?

A

NO

62
Q

Can you store HD in the refrigerator with other non-HD?

A

NO

63
Q

Can the facility write a policy saying all HD tablets will be handled the same way, for example, using gloves?

A

NO, each drug must be addressed in a separate assessment of risk.

64
Q

What stations should the HD compounding area have?

A
  1. a handwashing station
  2. an eye-wash station
  3. sinks and drainsmust be at least 1 meter away from the C-PEC
65
Q

What are the requirements for the C-PEC (hood) for non-sterile HD compounding?

A

Externally vented is preferred, but it may have redundant-HEPA filters in series instead.

66
Q

What are the requirements for C-SEC (clean room) for non-sterile HD compounding?

A

externally vented, 12 ACPH, negative pressure

67
Q

What is the difference between a Class I and Class II BSC?

A

Class I BSC (Biological Safety Cabinet) only protects one thing- the user. Contaminated air is flowing away from the user so the HD don’t reach him or her.
Class II BSC protects two things the user and the product. Clean air flows in (to protect the product) and contaminated air flows out (to protect the user)

68
Q

Can you do sterile compounding in a containment ventilated enclosure?

A

No, the only time you would use a CVE is to do non-sterile HD compounding. It only protects the user.

69
Q

What are the requirements for the C-SEC (clean room) for sterile HD compounding?

A

externally vented, 20 ACPH, ISO class 7 buffer room - negative pressure, ISO class 7 ante room - positive pressure

70
Q

What are the requirements for the C-PEC (hood) for sterile HD compounding?

A

It MUST be externally vented!

71
Q

How often do you need to do environmental wipe sampling? (to see if HD residue is on surfaces)

A

When the HD compounding area is first built and every 6 months.

72
Q

What PPE (Personal Protective Equipment) is required for compounding non-sterile HDs?

A

The same is required for all: Gown, head, hair and shoe covers, two pairs of chemotherapy gloves

73
Q

What are some examples of times when you would need to use a respirator when handling HDs?

A
  1. unpacking HD that are NOT contained in plastic
  2. cleaning HD spills larger than what can be contained with a spill kit
  3. deactivating, decontaminating and cleaning underneath the work surface of a C-PEC
  4. known or suspected exposure to airborne particles or vapors
74
Q

What are the components of a HD Communication Program under USP 800?

A
  1. a written plan describing how the standard will be implemented
  2. all containers of hazardous chemicals are labeled and have appropriate warnings
  3. a SDS is available for each HD used
  4. personnel who might be exposed to HD are given info and training before working with the chemical and whenever the hazard changes
  5. personnel of reproductive capability must confirm in writing that they understand the risks of working with HDs
75
Q

What are some rules for dispensing HDs that are in final dosage forms (such as tablets) that only need counting or repackaging?

A

use dedicated equipment for counting and repackaging, decontaminate equipment after each use, no special containment is needed, unless required by the manufacturer

76
Q

Can you put HD tablets into automated counting or packaging machines?

A

Antineoplastic HDs can’t go into these machines because it might create powdered contaminants.

77
Q

Name two things you must do to keep the HD compounding area clean.

A
  1. Put a plastic-backed mat onto the C-PEC work surfae at the beginning of the day and discard at the end of the day.
  2. Use dedicated equipment for HDs and decontaminate at the end of each use
78
Q

What are the rules for administering HDs?

A
    • Use CSTDs (Closed System Transfer Devices) whenever possible.
    • Wear appropriate PPE and dispose of as hazardous waste when you are done
    • Use protective devices and techniques
79
Q

What are some examples of protective medical devices?

A

needleless systems and closed systems

80
Q

What are some examples of protective techniques?

A

priming or spiking IV tubing with a non-HD solution such as 0.9% saline and crushing tablets in a plastic pouch

MPJE (11 decks)

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