Sterile compounding

sterile compounding is used to make what kind of preparations

• Injections

• Eye drops

• Irrigations

• Pulmonary inhalations

• Bath soaks for live tissue

• Implants

What is ISO?

stands for the international standards organization; this organization sets standards for air quality

• quality is determined by size and number of particles

What is there to know about HEPA filters?

HEPA provides the ISO 5 air for compounding

the air coming directly from HEPA filter is called the first air

Must be rectified every 6 months

Primary Engineering Control(PEC)

aka the hood

• provides ISO 5 air or better

• There are two types:

  • Laminar Air flow→air flows in unidirectional lines

  • Compounding Aseptic Isolator→ closed front PEC that can be in buffer room or placed in Segregated Compounding Area

Air pressure between the PEC and SEC

Needs to be positive

Secondary Engineering Control/SEC

the room that contains the PEC

• often called the buffer room because it provides a buffer of relatively clean air (ISO 7) around the PEC

Air changes per hour must be >30 in the SEC for non-hazardous

Anteroom in sterile compounding

connects the rest of the pharmacy to the buffer room/SEC

• provides ISO 7 or 8 air

• contains sinks, benches to facilitate garbing and preparation for compounding

• possess line of demarcation: separates room into clean and dirty sections

What pressure is required for sterile compounding between the buffer room and anteroom?

Postive pressure

What is a Segregated Compounding area?

this is a designated area with unclassified air

• requires a defined parameter around it

Personnel and training for sterile compounding

Need to have designated person

Must be trained & documentation initially and q12 months

What do staff need to demonstrate proficiency in prior to compounding sterile products?

• Hand hygiene

• Garbing and gloving technique

• Cleaning and disinfecting

• Sterile Drug preparation

Gloved fingerprint test

demonstrates competency in hand hygiene, garbing and gloving

Must be completed initially then every 6 months is CI or CII and every 3 months if CIII

Media Fill test

used to determine if a compounder can prepare a CSP with aseptic technique

Must be completed initially then every 6 months is CI or CII and every 3 months if CIII

Pass Criteria: Must remain clear liquid (no turbidity/cloudiness) after 14 days of incubation.

Types of sampling to know

• AIR SAMPLES: every 6 months
• SURFACE: every 30 days

• continuous air pressure monitoring

How often are PECs kept running?

PECs are preferred to be kept running at all times

If power outage occurs, what to do with PEC?

• Stop all compounding

• PEC needs to be cleaned and disinfected

• Apply 70% IPA prior to recitation of compounding activities

Note: PEC must be on for 30 mins before any compounding can begin

How is the PEC cleaned and how often?

PEC is cleaned daily and anytime contamination is suspected

• cleaned with a detergent, then disinfectant, then apply 70% IPA

Note: 70% IPA is applied very 30 mins

How to clean PEC:

• use sterile low lint wipes

• cleaned top to bottom, back to front

  • cleanest areas are done first and dirtiest are cleaned last

Which sites in cleanroom require daily cleaning and disinfecting

• PEC

• Pass through

• work surfaces outside PEC

• floors

These all get monthly sporicidial disinfectant

Which sites in the cleanroom require monthly cleaning and disinfecting

• walls, doors

• ceiling

• storage shelves and bin

• equipment outside pec

These all get monthly sporicidial disinfectant

Sterile compounding garbing order

1. remove anything on the body not clothing or hair ties

2. head and face cover then show covers while stepping across the demarcation line(in anteroom)

3. hand hygiene from hand to elbows with warm water and soap clean under fingernails and wash for at least 30 seconds

4. Don gown

5. enter buffer area apply surgical hand scrub ( chlorohexidine betadine)

6. don sterile powder free gloves

7. spray the gloves with 70% IPA

if garb is not soiled can be taken off and kept and reworn for current shift

What are ready to use medications

prepared iv bags or prefilled syringes that are not compounded

Automated equipment in sterile compounding:

Automated Compounding Device(ACD): aseptically transfers ingredients into a sterile final container interfaced with the EHR to prevent transcription errors

IV workflow management system: helps automate prep and verification

• helps to identify meds uses barcode scanning and PHOTO CAPTURE

How to set up items inside the hood

• all components wiped of with 70% IPA prior to entering PEC

• work performed 6 inches from the front

• Do not block spaces between the sterile objects and HEPA filter

  • place all items side by side

• open sterile syringes along the seal(not torn open)

Vial reconstitution in PEC

1. Swab the rubber stopper with a fresh 70% isopropyl alcohol (IPA) pad, rubbing back and forth.

2. Attach a standard sterile needle to your syringe. Pull the plunger back to draw in a volume of air equal to the volume of liquid you plan to remove.

3. Puncture the Stopper: Position the needle at a 45° angle with the bevel facing up touching the center of the stopper. Press downward and rotate the syringe upright to a 90° angle as the needle enters the vial.

4. Inject Air and Withdraw Liquid: Equalize pressure & invert

Ampule use in PEC

1. Clear Fluid & Disinfect: Wipe the neck thoroughly with a 70% IPA swab and let air dry.

2. Snap the Ampule Neck . Hold the base securely in one hand and snap the top away from your body using your thumbs.

3. Withdraw Solution with a Filter Device; Attach a filter needle or filter straw (typically 5-micron) to your syringe. Tilt the ampule slightly and insert the filter needle into the corner/shoulder of the ampule where fluid pools. Pull back on the plunger to withdraw the dose.

   

4. Replace the Filter Needle before injecting the solution into an IV bag or administering to a patient.

When is terminal sterilization required and what are the types?

for CSPs that are compounded with any non sterile ingredients

Types: steam(with autoclave) and dry heat sterilization

For drugs that are heat sensitive, how can they be sterilized?

Filtration using 0.22 micron filter

• If filtering is needed, bubble point test might be done to test integrity

How to avoid pyrogens?

Glassware and utensils should be rinsed with H2O and then depyrogenated with dry heat sterilization

• pyrogens come from using equipment washed with tap water

Immediate/emergncy use BUD

4 hours(any storage condition)

Category I BUD

• Room temp: 12 hours

• Refrigerated temp: 24 hours

• Frozen: N/A

category II BUD

• Room temp: 1-45 days

• Refrigerated temp: 4-60 days

• Frozen: 45-90 days

category III

• Room temp: 60-90 days

• Refrigerated temp: 90-120 days

• Frozen: 120-180 days

SDC vial bag bottle or syringe in ISO 5 BUD

up to 12 hours from puncture or opening

SDC ampule inside or outside of iso 5

any unused contents left in the ampule cannot be stored and must be discarded

MDC inside or outside ISO 5 environment

Up to 28 days from puncture or opening

When is the master formulation record needed?

Required whenever preparing a batch for more than one person OR when starting from non-sterile ingredients

Mnemonic: "MANY or RAW"

• MANY = Made for more than 1 patient.

• RAW = Uses raw/non-sterile ingredients (needs standard procedure written down).

What is the compounding record needed?

Rule: Immediate-Use Compounded Sterile Preparations (CSPs) made for 1 single patient under emergency/immediate care guidelines do not require a full Compounding Record.

• When it IS needed:

  • Immediate Use CSPs for more than one patient (batching emergency doses means a log/CR is required).

  • CI-CIII preparations

• Mnemonic: "LOG the BATCH & Category "

LOG required if Batching (more than 1 patient).

sterile compound labeling requirements

name, amounts or concentrations of ingredients, total volume, BUD, route of admin, and storage

aux labels for special handeling

and high alert meds should get a warning label

what to do if a recall

immediatly notify prescriber, pull all aftected csps to the pharmacy, quarintining remaining stock to see if any other lots are affected