Testing Compliance in the 2023 Pharmacy Cleanroom
With the revisions to the 2019 USP General Chapter <797> Pharmaceutical Compounding – Sterile Preparations to potentially come into effect at some point in 2023, there is no better time than to sit down and look at your efforts to meet and maintain compliance in your pharmacy cleanroom.
USP <797> incorporates compliance standards developed for the purposes of standardizing product quality and safety during the production process. Though stringent, these standards are in place to safeguard the compounded sterile product to catch any contamination issues at the earliest possible stage. Ensuring that end-user consumers can confidently know exactly what they are getting when a prescription is filled.
USP <797> covers a multitude of areas and breaks each down into sub categories. In this Article, we summarize a few important details when it comes to personnel and facility testing for your on-going compliance efforts.
Routine Staff Training
USP <797> puts a strong emphasis on staff competency training for the simple reason that compliance can be compromised through human error. For these standards (as well as your facilities policies and procedures) to truly be effective, everyone working on the staff needs to be properly trained. A well-trained staff understands how to avoid bringing contaminants into the classified environment, while also understanding how to properly sanitize and maintain the work stations.
Many sterility guidelines are straightforward and include relatively simple concepts. For Example: using sterile gloves, eliminating personal attire in favor of “sterile garb”, making training an ongoing effort, and performing regular lab testing to make sure that conditions haven’t lapsed.
While these policies and guidelines are easy to follow, they are often why lapses take place. Employees may forget something or cut a corner to expedite a process. Practices wishing to avoid the big regulatory messes must know they can stem from the small mistakes and should make training an ongoing priority.
Initial Employee Testing
New incoming employees should be screened for competency and required to pass several stages of observational tests before they can be considered fully onboard.
To perform initial employee testing, incoming workers replicate hygienic hand washing procedures as well as gowning and garbing. The objective is to make sure these employees understand the hygienic process, and that they will have the skills required to execute it every day without fail.
While new employee training/testing is important, it’s also vital to continue this type of training and refreshing to existing and seasoned employees on compliant and up-to-date practices.
All compounding personnel must be visually observed initially and every 6 months while performing hand hygiene and garbing procedures. The visual audit must be documented and the documentation maintained to provide a record of personnel competency.
Glove Tip Sampling Frequency
Following the initial hand hygiene evaluation, the standard is to have glove fingertip and thumb testing done. This form of sampling evaluates a compounder’s competency in correctly performing hand hygiene.
Before being allowed to independently compound, all compounders must successfully complete an initial competency evaluation, including visual observation and gloved fingertip and thumb sampling on both hands, no fewer than 3 separate times. Each fingertip and thumb evaluation must occur after performing a separate and complete hand hygiene and full garbing procedure. Gloved fingertip and thumb sampling must be performed on donned sterile gloves in a classified area or segregated compounding area (SCA).
After the initial competency evaluation, compounding personnel must successfully complete gloved fingertip and thumb sampling at least every 6 months after completing the media-fill test. Frequent testing is the backbone of clean, sterile conditions, to ensure that unforeseen circumstances don’t lead to prolonged corruption. The more often you test, the less likely prolific contamination will be.
Facility Design and Maintenance
Staff can only bear so much of the burden. ISO classified cleanroom purity at the microbial level cannot be achieved without the right facility design and environmental infrastructure.
Sterile compounding facilities must be designed, outfitted, and maintained properly to minimize the risk of contamination of compounded sterile preparations. The required air quality must be achieved and maintained through primary engineering controls (PECs) and secondary engineering controls (SECs) working together to support daily workflow and volume demands.
An effective microbiological air and surface monitoring program provides information on the environmental quality of the compounding area. In addition, an effective microbiological air and surface monitoring program identifies environmental quality trends over time, identifies potential routes of contamination, and allows for implementation of corrective actions to minimize the risk of compounded sterile preparations contamination.
Monitoring Microbial Air and Surface for Contamination
Air monitoring is a vital component of maintaining USP <797> standards. Microbial contaminants can easily hang in the air of a room that, by ordinary standards would be considered clean. From a cleanroom standard, however, these conditions are dangerous and unacceptable. Similarly, physical surfaces must also be routinely monitored for contamination. This can be done using periodic tests and contact plates to guarantee that ideal conditions are being maintained.
Microbiological air and surface monitoring must be conducted in all classified areas during dynamic operating conditions to confirm that the required environmental quality is maintained.
Following Sampling Guidelines
To make sure that testing is done properly, standardized guidelines are there to dictate how and what must be done. By following these standards, labs ensure that their definition of sterility is compliant with that established by USP <797>.
Sampling The PEC Interior
PEC refers to the primary engineering controls—the equipment used to develop pharmaceuticals. Sampling the interior of this equipment is an important component of ensuring that ideal lab conditions are being met and maintained. To make sure that testing is done properly, standardized guidelines are there to dictate how and what must be done. By following these standards, labs ensure that their definition of sterility is compliant with that established by USP <797>.
Sampling Work Areas Near The PEC
Similarly, it’s also important to take routine samples of the staging and work areas that are adjacent to the PEC. These stations are among the most touched places in the lab environment, making them a potential hotbed for contamination.
To that extent, any workstation or “frequently touched area,” should be considered a high priority for routine testing practices.
Sampling Surfaces Post-Compounding And Post-Shift
For surface sampling results to be considered accurate and within the guidelines, the test must take place during a very specific time frame. Evaluations must occur at the very end of compounding activities, but before the area has been disinfected. The idea here is to make sure that the surface test is evaluating the same conditions that took place during the processing and development.
How Often Is Air and Surface Sampling Required?
Because microbial contamination can occur in a split second, routine testing is vital to making sure conditions remain ideal. Air and surface monitoring must be performed initially for sterile compounding facilities to establish a baseline level of environmental quality. After initial sampling, the environment in which sterile compounding activities are performed must be frequently monitored (requirements indicate that tests should be done every six months at a minimum) to ensure that the environment remains suitable for sterile compounding. In addition to the specific sampling frequencies, sampling must be performed in the following circumstances:
In conjunction with the certification of new facilities and equipment
After any servicing of facilities or equipment
In response to identified problems (e.g., positive growth in sterility tests of CSPs)
In response to identified trends (e.g., repeated positive gloved fingertip and thumb sampling results, failed media fill testing, or repeated observations of air or surface contamination)
In response to changes that could impact the sterile compounding environment (e.g., change in cleaning agents)
Staying compliant is key both to maintaining a safe and healthy work environment, and to making sure that unsafe medications aren’t sent out to the public. To maximize the safety of your lab setting, test as often as you feel is necessary.
Stay in Compliance with Routine Personnel and Surface Testing
When it comes to maintaining a compliant pharmacy cleanroom, the stakes are high. Contamination can happen at any point, and when it does, you won’t usually know until after it is already too late. The more vigilant you are with your testing and training procedures the better prepared you will be to maintain compliance standards.
Staying on top of employee training is one way you can help keep your environment and employees safe. Train often and always make sure your staff is up-to-date with best practice protocols and understands the importance of guideline adherence.
Equally important, however, is to stay on top of your testing. Upcoming USP <797> standards indicate twice annual glove fingertip testing and surface sampling to remain compliant. These, at a minimum, must me following by pharmacy practices. However, you can always test more if you feel there is a risk of contamination, or if you just value being thorough.