Compounding Fundamentals: Sterile, Nonsterile, and Unit Dose Pharmacy Operations

Standard Precautions

Infection prevention practices developed by the CDC and OSHA that all healthcare personnel must follow.

Core Elements of Standard Precautions

• hand Hygiene

• Use of personal protective equipment (PPE)

• safe injection practices

• Safe handling of potentially contaminated equipment

• Respiratory hygiene/ cough etiquette

• Environmental cleaning and disinfection

Sterile Compounding (USP<797>)

Sterile Compounding involves creating products free from bacteria and other contaminants. It includes tasks such as:

• reconstituting injectable drugs

• Preparing Iv admixtures

• Transferring drugs using aseptic technique

To maintain sterility:

• Use cleanroom environments

• Wear PPE including sterile gloves, gowns, and masks

• Work in laminar airflow hoods

• Follow USP <797> regulations

Nonsterile Compounding

• Mixing creams, ointments, or suspensions

• Adding flavor to liquid medications

• Preparing customized oral capsules

OSHA’s Bloodborne Pathogen Standard

Pathogens come from accidental needle sticks, broken cut glass, contaminated equipment

Examples of Bloodborne Pathogens:

• Hepatitis B (HBV)

• Hepatitis C (HCV)

• Human immunodeficiency Virus (HIV)

OSHA requires employers to

• Provide PPE and proper disposal containers

• Train staff on exposure control

• Offer hepatitis B vaccinations

• Maintain records of any incidents

Vaccines

They help [prevent the spread of infectious diseases,especially in environments where exposure to bodily fluids or bloodborne pathogens is possible.

Key Point

OSHA requires employers to offer the Hepatitis B vaccine to all healthcare who might encounter blood or bodily fluids

Aseptic Handwashing Technique during vaccines

1. Remove jewelry, nail polish, and artificial nails

2. Wet hands, wrists, and forearms with warm water

3. Lather with amicrobial cleanser

4. Rinse downward from fingertips to elbows

5. Dry with a lint-free towel

6. Turn off water with a foot pedal or towel

Garbing - Putting on PPE (from dirtiest to cleansest)

1. Shoe covers (booties)

2. Hair covers (bouffant caps)

3. Beard cover (if applicable)

4. Mask (cover nose/mouth)

5. Aseptic Handwashing

6. Gown

7. Alcohol-based rub

8. Sterile gloves

Gloving Tips

• Only touch inside of gloves

• Pull gloves over gown cuffs

• Inspect for tears

• Apply alcohol rub if sterility is compromised

Product Compounding

Compounding refers to the process of preparing medications are not commercially available in the required form, strength, ot dosage. Two categories of compounding:

• Sterile

• Nonsterile

The Cleanroom and Laminar Flow Hood

Location matters: the laminar flow hood should be placed in a quiet, low-traffic room dedicated to sterile compounding.

HEPA filter: Filters out 99.7% of particles >0.3 microns. Never block or spray directly on the filter.

First air: Cleanest air from the HEPA filter. Always work within this area to maintain sterility.

Aseptic technique

Critical for preventing contamination

Key Points from USP <797>

Train and test compounding staff on sterile techniques

Media fill tests and fingertip sampling ensure ongoing competency

Clean the laminar flow hood:

• Before each batch

• Every 30 minutes during compounding

• After spill or suspected contamination

Clean the walls, ceilings, bins: Monthly

Use non shedding material

Clean in this order— sides— bar— work surface

Media Fill Testing

Stimulates the sterile compounding process using a solution that promotes microbial growth, such as soybean casein digest broth. If the technician contaminates the solution compounding, bacteria will grow—indicating a failure.

testing frequency

Category 1 & 2: Every 6 months

Category 3: Every 3 months

New Staff: Must pass 3 consecutive tests

Gloved Fingertip Testing

Purpose: To ensure no microbial contamination is introduced donning sterile gloves

Gloved Fingertip Testing Steps

1. Technician performs hand hygiene and garbing.

2. Press gloved fingers onto agar plate.

3. Incubate

• 48 hours at 30-25 C

• 5 days at 20-25 C

4. Read for bacterial growth

• Outcome:

• No growth = pass

• Growth = fail, requires remediation retest.

Process Steps Summary

1. Gather and clean all materials (use 70% IPA).

2. Maintain the 6-inch rule: Work at least inches into the hood

3. Wipe vial tops and ports with alcohol

4. Avoid critical site contract: Needle tips, vila tops, syringe plungers.

5. Use correct technique: Insert needle at 45 degrees (vials), 90 degrees (ampules), with the bevel up.

6. Inspect final product for clarity and particulates

Powder reconstitution

Use correct diluent (e.g., NS for Cubicin)

Match fluid tonicity:

• Isotonic: same as blood

• Hypotonic: fluid enters cells (can burst)

• Hypertonic: fluid leaves cells (shrinks)

1. Compounding Area Requirements

Compounding should be in an designated area, that’s clean after each use, with adjust light based on ingredient sensitivity, and clean equipment.

2. Equipment Calibration and maintenance

• Devices like the Baxa repeater Pump must be calibrated to disipense the correct volume

• Balances must be tared before each use

• Brass weights

3. Ingredient Standards

Use only USP-NF grade ingredients- the minimum acceptable quality standard.

Ingredients must be:

• Labeled with receipt and opening date

• First in, first out

4. Packaging and Storage

Use materials that won’t react chemically with contents

Protect light sensitive drugs with amber vials or light resistant bags

Temperature and humidity must meet the manufacturer’s guidelines

Repackaging decisions must be made by pharmacists only

Section 5: Documentation and Recordkeeping

four essential records in compounding:

• Master Formulation Record (MFR)

• Compounding Record (CR)

• Standard Operating Procedures (SOPs)

• Ingredient and Certificate of Analysis Record
  

6. Diluent or Base Product Selection

Each Iv medication must be mixed with a compatible diluent. Consult the package insert for compatibility

Section 7: Beyond-Use dating (BUD)

the date after which medication should not be used, due to potential loss of stability, sterility, or effectiveness.

• Factors that Affect Bud

• Type pf ingredient

• Dosage form

• Storage conditions

• Packaging

8. Final Inspection of Compounded Products

Use a light box:

• Black Background: Detects physical incompatibilities

• White background: detects coring (rubber fragments)

9. Compounded Product Labeling

labels must include:

• Patient’s name and ID

• Room number

• Medication name and strength

• IV solution and rate

• Date compounded and BUD

Adherence aids

Tools that help patients take medications correctly

Ex are dosage spoons, pill cutters, droppers and oral syringes

and pill organizers

Punch cards and Blister packs

Used mostly in long term care, punch cards or blister packs organize medications by time of daily dose.

Documentation for unit Dose Repackaging

Compounding Log: record for repackaged meds

Pharmacist Approval: signature required