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Critical Elements of Implementing Advanced Aseptic Technology

Feb 01, 2014


Critical Elements of Implementing Advanced Aseptic Technology

Feb 01, 2014

Knowledge – Collaboration – Discipline. These may seem like overused buzz words to some. Yet there is no more succinct way to describe the critical elements that drive successful delivery of a new or renovated manufacturing facility with advanced aseptic processing capabilities. Years of dedicated work by pharmaceutical and biopharmaceutical manufacturers in collaboration with equipment vendors and architectural and engineering firms have transformed the use of isolated aseptic filling lines from a novel approach to the reliable technology of choice. Quality of designs and the ability to qualify dependable, efficient bio-decontamination cycles are better than ever, yet this success does not come by chance. It results from minding the heart of aseptic facilities, the isolated filling line, understanding critical design facets and literally building a truly integrated facility around it. Doing this well requires a team with diverse technical and interpersonal skills, a team with a strong foundation of Knowledge about the technology, a Collaborative approach to achieve the best result possible and the Discipline to execute in an organized, efficient fashion.

Yes, it is true that these key elements make any project more successful. What separates the design of advanced aseptic facilities from most other types of projects is that teams simply cannot succeed without all of them in place. When technology is simpler, star technical leads, architects or construction management firms may be able to save the day when a project is not running so well. Their creative workarounds may make up for missed details in one place or another, sometimes even without significant cost penalties. The integration required in advanced aseptic processing facilities will not allow late-game heroics to make things right without consequences, including higher cost, delayed schedule and challenges in qualifying a usable facility. This brings us back to the importance of a solid team maximizing the benefits of Knowledge, Discipline and Collaboration.

Let’s start with Knowledge. The decision of pharmaceutical manufacturers to select integrated aseptic filling lines with isolation technology is just the start. Teams must recognize that there is far more to the facility than a filling line wrapped in glass with glove ports. Isolated lines do not replace Grade A space for free. Part of the cost is hidden above the filling line in the form of air handling equipment, and its footprint is substantial. Now, add one or more freeze dryers with isolated automatic loading/unloading systems to the suite and you have significant technical space requirements in the facility for added HVAC and freeze dryer mechanical systems. The Knowledgeable team understands that the integrated fill-finish suite is the heart of the facility.

A practical positive effect of initiating an advanced aseptic technology project with knowledgeable foundation is that it prepares expectations appropriately. For example, more accurate budgetary figures reduce the chances of sticker shock by executives approving capital. A smoother approval process leaves more time to execute the project, for we all know that completion dates are never allowed to shift. The Knowledgeable team will identify areas of advanced aseptic processing which might require early training or development of qualification plans earlier than usual, as might be the case with bio-decontamination using vaporized hydrogen peroxide.

A group of brilliant people can become a collection of strong and opposing opinions unless, of course, there is Collaboration. When process equipment is such an integral part of a facility, as with isolators over-filling lines and freeze dryer loading/unloading systems, a partnership approach between the client, equipment vendors and the engineering firm yields the most positive results possible.

Commercial agreements and tight specifications are still important. However, working with top-quality vendors eliminates the need of using “how to” specifications with additional stacks of boilerplate documents packed with too much and sometimes antiquated information. In the past, these documents specified details like metal thicknesses, wire gages and other machine design details. It was a time when engineering organizations in pharmaceutical companies actually researched and developed detailed design for equipment and they were pulling equipment vendors to provide what they needed. Defining the “how” was necessary to bridge the gap between the early industrial designs of suppliers that had more experience in heavy industry, and the more elegant GMP solutions needed to meet more stringent function and quality requirements in pharmaceutical manufacturing.

Today, the tables have turned in several ways. Most pharmaceutical clients have reduced engineering expertise and horsepower compared to just a few years ago. Top equipment suppliers have specialized in the pharmaceutical sector for decades and they understand it well. Their designs are more mature and also more standardized with configurable options. Architectural and Engineering firms are also filling the void for facility and process design. Top firms have staff with diverse backgrounds, including owner and supplier experience. This new paradigm of more standardized designs, a shift of process expertise from pharmaceutical manufacturers to engineering firms and the ever-present pressure to control capital investment makes Collaboration essential.

Increased trust in equipment technology enables project teams to specify “what” equipment must accomplish functionally, a more process-based approach for which suppliers will offer their own configuration. In addition, teams must focus on the integration of equipment and on areas critical to aseptic manufacturing: e.g., isolators mating to machine base plates, how seals will be made to bezels of freeze dryers, consideration of performing bio-decontamination on the full line in one cycle or running cycles on smaller sections of the machine. Ensuring good overall integration is not a single check box task. It is something on which the team must focus throughout the project.

The size of advanced aseptic process equipment, including the supporting ancillary equipment, makes it the heart of the facility. The long lead time usually associated with this specialized equipment creates challenges that must be minded during project workflow. In order for engineering firms to progress with conceptual building design, clients must make technical decisions early so equipment arrangements can be placed into floor plans. Strategic decisions about certain technologies have an impact on design. For example, Single-Use and Ready-to-Use technologies versus traditional cleaning and sterilization could significantly reduce ancillary equipment and associated facility space.

Knowledge makes an excellent foundation, and Collaboration between pharmaceutical clients, equipment vendors and engineering firms creates the potential for success. Still, there are so many important decisions to make and so little time. This is where Discipline comes in. It starts from the ground up with a well-defined business case. It is important because difficult decisions about technology and scope will be tested against it throughout the course of the project. Then Discipline takes form as a multi-skilled team using appropriate project management tools.

Risk analysis tools will identify potential problems early. One risk could be the ability to deliver the project on time. Another could be the need for an equipment specification outside a vendor’s standard offering. More tools in the toolbox enable Knowledgeable and Collaborative teams to manage and reduce such risks. Focusing on the critical path will often include paying special attention to delivery of the long lead aseptic equipment. Technical decisions and approval of design documentation by the project team are just as important to on-time delivery as the work completed by the machinist or welder. Use of Failure Modes and Effects Analysis (FMEA) on technical risks breaks them down to manageable problems that can be resolved through design. These are just a few examples of smartly using the right tool in the toolbox.
Wise organizations recognize that implementation of advanced aseptic technology requires a high-performing team. Teams with Knowledge who work Collaboratively and with Discipline are able to deliver results with confidence. 

This article originally appeared in the 2014 INTERPHEX Technologies Tours supplement from PharmPro.

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