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Sterile Compounding

What is Sterile Compounding?

Sterile compounding is the process of preparing medications in a sterile environment to meet the specific needs of patients. The sterile environment is critical because the medications are bypassing the human body’s defenses. This means the medication is likely being injected or inserted into the body with a more direct route to the bloodstream. This process is particularly important for patients who require medications that are not commercially available. Compounding allows the removal of ingredients that may be harmful to the patient due to allergies.

Sterile compounding involves the use of specialized equipment including sterile hoods and air filters. A clean and sterile environment is critical when formulating the medications.

Additionally, pharmacy technicians must follow strict guidelines and procedures to ensure that the medications they produce are safe and effective. Overall, sterile compounding plays a vital role in providing patients with personalized medication options that meet their unique healthcare needs.

Sterile Compounding vs Non-Sterile Compounding

Non-sterile compounding is still a very clean process. Pharmacy technicians wear protective garb, masks, gloves, and must routinely clean their compounding stations. Any bacteria or microorganisms that get by are no different from what we encounter in our everyday lives. These mediations are taken in a way that allows our body’s natural defenses to destroy any threat. This includes dosage forms such as ingestible medications (capsules, troches, liquid) and topical medications (creams, ointments, gels).

When medications are meant to bypass our body’s natural defenses, the environment in which they’re compounded must be sterile. This involves taking extra steps and precautions to ensure the sterility of the medications. The medications must be prepared free of bacteria and other potentially harmful microorganisms that our body would normally eliminate.

Both sterile and non-sterile compounding are essential in providing patients with customized medications that meet their unique needs.

Common Sterile Medications

Trimix Injections for ED

Trimix is a mixture of 3 ED medications. They are injected directly into the penis in order to help develop an erection firm enough for sex. The direct injection means it needs to be compounded in a sterile environment.

Phenylephrine Eye Drops

Eye drops must be compounded in a sterile environment because they are taken directly in the eye. Phenylephrine helps patients with post-operative inflammation. It helps manage fluids in the eyes by producing less and draining more.

Testosterone Injections

People who require testosterone supplementation may turn to testosterone replacement therapy (TRT) to help increase their levels. This form of testosterone is commonly used as an injectable because it provides the highest bioavailability.

Maintaining a Sterile Lab

Maintaining a sterile lab requires a strong effort. Our pharmacy must monitor the air pressure changes, temperature, and humidity on a daily basis. Additionally, the sterile room is certified every six months to ensure it meets the requirements of a clean and sterile environment. Every staff that enters the room must pass a recertification test. This includes 3 different forms of testing:

  • Media fill test: ensures we are filtering compounds properly.
  • Fingertip test: ensures we garb properly when entering the lab.
  • Multiple-choice test: ensures aseptic technique and rules and regulations are not forgotten.

The sterile lab is cleaned every month using both bleach and sterile alcohol from the ceiling to the floor, with all surfaces being wiped down.

The Sterile Compounding Process

Many steps have to be taken in order to compound in a sterile lab. The environment must be kept as clean as possible in order to make the best possible product. Before actually compounding, a pharmacy technician must:

  1. Check and log the pressure, temperature, and humidity of the lab.
  2. Wash hands with a surgical scrub.
  3. Put on garb from “dirtiest to cleanest.” This includes shoe covers, a hair net, a mask, and safety goggles.
  4. Wash hands again with an iodine scrub, all the way up to the elbow, making sure that the water runs down their arms towards their elbow as to not contaminate their hands.
  5. Dry one arm at a time with a separate lint-free towel.
  6. Anything brought into the lab must be sprayed down with alcohol before entering.
  7. Apply sterile hand sanitizer all the way up to the elbow before putting on gloves, following strict guidelines to maintain their sterility.
  8. Dress in coveralls, making sure no part of it touches the floor at any point, and ensuring only to touch the inside of the suit as to not contaminate its sterility.
  9. After spraying gloves down with sterile alcohol and wiping down all the surfaces, we are ready to start compounding.

An extensive amount of care must be taken when compounding sterile compounds.

Contact Us for Sterile Compounds

We understand that each patient has unique healthcare needs that may not be met by commercially available medications. Whether you require medications that are free of preservatives or are allergic to certain ingredients, our team of expert pharmacists can prepare customized medications that fit your requirements. We encourage you to contact us today to learn more about how sterile compounding can benefit you and to discuss your individual healthcare needs. Our team is always available to answer any questions you may have and to provide personalized guidance on the best treatment options for your specific condition.