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Questions and Answers
What is the primary purpose of using a 70% isopropyl alcohol (IPA) swab on a vial's rubber closure?
What is the primary purpose of using a 70% isopropyl alcohol (IPA) swab on a vial's rubber closure?
Why is it important to equilibrate pressure when working with vials?
Why is it important to equilibrate pressure when working with vials?
When withdrawing a solution from a vial, what is the purpose of injecting a volume of air slightly less than the volume being withdrawn?
When withdrawing a solution from a vial, what is the purpose of injecting a volume of air slightly less than the volume being withdrawn?
What is the see-saw
technique used for when working with vials?
What is the see-saw
technique used for when working with vials?
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Which of the following is a characteristic of cartridge systems, pen injectors, and auto-injectors?
Which of the following is a characteristic of cartridge systems, pen injectors, and auto-injectors?
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What is a key difference between vials/bottles and bags used in pharmaceutical preparations?
What is a key difference between vials/bottles and bags used in pharmaceutical preparations?
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Besides having a rubber closure for drug addition, what other feature do most bags meant for administration possess?
Besides having a rubber closure for drug addition, what other feature do most bags meant for administration possess?
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What is a significant disadvantage associated with needle-free injectors?
What is a significant disadvantage associated with needle-free injectors?
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How does overfilling in some containers help in pharmaceutical preparations?
How does overfilling in some containers help in pharmaceutical preparations?
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Which type of proprietary bag system involves a vial of drug and a bag of diluent separated until preparation?
Which type of proprietary bag system involves a vial of drug and a bag of diluent separated until preparation?
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Which of the following describes a main challenge when using bags for pharmaceutical preparations?
Which of the following describes a main challenge when using bags for pharmaceutical preparations?
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Which system utilizes a pre-filled cartridge that is inserted into a reusable injection device?
Which system utilizes a pre-filled cartridge that is inserted into a reusable injection device?
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Which of the following is a common characteristic of both auto-injectors and pen injectors?
Which of the following is a common characteristic of both auto-injectors and pen injectors?
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Which of the following systems delivers medication via high pressure?
Which of the following systems delivers medication via high pressure?
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Which of the following systems is an example of a pre-filled, disposable delivery system with a needle?
Which of the following systems is an example of a pre-filled, disposable delivery system with a needle?
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Which of the following is a characteristic of a Duplex bag system?
Which of the following is a characteristic of a Duplex bag system?
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What is the primary method of sealing ampules to ensure product sterility and prevent environmental exposure?
What is the primary method of sealing ampules to ensure product sterility and prevent environmental exposure?
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Why is it necessary to filter the contents of an ampule after opening it?
Why is it necessary to filter the contents of an ampule after opening it?
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What is the purpose of tapping or flicking an ampule before opening?
What is the purpose of tapping or flicking an ampule before opening?
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What is the main disadvantage of using an ampule as a packaging system for parenteral drugs?
What is the main disadvantage of using an ampule as a packaging system for parenteral drugs?
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After drawing the contents of an ampule into a syringe, what is the next critical step before drug administration?
After drawing the contents of an ampule into a syringe, what is the next critical step before drug administration?
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Why should the neck of an ampule be cleaned with 70% isopropyl alcohol (IPA) before opening?
Why should the neck of an ampule be cleaned with 70% isopropyl alcohol (IPA) before opening?
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What does the presence of a colored dot on some ampules indicate?
What does the presence of a colored dot on some ampules indicate?
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What is the final step mentioned after changing to a new needle when reconstituting from an ampule?
What is the final step mentioned after changing to a new needle when reconstituting from an ampule?
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Which of the following is a pre-filled, ready-to-use IV bag system?
Which of the following is a pre-filled, ready-to-use IV bag system?
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What is a crucial guideline to consider when selecting a syringe for measurements?
What is a crucial guideline to consider when selecting a syringe for measurements?
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Why are syringes NOT recommended for long-term storage of drug products?
Why are syringes NOT recommended for long-term storage of drug products?
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What gauge of needle would be most appropriate for compounding to reduce damage to rubber closures?
What gauge of needle would be most appropriate for compounding to reduce damage to rubber closures?
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If you were to administer a subcutaneous injection, which needle size would be most appropriate?
If you were to administer a subcutaneous injection, which needle size would be most appropriate?
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Which of the following drugs is known to be affected by components of rubber stoppers?
Which of the following drugs is known to be affected by components of rubber stoppers?
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Why is tungsten a concern for some medications when using certain needles?
Why is tungsten a concern for some medications when using certain needles?
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If you need to administer an intramuscular injection, what needle gauge and length would be appropriate?
If you need to administer an intramuscular injection, what needle gauge and length would be appropriate?
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Which characteristic is a known issue with rigid plastics such as polystyrene and PVC?
Which characteristic is a known issue with rigid plastics such as polystyrene and PVC?
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What is a potential consequence of using a plastic that is permeable to moisture for aqueous products?
What is a potential consequence of using a plastic that is permeable to moisture for aqueous products?
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What is the surface defect known as crazing, that can occur with some plastics?
What is the surface defect known as crazing, that can occur with some plastics?
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According to the provided table, which plastic has the best heat sterilization properties?
According to the provided table, which plastic has the best heat sterilization properties?
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Which additive is commonly incorporated into PVC formulations to enhance flexibility?
Which additive is commonly incorporated into PVC formulations to enhance flexibility?
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Why is PVC banned in certain countries like Germany, France and Scandinavia, for use in parenteral packaging?
Why is PVC banned in certain countries like Germany, France and Scandinavia, for use in parenteral packaging?
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What is the key process in preparing rubber for pharmaceutical applications?
What is the key process in preparing rubber for pharmaceutical applications?
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Which type of plastic has the highest moisture permeation?
Which type of plastic has the highest moisture permeation?
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What is the function of a curing agent in rubber formulation?
What is the function of a curing agent in rubber formulation?
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Which of the following is a potential consequence of using natural latex in a rubber formulation?
Which of the following is a potential consequence of using natural latex in a rubber formulation?
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What role do accelerators play in the vulcanization of rubber?
What role do accelerators play in the vulcanization of rubber?
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Which additive is primarily responsible for modifying the hardness of the rubber?
Which additive is primarily responsible for modifying the hardness of the rubber?
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What is the main purpose of plasticizers in rubber formulations?
What is the main purpose of plasticizers in rubber formulations?
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Which of the following is NOT a listed interaction between the rubber formulation and the drug product?
Which of the following is NOT a listed interaction between the rubber formulation and the drug product?
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Which component is added to rubber formulations to prevent degradation over time?
Which component is added to rubber formulations to prevent degradation over time?
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Which category of rubber formulation is used for providing color to the final product?
Which category of rubber formulation is used for providing color to the final product?
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Flashcards
Ampule
Ampule
Glass containers sealed by fusing the glass top, creating a closed system that protects the drug from the environment.
Ampule Opening
Ampule Opening
Breaking the top of an ampule exposes the drug to the environment.
Ampule Contamination
Ampule Contamination
Glass particles from breaking the ampule must be removed before using the drug.
Filter Needle
Filter Needle
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Removing Air Bubbles
Removing Air Bubbles
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Ampule Advantages
Ampule Advantages
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Ampule Disadvantages
Ampule Disadvantages
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Ampule Extraction
Ampule Extraction
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Cartridge Systems
Cartridge Systems
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Pen Injectors
Pen Injectors
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Auto-Injectors
Auto-Injectors
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Needle-Free Injectors
Needle-Free Injectors
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Proprietary Bag Systems
Proprietary Bag Systems
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ADD-Vantage Systems
ADD-Vantage Systems
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Galaxy Bags
Galaxy Bags
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Duplex Bags
Duplex Bags
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Vials and Bottles (Closed System)
Vials and Bottles (Closed System)
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Equilibrating Pressure in Vials
Equilibrating Pressure in Vials
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Infusion Bags (Closed System)
Infusion Bags (Closed System)
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Overfilling in Vials and Bottles
Overfilling in Vials and Bottles
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Advantages and Disadvantages of Vials/Bottles
Advantages and Disadvantages of Vials/Bottles
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Advantages and Disadvantages of Infusion Bags
Advantages and Disadvantages of Infusion Bags
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Disinfection of Vials and Bottles
Disinfection of Vials and Bottles
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Inserting Needle into Vials
Inserting Needle into Vials
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Impact Resistance
Impact Resistance
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Leachates and Extractables
Leachates and Extractables
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Moisture Permeation
Moisture Permeation
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Stress Cracking
Stress Cracking
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Crazing
Crazing
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Sealability
Sealability
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Plastic Additives
Plastic Additives
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Vulcanization
Vulcanization
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Syringe Selection
Syringe Selection
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Syringe Storage
Syringe Storage
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Drug-Rubber Stopper Interactions
Drug-Rubber Stopper Interactions
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Needle Size
Needle Size
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Needle Size by Route
Needle Size by Route
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Compounding Needle Gauge
Compounding Needle Gauge
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Tungsten in Needles
Tungsten in Needles
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Compounding Devices
Compounding Devices
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Elastomer in Rubber Closures
Elastomer in Rubber Closures
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Vulcanization in Rubber Closures
Vulcanization in Rubber Closures
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Accelerators in Rubber Closures
Accelerators in Rubber Closures
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Activators in Rubber Closures
Activators in Rubber Closures
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Antioxidants in Rubber Closures
Antioxidants in Rubber Closures
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Plasticizers in Rubber Closures
Plasticizers in Rubber Closures
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Fillers in Rubber Closures
Fillers in Rubber Closures
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Pigments in Rubber Closures
Pigments in Rubber Closures
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Study Notes
Sterile Products - Packaging and Administration Systems
- Packaging Types: Parenteral drug products use various container types like ampoules, vials, bottles (glass or plastic), pre-filled syringes, cartridges, and bags.
- Parenteral Product Stability: Stability concerns exist in packaging systems due to environmental exposure and interactions between the drug and container materials.
- Dosage Form and Formulation: Dosage form and formulation influence drug performance in different packaging systems.
- Ampoules: Hermetically sealed glass containers, typically single-use. Breaking the glass accesses the product.
- Ampoule Usage: Clean neck with 70% IPA, hold ampule at a 45° angle, flick top to open, use filter needle/straw to remove glass pieces.
- Vials/Bottles: Closed-system containers, reusable. These are sealed with rubber closures allowing repeated penetration without removing the seal.
- Vials/Bottles Usage: Ensure the liquid is in the bottom before opening, swab the rubber closure with 70% IPA and dry. Insert the needle bevel up to prevent septum puncture. Equilibrate internal pressure by adding or removing air to avoid aspiration of fluid.
- Bags: Flexible plastic closed-system containers with multiple ports. Frequently used for multiple drug administration and repeated penetration.
- Syringes: Modern syringes are disposable plastic units with interior rubber tips. Syringes can be staked or have a slip tip or Leur-Lok tip for needle attachment, used to accurately measure smaller volumes.
- Pre-filled Syringes: Pre-filled syringes are a significant market segment for self-administration. The syringes hold premeasured doses of medications.
- Dual-Chambered Syringes: These systems store incompatible liquids or lyophilized powder / liquid solutions in separate chambers. Pressure application causes mixing.
- Needleless Systems: Systems designed for safety featuring closed systems to reduce the risk of needle stick injuries and exposure to hazardous substances.
- Medication Transfer Devices: Various devices transfer drugs between containers. (Example: double-ended transfer needles, dispensing pins, etc.)
- Tubing/Administration Devices: Tubing systems for administering medication from large volume containers, featuring a drip chamber for flow rate measurement and control.
- Spike: A device for inserting into the container to receive the fluids for administration. Each administration set has a drop factor which indicates calibration.
- Drip Chamber: A chamber, filled with the fluid/solution, that allows for the measurement of dosage rate. Overfilling should be avoided.
- Roller Clamp: A device below the drip chamber to start/stop the flow rate and adjust the IV flow rate manually.
- Auxiliary Clamp: Used to stop the medication flow without changing the location of the roller clamp.
- Packaging and Labeling: Components of packaging systems affect the stability of the contents. The packaging should provide a tamper-proof seal to indicate product integrity. Care must be taken to avoid adverse drug interactions.
- Glass Usage: Glass containers are used for dispensing solutions for administration and should be chosen carefully to prevent adverse drug interactions.
- Plastic Usage: Plastic containers are more susceptible to drug-container interactions.
- Rubber Usage: Rubber components include closures used for repeated penetration. The mixture of chemical components influences firmness, elasticity, fragmentation & permeability.
- Drug Compatibility: Different drugs may be less compatible with different materials (glass, plastic, rubber).
- Dead Space: Residual volume within the needle and syringe that may cause the total volume to be delivered to fall below the intended dose. Priming volume is added to ensure adequate amounts of medication are delivered.
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Description
This quiz focuses on key practices related to the use of vials in pharmaceuticals, including the proper handling of rubber closures and the techniques for withdrawing solutions. It covers topics such as pressure equilibration, the see-saw technique, and characteristics of various injection systems.