As clean air experts, we talk a lot about making sure that the air in a cleanroom stays as clean as possible. We do this to meet Food and Drug Administration (FDA) Good Manufacturing Practices (GMPs) in pharmaceuticals and keep our products on the shelves and helping people.
When we contaminants into a cleanroom, we risk harm to the product and, in turn, harm to the consumer. This also comes with painful backlash for the company. So how exactly do particles impact pharmaceuticals?
If the pharmaceutical is exposed to external particles, there could potentially be a negative reaction in the product. This could then harm the consumer. While medications taken orally might not have major repercussions, intravenous medications or those taken through the eye could have fatal side effects.
Why? Because our stomachs are high in acidity and can defeat a lot of contaminants, but our other internal functions are not designed to do so. This means that contamination from particles in the air or cross-contamination can have major impacts on the consumer’s health.
This is perhaps one of the most financially painful impacts particles can have on pharmaceuticals. If you’re not following FDA GMPs, the FDA could issue recalls or shut your facility down. The side effects of this are quite clear: closed facility and damaged public image. But more on that in a moment.
This FDA violation will haunt your company - not just in the eye of the public, but from the FDA’s perspective. You can expect an expensive, intensive reopening process and a close watch from officials moving forward.
At the moment, when a particle impacts pharmaceuticals, you’re going to experience some level of yield loss. If you catch the contamination quickly, the yield loss can be kept to a minimum. But if you’re only checking particles and cleanliness occasionally, the yield loss could be multiplied.
This is a long-lasting impact that particles have on pharmaceuticals: your public image. Ideally, you’ll be able to catch medications that are contaminated before they make it to the public and solely experience yield loss. But if contaminated products do make it to the public and people experience negative side effects, you can expect to find your company’s name permanently damaged.
In the era of social media and expecting accountability from businesses, this can be catastrophic. It’s extremely difficult to live down a recall, lawsuits, or negative press when a simple Google search brings them all up. This is one of the reasons why it’s so critical to catch contamination while it’s happening in the cleanroom.
As cleanroom clean air experts, we believe you can limit yield loss and prevent this from happening with air particles by following a few best practices.
Air particles enter cleanrooms no matter how much we try to prevent them. They come in on humans, gowns, materials, equipment (even cleaning tools), and some even slip through the filters.
But we can still put our best foot forward in preventing particles from impacting pharmaceuticals. What precautions can you take to avoid contamination?
A properly designed cleanroom is able to meet the appropriate International Organization for Standards (ISO) requirements for the level of necessary cleanliness - which involves maintaining particles only under a certain size and number.
To do this, a cleanroom uses positive pressure technology and proper cleaning protocols. To prevent particle traps, the room and equipment in the room should be made from non-porous and easily sanitized materials.
It should also be structured in a way that allows for proper separation and cleaning of materials as they enter. This will prevent particle contamination.
So how else does the room prevent particle contamination? Through a well-designed ventilation system with the appropriate filters for the size and needs of the room. The functionality of these systems are monitored through particle monitoring.
When it comes to monitoring the size and number of particles in a cleanroom, we recommend real-time monitoring. It’s the tried and true method to prevent yield loss and maximize production.
In real-time monitoring, a particle counter is constantly being used to monitor the particles in the room. When the particles exceed set parameters, the user is immediately notified.
Since the monitoring is happening in real-time, only the products currently or very recently in the cleanroom can be considered impacted. This severely limits yield loss.
While you could go with the method of using a manual particle counter to check particle counts after the fact, using real-time monitoring takes the task off your shoulders while improving accuracy. There’s an immense amount of power in equipping yourself with tools that work for you.
When it comes to preventing particles from impacting pharmaceuticals, you want to use tools that work for you to make the process as simple and as user-friendly as possible. The goal is to take the burden off your plate so you can focus on your workflow and production yield.
One tool we highly recommend that works for you is the Apex Z - a real-time particle counter designed for maximum workflow streamlining.
The Apex Z is a user-friendly, quiet, light particle counter built from easy to clean material free from particle traps. It has the largest battery life and shortest recharge time on the market, so you don’t have to worry about your particle counter going down at the most important moment.
With programmable SOPs and a traceable GMP workflow approach to collecting data, it’s a particle counter designed for today’s world. The integrated alarm light and self-diagnostics are designed to give you ease of mind in knowing that your particle counter is always working for you.
From the easy file transfers to the top-of-the-line production quality, the Apex Z is an example of a tool that works to streamline your workflow and limit particles' impact on pharmaceuticals. Want to know how the Apex Z can change your cleanroom and production? Contact us today to learn more.