Creating pharmaceutical products safely has never been more demanding. The quality control landscape is ever changing, and the pressure increasing to go to market quickly to meet patient needs. Gone are the days when big batches of blockbuster drug compounds were concocted in huge steel containers. Back then, the powder ingredients could escape, causing contamination and threatening worker safety. Times have changed.
These days, medicines are far more specialized. They’re crafted in small batches that demand high precision for absolute purity, maximum therapeutic effect for patients and worker safety.
Over the past few years, the industry introduced a new group of highly potent active pharmaceutical ingredients (HPAPIs). These HPAPIs let manufacturers create precisely targeted drugs that work faster at lower doses—and they’re extremely toxic. Workers must be protected from being exposed to even the smallest amount.
ILC Dover considered this drastically different environment and responded in 5 approaches to help pharma companies produce these new medicines safely.
Powder Handling and Containment
A long-standing factor in drug manufacturing safety is powder handling and containment. Back in the day, powders for compounds were dumped out of buckets into manufacturing equipment, which is messy, inefficient and can expose workers to toxic ingredients. One solution was using existing bags designed for liquid applications, but those bags were made of films that would break easily.
The DoverPac Containment System was designed with Eli Lilly to provide high levels of reliable containment during operations. The system consists of a tough fabric outer restraint, a durable film liner and safe, effective additives that deliver reliable, high-level containment.
In the drug manufacturing process, a safe, smooth transfer of powders is essential for product purity. An operations team must rely on an effective transfer and containment system designed exclusively for powders; many companies achieve poor results because they adapt a system made to transfer liquids.
To satisfy this need, ILC Dover developed the EZ BioPac system, which allows easy, precise filling and complete discharge of powders into process vessels.
Some pharmaceutical operations are hazardous. For employee safety, workers who handle HPAPIs must wear protective, powered air-purifying respirator (PAPR) systems that shield them from airborne particles, toxic drug compounds and chemicals. At the same time, these suits must provide good visibility and functionality. Many hooded PAPR systems include cumbersome wiring and designs that cause snags in the equipment and interrupt work.
ILC Dover engineered the Sentinel XT system with an ergonomic design, light weight and a battery system integrated into the suit to help workers be productive while keeping them safe.
In the past decade, pharmaceutical companies have realized a need for more efficient processes and changed from traditional manufacturing to agile, flexible operations. The changes affected the details of manufacturing and the equipment needed to remain competitive. We enable CMOs to quickly change what they are producing with no additional cleaning validations making them nimble and able to meet increasingly difficult timelines and projects.
ILC Dover continues to pursue our goal of helping pharma companies achieve safety in the future through forward thinking. We’re applying our experience in handling and producing HPAPIs to next-generation medicines called antibody-drug conjugates (ADCs) – highly potent, targeted biopharmaceutical drugs for the treatment of cancer. These drugs target and kill only cancer cells and spare healthy ones. ILC Dover is researching ways to engineer products that help companies bring ADCs to market in a way that protects both the drug and the people who produce it.
As the pharmaceutical industry adapts to evolving market needs, ILC Dover has engineered a variety of products that reliably support operations from R&D through production. Our systems improve profitability by reducing capital and cleaning costs, and they reduce the time that companies need to get their life-saving products to market.
SOURCE: ILC Dover