Guidelines, Equipment and Supplies for Sterile Compounding

Patty Ghazvini, PharmD.

Assistant Professor of Pharmacy Practice

Florida A&M University

Special requirements

• Sterility

• Particulate material

• Pyrogen-free

• Stability

• pH

• Osmotic pressure

NABP Model Rules for Sterile Pharmaceuticals

• Policy and procedure manuals for compounding, dispensing, and delivering sterile products should be established and periodically reviewed.

• These records should be part of a documented, ongoing quality assurance program.

• Pharmacists and supportive personnel should be trained and adhere to hygienic and aseptic techniques.

Rules Con’t

• Sufficient reference materials about sterile products should be available

• Drugs and supplies should be stored, labeled, and disposed of properly

• Sterile compounding should be done in an area separate from other activities

Equipment, Supplies, and Devices

• Laminar flow hoods (horizontal and vertical)

- Used to control airborne contamination of sterile products during preparation.

- Horizontal flow hood are most commonly used, with the more costly vertical flow hoods being reserved for agents that may produce an environmental hazard.

HEPA filter – removes 99.97% of all particles 0.3 microns or larger.

Horizontal flow hood/Vertical flow hood

Laminar Flow hoods

• Downstream contamination – when any object comes between the HEPA filter and the sterile product, interrupting the parallel air flow.

• Cross-stream contamination – may occur due to rapid movements of the operator in the hood.

• Backward contamination – may be caused by turbulence created by objects being placed in the hood, or by coughing, sneezing, etc. by the operator.

Filtration/Filters

• Two types of filters:

- Depth filters – seldom used; microorganisms are adsorbed to the filter material.

- Screen filters – have a continuous uniform structure that consists of fixed size pores. Particles are larger than the pore openings cannot pass through the filter and are retained on the surface of filter.

- Example: “membrane filter”

Membrane Filters

• Thin microporous sheets made from a variety of plastics.

• Must have a pore size of 0.22 microns or less

• Eliminate the risk of air embolism• Hydrophilic filters are easily wetted and are

used for aqueous solutions.• Hydrophobic filters repel water but allow

solvents such as alcohol to pass

Syringes

• Basic parts: barrel, plunger and tip

• Come in different sizes ranging from 1 to 60 ml.

• As a rule, always select a syringe whose capacity is the next size larger than the volume to be measured.

Syringes

Needles

• Three parts:

- Hub

- Shaft

- Bevel

Large Volume Parenteral Solutions

• Bags or bottles containing larger volumes of intravenous solutions

• Packaged in containers holding 100ml or more

• Two types of containers:

- Plastic bags

- Glass bottles

Plastic Bags

• Advantages:

- Do not break

- Weigh less

- Take up less storage space

- Take up much less disposal spaceDisadvantages:

- Some drugs adsorb to the plastic

Glass Bottles

• Advantage:

- Administer drugs that are incompatible with plastic bags

Disadvantage;

- For solutions to flow out of a glass container, air must be able to enter the container to relieve the vacuum as the solution leaves and another administration set with a filtered airway must be used.

Small Volume Parenteral Solutions

• 100 ml or less

• Can be packaged as ampules and vials

• Ampules: Sealed glass containers with an elongated neck that must be broken off.

• Vials: Made of glass or plastic and are sealed with a rubber stopper

Ampules / Vials

Quality Control

• For each preparation of a sterile product or a batch of sterile products, there should be appropriate laboratory determination of conformity:

- Purity

- Accuracy

- Sterility

- Non-pyrogenicityWritten policies and procedures should specify

measurements and methods of testing.