Issue link: https://www.e-digitaleditions.com/i/1112785
Tablets & Capsules May 2019 33 Effective engineering controls are critical during mate- rial transfer. Worker safety is the primary focus, but it's also essential to contain the material in a manner that causes minimal disruption to the manufacturing process. Hours lost in production can delay a product's release and result in lost revenue, so it's vital to choose produc- tion-line technologies and components that fulfill both safety and production needs. Containment during production SODF production is a complex, multi-stage process that involves transferring materials from one process to the next—such as from dispensing to granulation to blending to tablet compression to coating. Transferring powder in a contained manner that safeguards workers and complies with regulations can be a challenge [5]. The key difficulty is that powder transfer involves moving material from one closed system into a separate closed system that may or may not be compatible. It's important to ensure that the design specifications of the transfer equipment meet accessibility, batch-size, and containment-performance requirements and that the The increase in hormonal balance disorders, coupled with rising cancer rates, is driving a growing demand for more effective, better targeted medications to treat these conditions. Many of these medications require the use of highly potent active pharmaceutical ingredients (HPAPIs). According to a recent study, the HPAPI mar- ket was worth $14.4 billion in 2016 and is growing at a CAGR of 10.3 percent [3]. An API is classified as highly potent if it has an occu- pational exposure limit (OEL) at or below 10 micrograms per cubic meter of air. Working with such cytotoxic sub- stances in a complex manufacturing environment can be a significant challenge for manufacturers. HPAPIs require special handling and containment strategies to protect both operator safety and the drug product. As a result, the containment solution market is expected to grow rapidly as HPAPI use increases. With SODFs such as tablets, capsules, and sachets making up roughly 60 percent of the total pharmaceutical products market, manufacturers are facing increasing pressures and quality demands that require efficient, modular, and flexible processes [4]. Photo 1: A split butterfly valve (SBV) consists of a passive unit attached to a mobile container and an active unit attached to the processing equipment. When joined, the two units form a valve that enables contained and efficient powder transfer. Photo 2: The passive SBV unit on the charge bottle shown here includes a GMP passive cover to prevent contamination and damage during storage and transport.