By Gina Shaw
In a perfect world, your cleanroom’s environmental monitoring logs and certification reports would read like an unremarkable heart monitor: steady, predictable and reassuringly boring. But that’s not realistic. Everyone gets certification reports from time to time that involve an excursion, and investigating and remediating them is imperative to maintaining a state of control in your pharmacy’s sterile compounding areas.
“When you receive an excursion on your certification report, your goal is to return your cleanroom to a state of control,” said Jackie Jaskowiak, PharmD, an inpatient pharmacist specialist at UC San Diego Health. “Your corrective action plan must be documented and should include resampling of failed areas to confirm that corrective action was successful.”
The extent of the investigation should be consistent with the deviation(s) that were found, and should include an evaluation of trends, she noted during a presentation at the ASHP Pharmacy Futures 2025 meeting, in Charlotte, N.C. “There are quite a few types of excursions that can appear on your certification report. They could be related to your primary or secondary engineering controls, pressure, temperature, humidity and/or environmental monitoring.”
Not all corrective action plans are created equal. If a microbial excursion takes place, they are dictated by the colony-forming unit (CFU) count and the microorganism recovered. In an ISO class 5 space, action levels are >3 CFUs for a surface sample and >1 for an air sample; in an ISO class 7 space, >5 and > 10; and in an ISO class 8 space, > 50 and > 100.
Common microorganisms that could appear on your certification report include the gram-positive bacteria Bacillus, Corynebacterium, Micrococcus, Staphylococcus aureus and S. epidermidis, as well as the gram-negative rods Acinetobacter, Pseudomonas and Ralstonia. “There can also be various molds and yeasts identified,” Dr. Jaskowiak said. “Many labs not only provide a list of the recovered microorganisms but also the likely sources.”
In addition to viable airborne and surface samples, viable enumerations, and laboratory analytical results, your certification report should also include a sampling diagram, nonviable particle counting results, incubation parameters, the lot and expiration dates of the media used, and conclusions regarding out-of-compliance samples, she explained.
Most compounding pharmacists probably know the primary source of microorganisms and contamination in the cleanroom: the people entering and leaving the space. There are also materials such as shipping totes and cardboard boxes that contain supplies, which can harbor bacteria and fungi; food and drink; water sources; nonsterile dosage forms; and “inappropriate conditions within the restricted compounding environment,” such as damaged/missing seals on doors, pass-throughs or HEPA filter frames; cracked or peeling paint; and improperly caulked seams.
Managing People a Big Challenge
“People are by far the most challenging factor,” said Abby Roth, CMQ/OE, the owner and a microbiologist at Pure Microbiology LLC, in a separate interview with Pharmacy Practice News. “Once you get your cleanroom set up and your engineering controls certified, they will usually do their job on an ongoing basis. It’s once you throw the variable of people into the mix that we end up with a lot more issues: shedding of skin particles, illness, not wearing proper clothing, not behaving properly in the space. We’re the dirtiest thing in that room, and the source of most of the contamination that leads to excursion findings.”
Key steps in your corrective action plan should include reassessing work practices, cleaning, procedures, air filtration systems and sources of contamination, with a focus on eliminating the source of contamination, effective cleaning and resampling the affected area. Per USP <797>, if the levels measured exceed action levels, an attempt must be made to identify any microorganism recovered to the genus level with the assistance of a microbiologist.
That’s actually a shortcoming in the requirements of USP General Chapter <797>, Ms. Roth suggested. “A species-level identification provides the information needed to conduct a far more effective investigation,” she explained. “Even though the chapter does not require it, obtaining that level of detail gives you a fuller picture. The field is moving toward proteotypic and genotypic methods, which deliver more precise microorganism identifications. By contrast, other methods are more prone to error, increasing the risk of pursuing costly investigations and remediation efforts without ever addressing the true source.”
Crafting an Effective Corrective Action Plan
There are multiple options for documenting the steps of your corrective action plan, Dr. Jaskowiak said. “Some colleagues of mine use checklists with decision trees for what to do next; others use an SBAR [Situation-Background-Assessment-Recommendation] template for their investigations. At my institution, we have standard operating procedures (SOPs), and we keep formal letters that are placed in our regulatory readiness file, so that we have both an electronic and written copy of the investigation and remediation plan.”
A good starting point for any microbial investigation is to focus on the potential sources and reservoirs of the identified microorganism(s), Dr. Jaskowiak noted. She shared a sample certification report from her institution in which the gram-positive bacterium Micrococcus (often found on human skin and one of the most common bacteria found in cleanrooms) led to an excursion in the ISO-7 classified anteroom, with 6 CFUs detected.
“Our SOPs dictate that we reach out to infection control, who will respond with a written assessment and conduct a physical walkthrough of the compounding suite,” she said. “These teams are great at helping to decipher the reservoir for the microorganism.”
In this case, she said, they made several recommendations:
• Reevaluate adequacy of personnel garbing and work practices. Since Micrococcus spp. was identified in one sample of the anteroom, incorrect donning of personal protective equipment or aseptic procedures could be the source of contamination.
• Evaluate cleaning/disinfection procedures and logs. Are there any missing days on the cleaning log?
• Reevaluate operational procedures. Are supplies brought into the cleanroom properly cleaned and disinfected?
• Investigate facilities issues. Have there been any issues with your HEPA filter, HVAC system or any disruption or building materials in the area?
• Clean and disinfect involved area.
• Follow additional approved guidelines in SOPs and retest during dynamic conditions.
In the case of this particular excursion, Dr. Jaskowiak’s team determined that Micrococcus spp. was likely tracked into the cleanroom on either employees or supplies. “We had performed an audit on the previous day before the certifier arrived, which found that a pharmacy staff member who dropped off supplies on a supply cart did not wear gloves or wipe down the supplies with a one-step germicidal agent,” she said. “We performed remedial training of that staff member, including a detailed review of our SOPs, which was documented by our designated person.”
They also provided additional education to the pharmacists working in the cleanroom at the time. “Unfortunately, if one staff member thinks that they can bypass a work practice, it can cause other staff to think that they can do the same,” Ms. Jaskowiak said. "With some of our excursions that we traced back to frontline staff, in particular the non-pharmacy team members, we also added more visual alerts at the entrances to our sterile compounding areas on how to appropriately enter the space.”
Ultimately, she added, “we retested the space and no growth on any samples was found, so we were able to close out that investigation. The test results are always shared with staff at our department meetings, so it’s not just reeducating one or two people. We want to talk about these incidents and excursions with all staff to reiterate the process and why it’s important to protect the patient.”
Staff education is essential, Ms. Roth agreed. “If we don’t do a good job with the fundamentals of contamination control for new staff and existing staff, we’re going to have ongoing risks of excursions. We need to focus on behavior, hand hygiene, garbing, all the little things. If they are trained properly, it should become effortless.”
The opinions expressed by Dr. Jaskowiak are her own and do not reflect those of UC San Diego Health or UC Regents. The remaining sources reported no relevant financial disclosures.
