Sweco Scandal

DEVIATION BACKGROUND:
On 10/18/2017, the granulation completed a full clean (#3) for Sweco TG1085 after a 10 batches campaign for HYPAM (4 batches of 25 mg GMID 50017724 and 4 batches of 50 mg GMID 50017725) occurred on 10/10/2017 – 10/17/2017 in TG9 (big Z-bar). However, while the authorized associate of the granulation equipment clean room was putting the parts away into the appropriate storage location; he discovered that the required cleaning green card was missing for the 14 mesh Sweco screen (TG1085), which he later found inside the process room. However, as he was matching the screen info from the green card, he discovered that the Sweco screen used is dedicated to BUDESONIDE.

ROOT CAUSE ANALYSIS:
Per routine standard practices and to prevent cross-contamination, If a screen is dedicated to a specific product or highly colored product, the date which it was placed into service, along with GMID(s) of the specific commodities are engraved in a very legible manner on the equipment. In order to understand the circumstances that led to this incident, several interviews were held with the operators and SMEs.

1- EQUIPMENT:

QA inspected the screen during this investigation and confirmed that the screen was engraved with the product name. It was also noted that the letters were not large enough to differentiate the screen from basic equipment info to special notation. Although, the equipment engraving could be adjusted to make it stand out, the equipment was not determined as the root cause for this incident as there was enough information to prevent similar incidents using current department batch preparation