Compounding Flashcards
What is meant by ISO 5 room?
This is the level of air quality when compounding. The smaller the number, the less particle count and the cleaner the air.
ISO 5 - used in critical areas such as the sterile hood (PEC)
3520 particles/m3
ISO 7
The further away from the PEC, the dirtier the air.
ISO 7: the buffer area (SEC) - this contains the PEC
ISO 8
The anteroom must be ISO 8. This is where the hand washing and garbing occurs
Anteroom must be
-ISO 8, if opened up to a positive pressure room (non-HD sterile compounding)
-ISO 7, if opened up to a negative pressure room (HD sterile compounding)
HEPA Filters
-Removes >99.97% of particles as small as 0.3 microns
-Must be re-certified by a specialist every 6 months and anytime the PEC has been moved.
-Compound at least 6 inches inside the sterile hood to prevent exposing CSPs to dirtier ISO 7 air from the SEC.
Air Pressure when compounding HD and non-HD
Positive Air Pressure - when compounding non-HD
Negative Air Pressure - when compounding HD
What is a CAI?
Compounding Aseptic Isolator is a closed front PEC that can be located in a buffer room (SEC).
The closed front keeps the unclassified air around it from mixing with the clean air inside the PEC.
What is the SEC?
SEC - Secondary Engineering Control
The SEC contains the PEC or multiple PECs. It is commonly referred to as the “Buffer Area”
What is the Anteroom?
-This room connects the rest of the pharmacy to the buffer room (SEC).
-It contains a sink, cabinets and benches to facilitate garbing and preparation for compounding.
Line of Demarcation - this is a large visible line which separates the room into clean and dirty sections.
-The side closer to the access to the rest of the pharmacy is considered the ‘dirty’ side, and here the hair and face covers are donned.
-Shoe covers must be applied one at a time while stepping over the demarcation line.
-Handwashing and donning of gown occurs on the clean side of the anteroom.
What is an SCA?
SCA - Segregated Compounding Area
-This is an option when a cleanroom is not able to be installed.
-It is a designated area with unclassified air, such as a corner of a pharmacy
-It does not have a buffer area or anteroom, and can only be used for low-risk CSPs
MAX BUD: 12 hours
C-PECs for Hazardous Compounding
1) Biological Safety Cabinets (BSCs) - These have vertical laminar airflow and negative air pressure
2) Containment ventilated enclosures (CVE)a re powder containment hoods with HEPA-filtered air and negative air pressure for non-sterile compounding only.
3) Compounding Aseptic Containment isolators (CACI) are closed-front C-PECs (gloveboxes) that can be located in a buffer room (SEC).
Can we keep a sterile C-PEC and a non-sterile C-PEC in the same room?
yes, 1 meter apart
Air Changes and HD Compounding
Non-sterile HD: 12 ACPH (Air changes per hour)
Sterile HD: 30 ACPH
Hazardous Drugs Storage
-Stored separately
-Externally ventilated area
-Negative-pressure room
-12 ACPH
How to tell if staff has good aseptic technique when garbing and gloving?
Gloved Fingertip Test
-A passing score on the gloved fingertip test is required initially, then annually (low and medium risk CSPs) or semi-annually (high-risk CSPs).
-Passing requires 3 consecutive gloved fingertip samples taken after garbing, with 0 CFUs (Colony-forming units) for both hands.
-Ongoing competency: at least one sample taken from each hand immediately after completion of the media-fill test, with a goal of <= 3 CFUs total for both hands.
-The evaluator collects a gloved sample from each hand of the compounder by rolling the pads of the fingers and thumb over a surface which contains tryptic soy agar (TSA).
-The plates are incubated for 2-3 days and then inspected for microbial growth
How can you tell if adequate aseptic technique is done when preparing sterile drugs?
Media-fill test
-Preformed initially during training and at least annually
-Tryptic soy broth takes the place of the drug in the preparation. Multiple aseptic manipulations are done and then the product is incubated and checked for bacterial growth. Turbidity means contamination is present!
-IF the liquid stays clear after 14 days of incubation, the compounder passed the test
Temperature Monitoring
-Monitoring and documentation must be done on days when compounding occurs
ONCE DAILY: SEC room, Refrigerator and Freezer
TWICE DAILY: Refrigerator and Freezer if they contain vaccines.
SEC: <= 20 C
Refrigerator: 2-8 C
Freezer: -25 to -10 C
Air and Surface Testing
1) Air Sampling: Every 6 months
2) Surface Sampling: End of the day
3) Air Pressure Testing: Once daily to confirm the correct differential between 2 spaces and ensure that the airflow is unidirectional.
4) Humidity: Once daily. Maintained below 60%
Cleaning a Horizontal Laminar Airflow PEC
1- Clean the ceiling of the hood, from back to front
2- Clean the grill over the HEPA filter, from top to bottom
3- Clean the side walls starting from back to front, wiping up and down in a long sweeping motion. Clean the IV bar and hooks. Either the side walls or the bar can be cleaned first.
4- Clean anyting kept in the hood
5- Clean the bottom surface (the work area) starting from back to front, with a side to side motion.
Do not start compounding until the surfaces have dried.
Cleaning Hazardous Drugs
1) Deactivate (2% Bleach)
2) Decontaminate (Peroxide or Water)
3) Cleaning (Germicidal Detergent)
4) Disinfection (70% IPA)
Exposure to HD
1) For an exposure to gloves or gown, immediately remove the garb that has the drug on it.
2) Immediately cleanse any affected skin with soap and water
3) For an eye exposure, flood the affected eye at an eyewash fountain, or with water or an isotonic eyewash for at least 15 minutes.
4) Obtain medical attention when warranted
5) Document the exposure in the employee’s record
Administration of HD
-2 chemotherapy gloves must be worn when administering HD
-A Chemotherapy gown must be worn when administering IV HDs
Closed System drug transfer devices (CSTDs) are vial transfer systems that offer an additional level of protection against exposure. They reduce leaks and spills when withdrawing solutions from vials.
CSTDs have a built-in valve that equalizes the air pressure when fluid is added or withdrawn from the vial.
Different Colored Waste Bins
Black - Bulk HD waste (IV bag, drug vials
Yellow - Trace HD waste (syringe), PPE
Red - Infectious waste (IV tubing and used culture dishes)
Garbing for sterile HD
-Head Covers
-Face Mask
-Beard Covers
-2 Shoe Covers
-Impermeable Gown
-2 ASTM D6978 (Chemo)-rated gloves
-A full-face-piece respirator or a face shield with goggles when there is a risk for spills or splashes
BEFORE ENTERING ANTE-AREA:
1) Remove coats, Jewellery and make up
ANTE-AREA:
2) Head, facial hair covers and face masks
3) Shoe covers while stepping over the line of demarcation. A second pair is needed for HD.
4) Wash hands with soap and warm water working from fingertips to the elbows for 30 seconds.
5) Put on gown
C-SEC:
6) Enter the buffer area (SEC)
7) Apply hand sanitizer, and allowed to dry
8) Sterile Powder-free gloves. For HD, two pairs of ASTM D6978 chemotherapy rated gloves.
9) Sanitize gloves using 70% IPA. Wait until dried before compounding.
Torsion Balance
Aka. Class A torsion balance
-Used to weigh quantities < 1 g
-If weighing > 1g, use weights
-Torsion balances have a sensitivity requirement (SR) that is normally 6 mg. Meaning 6 mg can be added or removed before the dial moves 1 division.
Minimum Weighable Quantity
MWQ = SR / Acceptable Error Rate (0.05 or 5%)
MWQ = 6 / 0.05 = 120 mg
Capsule Sizes
000 - largest
5 - smallest
What is the purpose of a Surfactant?
A surfactant is added to keep 2 phases (oil and water) from quickly separating.
-Surfactants lower the surface tension between 2 ingredients to make them more miscible (easier to mix together).
Other names for Surfactants
1) Wetting Agents
2) Emulsifiers
3) Suspending Agent
4) Levigating Agent
5) Foaming Agent
Wetting Agent
Wedding agents are substances that reduce the surface tension between a liquid and a solid to permit the substance to more easily spread.
A fine powder that will be incorporated into a suspension is wetted with a wedding agent and stirred into a thick paste prior to being put into the delivery vehicle .
Example: Mineral Oil, Glycerin
Emulsifiers
An emulsion is a mixture of two or more liquids, which are not able to be blended together (immiscible), such as water droplets dispersed in oil, or oil droplets dispersed in water.
Emulsifier are added to an emulsion to help keep the liquid droplets dispersed throughout the liquid vehicle. This helps prevent the two liquids from separating a multipliers can be called emulgents.
Example: Acacia, PEG
Suspending Agents
A suspension is a solid dispersed in a liquid. Suspending agents are added to suspension to help keep the solid particles from settling.
Levigating Agents
Levigation and tituration are both used to grind down particles.
Levigation uses a levigating agent such as glycerin or mineral oil to aid in the grinding.
Trituration is the grinding of particles without the addition of a liquid.
Foaming Agents
These help in the formation of foam.
Anti-foaming agents: simethicone
HLB Number
HLB (Hydrophilic-Lipophilic Balance)
Range: 0-10
<10 : More Lipid soluble, and are used for water-in-oil (w/o) emulsions. [Lower - Lipid]
>10 : More Water soluble, and are used for oil-in-water (o/w) emulsions. [Higher - H20]
Excipients: BINDERS
Buyers allowed the contents of a tablet to stick together while permitting the contents to be released once ingested. They can provide stability and strength.
Examples: Acacia, Starch Paste, Sucrose syrup
Excipients: DILUENTS AND FILLERS
Tablets: Sugars such as lactose, mannitol, sorbitol, starches, calcium salts, cellulose
Liquids: Water, glycerin, alcohol
Topicals: Petrolatum, mineral oil
Excipients: DISINTEGRANTS
Facilitates the breakup of a tablet after oral administration. Alginates and cellulose absorb water, causing the tablet to swell and release its content.
Examples: Alginic acid, cellulose, starches
Excipients: Lubricants
These prevent ingredients from sticking to each other and to the equipment. This can be useful for tablet molds, and punches, suppository molds, and for capsule filling.
Example: magnesium stearate, talc, PEC, mineral oil, glycerin
Excipients: Preservatives
Do not use preservatives in neonates.
Examples:
-Chlorhexidine
-Povidone iodine
-Sodium benzoate/benzoic acid
-sorbic acid
-parabens
-EDTA
-Thimerosal
-Cetylpyridium chloride
Emollients
An emollient refers to a product that softens and soothes the skin. It is also called a moisturizer.
Occlusive ointments - petroleum jelly, theobroma (cocoa butter), beeswax, paraffin. These form a protective barrier to prevent the loss of water molecules from the top layer of the skin.
Humectants - these pull in water from the atmosphere to moisturize the skin. Glycerin, glycerol, propylene glycol, PEG, hyaluronic acid.
Ointments - 80-100% oil, 0-20% water [best for extremely dry skin and thick skin]
Creams - 50% oil 50% water [normal and dry skin]
Lotions - mostly water [oily skin]
Excipients to avoid in children
Alcohol
Benzyl Alcohol (neonates)
Excipient avoid in Phenylketonuria
Aspartame (contains phenylalanine)
Excipient to avoid in IBS
Sorbitol can cause GI distress in IBS
What is Comminution?
This means to reduce particle size by grinding, crushing, milling, vibrating or other processes.
Methods:
1) Trituration (Grinding into a fine powder)
2) Levigation and Spatulation (involves trituration the powder with a mortar and pestle and incorporating a small amount of liquid. This helps with the grinding process and creates a uniform paste.)
3) Pulverization by intervention (used for crystalline powders that will not crush easily. The crystals are dissolved with an intervening solvent and mixed until the solvent evaporates. When the powder re-crystallizes the particles are finer.
Geometric Dilution
This is a method of mixing ingredients to ensure that ingredients are evenly distributed in a diluent or delivery vehicle.
1) a small amount of the drug is mixed into an equal amount of the diluent.
2) after the initial small amount is thoroughly mixed, another equal amount of the ingredients is mixed in
