542 - Drug Delivery Systems Ii Lab - Sterile Products Exam - Usp Chapter <797>

Front 1

What is a compounded sterile preparation (CSP)?

Back 1

Any compounded:
Biologic, diagnostic, drug, nutrients, radiopharmaceutical

Front 2

What is the justification for 797?

Back 2

USP Chapter 797 evolved over a number of years as a means of addressing compounding practices as sources of infections

Front 3

Which 797 chapters are enforceable by the FDA?

Back 3

General chapters numbered <1> to <999>

Front 4

What 797 chapter are not enforceable?

Back 4

General chapters <1000> to <1999> are considered informational and not enforceable

Front 5

Which 797 chapters pertain to nutritional substances?

Back 5

Chapters greater than <2000>

Front 6

True or False

The least expensive changes by USP <797> typically tend to be the most effective in reducing CSP contamination and inaccuracy

Back 6

True

Front 7

What are the exceptions to the <797> risk level assessment?

Back 7

Immediate Use and Low Risk with <12 hr or less BUDs

Front 8

Describe the compounding techniques and requirements for Low-Risk Level drugs

Back 8

- All are compounded using aseptic techniques using sterile ingredients
- Limited to using not more than 3 commercially manufactured products
- Manipulations with low risk CSP's are limited opening, penetrating stoppers, transferring and packaging for storage and dispensing

Front 9

BUD for Low Risk Level

Back 9

48 hours (at room temperature)
14 days (refrigerated)
45 days (frozen)

Front 10

Low Risk Level with <12 hour BUD

Back 10

-to accommodate satellite pharmacies compounding only low risk level CSPs
-compounding of hazardous drugs are not permitted
-low risk level CSPs do not require the ISO class 7 clean room or buffer area and only require an ISO class 5 hood
-Area needs to be segregated from other parts of the pharmacy and designated for use as a compounding area
-personnel shall follow cleaning and garbing requirements
-sings should not be placed adjacent to the ISO class 5 hood

Front 11

Medium Risk level

Back 11

-utilized in bulk quanitites
-aseptic manipulations using only sterile ingredients
-intended for multiple patients or for one patient for multiple occasions
-more complex than low risk compounding
-may require unusually long duration such as that require to complete dissolution or homogenous mixing
-no bacteriostat and administered over several days

Front 12

BUD Medium Risk level

Back 12

30 hours (room temperature)
9 days (refrigerated)
45 days (frozen)

Front 13

High risk Level

Back 13

-prepared from non-sterile ingredients
-these CSPs are either contaminated or at high risk for being contaminated
-sterilization occurs after compounding
-if the components is assumed but not verified by documentation such as with bulk ingredients where a certificate of analysis is available

Front 14

Examples of High Risk Level

Back 14

-Compounding using non-sterile water that will not be sterilized within 6 hours of being compounded
-sterile ingredients that are exposed to air quality that is worse than ISO class 5 for more than 1 hour
-CSPs compounded (or exposed to) personnel that are not properly garbed and gloved

Front 15

BUD High risk level

Back 15

24 hours (room temp)
3 days (refrigeration)
45 days (frozen)

Front 16

Immediate use category

Back 16

-Immediate use compounds are exempt from ALL requirements in <797> and is intended for situations where there is a need for emergency or immediate patient administration (examples include: cardiopulmonary resuscitation, emergency room treatment, preparation of diagnostic agents)
-the intent is that once compounding begins that there are no delays or interruptions of the process all the way to administration to the patient
-the dose must be discarded if the administration has not begun within 1 hour, the dose must be labeled if not administered by the preparer

Front 17

Low Risk CPCs that qualify for immediate use category

Back 17

-only simple aseptic measuring and transfer are needed
-only non-hazardous products or diagnostic radiopharmaceutical products are used
-not more than two entries into any one container or package prepared
-aseptic is followed during preparation
-administration begins within 1 hour of the start or preparation

Front 18

Low risk 12 hour BUD

Back 18

12 hour (room temperature)
12 hour (refrigeration)

Front 19

Immediate use BUD

Back 19

1 hour (room temperature)
1 hour (room temperature)

Front 20

What are the facility design requirements?

Back 20

-must have an ISO class 5 environment as a PEC for critical site exposure. Laminar airflow workbenches, BSCs, CAIs, and CACIs are common ISO class 5 environments

-The compounding area must be separate from activities not essential to CSP preparation and must be a controlled particle (particle, temperature) environment

-Must have an ISO class 7 environment for buffer area or cleanroom
-must have an ISO class 8 environment for anteareas

-Buffer areas physically separated from ante areas must have a positive pressure differential; if no physical separation is present displacement airflow principles be used (high airflow velocity, low pressure differential)

-high risk compounding is not eligible for displacement airflow, a physical separation must exist between buffer room and anteroom

-Must have adequate ACPHs to maintain appropriate ISO class, ACPH May be improved upon by PECs that recirculate air between the room and the PEC itself

Front 21

Three primary environmental areas are:

Back 21

Direct Compounding Area (cleanest)
Primary engineering control (PEC) (clean)
Buffer Area and the Ante Area (dirty)
The rest of the pharmacy (dirtiest)

Front 22

Environmental and engineering controls

Back 22

Placement of non-essential items within buffer and ante areas is determined by the impact on environmental quality as verified by monitoring

PECs must be physically located within an ISO class 7 buffers

Front 23

Environmental testing

Back 23

Environmental monitoring must be routinely performed to prove that the compounding environment is properly maintained
-documentation that proves control is required
-must conduct regular surface sampling to test for adherence to cleaning and disinfecting procedures

Front 24

Cleaning procedures

Back 24

-there must be detailed cleaning and sanitizing procedures for ISO class 5 PECs in or to maintain the cleanliness of the direct compounding area
-buffer area and ante area ceilings , walls, and shelving must be cleaned monthly, while counters, work surfaces, and floors must be cleaned daily
-Visual observation of cleaning and disinfecting techniques for all compounding and non-compounding personnel must occur specified intervals

Front 25

Prior to entering buffer area or segregated compounding area

Back 25

Remove all personal outer garments
-remove cosmetics
-remove jewelry from hands, wrists, or any other visible body parts
-no artificial nails allowed
-Don PPE in the following:
1. dedicated shoes or shoes covers
2. head and facial covers
3. face masks/eye shield
4. perform hand cleansing procedures
5. non-shedding gown

Front 26

What do you do upon entering buffer area or segregated compounding area?

Back 26

1) Antiseptic hand cleansing with surgical scrub
2) Don sterile powder-free gloves

Front 27

Personnel training and competency testing

Back 27

In addition to media fill testing, subjects matter areas of garbing, aseptic technique, achieving and maintaining various ISO class conditions and cleaning and disinfection techniques must be included in training procedures and competency evaluations
-gloved fingertip sampling and witnessed handwashing and garbing for all compounding personnel competency assessments
-competencies, didactic training, written examinations, media fill testing, and gloved fingertip testing must be repeated on an annual or semiannual basis for low and medium risk and high risk level compounding respectively

Front 28

Finished preparation release checks and tests

Back 28

-physical visual inspection for preparation integrity, absence of cores, other particulate matter, phase changes and discoloration
-verification of compounding accuracy conducted someone other than the compounded to ensure proper measurement, reconstitution and component usage
-high risk level CSPs in groups of >25 must be tested according to USP chapter <71> sterility test and <85> bacterial endotoxin test
-low and medium risk level CSPs that exceed the USP chapter guidelines for BUD must be tested according to USP Chapter <71>
-Accurate labeling and determination of correct fill volumes or quantities are outlined in written procedures

Front 29

What are the 13 issues addressed in <797>?

Back 29

1) The responsibility of compounding personnel to ensure that CSPs are prepared, stored, dispensed, and distributed safely
2) Contamination risk levels
3) Procedures to verify the accuracy and sterility of CSPs
4) Personnel training and evaluation
5) Verification of Automated Compounding Devices (ACDs)
6) Environmental quality and control
7) Checks and tests of finished preparations before dispensing
8) Storage and beyond-use dating
9) Product quality and control after the CSP leaves the pharmacy
10) Patient or caregiver training so they can store, administer, and dispose of the CSP
11) Patient monitoring to track their response to the therapy
12) The need for a feedback mechanism so patients and caregivers can report concerns about CSPs
13) A quality assurance program that documents CSP policies, processes, and procedures

Front 30

List the steps towards 797 compliance

Back 30

1) Educate yourself on the new standards
2) Determine CSP risk level
3) Complete revised gap analysis to determine level of current compliance
4) Develop action plan
5) Prioritize action items
6) Report gap analysis results and action plan to staff
7) Assign action plan items and timelines to specific employees
8) Document all action plan progress
9) Continually reassess for compliance

Front 31

True or False

Not all sterile compounds are assigned a risk level

Back 31

False

Front 32

True or False

When making a low-risk drug product, it is acceptable to use more than 3 commercially available products

Back 32

False

No MORE than 3 products can be used

Front 33

True or False

Low-Risk Level with <12 Hr BUDs only require a ISO Class 5 hood for compounding

Back 33

True

Front 34

True or False

USP Chapter <608> outlines all pertinent safety rules for compounding sterile products

Back 34

False

What's the title of this card set called?

Front 35

True or False

Medium Risk level products can be made from non-sterile products

Back 35

False

Only High Risk products are made from non-sterile products

Front 36

True or False

Immediate-Use products cannot contain more than 1 product

Back 36

False

They can contain UP to 2

Front 37

True or False

PECs must be physically located within an ISO Class 7 buffer area

Back 37

True