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WorksheetsSterile Dosage Forms Dr. Miroshnyk
Total questions: 60
Worksheet time: 6hrs 41mins
All parenteral routes of administration are sterility demanding.
True
False
All parenteral injections or ophthalmic are sterility-demanding.
True
False
Which of the following provides the minimum practice and quality standards for compounded sterile preparations (CSPs)?
USP (707)
USP (797)
USP (420)
USP (690)
Small-volume parenteral (SVP): an injection packaged in containers up to 100 mL.
True
False
Large-volume parenteral (LVP): a single dose injection intended for IV use and is packaged in container larger than 100 mL.
True
False
Which of the following is the destruction of ALL living organisms and their spores or their complete removal from the preparation?
Ionization
Sterilization
Catabolism
Epigenesis
Which of the following are considered Methods of Sterilization? Select all that apply
Dry Heat
Ionizing Radiation
Moist-heat (steam)
Filtration
Gas
A pharmacist intern is asked to compound a sterile preparation using nonsterile excipients. How would you assess the microbial contamination level of this preparation?
Low risk level
Medium risk level
High risk level
Impossible to determine
A pharmacist intern is asked to compound a sterile preparation using all ingredients and equipment sterile; minimal manipulation in a ISO Class 5 environment. How would you assess the microbial contamination level of this preparation?
High risk level
Medium risk level
Low risk level
Impossible to determine
A pharmacist intern is asked to compound multiple products, complex and time-consuming manipulations. How would you assess the microbial contamination level of this preparation?
High risk level
Medium risk level
Low risk level
Impossible to determine
Which of the following methods of sterilization is the method of choice in which temperature is responsible for sterilization and pressure increases temperature?
Steam sterilization
Dry heat sterilization
No sterilization is required in this case
Sterilization by filtration
Which of the following is the methods of sterilization is used for sterilizing glassware, surgical instruments, oils, glycerin, mineral oil and heat stable powders heated by gas or electricity?
Steam sterilization
Dry heat sterilization
No sterilization is required in this case
Sterilization by filtration
Gas sterilization
Which of the following methods of sterilization is the most appropriate for a heat sensitive API?
Steam sterilization
Dry heat sterilization
No sterilization is required in this case
Sterilization by filtration
Gas sterilization
Which of the following are advantages of doing sterilization by filtration? Select all that apply
Faulty assembly
Relatively inexpensive
Speed
Inspection needed
Which of the following are disadvantages of doing sterilization by filtration? Select all that apply
Inspection needed
Speed
Relatively inexpensive
Faulty assembly
Which of the following methods of sterilization removes of bacteria and spores by filtration, using a 0.22µm filter?
Steam sterilization
Dry heat sterilization
No sterilization is required in this case
Sterilization by filtration
Gas sterilization
Which of the following are possible complications that can arise from IV administration? Select all that apply
Air emboli
Dehydration
Thrombosis
Phlebitis
Infection
A pharmacist will be compounding a sterile preparation. Which of the following documents is considered as a standard of practice for this activity?
USP monograph 767
USP monograph 795
USP monograph 797
USP monograph 1097
Which of the following statements is TRUE about Gas Sterilization?
The mixtures with air does not have any effect
The mixtures with air is necessary for better sterilization
The mixtures with air very flammable
The mixtures needs to be with water and air for better sterilization process
Which of the following is TRUE about the mechanism of Gas Sterilization?
Removal of bacteria and spores by filtration, using a 0.22µm filter
Ethylene oxide is thought to sterilize by interfering with the metabolism of the bacterial cell
Used for sterilizing glassware, surgical instruments, oils, glycerin, mineral oil and heat stable powders
Temperature is responsible for sterilization, pressure increases temperature
Often the method of choice
Which of the following uses gamma and cathode rays in some applications like bulk pharmaceuticals & medical devices?
Beta radiation
Ionizing radiation
Alpha radiation
pH radiation
Which of the following parenteral route of administrations has the longer onset of action?
Subcutaneous (SQ/SC)
Intramuscular
Intravenous (IV) injections
Which of the following parenteral route of administrations has the shorter onset of action?
Intravenous (IV) injections
Intramuscular
Subcutaneous (SQ/SC)
Which of the following injections is introduced into the loose interstitial tissue "slowly"?
Subcutaneous
Intramuscular
Intravenous
Intradermal
Which of the following are TRUE about Intradermal (intracutaneous)? Select all that apply
0.1 mL or less of medication
10 – 15 needle degree angle
Used for Diagnosis, desensitization, and immunization
Injection into the more vascular layers of the skin just under epidermis
Introduced into the loose interstitial tissues – ‘give slowly’
Which of the following injections or parenteral route of administrations takes 10 – 30 min to “work”?
Intradermal (intracutaneous)
Intravenous
Subcutaneous
Intramuscular
Which of the following statements are TRUE about the use of Parenteral Routes? Select all that apply
Drug itself is ineffective by other routes
Rapid action is required
Patient is uncooperative or unconscious
Patient is unable to tolerate or accept oral medication
Long onset of action more than 2 hours is required
Which of the following are TRUE about the weaknesses/drawbacks for Parenteral Routes of administration? Select all that apply
Invasive ROA
More expensive
Must be administered by trained personnel
The effect of overdose or hypersensitive reaction to the drug is difficult to reverse
Aseptic procedures are required
Contamination of dosage form prior to injection is possible
Which of the following solvents for injections are NOT suitable for use in neonates?
Water for injections
Sterile water for injections
Bacteriostatic water for injections
Which of the following solvents for injections has an USP labeling requirement: “NOT FOR USE IN NEONATES”?
Ethanol
Diphenhydramine
Benzyl alcohol
Zinc oxide
A pharmacist needs to compound a large volume parenteral solution for IV infusions. Which of the following solvents would be appropriate to use? Select all that apply
Purified Water USP
Water for Injections USP
Sterile Water for Injections
Bacteriostatic Water for Injections
Tap water
Which of the following excipients is linked to poisoning causing Gasping Syndrome?
Benzyl Benzoate
Benzyl Salicylate
Benzoic Acid
Benzyl Alcohol
Which of the following are the symptoms caused by Benzoyl alcohol poisoning? Select all that apply
metabolic acidosis
central nervous system depression
gasping respirations
high levels of benzyl alcohol and its metabolites in the blood and urine
lupus like syndrome
Which of the following is TRUE about Gasping syndrome (benzyl alcohol poisoning) association dosages?
>19 mg/kg/day, but less than 90 mg/kg/day
>99 mg/kg/day
>19 mg/kg/day, but less than 75 mg/kg/day
>19 mg/kg/day, but less than 50 mg/kg/day
Which of the following is often used to prepare bacteriostatic WFI?
0.9% w/v sodium chloride
0.9% v/w benzyl alcohol
0.9% w/v benzyl alcohol
0.9% v/w sodium chloride
Sesame oil is a Non-Aqueous vehicle used in IM and IV routes of administration.
True
False
Sesame oil is a Non-Aqueous vehicle used in IM route of administration only.
True
False
Which of the following are TRUE of when do we use Non-Aqueous Vehicles? Select all that apply
susceptibility of APIs to hydrolysis
to create the internal phase of parenteral emulsions
water-insoluble APIs
water-soluble APIs
Visual inspection of parenteral solutions can reveal the presence of which of the following?
particle contamination and precipitation
pH and precipitation
chemical degradation of a drug and osmolarity
pyrogens and precipitation
ALL parenteral injections are required to have the final pH of around 7.4.
True
False
Final pH of ALL parenteral injections depend on the administration route.
True
False
Which of the following are TRUE about pH depending on the administration route? Select all that apply
IV: pH 2-12
IM: 3-11
SC: 3-6
IM: 2-12
Which of the following buffers can be used to control pH when change during manufacturing process, sterilization or storage? Select all that apply
citrate
acetate
phosphate
mononitrate
Which of the following is TRUE about Isotonicity in parenteral preparation? Select all that apply
it will make the preparation more irritable
it will make the preparation less irritable
Decreases risk of hemolysis
Increases risk of hemolysis
All of the following are the most commonly used agents to control isotonicity, EXCEPT:
NaCl
Benzoyl alcohol
Glycerol
Mannitol
Glucose
Parenteral nutrition solution are extremely hypertonic and they should be administered only into large veins so that the preparation is diluted quickly to the blood circulation.
True
False
Parenteral nutrition solution are extremely hypotonic and they should be administered only into large veins so that the preparation is diluted quickly to the blood circulation.
True
False
Which of the following is a drawback of Non-Aqueous Vehicles?
Hydration
Sensitivity/Pain/irritation on injection
Which of the following is one of the main attributes of Sterile Parenteral Dosage forms?
Not isotonic
Pyrogen free
Free soluble material
Longer onset of action exceeding 6 hours
Large Volume Parenterals must not contain bacteriostatic agents or other additives.
True
False
Which of the following are examples of Large Volume Parenterals? Select all that apply
Piggy
Ringer’s injection, USP
Lactated Ringer’s Injection, USP
Which of the following are TRUE about Bacteriostatic Water for Injections? Select all that apply
Sterile WFI + one or more antimicrobial agents
Container label must state the names and proportions of the antimicrobial agents
Packaged in pre-filled syringes or multiple-dose vials NMT30 ml
Due to the presence of antimicrobial agents used only for SVP
Compatibility of the antimicrobial agents and APIs has to be considered
Which of the following are TRUE about Water for Injections(WFI), USP? Select all that apply
Freely soluble APIs (injections)
The external phase for injectable emulsions
Poorly water soluble APIs (suspensions)
It is non-sterile and is used in preparation of terminally sterilized preparations
Must be pyrogen-free
Which of the following uses healthy rabbits (n=3) to inject a product to be tested?
Pyrogen Test (USP)
Bacterial Endotoxine Test (USP)
Which of the following is the most commonly used test and utilizes LAL (Limulus amebocyte lysate) ?
Bacterial Endotoxine Test (USP)
Pyrogen Test (USP)
Which of the following are additional formulation requirements for parenteral? Select all that apply
hygroscopicity
Isotonicity
pH in physiological range
Sufficient chemical and microbiological stability
Which of the following statements is TRUE regarding Preservatives?
Single-dose containers must contain one or more preservatives regardless of the method of sterilization
Multiple-dose containers must NOT contain one or more preservatives regardless of the method of sterilization
Multiple-dose containers must contain one or more preservatives regardless of the method of sterilization
Typically, NO preservatives added to injections of volume more than 15 ml.
True
False
Which of the following are TRUE regarding Packaging? Select all that apply
Should protect the product from contamination during the entire shelf-life
Containers, including the closures, must be inert
Should NOT allow visual inspection of the solution
Should allow visual inspection of the solution
Which of the following are packaged in single-dose containers up to 1 L
Pyrogen-free, with an allowable endotoxin level?
Water for Injections(WFI), USP
Bacteriostatic Water for Injections
Sterile Water for Injection, USP
