Implementation of 5S Methodology to Improve GMP Compliance in a PET Radiochemistry Cleanroom

Objectives: There are often significant challenges associated with maintaining a working cleanroom environment within a GMP-regulated PET Radiochemistry Facility. Limited space is a common problem due to the requirements of large hot cell enclosures for radiation safety purposes. This can lead to the accumulation of materials and consequently a disorganized, inefficient workspace. In addition, the need to minimize microbiological contamination in a high traffic area adds another layer of complexity to cleanroom operations. The concept of 5S has emerged as an important tool in creating a Lean workplace environment. Generally speaking, 5S is an organizational tool designed to identify and eliminate waste and increase efficiency. The application of 5S methodology to a PET Radiochemistry cleanroom environment represents a unique way to improve process flow, reduce contamination, and identify critical space needs.

Methods: The 5S methodology consists of the following steps: Sort, Set in Order, Shine, Standardize, and Sustain. A “red tag” exercise was conducted to identify critical versus unnecessary items in the work area. An analysis of the minimum and maximum quantities that should be stored inside the cleanroom was also performed. A suitable offline location was then found for items that were seldom used. All necessary items were then set into individually designated spaces based on ease of workflow. For larger items on the benchtop, taped outlines delineated the position of each item. For those “loose” items required for drug product vial assembly, custom designed bins were printed in-house on a Lulzbot TAZ 3D printer. Each color-coded bin is designed for a specific drug product and has distinct sections for different materials. They are also specially designed to be easily cleanable for use inside a cleanroom environment. Shelves were also installed under the countertops to relocate equipment and free up benchtop space.

Results: There were some immediately observable benefits after the implementation of 5S methodology in the PET Radiochemistry cleanroom. The use of the custom designed bins for supplies has minimized the chance of forgetting a material, and therefore minimized movements in and out of the cleanroom. This has obvious benefits for the control of microbiological contamination within the room. The cleanroom itself is less cluttered, with obvious visual cues for equipment and materials. The staff can find materials faster and can see quickly if something is missing. In addition, the removal of excess materials from the cleanroom has made the disinfection process easier, faster, and more efficacious. All of these factors have contributed to less stress on staff members during production. This process has also been instrumental in identifying critical space needs and justifying the request for more space, if necessary.

Conclusions: Overall, the 5S techniques employed inside the PET Radiochemistry cleanroom have opened up critical counter space, improved workflow, eliminated waste, and reduced employee stress. The focus now turns to the ability to standardize and sustain these efforts by setting a regular frequency with which these tasks are reevaluated. Staff training and compliance will be monitored on a regular basis. In addition, the possible benefits of the extension of 5S methodology to the rest of the laboratory space are currently being assessed.