Single-use powder transfer bags can be removed, discarded and replaced when a manufacturing process is finished.
One word frequently surfaces during discussions on pharmaceutical manufacturing. That word? Containment. Because confining the toxic substances involved in the manufacturing process— like powder, dust and vapors—is a necessity for safety. And even microscopic amounts of those materials that escape into the air can harm workers and contaminate life-saving medications.
Containment lapses can result in manufacturing plant closures and huge losses. In 2009, one manufacturing plant closed after a virus contaminated a bioreactor. And the shutdown halted production of two medications that were used by 8,000 patients globally. The company lost $300 million in sales.
After six months, manufacturer began producing the medications again, but both drugs were still in short supply more than one year later.
Extensive Manufacturing Processes Include Many Points for Containment
Pharmaceutical compounds progress through a wide range of manufacturing processes before reaching patients. In tablet manufacturing, for example, chemical ingredients run through as many as eight different machines on their path to taking the form of a usable tablet.
The most common processing method, wet granulation, involves dispensing, blending, milling, drying, mixing and pressing, with ingredients relayed from machine to machine. This lengthy process provides powders with plenty of opportunities for escape.
High Containment Challenges for CMOs
Powder containment poses serious challenges for pharma companies that use contract manufacturing organizations (CMOs) to make their products. Pharma firms use CMOs so they can put more time into research, development and marketing; however, problems can arise because CMOs use fast-moving production lines and make many different products at the same time. The process of transferring powder from one container to another comes with a range of potential issues, including spillage and waste. And with a variety of active pharmaceutical ingredients used in a plant, CMOs face the difficult task of keeping them separated. Failure to do so can contaminate multiple products.
Biologics and Reducing Contamination
Machinery handles these powders through much of the process, but human operators still come into contact with materials and packaging at various stages. According to the National Sanitation Foundation, people pose the greatest risk of contamination — because even the cleanest environment can become contaminated by something as seemingly minor as an unwashed hand.
In addition to a company’s financial health, another type of health is at stake in the event of contamination. “Financial losses from ineffective powder containment can be devastating,” says Curtis Gingles, vice president and division manager, pharmaceutical/biopharma, ILC Dover, “but it’s the effects contamination can have on people that are a more important concern. Employees exposed to toxic pharmaceutical powders can face serious health problems, and if patients are given contaminated medications, it can be life-threatening.”
To comply with regulatory standards, CMOs must prove that their facilities and equipment are cleaned frequently and effectively. The cleaning and subsequent validation process, however, can be time-consuming and difficult to coordinate.
“Pharmaceutical manufacturers want a way to contain potent, potentially poisonous materials to give employees and patients better safety, and they want it to be easier to use than the systems they were using previously,” says Gingles. “They want to eliminate or minimize the challenge of cleaning their process equipment between production runs.”
The Value of Single-Use Solutions
Single-use, disposable solutions are valuable to CMOs because they reduce the need for a deep clean when switching processes. The plastic film material called ArmorFlex, for example, is a single use disposable used in ILC Dover containment solutions such as EZ BioPac single-use powder transfer bags, specifically designed to handle biopharmaceutical powders.
BioProcess International touts the advantages of solutions tailor-made for handling powders: “Liquid-handling systems are often adapted for dry-powder applications, but flow rates, handling characteristics, and dispensing volumes differ dramatically. ILC Dover’s purpose-built, single-use EZ BioPac system is designed specifically to contain and release dry powders. With single-use bags engineered for the task, it can deliver several advantages: reducing spillage, waste, and processing time by filling quickly and precisely, sealing completely and dispensing swiftly and cleanly, leaving no residue inside, and eliminating unwieldy barrels and containers.”
“Since single-use products significantly reduce the cleaning portion of the manufacturing process for CMOs, the time between production batches is shortened,” says Gingles. “This optimizes the efficiency of the entire operation, while protecting employees and patients from the effects of contamination.”
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