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Isolation and containment equipment for highly potent active pharmaceutical ingredients (HPAPIs)
 
Q: HPAPIs are becoming more common in solid dose manufacturing. How can isolation and containment equipment help manufacturers ensure safe and pure environments for working with these toxic compounds?
 
imageA: Gerard Geiger, Nilfisk, says:
 
In the last 5 to 7 years, pharmaceutical manufacturers have focused on developing highly targeted drugs that can treat patients faster using lower doses. This shift has brought with it a rapid increase in the use of HPAPIs, which are extremely toxic and can cause irreversible health problems. By one estimate, more than 25 percent of drug products worldwide are highly potent [1].
 
Traditionally, many pharmaceutical companies have used a five-band system to categorize API toxicity and determine safe protocols for handling compounds. Under this system, toxic APIs, meaning those in the occupational exposure band (OEB) of 3 or higher, typically require engineered controls for dust containment, such as an isolator or a dust containment unit [2]. Recently, with the increase in HPAPIs, some companies have added a new category—OEB 6—to their categorization system to account for increased toxicity, heightening the challenge for solid dose manufacturers because even nano-sized particles of these chemicals are extremely toxic.
 
Ensuring a safe and pure environment when working with HPAPIs requires specialized isolation and containment equipment. Use of containment equipment with tablet presses, capsule fillers, and blistering machines must meet manufacturers' specified containment performance targets (CPTs). A dust containment system designed to collect ultrafine particles can effectively help manufacturers reach those goals, reducing the risk of environmental contamination, preventing contact with the collected materials, and protecting operators from risk of exposure during the manufacturing process.
 
What distinguishes a dust containment system from a more traditional vacuum cleaner is the use of a Bag-In/Bag-out (BIBO) filter system, which means that operators have limited-to-no exposure to the dust being captured by the units, even while performing maintenance on the containment system. Each manufacturer can also test dust containment systems to ensure that the CPTs meet its own standards.
 
In addition to the ability to capture and retain toxic materials, you must consider three additional factors when evaluating isolation and containment equipment for use with highly toxic compounds.
 
First, how will the equipment integrate with your current manufacturing process? For example, you might use low voltage signals to transfer airflow information from one process machine to the next. In that case, your equipment must integrate seamlessly and allow you to solve any problems by placing the entire system on hold.
 
Second, does the equipment meet cGMP? Here, you'll want to ensure that the system is constructed of stainless steel and has the appropriate level of filtration, e.g., high-efficiency particulate air (HEPA) or ultra-low penetration air (ULPA) filters, according to the size of the particles it needs to collect.
 
Finally, what is the machine's footprint? If you're working in a confined space, the equipment must fit into a relatively small footprint.
 
The best way to meet all of those requirements is to have your vendor conduct a site assessment to discuss and evaluate your application's and facility's unique needs. That way, the vendor can help you select the right equipment for your manufacturing process.
 
Solid dose manufacturers are increasingly under the regulatory microscope to guarantee the quality of their products [3] and the safety of their workplace [4]. With the growth of HPAPIs, that focus on safety will only grow. Specialized isolation and containment equipment designed with HPAPIs in mind can help solid dose manufacturers achieve the goals of safe and pure.
 
 

Gerard Geiger is business development manager for the pharmaceutical industry at Nilfisk, Morgantown, PA. The company manufactures industrial vacuum equipment.
 
 
 
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