GMP Facilities: The Magical Properties Of Yellow Tape (HVAC)

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Over the years we have seen many magic tricks on TV and in live shows; however, I always was intrigued by the magic of yellow tape – or the even more powerful yellow and black striped tape. One U.S.-based CMO recognized the need to conform to EU as well as FDA requirements, but it had a tough problem with the lack of airlocks for both personnel and materials. Between CNC to Grade D, there was an airlock (actually a storage room with gowning racks), but there was no discernable airlock from EU Grade D to the many C suites. As a solution, the company put a yellow tape rectangle segment that looked like an airlock outline on the floor adjacent to the door. When you needed to enter from the D space, you stepped in the “tape airlock,” put on another bootie (third one), sanitized your hands, and stepped across the line into EU Grade C!

The more powerful tape is the black and yellow striped version. A major pharmaceutical company had shoe-horned a high-volume filling line into an old building. Their fundamental problem was not providing enough room for a pathway to go from a busy, congested CNC hallway into the Grade C area. Realizing they had only enough room for two doors (or one airlock), they decided to place the yellow and black tape on the floor midpoint across the airlock and up both walls to the ceiling. In addition, they had a placard on the wall showing D/C, with the slash in black and yellow. Instant airlock! I asked them how that airlock was qualified and what the ACR (air change rate) was, and I received blank stares. Airlocks and Annex 1 are actually spelled out in the regulations. Not having a design that accommodates the regulations is not an escape clause. This case called into question the CMO’s design, compliance, and how they validated this and what criteria they used.

 

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More Magical Properties Of Yellow Tape (Virtual Cages)

That black and yellow tape from the previous case study has global applications. In an aseptic facility in the Eastern U.S., the magical tape was used instead of a product quarantine cage. I observed open trays of unlabeled, bright stock 10 R flint vials stacked 4 feet high on a pallet in a pedestrian walkway in the plant, with only an 8½ x 11” sheet of paper designating the lot number and product code taped to one of the trays. Directly adjacent to these two pallets were more stacks of vials, all of which appeared to be clear 10 R flint vials with a different lot number. These were all unsecured, uncontrolled, unlabeled, and vulnerable to future mislabeling.

Apparently, the facility’s warehouse was overwhelmed with product and had no physical space to secure the unreleased product, so the hallway (where visitors and employees alike traveled) was deemed good enough to store the vials, since it was protected by the black and yellow striped tape.

This facility was under consent decree just prior to this observation. The facility went through no renovation, was shut down, and is today a large warehouse that no longer functions as a manufacturing plant.

 

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