Designing & Implementing Pharmaceutical Clean Rooms - Pharmaceutical Technology

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Designing & Implementing Pharmaceutical Clean Rooms
Overview of the key issues and choices to consider when designing and implementing a clean room for a new pharmaceutical product or process.


Pharmaceutical Technology Europe


Clean rooms are now used in a variety of industries, including microelectronics, nanotechnology, defence, pharmaceuticals and biotechnology. They range from small rooms and large suites to modular purpose-built structures feeding a comprehensive and complex maze of utilities and serviced equipment.

The principal function of a clean room is to protect the manufacturing product from contamination. In the pharmaceutical sector the commercial survival of the manufacturer depends on the integrity of the finished product. Therefore, it is important to identify a potential source of contamination, which could include the working environment itself.

However, it is important to remember that the quality control and standard operating procedure (SOP) requirements of a clean room are prerequisites for a successful clean room operation. A clean room can be defined as an environment where the supply, distribution and filtration of clean air and the material of construction are regulated to meet the appropriate cleanliness levels required and defined by the governing authorities to execute a validatible clean room.

Fundamental Design Clean rooms within the pharmaceutical industry cannot be considered in isolation. The decision to use designated space within a production facility cannot be taken lightly. They are expensive to build and operate, which gives the design team the task of balancing a number of factors:
  • What level of clean room environment is required?
  • Is there enough space?
  • Are the logistics surrounding the proposed facility affordable?
  • Does it fit the budget?

The design team will have to consider these options at the conceptual stage because different types of clean room design require different disciplines to lead the design and layout process.

Primary pharmaceutical clean room environments. For these facilities the process engineering equipment and piping layouts determines the strategy because they are key elements of the manufacturing process (i.e, the process will be the lead discipline). The clean room is likely to be a small offloading, vessel charging or dispensing suite.

Secondary pharmaceutical clean room environments. Here, the architecture of the room layouts and the air environment are the 'manufacturing vessels' where products and people populate a given space. The architecture or mechanical services are the crucial factor in getting a correct synergy in people and product traffic flows

Biopharmaceutical clean room environments. For these facilities, the process vessels and equipment, the room layouts, and the flow of people are equally important to the process. Both processes and architecture are the lead disciplines to produce an integrated solution.


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