Aseptic Technique in Sterile Compounding: Why It's a Matter of Life and Death
- candace846
- Jun 24
- 5 min read
In the world of pharmaceutical compounding, aseptic technique isn’t just a best practice—it’s a lifesaving necessity. Whether preparing intravenous medications, eye drops, or injectable steroids, every compounder bears the responsibility of keeping patients safe from harmful contamination. The tragic case of the New England Compounding Center (NECC) shows exactly what can happen when those standards are ignored.
What Is Aseptic Technique?
Aseptic technique is a set of strict procedures used to prevent contamination by microorganisms during the preparation of sterile products.
This is the level of cleanliness this guy is known for! Unfortunately, not everyone gets it right—and when they don’t, people can die. Yeah, it’s that serious.
Aseptic Technique Includes:
Proper hand hygiene (washing vigorously for 15 seconds with soap and water)
Use of personal protective equipment (PPE)
Sterile work areas and tools (according to USP <797> guidelines)
Environmental controls (HEPA-filtered laminar airflow hoods - vertical flow hood for hazardous compounds)
Validated cleaning and disinfection protocols (remember to clean with 70% isopropyl alcohol)
Sterile handling and accurate labeling
Every aspect of sterile compounding is built on preventing microbial intrusion. Remember, most sterile preparations are being used for patients with compromised immune systems, so even the common cold could lead to catastrophic outcomes.
The NECC Disaster: When Aseptic Technique Fails
In 2012, NECC, a compounding pharmacy in Massachusetts, shipped 17,000 vials of methylprednisolone acetate, a commonly used steroid, to clinics across 23 states. While shipping compounded medications is legal, pharmacies are only permitted to produce them with a valid prescription for an individual patient. Instead, NECC manufactured the drugs in bulk, operating like a pharmaceutical factory without FDA oversight...
The demand was so high, they ignored aseptic procedures to speed up the process. Their so-called cleanroom, “Clean Room 1,” was found to be unsanitary and unsafe. According to one technician, “the company got greedy and we got sloppy.”
To skirt the law, NECC fabricated fake patient names on prescription orders—including names like “Bart Simpson”—to appear compliant while they mass-produced and shipped tens of thousands of vials.
Hospitals ordered the medication because it was cheaper than going through the proper channels. Hospital staff assumed the medication was safe and began administering it, but the vials were contaminated with fungus—specifically fungal meningitis (a rare but deadly infection caused by contaminated injections). At first, doctors did not know what was causing patients to become ill, and unfortunately, delayed treatment for this type of fungal infection can be fatal...
The result was one of the worst public health tragedies in modern pharmaceutical history. Click on the link to watch the YouTube video below:
48 people died
Over 720 suffered from persistent fungal infections
Dozens spent months in hospitals enduring harsh and painful antifungal treatments
Some will live with permanent health damage
Why did this happen? Because NECC ignored proper aseptic technique and cut corners to speed up production.
What Changed: New Federal Oversight and the DQSA
The fallout from the NECC tragedy exposed critical gaps in the regulation of compounding pharmacies, particularly those operating on a larger, quasi-manufacturing scale.
In response, Congress passed the Drug Quality and Security Act (DQSA) in 2013. This law had two major effects:
Creation of "Outsourcing Facilities"
A new category of compounders was established: 503B Outsourcing Facilities.
These facilities can compound sterile drugs without individual prescriptions, but they must register with the FDA and follow Current Good Manufacturing Practices (cGMP)—the same strict standards applied to pharmaceutical manufacturers.
Clarification of State vs. Federal Roles
Traditional compounders (503A pharmacies) remain under state board oversight, but must comply with USP <797> and only create compounds with valid prescriptions.
The FDA was given greater authority to inspect, regulate, and enforce actions against non-compliant compounding entities operating outside the law.
Why This Matters to Every Compounding Pharmacy
The NECC tragedy wasn’t a result of bad luck—it was the predictable outcome of ignoring compounding protocols, especially aseptic technique. Greed is never worth someone else’s life.
Whether you’re compounding one IV bag or prepping for the entire ER, you have to:
✅ Know your training
✅ Respect the cleanroom
✅ Understand that sterile = safe
Every pharmacy staff member must understand that aseptic technique is not just a checkbox—it's a commitment to patient safety. Whether you're prepping a single-dose syringe or a batch of IV bags, lives are on the line.
“Compounding is an important component to pharmaceutical practice. When it comes to sterile compounding, it is crucial to follow guidelines outlined by the United States Pharmacopeia due to the risk for potential contamination. It is part of our job to minimize the risk of infection while ensuring the potency and integrity of the compounded sterile product. By strictly following these protocols, pharmacy professionals can protect patients from life-threatening complications as well as uphold the highest standards of pharmaceutical care.”
- Jordan Wilson, Pharm D - Clinical Pharmacist for the Indianapolis VA Pharmacy
A Few Words From KLR Graduate Kenzy Bryan
“It is important to maintain a sterile work environment while preparing IV medications because they are administered directly into the patient's bloodstream. The intent is always to help our patients heal, and the best way to do that is by ensuring no contaminants enter their IV. It is also very important to maintain proper aseptic technique with smooth and consistent movements, so there are no disruptions in your first air while working in the LAFW (IV hood). This goes hand in hand with maintaining your sterile work environment, because if done incorrectly, it can lead to contamination of the product you are preparing — a product intended to help your patient feel better.
As a Pharmacy Technician, I love knowing that whatever type of IV I make, it will be going to a patient who is relying on us to feel better again. I take great pride and passion in the work I do inside my sterile compounding room.”
-Kenzy Bryan, CPhT - Pharmacy Technician Team Lead at IU Arnett, and KLR Alumni
Closing Thoughts
What happened at NECC wasn’t just a mistake. It was one of the worst pharmaceutical tragedies in U.S. history, and the saddest part? It was completely preventable.
That’s why what you’re learning here matters so much. As future pharmacy technicians, you’ll be trusted with preparing medications that go straight into patients' bodies. There’s no room for shortcuts. That means knowing and following USP guidelines, practicing strict aseptic technique, and making sure proper hand hygiene is second nature.
Every time you step into a compounding room, remember this: you’re not just preparing an IV bag or filling a prescription, you’re protecting someone’s life. So take what you’ve learned seriously. Do it right. Do it safely. Every time. For every patient. That patient could be someone you care about. -Mr. and Mrs. Grisham
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