Issue link: https://www.e-digitaleditions.com/i/1244583
26 May 2020 Tablets & Capsules Some applications require more stringent cleaning, such as clean-in-place (CIP), wash-in-place (WIP), or wet- in-place methods. These techniques usually involve inte- rior spray nozzles, conveyor flooding, or a combination of both, and are useful for containing dust when disassem- bling the equipment. The biggest challenge in the clean- ing process, however, isn't wetting the unit but rather drying it such that a swab test can validate the cleaning. This is one area where conveyor parts that are manufac- tured for easy assembly and access without the use of tools become particularly beneficial. Hose design can also influence a vacuum system's effectiveness. Hoses should be light and sanitary for ease of use and cleaning. Recent advancements such as static-dissipative opaque hoses that include molded cuffs with sanitary fittings (Photo 1), have improved the practicalities of hose handling. The following are two examples of how pharmaceutical manufacturing clients achieved high-containment material transfer using customized pneumatic vacuum conveyors. Example 1: High-containment ingredient transfer and filling integrated into a containment facility Objective: A pharmaceutical manufacturer in Switzer- land needed to integrate a vacuum conveying system into a special containment facility for transferring and filling high-potency ingredients and excipients. The project's objective was to develop a closed-process concept that met OEB 4 exposure limits—1 to 10 µg/m 3 , including WIP cleaning. Solution: The system consisted of a material transfer compartment with an upstream material lock for inserting the various ingredient containers, a filling compartment integrated with a Type 316L stainless-steel pharmaceuti- cal pneumatic vacuum conveyor sized to suit the demand of the packaging line (Photo 2), and a container station with a docked double-flap container system for filling the multiple containers with the ingredients. Process: Containers with the high-potency ingredi- ents are first positioned over the material lock in the transfer compartment. Using the integrated gloves in the transfer compartment, the operator opens the ingredient Secure, hygienic vacuum conveying Vacuum transfer is inherently clean and contained because any potential leaks in the system leak inward, drawing outside air into the system rather than exhaust- ing the hazardous material out into the workspace. Sim- ple steps can be taken to minimize the potential for powder escaping and posing a danger to operators or the environment; examples of such steps include ensuring adequate venting at discharge or transfer points and using correctly designed connectors. In a vacuum transfer system, filtration and separation of the material from the airstream is critical. Commonly used O-rings or felt seals can be ineffective as a means of sealing the connection between the vacuum pump and the mate- rial areas, as they aren't designed for this type of applica- tion. An O-ring is designed to seal a shaft and a felt seal is porous and compresses when the filter is secured, which undermines the seal. Some modern filter designs are rated to capture particles as small as 0.3 micron. For even greater security, some systems include a secondary HEPA filter or an exhaust air adaptor to pipe the filtered exhaust air from the rear of the vacuum pump away to a safe area. Contained material handling isn't limited to pre- venting emissions during transfer. A safe environment includes being able to clean the equipment quickly and efficiently while avoiding the potential for cross con- tamination or dust explosions. Vacuum conveyors made from Type 316L stainless steel that use simple modules and feature tool-free disassembly are ideal for thorough and quick cleaning. Also, using common-size seals, nonadjustable clamps, and quick connects for everything from the valve actuators to the pneumatic connections will simplify standard operating proce- dures (SOPs) and save time during cleaning. Photo 2: This vacuum conveying system is integrated into a special containment facility for transferring and filling high- potency ingredients and excipients. Photo 1: Lightweight sanitary hoses with molded cuffs provide simple connection to a vacuum receiver.