Whether you are a new compounding pharmacist or have been around for a while, you know that compound pharmacies are unique. In your workspace, you have to gown and operate under strict contamination control protocols, but do you know why?
As the world’s clean air experts, Lighthouse Worldwide Solutions is here to help explain exactly what’s going on and why it matters!
When you imagine a cleanroom, what comes to mind? A sterile white room, filled with delicate equipment and workers gowned from head to toe? That situation definitely exists, but there are a wide variety of cleanrooms. The International Organization for Standardization (ISO) has a number of classifications for cleanrooms. These classifications range from ISO 1 to ISO 9, where ISO 1 is the cleanest and ISO 9 is normal room air. The classifications are defined by how many particles and their size are found in a square meter of air through regular testing. Typically in a pharmacy, classification is performed every 6 months, but routine monitoring should be conducted daily (if not continuously) to ensure classification standards are met.
The United States Pharmacopeia (USP) dictates that critical areas, or a central location where sterile work occurs, should be maintained at an ISO 5 classification. This means that there should be fewer than 3,520 particles, at 0.5 microns, in each cubic meter of air.
While the critical area is where the primary compounding occurs, the supporting areas around the central location are also important. This is where non-sterile components, in-process materials, equipment, containers, and formulated products are handled. These areas should be maintained at an ISO 6 or 7 classification, depending on the area’s applications. Behind the scenes, in the design of your pharmacy, the airflow between these areas also matters! But more on that later.
Consistently, humans are the main source of contamination in every form of a cleanroom. If humans are present, so is the risk of contamination. To prevent contaminating your materials, it is critical that you properly gown with approved gowns, gloves, face masks, etc. Regular training can help keep this top of mind.
Speaking of gowning, did you know it’s not for your safety? While gowning does protect you, it is primarily for the safety of those who are taking the medication. Thus, sloppy gowning practices don’t put you at risk: they put your patients at risk.
To maintain ISO classifications, routine or continuous monitoring of air particle contamination is required. As clean air experts, Lighthouse highly recommends continuous monitoring for best results. But this type of monitoring really only looks at nonviable particles. These are particles that are non-living organisms, so knowing their size and number is important, but it’s missing a critical piece of information…
Viable particles are living microorganisms, like yeast, mold, and fungi. This type of contamination presents a unique risk because it can grow and spread at an alarming rate. In a normal particle counter, they just present as a particle. But using an active air sampler will tell you if the contamination is viable. This type of particle monitoring is more complex, so it is not yet routine practice. It is, though, incredibly valuable.
The USP dictates that a compounding pharmacy must complete classification steps every 6 months to maintain its status.
In all cleanrooms, temperatures matter, but this is especially true in compounding pharmacies. This is maintained through air flow and carefully filtered HVAC systems. In a compounding pharmacy, your working environment should be between 20 to 25°C (68 to 77°F). This helps create stability in materials, as well as comfort for employees.
Air flow is one of the most important design factors in a cleanroom. Air flowing into a cleanroom needs to pass through a variety of filters and then it should continuously move. Stagnant air can increase contamination risk, whereas moving air can move contamination out of the room. But this does also mean there is the risk of moving contaminants. Thus, the cleanest air should be found in the strictest clean zones and move out towards less strict areas. For example, air should NOT move from an ISO 7 supporting area to an ISO 5 critical area.
This is called laminar flow! It is the foundation of a cleanroom air distribution strategy.
Your environment is critical in a compounding pharmacy, and sensors can keep you on track. These don’t even have to be complex monitors, like particle counters, but can be simple sensors to keep your pharmacy in check. These include air pressure sensors, humidity sensors, and thermometers.
In the 2019 USP <797> Compliance Survey, only 66% of respondents reported having a plan to establish formal environmental monitoring. As a reminder: a compounding pharmacy is a form of a cleanroom. The foundation of a cleanroom is being clean and the only way to ensure compliance and true cleanliness is through regular environmental monitoring. A contamination control plan (CCP) is how you make sure this happens. A CCP should include sample locations, collection method, and sample volume based on a critical risk assessment.
If you’re looking to up your contamination control knowledge and better understand your workplace, Lighthouse Worldwide Solutions recommends exploring their FREE Knowledge Center! The company has been the world’s clean air experts for 40+ years and have compiled that knowledge into easy to understand articles, videos, and white papers, which are all available for free through their Knowledge Center.