Primary- the point of use (i.e. the hood)

Secondary- facility design (i.e. the building)

Put these in order from the area of greatest pressure the area of least pressure. 

Rest of pharmacy, hood, antearea, buffer area

(Greatest Pressure)

Hood

Buffer Area

Antearea

Rest of Pharmacy

(Lowest Pressure)

1) Laminar Air Flow Workbench

2) Biological Safety Cabinet (BSC)

3) Compounding Aseptic Isolator (CAI & CACI)

When you compound hazardous materials (cytotoxic drugs), the antearea is ISO class 7, and air flows from the antearea into the buffer area.

In a nutshell, the antearea has to be cleaner because of this.

Fill in the blank:

Engineering controls employed in sterile compounding use ________ through ____________ to create air of appropriate _____________.

Airflow

Filtration

Cleanliness Classification

True or False:

HEPA filters do not allow anything to pass freely through them.

False.

HEPA filters allow gasses to pass freely through.

Interception

Impaction

Diffusion

Electrostatic Deposition

Finish this sentence:

As particle size increases, ______ decreases and _______ increases in the HEPA filter.

Which of these is filtered with the greatest efficiency by the HEPA filter?

1) Particles larger than the MPPS

2) Particles equal in size to the MPPS

3) Particles smaller than the MPPS

Which of these is best able to penetrate the HEPA filter?

1 & 3

1) Particles larger & 3) particles smaller than the MPPS are filtered MOST effectively by the HEPA filter.

This means that 2) Particles equal in size to the MPPS pass through the HEPA filter easiest.

How many different types of HEPA filters are there?

Bonus if you name them! :-)

Two.

Type C Filter

Type K Filter

To refresh, give the particulate count for each class.

ISO Class 5

ISO Class 7

ISO Class 8

ISO Class 5 (Class 100) = 3,520 particles/m³

ISO Class 7 (Class 10,000) = 352,000 particles/m³

ISO Class 8 (Class 100,000) = 3,520,000 particles/m³

Fill in the blank:

Sterile products must be manipulated in an

ISO Class ____ environment or better.

This area is housed within an environment of

ISO Class ____ or better.

Sterile products must be manipulated in an 

ISO Class 5 environment or better.

This area is housed within an environment of

ISO Class 7 or better.

1) Occupancy State

(at rest, operational, etc.)

2) Particle Size

(0.5 microns and larger)

3) Locations where samples are taken

(not more than 1 ft. away from work site)

CETA

(Controlled Environment Testing Association)

What is first air?

What do you want to be careful about, regarding first air and your critical sites?

First air is air that is coming DIRECTLY from the HEPA filter that has not touched anything else first.

You want to be very careful that you never place ANYTHING between the HEPA filter and the critical site. (i.e. we want to make sure that only first air hits critical sites)

It's the turbulent area downstream of an obstruction and a possible source of contamination.

All objects placed in the hood have a zone of confusion.

Blower motor on top: Easier to clean

Blower motor on bottom: Helps to control airflow (pulls from top to bottom, which is what we want), generally quieter. 

1) Don't place your PEC near where doors are opening & closing.

2) Don't place your PEC in high traffic areas where lots of people are moving back & forth.

3) Don't place your PEC near where the air conditioner for the room blows.

4) Don't place your PEC too close to other airflow devices.

There should not be air exchange between the isolator and the surrounding environment unless the air has first passed through a HEPA filter.

(i.e. it should be at positive pressure compared to the area it's in)

What is the difference between a CAI and a CACI?

(in terms of how it relates to the person using it and the pressure of each)

CAI (Compounding Aseptic Isolator)

-at positive pressure to the rest of the room

-designed only to maintain an aseptic environment.

CACI (Compounding Aseptic Containment Isolator)

-at negative pressure to the rest of the room.

-designed to both provide an aseptic environment AND protect the worker from harm!

Compounding Isolators must be placed in an

ISO Class ___ cleanroom unless they meet three certain conditions, which are ______, ______, and _______.

Compounding Isolators must be placed in an

ISO Class 7 cleanroom unless they meet three certain conditions, which are:

1) Must provide isolation from the room

2) Must maintain ISO Class 5 during dynamic operating conditions

3) Must maintain ISO Class 5 during the transfer of materials in and out of the isolator

Establishing Standard Operating Procedures are necessary to reduce the change of contaminating the isolator by compromising the barrier between it and the environment.

What are some SOP topics we need to consider for CAI's?

1) The process by which material is taken into and out of the CAI.

2) The recovery (purge) time for air

3) Cleaning and disinfection protocol

True or False:

It's not necessary to use anything other than the built-in glove ports when you compound in a CAI.

FALSE

It is necessary to put on gloves on top of the built-ins (though difficult), because the built-in gloves are not aseptic. 

1) Must be filtered downflow of air for ISO Class 5 conditions (means air is non-recirculating and is externally vented)

2) Must be a means for safe material transfer (HEPA filtered, pressurized pass through for products into the CAI)

3) Exhaust must be HEPA filtered

4) Must operate at negative pressure to the room

True or False:

Primary Engineering Controls should be turned off at the end of each day.

FALSE.

It's better to leave them on all the time.  Turning them off messes with the air-balance of the room for externally vented devices, and there's a recovery time whenever you do turn the PEC back on where you just have to sit and wait.

Give key facts about low risk compounding, including:

1) the kind of products you start with

2) The number of products you can use

3) The B.U.D. at room temp, refrigerated, & frozen

4) Give an example of such a product

1) Low risk compounding starts with sterile products made by a licensed manufacturer.

2) Low risk compounding uses no more than 3 products, including diluent.

3) BUD: 48 hrs @ room temp, no more than 14 days @ 2-8°C, & no more than 45 days @ -5 to -10°C

4) An example would be injecting 5 mL of KCl into a 50 mL bag of D5W

Give key facts about medium risk compounding, including:

1) the kind of products you start with

2) The number of products you can use

3) The B.U.D. at room temp, refrigerated, & frozen

4) Give an example of such a product

1) Medium risk compounding starts with sterile products made by a licensed manufacturer.

2) Medium risk compounding uses more than 3 products (usually many products)

3) The B.U.D is 30 hrs @ room temp, 9 days @ 2-8°C, or 45 days frozen (-5 to -10°C)

4) An example would be a TPN (total parenteral nutrition) solution

Give key facts about high risk compounding, including:

1) the kind of products you start with

2) The number of products you can use

3) The B.U.D. at room temp, refrigerated, & frozen

4) Give an example of such a product

1) High risk compounding inlcudes anything where you start with non-sterile products.

2) # of products is not really relevant here

3) B.U.D. = 24 hrs @ room temp, 3 days @ 2-8°C, or 45 days frozen

4) ANYTHING where you started with a non-sterile product (like a non-sterile powder for reconstitution)

Outer cardboard boxes (like for packaging) should be limited to what area?

What must you do before you move those items into the next area?

the ante area

wipe them down & transfer to a cart/tote/etc.

True or false:

Nothing but sterile components and disinfected materials are moved into the DCCA withing the ISO Class 5 device.

Fill in the blank:

The _________ is only the portion of the PEC dedicated to the task of aseptic manipulation.

Fill in the blank:

The buffer area should maintain at least ISO Class ____ conditions for ______ and larger particles under ______ operating conditions

7

0.5 microns

dynamic

NOPE.

Only low-risk compounding.

The air pressure segregation in secondary engineering controls should be monitored:

1) Continuously

2) Daily

3) Weekly

4) Monthly

5) Every 6 months

Can sinks be near the PEC?

Why or why not?

Nope.

The moisture & drain cause microbial growth.

About what temperature do you want to aim for in your clean room?

And what humidity?

What's the #1 reason you care about these things?

1) between 64-68°F

2) 30-60% relative humidity

Besides simply the product, operator comfort. It's a lot easier to make mistakes if you're focusing on being sweaty and miserable.

-Injected into superficial layer of skin/dermis

- Small amount injected (≤0.1 mL)

-Wheal can result (several mm in diameter)

- Slow absorption, generally slow onset of action

-used for diagnostic tests, some vaccines, & skin tests

- injection into the loose interstitial tissues below the skin (outer surface of thigh, arm, abdomen)

- 0.5 mL to 2 mL can be injected

- We prefer this to be isotonic & non-irritating

- better blood supply = better absorption

- Used for acute, short term therapy of a few days

- heparin, epinephire, insulin (exception to use rule)

- injection into (skeletal) muscle

- Butt= 5 mL per cheek, Deltoid = 2 mL, Vastus Lateralis=infants

- Drug absorption usually faster than SQ

- Absorption can be prolonged by placing drug in oil or suspension

- Example: antibiotics, analgesics

- injection directly into a vein through a needle or catheter

-can be push, intermittent, or continous infusion

- rapid onset of action, predictable response

- no recall = drawback

- less limitation to volume: replace elecytrolytes, correct fluid imbalances, TPN

- acceptable for many irritating drugs (b/c the blood very rapidly dilutes the drug, minimizing the irritating effect

-injection directly into an artery

- can be used to deliver a drug to a specific organ/area (localized effect)

- high drug concentration delivered; not diluted by venous circulation

- often requires an infusion pump for administration (b/c it's hard to push against the pressure of the arteries)

- Examples: contrast media, some chemotherapies

- Complications: arterial spasm (when you put drug in there when it's not supposed to be) or gangrene (drug is irritating & causes infection)

Give the location of this route of administration:

intraperitoneal

abdominal cavity

example of use would be CAPD, a form of dialysis

Give the location of this route of administration:

 intra-articular

joint fluid

(arthritis)

Give the location of this route of administration:

Intracardiac

heart

(inject epinephrine straight to heart during CPR)

Give the location of this route of administration:

intraocular

Give the location of this route of administration:

intrathecal

Give the location of this route of administration:

Epidural

Give the location of this route of administration:

intraspinal

Give the location of this route of administration:

intraplural

Give the location of this route of administration:

intrauterine

1) Useful for drugs that are not affected orally

2) Effective for patients who are NPO

3) Assurance that the drug has been administered

4) Immediate response

5) Possible to vary drug's action/duration to your need

6) Correct fluid/electrolyte imbalances

7) Provide patient nutritional needs

1) pain on injection- pediatric patients especially

2) Requires aseptic technique to assure sterility (expensive)

3) No drug recall- you can only try to counterract adverse effects

4) Requires unique production & manufacturing facilities

5) Expensive-- drugs, supplies, equipment, trained personnel, complications, etc.

- longer term infusion therapy

-source of patient discomfort

-patients get bad impression of institute/caregiver

- adds to length of stay & cost of care

How long does phlebitis usually last?

Can you get it regularly, or is it a one-time deal?

Can you die from it?

-Usually lasts about a week

-Yes, some people develop it repeatedly

- Probably not, the vast majority of the time it is not life threatening

Give the symptoms present for each stage of the phlebitis rating scale.

0

1

2

3

4

0 = no symptoms

1 = tenderness above site

2 = tenderness + redness @ site

3 = pain on touch, redness @ site, erythmatous streak

       forms

4 = All of previous symptoms + vein feels firm to the

       touch, meaning infection is probably forming

-type of cannulation device (device used to enter the vein such as needles/catheters)

- location of said device

- duration of therapy

- insertion technique

- usually main of stainless steel

- non-thrombogenic surface

- small bore devices

- more easily inserted

- can be hard to keep in vein

-usually short-term therapy (24-72 hrs)

-tend to cause less phlebitis than other things

The ______ the gauge, the smaller the bore size of the needle.

Basically, do you want somebody sticking you with a 16 gauge needle or a 20 gauge needle?

larger

You want the 20, because it will be smaller!! :-D

-vein infusion set with attached resealable latex injection port

-used for repeat injections

Describe catheters & their properties, especially those pertaining to phlebitis.

- plastic tube placed in the vein

- can be made of various materials of varying degrees of flexibility (Silicon being the most flexible)

- catheters can be over-the-needle or through-the-needle

- available in different lengths & diameters

- Can be radiopaque (meaning you can see it on x-ray, which is useful for TPNs)

- tend to stay in the vein better than needles

-intended for longer therapy than needles

- higher incidence of phlebitis than needles

-location & cannula position (hand = higher chance of phlebitis, foream is preferred for longer therapy)

- A cannula rubbing against the vein wall will cause more phlebitis

- duration of therapy (longer = more phlebitis)

- insertion technique (good technique = less vein trauma & less phlebitis)

-poor insertion technique

-poor site care

Which came first, the chicken or the egg?

Basically, we're not 100% if phlebitis causes the infection or of the infection causes the phlebitis

Chemical irritation

pH

Osmolarity

-It's often caused by the drugs. Some of the ones we use are very acidic & thus, very irritating.

- We can adjust the concentration of the drug so as to make it less irritating

-We can use preventative drugs like heparin & hydrocortisone to prevent irritation

- We have even redesigned drugs entirely so as to make them less irritating (Amphotericin B)

In regards to pH & Osmolarity, which is more irritating?

Basic drugs or acidic drugs?

Hyper-osmolar solutions or hypo-osmolar solutions?

Acidic drugs have an increased incidence of phlebitis.  Even plain ole D5W has a pH between 4.5-5.5

Hyper-osmolar solutions are quite irritating as well, so we usually try to give them through large bore veins so as to quickly dilute the sol'n & quickly reduce osmolarity.

1) Particulate matter (coring a vial, undissolved drug, glass fragments from ampules... fix by filtering, even if slow & expensive)

2) Patient Age (Blood flow slows w/ age, veins become more fragile)

3) Infiltration (fluid where it doesn't belong, such as outside of the vein & in the tissue, caused by cannulation device displacement)

4) Nosocomial Infection (Hospital-aquired infection, 3-5% of patients develop, raises costs, caused by lack of sterility, poor site care, etc.)

5) Air Embolism (air introduced during administration, >5mL is critical & can cause death, remove air by priming sets)

6) Labeling (color coding tricks nurses, tiny writing)

7) Preservative toxicity (benzyl alcohol in babies)

8) Solution containers (pinhole leaks, single dose containers used as multi-dose)

9) Improper mixing (must shake bags well after addition, caution in adding drugs to hanging bags b/c you could bolus the patient)