The latest regulations call for a shift in particle monitoring strategies.
By Mark Hallworth and Edward Applen, Particle Measuring Systems
For aseptic manufacture of pharmaceutical products there has been a shift, primarily due to legislative regulations.1 Traditionally, monitoring has involved the classic portable monitoring of a cleanroom. New regulations have led to a requirement for an automated, remote monitoring solution. Various steps must be undertaken to implement an automated monitoring solution for a non-viable particle counting system. The steps also apply if you later enhance the non-viable system to include a viable monitoring or other environmental parameter component.
There are several steps to be followed for the implementation of a system and the Good Automated Manufacturing Practices (GAMP2) guidance for the validation of these systems certainly forms the core of the requirements. A typical project follows the format design, build, install, test, and validate. Each of these has its own timeline.
Building the timeline
The key to a successful project is to ensure that all phases of the implementation are executed in a timely manner. The identification of each of the major steps can be presented as a GANT chart, which will also identify when obstacles, such as shut downs, need to be accommodated. Figure 1 shows a typical timeline GANT chart for a complete project.
 Figure 1. Project plan outline as a GANT chart. Image courtesy of Particle Measuring Systems. |
Each of these summary tasks can be broken down into individual tasks so that resources–both material and labor–are available. This becomes more critical when multiple components of a project are encroaching on each other. This often occurs during installation when different trades are vying for the same space and during validation when deadlines are tight.
System design
There are several documents3,4 that identify how best to design a particle monitoring system. Considerations include selection of sample points, which hardware to use for each application, and the relationship between risk vs. instrumentation. Figure 2 shows a typical system designed to monitor the environmental conditions within a cleanroom.
The driving factors in designing a cleanroom monitoring system should be defined in the User Requirement Specification (URS), the contents and format of which is fully described in the GAMP guidance documentation. Any changes required to a system that make it user-friendly should be incorporated as early in the project as possible to avoid costly changes to project scope later. When the speed required to implement a system does not allow sufficient time for the generation of a “perfect” URS, it can be subcontracted to a design company for preparation. It is important to ensure the end users or system owners review the document because the liability of using a system lies with them.
System installation
As can be seen from Fig. 2, there are many components to the installation of a monitoring system.
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Wiring. The infrastructure of wiring includes power cables (24 VDC, 120