Closely monitored project management is essential to the success of clean room manufacturing. This article showcases methods in which to approach a project involving a clean room and the differences involved whether purchasing the necessary equipment or outsourcing the responsibilities to a clean room manufacturing partner.

By Tom Opielowski, James DeLaHoussaye, and Chuck Hoar
On the cover: There is more to clean room assembly than eye-hand coordination—manufacturing here requires careful orchestration of design, component manufacture/sourcing, process development, associate training, and of course, the room and its equipment.
  • Outsource or in-house?
  • Stage management
  • Collection of subsystems
  • Addressing validation
In the long run, if a product is destined for clean room manufacturing, formal project management will be of a tremendous benefit. Whether a brand new product is being introduced into a clean room environment or a mature product is being relocated as a means of controlling costs, pursue a process that guides a cross-discipline team. It is an excellent way to introduce on time a high quality, profitable manufacturing program that meets customer specifications.

In this scenario, project management refers to a formal, step-by-step, managed transition of the product into the clean room. This article examines five steps to a successful project of this nature:

• As early as possible, understand each element—the product, the clean room, and the project management itself—as a system• Design the production environment• Execute on each step• Validate• Manage
Make or Buy?
An early step, at least for small to medium medical marketers, is to resolve the classic question, “Make or buy?” That is, should a clean room be built or should the clean room manufacturing be outsourced? Where many large medical device providers have access to internal clean room facilities, smaller companies and newer companies often do not. Many of the latter are turning to outsourcing, since this shifts the burdens of construction, capital, and operational costs to an outside supplier.
Typical stages in successful project management.
The Right Kind of Project
Every project has varying levels of intensity. The right program sequence places the most intense moments up front, where a poorly planned or badly executed project raises the level of activity and anxiety at the wrong time—when the product is being launched into production.

One of the best modes of project management is the stage-gate or phased project, in which there are five critical stages that typically follow initial product design. The initial planning phase is beyond the scope of this article—that is performed prior to design and production. Rather, the focus is on the second stage, which begins during the program execution phase (formalized project management).
Stage Elements
1. Business
planning &
cost estimates
  • Go-to-market needs (ideal price, distribution, supply chain)
  • Facilities audit (manufacture in-house or outsource?)
  • Regulatory audit (preliminary quality systems)
  • Stage 1 review: all elements complete?
    2. Process
    and tooling
  • Identify teams (design, manufacturing, production planning, quality, regulatory...)
  • ID milestones a review schedules
  • Ratify budget
  • Develop manufacturing procedures
  • Establish quality validation
  • Develop and obtain tooling
  • Develop and obtain fi xturing
  • Perform clean room audit (is facility ready for the processes and products?)
  • Stage 2 review: all elements complete?
  • 3. Tool
    & equipment
  • Confi rm tooling: in-house and qualifi ed?
  • Confi rm fi xturing: in-house and qualifi ed?
  • Prove-out tools & fixtures
  • Determine and schedule maintenance
  • Determine and schedule clean room monitoring and validation
  • Stage 3 review: all elements complete?
  • 4a. Production approval
  • Perform preliminary capability study
  • Validate suppliers & supplied components
  • Validate particulate control
  • Validate material fl ow
  • Validate product fl ow
  • Develop full production ramp plan
  • 4b. Process
  • Validate work station processes
  • Validate quality procedures
  • Document manufacturing procedures
  • Evaluate initial product: dimensions, functionality, aesthetics...
  • Finalize documentation
  • Stage 4 review: all elements complete?
    5. Production
  • Ensure closure of all project elements
  • Final capability study: throughput, lot sizing
  • First lot shipment
  • Evaluate costs, actual versus estimated
  • Complete & document hand-off to production
  • A well-executed project places the point of highest activity well before manufacturing launch. Doing so allows participants to handle issues thoroughly, rather than trying to bat down a growing number of gremlins that pop up as the result of incomplete planning.

    Process and Tooling Development
    There is a broad range of activities during this stage, ranging from the chartering of the teams to initial process development. The teams need to be drawn from all functional areas, including design, manufacturing, supply chain management and procurement, quality, and compliance.

    To ensure smooth transfer for outsourced programs, teams of similar functions need to be built both within the OEM and the contract manufacturer. The more closely these teams can communicate, the better, such as through the use of web-based tools. These can be used to enhance communications by facilitating transfer, mark-up and discussion of computer aided design (CAD) drawings, documents, schedules, and progress charts. Some may even include messenger functions and live forums or chat rooms.

    A key element in this phase is a full audit of manufacturing capability. This is naturally a key element in developing a relationship with a contract manufacturer. An OEM needs to pursue due diligence by examining, as thoroughly as possible, the technologies, approaches, and personnel available at the contract manufacturer.
    Conceptualize as a System
    In looking at the manufacturing infrastructures available, it is best to begin with a top-down or system view of both the facilities and the product being manufactured. There is ever-increasing awareness of the need to accommodate changes in product lifecycles and/or lower costs for a broad range of medical products. What might start out as an innovative, high-margin product may well evolve at maturity into a commodity. If that happens, cost reduction is mandatory if profitability is to be retained in the face of price pressure.

    Whether a product is new or mature, commodity or specialized, the best plan is to consider the possible effects of future price pressures, regardless of the current market or reimbursement practices. The medical industry will continue to face increasing scrutiny of its profit structures as time goes by.

    Low-cost manufacturing may well be in the future for almost any product. In this context of dynamism, a company almost certainly will benefit by stepping back to take a general look at clean room manufacturing. Rather than forcing a single product’s specific design on the clean room, take a moment to understand the systems and parameters of the clean room manufacturing environment then think about how to fit the manufacturing of a specific product into that environment. Doing so can provide tremendous flexibility.

    For instance, it can offer ways to evaluate clean room manufacturing options—including those available through outsourcing—for new kinds of products. These new products may well offer more functionality or exhibit more complexity than current designs. A system view allows you to pull products into a clean room ready for them, rather than pushing them on a facility that is unprepared.

    The greatest long term benefit of a system view is that it allows you to design or adopt processes and procedures that can remain in force across as much of the product lifecycle as possible. This includes an ability to design modular components and processes that can be relatively easily transferred into manufacturing in low-cost countries—a growing trend.
    The Clean Room as a Whole
    Clean rooms are not a single system but a series of subsystems, and are best viewed as a (changeable) place in which to execute (changeable) processes. Since change is a given, the more modular and easily reconfigured the clean room, the better. The subsystems include the systems around the physical facility itself; the production, or capital equipment system or systems; personnel systems, including training; and regulatory systems, including validation, registration, ongoing cleaning, maintenance, and revalidation.

    Modular components help today’s clean rooms achieve flexibility.
    Clearly, the physical structure of the clean room is the background against which all other systems play. The design and construction of clean rooms is a subject unto itself—in fact, it is the subject of several good books. Most of today’s clean rooms are modular, which means, in theory, any given clean room can be expanded to any size.
    Advantage: Outsourcing
    Clean room space is on average 20% to 40% more costly than conventional manufacturing space when both the structure and the equipment housed there is taken into consideration. Consequently, the tough job of capitalizing a manufacturing plant becomes even tougher when that plant is embedded in a clean room.

    Project milestone chart for transfer to production of a mature medical product. Blue vertical lines intersecting the timetable are a series of facility milestones. Project management, tooling, resin, assembly, painting, supply chain, and quality tasks are called out here and each task is subject to audit by the end of the project (Click here to enlarge).
    This is where outsourcing has a distinct edge over a captive clean room. A contract facility can spread the costs of building and capitalization across a number of OEM customers and products. The more customers and the more products handled by the outsourcing facility, the less cost levied against individual customers and products. Also, a company is likely to find a broader range of technologies in better outsourced facilities than in a captive clean room, in part thanks to the ability to spread costs across a broad base, and in part thanks to continuous, multiple customer demands.Outsourcing also relieves OEMs from day-to-day tasks involving manufacturing personnel. Recruitment, training, gowning, and detailed record keeping become the responsibility of the contract manufacturer. The same is true of the multifaceted maintenance and documentation aspects of registration, validation, and monitoring.
    Design of Production
    While nearly any production technology can be applied in a clean room, there are some that pose extreme difficulties. Procedures involving cutting or abrasion clearly are a bad fit, as those processes create particulates. Likewise, machinery with unsealed moving parts or hydraulic or pneumatic actuation is best kept out of the clean room, owing to the potential for contamination and particulates.

    Other processes, including thermoplastic molding, can be adapted to clean room production by opting for specialized equipment, such as electric machines with sealed motors fitted with closed material handling systems that feed from outside the clean room itself. In-room molding, despite higher initial capitalization costs, can offer overall cost savings by eliminating cleaning steps (and necessary quality checks on those steps), as well as wasteful extra handling of components and subassemblies.

    This kind of efficient material and component flow is a basic tenet of lean manufacturing and lean manufacturing principles dovetail especially well with clean room manufacturing. The workstation housekeeping, lack of clutter, and ergonomics that are highly prized in lean manufacturing are of obvious value in this environment as well. Equally useful is the modular approach both to the configuration of the workstations themselves and to the workflow from raw material to finished product. In addition, the continuous improvement inherent in lean is to any manufacturer’s advantage.
    Approvals and Validation
    Approval and validation first applies to the clean room itself. Here, the physical structure, the filters and air handling, entrance airlocks, particulate monitors, etc., must come under scrutiny. Likewise, validation must happen for all equipment, including any molding machines, cleaning equipment, quality instrumentation, decorating equipment, and adhesive and assembly fixturing and equipment.

    Making the Low Cost Manufacturing Move

    Fortunately, resources in such low-cost areas as China and Mexico make such a move possible today, where five years ago, it would have been difficult. Highly skilled and motivated labor is increasingly available in low-cost regions, and contract manufacturers have developed methodologies for attracting and retaining the best. The personnel involved in clean room manufacturing and assembly have to be a cut above the norm. Interestingly, the clean room environment is one that tends to bring out the best in the best people, because working in the clean room, wearing special garments, and being aware of the special needs of products all contribute to a heightened sense of responsibility.
    For any manufacturing project, the transfer of design, drawings, specifications, and other engineering documents is paramount. They provide the basis for manufacturing engineering and serve as the backdrop for the design and validation of tooling and fixturing.Finally, all outsourced materials, components, and subassemblies must be evaluated. If assembly is being outsourced and the manufacturing partner is managing the supply chain, ensure that the partner’s sources, methods, incoming inspection, and documentation all meet specifications.

    In the long run, process development and validation touches every aspect of medical manufacturing. Obviously, production is involved, but tooling, assembly, quality, and compliance are intertwined, making sign-off by those functions a necessity.For those projects where a mature product is moving to a new manufacturing location, it pays to examine the manufacturing procedures and the tooling to see if they can be upgraded, simplified, or otherwise modified for the better.

    The final moments of transfer prior to moving into full production can be a flurry of checklists, validations, and tying-up of loose ends. However, provided that program management to this point has been rigorous and has enforced the completion of all requisite steps prior to moving on, this point in time can be a reasonably satisfying one.

    This stage, of course, is a time of intensive training. Clean room assembly and manufacturing personnel need to become familiar with methods and procedures. Easily seen poster-sized procedure sheets or projected computer images for ready reference are examples of techniques that can compliment this step.
    The last stage—launch—is a point of new beginnings, and potentially, of new projects. Provided that the transfer from design to production has been handled well, these new projects (whether they are designed to increase throughput, reduce costs, or improve quality) will have a solid grounding on which to build. If the clean room manufacturing is outsourced, adopt the means for continuous communication with the contract manufacturer to realize additional benefit—not simply for production numbers, but for ongoing improvements, as well as for monitoring of the clean room and its equipment and personnel.
    There can be no doubt about it: successful clean room manufacturing depends on successful program management, and is highly dependent on the quality and rigor of the projects that fall between the release of design and the launch of full production. The skills needed, whether in-house or outsourced, include much more than baseline manufacturing, and encompass technologies, attitudes, experience, and dedication out of the ordinary.
    For additional information on the technologies and products discussed in this article, visit United Plastics Group Inc. online at

    Tom Opielowski is the vice president-Asia at United Plastics Group (UPG) Inc. and Chair, UPG China. James DeLaHoussaye is the director of program management and global tooling for UPG. Chuck Hoar is vice president of sales and marketing. UPG—with headquarters at 1420 Kensington Rd., Suite 209, Oak Brook, IL 60523—is a contract manufacturing partner to a variety of industries, including medical device. The authors can be reached at,, and respectively.