How many myths are ingrained in your organization’s sterile compounding practices? Whether it’s the need for huge eyewash stations in anterooms or the infallibility of primary engineering controls, you might be surprised at how many faulty beliefs underpin these processes.

Abby Roth, BS, CMQ/OE, the owner of Pure Microbiology, and Daniel Kyes, CPhT, a regional pharmacy training and quality specialist at New England Life Care, discredited some of the more common cleanroom myths during NHIA24, in Austin, Texas.

MYTH: Compounding in a primary engineering control (PEC) ensures that the compounded sterile preparation (CSP) will be sterile.

FACT: “Aseptic technique matters! CSP sterility is dependent on aseptic technique and work practices,” Mr. Kyes said. “USP <797> provides very generic information, and leaves it to the organization to define appropriate technique and behavior. Your organization must have SOPs [standard operating procedures] on aseptic technique and cleanroom behavior. This includes elements like movement, organization, comfort level in the cleanroom, communication—we shouldn’t be talking a lot—ability to concentrate, sanitization and behavior.”

He described an experience doing remote observation of a particular cleanroom. “I said, ‘Why is Jim dancing in front of the hood right now?’ That’s not part of the job. We had a chat with Jim, and he no longer dances in front of the hood. It’s important to watch cleanroom behavior.”

MYTH: The technique and location of opening syringes and needles in the PEC do not affect the environment.

FACT: Technique and location matter. “Popping supplies through the packaging may be easier, quicker and more efficient than peeling open the packaging the way it is intended, but it also creates many more particles in the PEC,” Mr. Kyes said. One study found that peel-and-present generated dramatically lower mean particle counts than pushing the syringe or needle through the packaging: 938 compared with 17,937 for one 18-gauge needle and 269 compared with 2,397 for one 1-mL syringe, for example (Am J Health Syst Pharm 2008;65[15]:1443-1450).

“Perform all package manipulation downstream of your direct compounding area, and keep a clear zone 12 inches on both sides,” Mr. Kyes recommended. “And never manipulate your packages over open sanitized vials.”

MYTH: If a PEC is shut off, it must be allowed to run 30 minutes before use.

FACT: This differs by the PEC. “Each manufacturer specifies how long the PEC must run before use, but it’s not 30 minutes for any of them,” said Ms. Roth, citing a range of three to 15 minutes for several leading PECs.

MYTH: A plumbed eyewash is required to be in the anteroom if you compound hazardous drugs.

FACT: “This is not necessarily the case,” Ms. Roth said. “The need for plumbed eyewash is determined by the eye damage rating of the drug or chemical in the SDS [safety data sheet]. Having a giant green monster of an eyewash station in your facility generates more requirements for cleaning and plumbing. You only need that if you are handling chemicals or drugs that are eye hazard Category 1, causing serious damage that is not reversible within 21 days. Every facility must do a risk assessment on this; consult with your environmental safety experts.”

MYTH: Initial gloved fingertip testing must be collected in the PEC, so the sampling device doesn’t get contaminated.

FACT: Initial gloved fingertip testing is collected where gloves are donned. “Your position should be away from the doors and under a HEPA filter,” Mr. Kyes said. “Collection should use one plate per hand, with a rolling motion over the surface, sampling the pad of the finger. We do not mix with the actual tips of our fingers, so we shouldn’t sample like that either.”

MYTH: The viable air sampler should always be under a HEPA filter or pointing toward the HEPA filter in a PEC to ensure the filters are working properly.

FACT: Viable air sampling does not prove that the HEPA filters are working properly; rather, it assesses the microbial state of control. “If your sampler is under the HEPA filter, you’re going to have a really clean plate and you’re not going to learn anything,” Ms. Roth said. “Your air sampling locations should be focused on areas of risk, such as high human activity, points of lower to higher classification like pass-throughs and doors, and equipment and sinks.”

MYTH: Since we didn’t recover any microorganisms during our dynamic sampling, our CSPs are sterile, and we have a great microbial state of control.

FACT: No recovery during dynamic conditions is suspicious. “Just because you didn’t recover any microorganism doesn’t mean they aren’t there,” Ms. Roth said. “Everybody loves seeing zeros, but when we’re getting zeros during dynamic conditions, that’s not realistic. Compounding equals people equals bugs. If you have no growth at all, there are a number of possibilities to investigate. Are you cleaning before sample collection? Are you sampling under ‘not normal’ conditions? Was your media dried out? Was the sampling technique correct? Did the samples get lost in shipping or were not incubated properly?”

MYTH: Sterile 70% isopropyl alcohol (IPA) is a cleaning agent and is all that is needed to clean and disinfect the sterile compounding area.

FACT: Sterile 70% IPA is not a cleaning agent. “No matter how many people tell you it is, it is not, and you should not use it as one,” Mr. Kyes said. So what is it? “It’s a sanitizer and residue remover. Especially on stainless steel, it gives it that nice shiny look, but it does not contain detergent to remove dirt. It’s just sanitizing what’s there, so it falls under the category of a disinfectant. You cannot effectively disinfect a surface until it is cleaned, so you need an EPA [Environmental Protection Agency]–registered one-step disinfectant cleaner that can clean and disinfect in one application in the presence of a light-to-moderate soil load.”

MYTH: The diffuser screen on the PEC must not be cleaned because you could damage the HEPA filter.

FACT: All interior surfaces of the PEC must be cleaned, even the diffuser screen. “Don’t be afraid to clean the screen. Use a wipe or cleaning tool to apply your cleaning solution—don’t spray it into the filter,” Mr. Kyes said. “When your certifier comes in, they should be removing the screen as part of the leak testing, and that’s a great opportunity to clean the whole thing without any concern that you’ll gouge the filter. Then you can let the certifier put it back.”

“Be open to change,” Ms. Roth said. “Many of these myths exist because of the ‘this is what we’ve always done’ mindset.”

Mr. Kyes reported that he is a consultant to Baxter. Ms. Roth reported that she is a consultant to Equashield.