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News from Europe's pharmaceutical manufacturing industry coupled with upcoming events, and exclusive articles and interviews from industry experts.
Accidents by Flood and Field
A fire sprinkler named Katrina?
And again! "After several corporation changes, our division was sold, and we had farmed our distribution out to a contractor," our GMP Agent-In-Place continues. "A couple of years later, another fork lift operator raised the fork too high and broke off a fire-sprinkler head, soaking the operator and 43 full pallets of product. This time, however, the pallets were completely covered with plastic and stretch wrap, so the product could be salvaged."
Working in the drenches
"Arriving to work one fine winter morning, we found a flood of water cascading down the stairs of the laboratory and out the door," reports our GMP Agent-In-Place. "Not just a trickle, but inches of water! It had been an exceptionally cold night, and the fire sprinkler header pipe froze, then broke. Apparently the header pipe hadn't been insulated properly against extreme cold temperatures. Nothing much was damaged because the break occurred along an exterior wall, but the laboratory was out of commission for a couple of days."
My barrel runneth over
"It started as a routine, annual test of the emergency shower in the hallway—one of those where you pull the chain and stand under it to flush dangerous chemicals off," notes our GMP Agent-In-Place. "To perform the test, the mechanic moved an empty, topless barrel under the shower and pulled the chain. Because it was for emergency use only, no drain was provided.
"The shower got stuck in ON position, and the mechanic couldn't shut it off! The barrel overfilled, and the water started swamping the hallway floor and making its way to the production areas. The water was finally turned off at the source, and the mess was cleaned up After that, a local shut-off valve was installed at each shower!"
"We had an older facility—meaning it hadn't been refurbished or kept up to date," says our spin-doctor GMP Agent-In-Place. "In such facilities, the retain product storage areas are stuck in out-of-the-way locations such as the basement under the autoclaves. Then, the autoclave drain pipe leaked, flooding the retain samples stored beneath it, ruining the cartons, and rusting the cabinets.
"The corrective action was to put drip pans beneath the leaks to catch the water, and then pipe the drip pans to the floor drains. They couldn't be bothered to fix the source of the water, as that required moving the autoclave. Ultimately, the autoclave was replaced, the drain pipe was fixed, and the retain sample storage area moved to a more suitable location, but not until years later. Luckily, FDA inspectors never noticed."
Pharmaceutical Technology's monthly "Agent-in-Place" column distills true-life cautionary tales from the secret files of Control, a senior compliance
officer. If you have a story of clueless operators, oblivious management, inopportune lapses of judgment, or Murphy's Law
in action, please send it to Control at AgentinPlace@advanstar.com