Pharmaceutical Vials and Injection Techniques

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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?

  • To remove any residual adhesive from the rubber
  • To lubricate the rubber closure for easier needle insertion
  • To sterilize the rubber closure before piercing (correct)
  • To cool the surface of the rubber

Why is it important to equilibrate pressure when working with vials?

  • To prevent the needle from breaking
  • To minimize the risk of product loss or contamination (correct)
  • To keep the vial at a perfect temperature.
  • To make the solution flow faster

When withdrawing a solution from a vial, what is the purpose of injecting a volume of air slightly less than the volume being withdrawn?

  • To prevent a vacuum from forming within the vial (correct)
  • To increase the pressure inside the vial
  • To help sterilize the vial
  • To create a vacuum to help pull out the liquid making withdrawal easier

What is the see-saw technique used for when working with vials?

<p>To simultaneously exchange air and liquid in a vial. (D)</p> Signup and view all the answers

Which of the following is a characteristic of cartridge systems, pen injectors, and auto-injectors?

<p>They use a reusable device into which a pre-filled cartridge is inserted. (C)</p> Signup and view all the answers

What is a key difference between vials/bottles and bags used in pharmaceutical preparations?

<p>Vials are non-flexible while bags are flexible containers. (A)</p> Signup and view all the answers

Besides having a rubber closure for drug addition, what other feature do most bags meant for administration possess?

<p>A removable plug for insertion of administration tubing (B)</p> Signup and view all the answers

What is a significant disadvantage associated with needle-free injectors?

<p>High cost of the device (C)</p> Signup and view all the answers

How does overfilling in some containers help in pharmaceutical preparations?

<p>It ensures that the total labeled volume can be withdrawn (A)</p> Signup and view all the answers

Which type of proprietary bag system involves a vial of drug and a bag of diluent separated until preparation?

<p>ADD-Vantage (D)</p> Signup and view all the answers

Which of the following describes a main challenge when using bags for pharmaceutical preparations?

<p>Bags are susceptible to plastic-product interactions. (D)</p> Signup and view all the answers

Which system utilizes a pre-filled cartridge that is inserted into a reusable injection device?

<p>Lantusâ„¢ Opticlikâ„¢ system (B)</p> Signup and view all the answers

Which of the following is a common characteristic of both auto-injectors and pen injectors?

<p>They automatically administer a pre-measured dose upon activation. (B)</p> Signup and view all the answers

Which of the following systems delivers medication via high pressure?

<p>Needle-Free Injectors (A)</p> Signup and view all the answers

Which of the following systems is an example of a pre-filled, disposable delivery system with a needle?

<p>EpiPen (B)</p> Signup and view all the answers

Which of the following is a characteristic of a Duplex bag system?

<p>It uses a rubber or plastic divider to separate the drug and diluent before use. (D)</p> Signup and view all the answers

What is the primary method of sealing ampules to ensure product sterility and prevent environmental exposure?

<p>Hermetically sealing by fusing the glass top. (C)</p> Signup and view all the answers

Why is it necessary to filter the contents of an ampule after opening it?

<p>To eliminate any glass particles generated during the breaking process. (D)</p> Signup and view all the answers

What is the purpose of tapping or flicking an ampule before opening?

<p>To ensure all liquid has moved to the lower body of the ampule. (C)</p> Signup and view all the answers

What is the main disadvantage of using an ampule as a packaging system for parenteral drugs?

<p>They are single-use containers that do not allow resealing. (D)</p> Signup and view all the answers

After drawing the contents of an ampule into a syringe, what is the next critical step before drug administration?

<p>Changing to a new, non-filter needle. (C)</p> Signup and view all the answers

Why should the neck of an ampule be cleaned with 70% isopropyl alcohol (IPA) before opening?

<p>To create a sterile environment and prevent contamination. (D)</p> Signup and view all the answers

What does the presence of a colored dot on some ampules indicate?

<p>The recommended place to apply force when breaking the ampule. (A)</p> Signup and view all the answers

What is the final step mentioned after changing to a new needle when reconstituting from an ampule?

<p>Remove air bubbles by gently knocking against the side of the syringe. (D)</p> Signup and view all the answers

Which of the following is a pre-filled, ready-to-use IV bag system?

<p>Minibag Plus (B)</p> Signup and view all the answers

What is a crucial guideline to consider when selecting a syringe for measurements?

<p>Select the syringe with the closest volume to that being measured. (D)</p> Signup and view all the answers

Why are syringes NOT recommended for long-term storage of drug products?

<p>Drug stability may be compromised due to adsorption or leaching. (C)</p> Signup and view all the answers

What gauge of needle would be most appropriate for compounding to reduce damage to rubber closures?

<p>a larger gauge needle like 18G (B)</p> Signup and view all the answers

If you were to administer a subcutaneous injection, which needle size would be most appropriate?

<p>35-30G; 1/2&quot; - 5/8&quot; (B)</p> Signup and view all the answers

Which of the following drugs is known to be affected by components of rubber stoppers?

<p>Fentanyl (B)</p> Signup and view all the answers

Why is tungsten a concern for some medications when using certain needles?

<p>It can cause drug degradation. (A)</p> Signup and view all the answers

If you need to administer an intramuscular injection, what needle gauge and length would be appropriate?

<p>20 - 22G; 1/2&quot; - 1 1/2&quot; (A)</p> Signup and view all the answers

Which characteristic is a known issue with rigid plastics such as polystyrene and PVC?

<p>Poor impact resistance (A)</p> Signup and view all the answers

What is a potential consequence of using a plastic that is permeable to moisture for aqueous products?

<p>Increase in drug concentration (B)</p> Signup and view all the answers

What is the surface defect known as crazing, that can occur with some plastics?

<p>A fine surface network of cracks (B)</p> Signup and view all the answers

According to the provided table, which plastic has the best heat sterilization properties?

<p>PP (B)</p> Signup and view all the answers

Which additive is commonly incorporated into PVC formulations to enhance flexibility?

<p>Plasticizers (A)</p> Signup and view all the answers

Why is PVC banned in certain countries like Germany, France and Scandinavia, for use in parenteral packaging?

<p>Due to concerns about leachates and extractables (D)</p> Signup and view all the answers

What is the key process in preparing rubber for pharmaceutical applications?

<p>Vulcanization (A)</p> Signup and view all the answers

Which type of plastic has the highest moisture permeation?

<p>HDPE (B)</p> Signup and view all the answers

What is the function of a curing agent in rubber formulation?

<p>To form crosslinks that shape the rubber (D)</p> Signup and view all the answers

Which of the following is a potential consequence of using natural latex in a rubber formulation?

<p>Potential for allergic reactions (D)</p> Signup and view all the answers

What role do accelerators play in the vulcanization of rubber?

<p>They increase the cure rate of the rubber. (D)</p> Signup and view all the answers

Which additive is primarily responsible for modifying the hardness of the rubber?

<p>Fillers (B)</p> Signup and view all the answers

What is the main purpose of plasticizers in rubber formulations?

<p>To aid in the shaping process of the rubber (C)</p> Signup and view all the answers

Which of the following is NOT a listed interaction between the rubber formulation and the drug product?

<p>Chemical alteration of the drug product (A)</p> Signup and view all the answers

Which component is added to rubber formulations to prevent degradation over time?

<p>Antioxidants (D)</p> Signup and view all the answers

Which category of rubber formulation is used for providing color to the final product?

<p>Pigments (C)</p> Signup and view all the answers

Flashcards

Ampule

Glass containers sealed by fusing the glass top, creating a closed system that protects the drug from the environment.

Ampule Opening

Breaking the top of an ampule exposes the drug to the environment.

Ampule Contamination

Glass particles from breaking the ampule must be removed before using the drug.

Filter Needle

A sterile needle with a built-in filter, used to remove glass particles from ampule contents.

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Removing Air Bubbles

To remove air bubbles from a syringe, gently tap the side of the syringe with your knuckles.

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Ampule Advantages

Single-use containers for parenteral drugs, offering hermetic sealing to protect the drug product.

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Ampule Disadvantages

Broken glass requires filtration, and only one use is possible.

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Ampule Extraction

The process of drawing up drug solution from an ampule using a syringe and filter needle.

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Cartridge Systems

Drug delivery systems that use a reusable injection device with a pre-filled cartridge, delivering a pre-measured dose upon pushing a button or applying pressure.

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Pen Injectors

Pen injectors are similar to cartridge systems, but they are designed to automatically administer the drug dose upon depression of a trigger.

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Auto-Injectors

Auto-injectors are a type of pen injector that delivers the drug dose automatically when the device is pressed against the skin.

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Needle-Free Injectors

Needle-free injectors use high pressure to deliver liquid or powder drugs into the skin, subcutaneous layer, or muscle.

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Proprietary Bag Systems

Systems for rapid preparation of drug products that use a quick-connect mechanism or pre-mixed products.

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ADD-Vantage Systems

Separate vial containing the drug and a bag containing the diluent (infusion solution) that are connected for quick preparation.

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Galaxy Bags

A bag containing a pre-mixed drug solution, ready for immediate infusion.

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Duplex Bags

Double-chamber IV bags where the drug and diluent are separated until just before preparation.

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Vials and Bottles (Closed System)

Glass or plastic containers with a rubber closure allowing for repeated penetration without compromising the sealed system. They are hermetically sealed to prevent contamination from the environment and/or atmosphere.

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Equilibrating Pressure in Vials

Vials and bottles use a rubber stopper that needs to be pierced with a needle. Before withdrawing liquid, inject a small amount of air to prevent a vacuum. When adding liquid, release the same amount of air to avoid over-pressurizing the vial.

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Infusion Bags (Closed System)

Flexible plastic containers with a rubber port for repeated penetration. They usually have a second port for connecting administration tubing.

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Overfilling in Vials and Bottles

Vials and bottles can sometimes have a larger volume than the labeled amount to ensure the desired amount can be withdrawn. This is a common practice in sterile preparation.

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Advantages and Disadvantages of Vials/Bottles

Vials and bottles are considered multi-use, allowing for repeated access without breaking the seal. However, they are non-vented, meaning they require pressure equilibration.

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Advantages and Disadvantages of Infusion Bags

Infusion bags are flexible and adaptable. They can be squeezed or molded to fit into different spaces. However, the plastic material can interact with the drug, affecting its stability and effectiveness.

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Disinfection of Vials and Bottles

Before using vials and bottles, all rubber closures should be meticulously disinfected using a sterile 70% isopropyl alcohol (IPA) swab and allowed to dry completely.

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Inserting Needle into Vials

When inserting a needle into a vial septum, use a slight added pressure but insert the needle bevel up. This helps minimize the risk of damaging the septum.

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Impact Resistance

Resistance to bending, denting, or breaking upon impact.

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Leachates and Extractables

Substances released from plastic packaging into the drug product, potentially affecting its quality or safety.

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Moisture Permeation

The amount of water vapor or gases that can pass through a plastic material.

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Stress Cracking

A type of stress cracking that occurs in plastics due to exposure to specific chemicals like surfactants or oils.

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Crazing

A type of surface cracking that forms a fine network of lines on the plastic surface.

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Sealability

The ability to form a seal that prevents the entry of air or moisture. Important for maintaining the sterility of pharmaceutical products.

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Plastic Additives

The process of adding substances to plastics to improve their properties like flexibility, stability, or color.

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Vulcanization

A process used in the production of rubber where heat and pressure are applied to mold and solidify a mixture.

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Syringe Selection

Syringes are frequently used to measure small volumes of medication. Select a syringe size as close as possible to the volume being measured. Do not use 80% of the syringe's maximum volume, especially for hazardous substances.

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Syringe Storage

Syringes are used for individual doses but not for long-term storage of drug products. Drug stability and interactions with syringe components can be issues.

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Drug-Rubber Stopper Interactions

Certain drugs can be affected by the components of rubber stoppers used in vials. These drugs may interact with the stopper materials, leading to changes in their stability or effectiveness.

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Needle Size

Needle size is indicated by gauge (diameter) and length. Larger gauge = smaller diameter. Appropriate needle selection depends on injection site, compounding, and drug stability.

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Needle Size by Route

The appropriate needle gauge and length depend on the route of administration (IV, IM, SQ, ID).

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Compounding Needle Gauge

Larger-gauge needles are used for compounding to minimize damage to rubber closures (e.g., vials).

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Tungsten in Needles

Some needles contain tungsten, which can affect the stability of certain drugs, such as epoetin.

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Compounding Devices

Individual doses should be prepared using appropriate compounding devices such as syringes, needles, mixing containers, and minibags.

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Elastomer in Rubber Closures

A material used in the manufacture of rubber closures that, when mixed with other ingredients, creates the desired properties such as hardness, elasticity, and resistance to vapor transfer.

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Vulcanization in Rubber Closures

This process involves the creation of cross-links within the rubber polymer chains. It helps to solidify the rubber's structure and provides the desired shape and resistance.

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Accelerators in Rubber Closures

These chemicals are added during the vulcanization process to speed up the cross-linking reaction, resulting in faster curing times and a smoother rubber texture.

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Activators in Rubber Closures

These substances work in conjunction with accelerators to enhance their effectiveness, ensuring a complete and efficient vulcanization process.

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Antioxidants in Rubber Closures

These compounds are incorporated into the rubber formulation to protect it from degradation caused by factors like oxidation. They help extend the shelf life and prevent the rubber from becoming brittle.

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Plasticizers in Rubber Closures

These substances make the rubber mixture easier to mold and shape, allowing for precise manufacturing of closures. They help in achieving the desired size, shape, and flexibility of the final product.

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Fillers in Rubber Closures

These additives are used to modify the hardness of the rubber, adjusting it for different applications and requirements. They provide the desired level of firmness or flexibility.

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Pigments in Rubber Closures

These are added to give the closures a specific color, which might be important for identification or branding purposes. They are often added to improve the visual appeal of the product.

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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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