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Sterile Products > Test 1 > Flashcards

Test 1 Flashcards

1
Q

Section 503-A

A

traditional pharmacy practice is allowed to compound as long as it operates within the patient, physician, and pharmacist (in a licensed pharmacy) triad; facilities are exempt from the following sections of the federal Food, Drug, and Cosmetic Act:

  • 501(a)(2)(B): current Good Manufacturing Practices
  • 502(f)(1): labeling requirements (no package insert with product)
  • 505: compounded preparations do not have to have FDA approval
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2
Q

Section 503-B

A

outsourcing facilities must register with the FDA and be inspected by the FDA to ensure that they are following current Good Manufacturing Practices as stated in Section 501 (a)(2)(B); all of their products must be compounded by or under the direct supervision of a licensed pharmacist; outsourcing facilities are exempted from the following sections of the Food, Drug, and Cosmetic Act of 1938:

  • 502(f)(1): labeling requirements (no package insert with product)
  • 505: compounded preparations do not have to have FDA approval
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3
Q

Who inspects licensed pharmacies for compliance with USP Chapter 797?

A

state boards of pharmacy

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4
Q

aseptic processing (technique)

A

a mode of processing pharmaceutical and medical products that involves the separate sterilization of the product and of the package (containers - closures or packaging material for medical devices) and the transfer of the product into the container and its closure under at least ISO Class 5 conditions

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5
Q

preparation

A

also called a CSP; a sterile drug or nutrient compounded in a licensed pharmacy other healthcare-related facility pursuant to the order of a licensed prescriber; the article may or may not contain sterile products

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6
Q

product

A

a commercially manufactured sterile drug or nutrient that has been evaluated for safety and efficacy by the FDA; products are accomplished by full prescribing information, which is commonly known as the FDA-approved manufacturer’s labeling or product package insert

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7
Q

purpose of USP 797

A

describe conditions and practices to prevent harm, including death to patients that could result from the following:

  • microbial contamination (non-sterility)
  • excessive bacterial endotoxins
  • variability in the intended strength of correct ingredients that exceeds either monograph limits for official articles
  • unintended chemical and physical contaminants
  • ingredients of inappropriate quality in compounded sterile preparations
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8
Q

Who must comply with USP Chapter 797 standards?

A

They apply to everyone who compounds sterile products and the facilities in which that occurs, including hospitals and other institutions, patient treatment clinics, pharmacies, and physicians’ practice facilities

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9
Q

CSP

A

compounded sterile product/preparation; dosage forms that must comply with USP Chapter 797 include:

  • aqueous bronchial and nasal inhalation
  • baths and soaks for live organs and tissues
  • injections (ex. collodial dispersions, emulsions, solutions, suspensions)
  • irrigations for wounds and body cavities
  • ophthalmic drops and ointments
  • tissue implants
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10
Q

ISO

A

International Organization of Standards; defines the level of airborne particulate cleanliness in terms of ISO Class #

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11
Q

ISO level for inside the Primary Engineering Control

A

ISO 5

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12
Q

ISO level for sterile non-hazardous drug preparation in the buffer room

A

ISO 7

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13
Q

ISO level for sterile hazardous drug preparation in the buffer room

A

ISO 7

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14
Q

ISO level for sterile non-hazardous drug preparation in the ante room

A

ISO 8

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15
Q

ISO level level for sterile hazardous drug preparation in the ante room

A

ISO 7

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16
Q

ante room

A

room that connects to one or more buffer rooms and the rest of the pharmacy
design requirements:
- ceiling must be sealed, and lighting fixtures must be covered; nothing can be hanging down; must be washable
- walls must be smooth and painted with a special paint that can be washed often
- floors must be one solid sheet - any seams must be sealed properly and also smooth; should be covered at the walls
- shelving, cabinets, and counters cannot be made of wood, they should be able to be cleaned; bins should be limited
- work surfaces and carts should be stainless steel
- sinks should be touchless automatic or operated using foot pedals
- air change per hour should not be less than 20
- ISO Class 7 or 8 depending on the type of sterile compounding being done
activities that occur:
- removal of personal outer garments; certain jewelry, cosmetics, and other items banned from the buffer room
- donning of dedicated shoes or shoe covers, head and facial hair covers, and face masks/eye shields
- hand and forearm cleansing
- donning of gown designated for buffer area use (non-shedding with sleeves that fit snugly around the wrist and enclosed at the neck)

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17
Q

buffer room

A

contains the PEC and connects to an ante room
design requirements:
- same as ante room except there should be no sources of running water or floor drains (air flow per hour should be not less than 30)
activities that occur:
- application of waterless alcohol-based surgical hand scrub
- donning of sterile gloves
- actual compounding activities

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18
Q

SCA

A

sterile compounding area; non-classified space or room equipped with a PEC of ISO Class 5; should be away from unsealed windows, doors that connect to the outdoors, and significant traffic flow; cannot be located adjacent construction sites, warehouses, food preparation areas, or other environmental control challenges
- only used for compounding low-risk CSPs with a 12-hour BUD

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19
Q

conventional LAFW (laminar airflow workbench)

A
  • horizontal air flow
  • non-hazardous sterile compounding
  • uses positive pressure
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20
Q

isolator CAI

A

compounding aseptic isolator; “glove box”: front portion is like an ante room with a window to the back portion that serves like a buffer room - operator puts hands through fixed gloves to manipulate things inside the box

  • non-hazardous sterile compounding
  • uses positive pressure
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21
Q

conventional BSC

A

biological safety cabinet

  • vertical air flow
  • hazardous sterile compounding
  • uses negative pressure
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22
Q

isolator CACI

A

compounding aseptic containment isolator

  • “glove box”
  • hazardous sterile compounding
  • uses negative pressure
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23
Q

airflow in the PECs

A

all PECs have a HEPA filter to maintain ISO Class 5 conditions with laminar flow that can be either horizontal or vertical

  • air should move at 90 feet +/- 20 feet per minute
  • PECs for nonhazardous compounding have positive pressure to keep contaminants out; air from the PEC exits to the buffer room to become room air that is recycled through the HEPA filter before re-entering the PEC
  • PECs for hazardous sterile compounding have negative pressure to keep hazardous substances from contaminating the outside area; air from the PEC exits the building
  • PECs should be placed in an ISO Class 7 buffer room unless it is an isolator with documentation from the manufacturer
24
Q

items that should not be brought into the sterile compounding area

A
  • food, gum, and/or beverages
  • any materials exposed in patient care and treatment areas
  • items that are to be removed as part of personnel cleansing and garbing
  • persons experiencing rash, sunburn, weeping sores, conjunctivitis, or an active respiratory infection
25
Q

personal items to be removed prior to entering the sterile compounding area

A
  • outer garments (jackets, scarves, etc.)
  • watches
  • jewelry (including exposed piercings)
  • makeup/cosmetics
  • nail polish and/or artificial nails or nail extenders (natural nails should be neat and trimmed)
26
Q

Where does personnel cleansing and garbing occur?

A

ante room

27
Q

proper hand/forearm cleansing procedure

A

Remove debris from underneath fingernails using a nail cleaner under running warm water.
Vigorously wash hands and forearms to elbows for at least 30 seconds with soap and water.
- rub palms and back of hands
- in between fingers using interlaced hands
- backs of fingers against opposing palms
- around each finger
- fingertips into palms in a circular motion
- from wrist to elbow using a “C” hand in a back-and-forth motion as you move down
Use of scrub brushes is not recommended as they can cause microtears and/or bleeding
Dry hands and forearms with lint-free disposable towels always moving from fingers to elbow - never back up (while drying, keep hands and arms so that water drips down from hands towards elbows)

28
Q

garbing procedure

A

“dirtiest to cleanest”
in the ante room, the order is as follows: shoe covers (booties), cover head and facial hair, face mask (and protective eyewear if appropriate), cleanse hands and forearms, & put on gown (long sleeve, fits snuggly at wrists, neck is closed)
in the buffer room: use hand sanitizer and follow hand rubbing procedures (like washing but do not do wrists and forearms) then put on sterile gloves

29
Q

placement of supplies in the PEC

A
  • Place supplies at least 3 inches from the back and side walls of the LAFW and at least 6 inches from the front edge of the LAFW
  • Supplies should be placed side to side in a horizontal row so as to not block first air from each other
  • Critical sites should be arranged so that they receive first air
  • The direct compounding area (DCA) should remain clear
  • Sharps trash should be in a pile in front of non-sharps trash to the far side of the LAFW, between the HEPA filter and the non-sharps trash
30
Q

process of cleaning the PEC

A
  • ceiling, side-to-side, from back to front
  • HEPA filter grill (do not saturate filter)
  • bar and hooks
  • sides, up-and-down, from back to front
  • floor, side-to-side, from back to front
  • Use a clean wipe surface for each step
31
Q

How frequently do you clean sterile compounding areas?

A
  • at the beginning of each shift
  • before each batch
  • not longer than 30 minutes following the previous surface disinfection when ongoing compounding activities are occurring
  • after spills
  • when surface contamination is known or suspected
32
Q

peripheral TPN

A

infusion into IV line; short term only (10-14 days), must be aware of excessive osmolarity to avoid phlebitis (max 600-9– mOsm/L)

33
Q

central TPN

A

administered via catheter directly into superior vena cava; allows for greater osmolarity

34
Q

Hickman catheter

A

type of central TPN device; via subclavian vein into superior vena cava (has external lines)

  • placement is done surgically and must be checked with an X-ray
  • infection is a major concern
  • lines must be flushed with heparin to prevent clotting
35
Q

Mediport catheter

A

type of central TPN device; via subclavian vein into superior vena cava (NO external parts)

  • surgical placement
  • port is accessed using a special bent needle
  • line must be flushed with heparin to prevent clotting
36
Q

PICC (peripherally inserter central catheter) line

A

type of central TPN device; via the basilic, branchial, cephalic, or medical cubital vein of the arm into the superior vena cava (has external lines)

  • non-surgical placement
  • line must be flushed with heparin
37
Q

BEE

A

basal energy expenditure; calculates a patient’s caloric need to support basal metabolism; takes into consideration a patient’s gender, weight in kg, height in cm, and age in years

  • adjusted by multiplying by activity and stress factors to take into account the effect of the patient’s disease state on metabolism and the patient’s activity level (bedridden v. ambulatory)
  • activity factors generally range from 1-1.3
  • stress factors generally range from 1.2 to 2.1
38
Q

nutritional properties of components of a TPN

A
  • lipids (emulsified FAs or EFAs)
    • 10%: 1.1 kcal/mL
    • 20%: 2 kcal/mL
  • proteins (AAs)
    • 8.4% and 10% solns. available
    • 4kcal/g
  • carbs (dextrose)
    • stock solns. of 50% or 70% often used
    • 3.4 kcal/g
39
Q

Additional considerations for compounding TPNs?

A
  • patient allergies (EFAs contain phosphatidylcholine that is usually from an egg source)
  • Dextrose solutions are acidic. Never mix dextrose solution with lipids alone because lipids are sensitive to pH changes, especially to acidic ranges
  • AA solutions buffer acidity of dextrose
  • correct mixing order:
  • dextrose + amino acids
  • add phosphate
  • add calcium
  • add lipids
  • Total volume in mL a patient needs/day = 1500 + 20(weight in kg - 20)
  • not always used - TPN can be made to minimum volume and the remaining fluid is given in a separate IV line
  • Must adhere to aseptic technique when compounding a TPN
  • Check that osmolarity is compatible with the type of administration
  • Pay critical attention to stability considerations
  • Triple check Ca and Ph
40
Q

Predict compatibility based on Ca/Ph values

A

Calcium should be no greater than 1:2 ratio with phosphate

  • Total mEq of Ca + Ph should not exceed 45 mEq/L at the time of mixing
  • Ca will be given in mEq, but phosphate will be given in mmol
  • Assume all of phosphate is “bad” phosphate: the significantly less soluble dibasic phosphate, HPO42‒. Convert mmol of phosphate to mEq by multiplying mmol by the valence (2).
  • Add mEq of Ca + Ph together and divide by the volume at the time of mixing
  • If answer is <45 mEq/L, proceed with mixing
41
Q

affect of PH on calcium phosphate solubility

A

lower pH (acidic conditions) enhances calcium phosphate solubility

42
Q

Define risk in terms of sterile compounding

A

the odds or probability or chance that the product which is being prepared will be contaminated with bacteria, and that those bacteria will survive and multiply
- not only dependent on microbial contamination of pharmaceutical products during manufacture in cleanrooms and controlled zones, but the chance that any microbes deposited in the product will survive and multiply during it’s shelf life (this aspect of patient risk is considered with compounding)

43
Q

factors that contribute to risk while compounding

A
  • number of items and products that are manipulated, or entered, as with a needle into a vial
  • the number of products which are combined to make the final product
  • whether the products and containers were sterile when compounding commenced
  • temperature of the product
  • how long the product sits between mixing and final packaging
  • how long the product is to be stored before use
  • number of doses made/number of people using doses from the same lot
  • correct use of cleansing, garbing, and aseptic technique
44
Q

three risk levels

A
  • low risk, medium risk, and high risk
45
Q

special circumstances considered separate risk levels

A
  • immediate use

- low risk with a 12-hour (or less) BUD

46
Q

factors of immediate use

A
  • intended for situations where there is an emergency or immediate patient administration of a CSP where a delay due to preparation under low-risk conditions would put the patient at risk of harm
  • can be done outside a sterile compounding room and outside any sort of hood, but preferably in a clean, uncluttered area
  • no more than 3 containers with no more than 2 sticks to any one container
  • all starting ingredients must be purchased as sterole
  • one dose for 1 patient
  • no more than 1 hour between beginning of compounding and start of administration to patient
  • if not used immediately, CSP must be labeled with time of compounding and time of administration and remain under continuous supervision of the person who compounded it
47
Q

low risk with a 12-hour (or less) BUD

A
  • done in a PEC of ISO Class 4 that is not located in an ISO Class 7 room
  • compounding area must be segregated away from non-compounding areas
    • cannot be near water (at least 1 m away), a restroom, or an eating area
    • area must have minimal traffic and no outside entrance
  • personnel still follow cleansing and garbing procedures and use aseptic technique
  • only low-risk CSPs can be made
    • no more than 3 containers with no more than 2 sticks to any one container
    • all starting ingredients must be purchased as sterile
    • 1 dose for 1 patient
  • finished product must have the time compounding was finished
  • no more than 12 hours between completion of compounding and start of administration of product (less if recommended in the manufacturer’s package insert)
48
Q

low risk

A
  • done in a PEC of ISO Class 5 in an ISO Class 7 (or better)
  • personnel follow cleansing and garbing procedures and use aseptic technique
  • no more than 3 containers with no more than 2 sticks to any one container
  • all starting ingredients must be purchased as sterile
  • one dose for 1 patient
  • limited to transferring, measuring, and mixing manipulations
49
Q

medium risk

A
  • done in a PEC of ISO Class 5 in an ISO Class 7 room (or better)
  • personnel follow cleansing and garbing procedures procedures and use aseptic technique
  • all starting ingredients must be purchased as sterile
  • one of more of the following conditions are met
    • multiple doses are compounded
    • multiple patients will receive the CSP
    • more than 3 containers are involved and/or more than 2 sticks per container
    • process is more complex than single-volume transfers
    • unusually long duration of compounding process
50
Q

high risk

A
  • one of the following conditions are met:
    • prepared from at least one non-sterile ingredient
    • compounding personnel are importantly garbed and gloved
    • compounder does not verify by labeling and documentation of by direct determination that the purity and content strength of ingredients meet their original or compendial specifications in unopened or in opened packages of bulk ingredients between uses
  • any of the following are exposed to air quality worse than ISO Class 5 for more than 1 hour:
    • sterile contents of commercially manufactured products
    • CSPs that lack effective microbial preservatives
    • sterile surfaces of devices and containers for the preparation, transfer, sterilization, and packaging of CSPs
  • Done in a PEC of ISO Class 5 in an ISO Class 7 room (or better)
  • Personnel should follow cleansing and garbing procedures and use aseptic technique
51
Q

situations where sterile testing is needed for CSPs

A
  • If you plan to give an injectable made at ANY risk level an extended BUD (must be tested for potency, stability, sterility, and endotoxins)
  • If CSP is high risk and you made more than 25 single-dose packages
  • If CSP is high risk and you make the product in multidose containers (no matter how many you make or what the BUD is)
  • If CSP is high risk and exposed longer than 12 hours at refrigerator temps or longer than 6 hours at warmer than refrigerator temps before being sterilized
52
Q

responsibilities of compounding personnel

A
  • must know how long a CSP will remain sterile with proof
  • use reputable sellers to purchase sterile products
  • follow closely facility requirements, personnel cleansing and garbing requirements, and use of aseptic technique
  • assign an appropriate BUD
53
Q

information located on IV fluid and syringe labels

A
  • names and amounts/concentrations for all ingredients
  • directions for use including:
    • site of administration
    • type of administration
    • speed of administration
    • length of administration
  • storage conditions and times, including BUD
  • precautions or signs to monitor
  • correct patient’s name (and physician’s name)
  • any reasons the patient should not have the drug (check chart/file for…)
54
Q

how to perform a Finished Product Release Check

A
  • inspect product and review compounding procedures
  • review procedures and documents for sterility, correct drugs and amounts, stability
  • visually check for particulate matter, color, intact seals
  • do required tests: sterility, stability, potency, and endotoxins
55
Q

What is observed during the visual inspection of a compounded CSP?

A

particulate matter, color, physical integrity of container (seals, etc.)

56
Q

how to handle a CSP with observed defects

A
  • do NOT dispense
  • label CSP and place somewhere safe
  • pull or check rest of the lot
  • report failure to quality control person
  • there must be an investigation to determine why the failure occurred and how to prevent it in the future

Sterile Products (1 decks)

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