Supplies for Sterile Compounding: Part 1

Cylindrical-shaped area of syringe that keeps liquids contained within the syringe; has calibration marks for accurate measurement of liquids

Barrel

Slanted opening at the tip of the needle

bevel

sharp, pointed end of needle that enters vial

Bevel tip

short end of the bevel; opposite bevel tip

Bevel heel

Syringe markings used to accurately measure the appropriate volume of liquid

Calibration marks

When pieces of the rubber stopper of a vial fall into the liquid upon puncturing the vial, contaminating the liquid inside

Coring

Certain parts of sterile compounding supplies that must never be touched in order to remain sterile during the compounding process

Critical sites

A needle with a built-in filter designed to remove any particulates that may have contaminated a solution when withdrawing fluid from an ampule

Filtered needle

The diameter of a needle or width of the needle opening

Gauge (ga)

The base of the needle which attaches to the syringe

Hub

A type of syringe to which a needle can be screwed on in order to attach securely

Luer-lock

The hollow part of the needle that fluid moves through

Lumen

Attaches to the ends of syringes and is used to withdraw and inject fluids

Needle

Black plastic tip attached to a syringe plunger used to accurately measure the substance in a syringe

Piston

Long, slender stem portion of the needle

Shaft

Used to measure liquid volumes

Syringe

________________ (e.g., beakers, utensils, needles, syringes, filters, and tubing sets) should be of suitable composition such that the surfaces that contact components are not reactive or sorptive

Supplies

Supplies in direct contact with the CSP must be ___________________

sterile and depyrogenated

Components must follow the ______________, which must address the selection, receipt, evaluation, handling, storage, and documentation of all CSP components, including all ingredients and container closures

facility's SOPs

Components that must follow facility's SOPs

1. receipt

2. evaluation before use

3. handling and storage

APIs must comply with the criteria in the _____________, if one exists

USP-NF monograph

APIs must have a ________________ that includes the specifications (e.g., compendial requirements for quality) and that test results for the component show that the API meets expected quality

COA (certificate of analysis)

In the United States, APIs must be manufactured by an _________________

FDA-registered facility

basics of needles

1. stainless steel

2. sterile

3. individually packaged

Select needle _________________ based on intent of use

length and gauge

distance from hub to tip

length in inches

diameter of lumen

Gauge

relationship between the gauge (diameter) and length (distance)

The larger the gauge, the smaller the needle diameter

Needle hubs are color coded based on the _____________ size

gauge

how are needles labeled

a number, followed by a G, followed by another number

Needle nomenclature for 22G ½

1. 22 refers to the gauge (G)

2. "G" is an abbreviation for gauge

3. ½ refers to the length of the needle in inches

Select gauge depending on type of ______________ being transferred

solution

There is an increased risk of coring with _________ gauge needles so only use when necessary

smaller

_______________ is commonly used for sterile compounding

18 gauge

needle gauge and length for 1, 3, and 5 mL syringes

20 gauge and 1 inch

needle gauge and length for 10, 20, 30, 60 mL

18 gauge and 1 ½ inch

needle gauge and length Large viscous solutions

16 gauge and 1 ½ inch

types of needles

1. transfer needles

2. filter needles

3. vented needles

2 needles joined with plastic hub used to transfer solutions directly from one container to another without a syringe

transfer needle

Filter embedded within the hub used to To prevent pieces of ampule glass/unwanted material from being transferred into final preparation

filter needle

A needle with side openings used to reconstitute powered medications used to prevents pressure differences and minimizes spraying and foaming during reconstitution

vented needle