Cleaning Disaster or True Worst Case?

How robust are your cleaning validation measures? Could your storage procedures withstand the impacts of a fire within your facility, or would such a disaster set back your production time indefinitely? In a recent test at one client’s site, we discovered just how thorough their cleaning and storage procedures are, and whether they could endure a true worst case scenario.

During the recent execution of a clean hold study for one of our clients, our target time of 336 hours - or 14 days - was nearly complete for several wash loads. According to our client’s procedure for beakers and carboys, the product contact areas of our clean glassware were covered with foil while vials were placed in stainless steel bins with lids then stored in the clean hold area prior to sterilization. While we all understand that anything can happen at any given time, we usually do not expect an oven fire- which unfortunately, is exactly what happened. The oven fire dumped smoke into the entire clean storage area prompting an early shutdown of the production area, and threatening the results of our validation process.

After the fire and ensuing shutdown, our total hold time was at 1990 hours - nearly 83 days - well beyond our planned 14-day hold time. For this study, the acceptance criteria were < 0.25 EU/mL endotoxin and ≤ 10 CFU/100 mL bioburden from direct rinse sampling, and were focused only on the internal product contact surfaces. Because of this, the smoke residue and general air quality for the area should have no impact on the product contact surfaces of the glassware, providing the packaging material barrier was never breeched. With little to lose, we decided to proceed with rinse sampling and see how effective the cleaning and storage processes had been, keeping in mind that the extensive duration of our actual hold time over our planned hold time would have been an easy exception to justify in the final report of our protocol should any failure arise from sample results.

In this case, all samples met the acceptance criteria of < 0.25 EU/mL endotoxin and ≤ 10 CFU/100 mL bioburden, demonstrating the true robustness of the packaging and storage procedures as well as preventing the loss of the additional two weeks it would have taken to re-run the tests.

In most circumstances, a fire within a facility certainly would have a significant impact on production and validation activities. Had we not been looking at clean hold times, the test would have been aborted; a protocol exception would have been generated, then the test would need to be restarted after the investigation and exception were approved. In this case, the fire helped demonstrate that even after 83 days the acceptance criteria were met and there are, in fact, robust cleaning procedures in place. In the end, we had a worst case scenario instead of an absolute cleaning disaster.