Aseptic options for pharmaceutical packaging

Four aseptic packaging choices to consider. Today, various technologies targeting pharmaceutical and biopharmaceutical manufacturers are: (1) full class 100 cleanrooms, (2) isolators, (3) restricted access barrier systems (RABS), (4) single use systems. Which one is best for you?​1. Class 100 Cleanroom: Cleanroom technology was originally developed in the 1960s for use in the aerospace and electronics industries to avoid particulate contamination of small parts. Bacteria are particles, and the pharmaceutical industry soon realized that this skill could guarantee sterile air. aleksandarlittlewolf - www.freepik.comPharma-gowning-young-technologist-putting-protective-rubber-gloves-production-factory-freepik-web.jpg Class 100 cleanrooms are the most common in aseptic manufacturing (ISO 5 and A/B Class performance is equivalent), using a high-efficiency particulate air (HEPA) filter to remove all particles and bacteria. Large volume laminar or unidirectional air flow reduces the transfer of particles from one location to another. In the 1970s, aseptic filling was done on spec machines under HEPA filter panels. The machine parts above the container are a potential source of contamination, and over time they are moved as far as possible below the working level. To better concentrate the filtered air on the machine, plastic window coverings have also been added. The window cloth also reminds the operator to avoid touching the machine or product. Manufacturers turned to 100% HEPA ceilings to control entire rooms to class 100. This improves control, but increases capital and operating costs, especially the air handling system. 2. Opto-Isolators: In the 80s and 90s, isolators were developed to improve the barrier between people and products while reducing costs. The isolator is described as a clean room in a box. The entire process is closed in a sealed cabinet, pressurized with air filtered by HEPA filters. During operation, no operator is allowed to enter except through the glove interface. Image courtesy of chase-logeman anchaselogeman-isolator-web.jpg for isolation system (top unit HEPA filter not shown). Image courtesy of chase-logeman anchase-logman-isolator-inside-web.jpg feeds the isolator interior showing the glove port. After a production run, the isolator will be opened, cleaned, and ready for the next run. Once resealed, the isolator is filled with a sterilant, usually vapor hydrogen peroxide (VHP), to sterilize everything inside. Unlike traditional spray or scrub disinfection, VHP gets into the tiniest crevices. Once sterilized, any final setup is done through the glove port. In theory, it should be possible to operate the isolator in an uncontrolled space, such as a warehouse, by an operator wearing a lab coat. Theoretically it is. In fact, many companies have installed isolators in class 100 cleanrooms. This provides an extra layer of cleaning, but the value is to develop an isolator to avoid. 3. Restricted Access Barrier System (RABS): RABS is a compromise between an open system and an isolated system, RABS contains the process within a rigid enclosure. Operational interventions enter through the glove port. Syntegon Pharma technologies Syntegon-Pharma- products_filling and Closing_FXS_3100-web.jpg The open RABS extends to the ceiling, relying on the room's air handling and filtration system. Closed RABS contains its own air handling and filtration system. RABS has significant cost advantages over isolators because of its simplicity. This is especially true if they can be located in existing cleanrooms and then minimize construction costs. The need to build a clean room offsets some of the cost savings compared to isolators. 4. Disposable systems: Disposable product handling systems are becoming more and more popular in aseptic applications. These systems contain a plastic bag to replace the traditional metal can. The bag comes pre-packaged with everything filters, tubing, ports, filling nozzles, and other required accessories. It is sealed in a protective bag and sterilized. The manufacturer device completes the system sterile and ready for operation. Image courtesy of sartorioussaritus Img_OctoPlus-_4154-web.jpg Some manufacturers offer custom single-use systems, including Sartorius (its PreVAS - pre-validated, pre-assembled, pre-sterilized - Project Syntegon), Pall Corporation (its Biotech once Sexual Use System) etc. According to Marion Monstier, Sartorius Freeze-Thaw Products Manager, the advantages of single-use systems include: • Closed systems reduce product transfer and handling, reducing the risk of contamination. • Replacing single-use systems between product runs eliminates the potential for cross-contamination due to incomplete or inappropriate cleaning. • Compared to reusable systems, these alternative systems reduce changeover and setup time. • They eliminate cleaning validation requirements. • They drain better, thereby increasing product recovery.