A lighthearted look at the things that can go wrong with a clean room design, right in time for the holiday season.
A Christmas gift
Yah! Joe had finally gotten approval to build a new clean room as part of the building project he was responsible for. They desperately needed it to make the new sterile wonder drug his company had finally managed to get through clinical trials.
He wasn’t surprised – his business case had been stellar (a quick search and replace of the one he got from his mate who works at DownTheRoad BigPharma) and now he’d have a new clean room by Christmas. He couldn’t wait to run his hands over its smooth, shiny perfection-ness. No bacterium or fungi spore would dare enter his GMP temple of sterility.
The journey begins
Bob, the clean room builder, assured Joe that his engineer has designed and built many clean rooms before (although Joe was not sure if he was confusing clean room with cool room…). The first requirements meeting was held and the engineer asked surprisingly few questions – just nodded sagely. The engineer told Joe that he’d produce the initial clean room design and come back to him.
Meanwhile, Joe got caught up in the other aspects of the building project – the Quality department was threatening to walk out if their demands for an espresso machine weren’t met. Secretly, Joe wondered how long it would take for anyone to notice they were gone. Of course, no one wanted to the ask the Process guys, they were way too busy getting the Christmas rush orders out the door and just glared at anyone that went near them.
The clean room design arrives
Another endless building project meeting was held, and the design drawings were presented. The clean room was just part of the scope of works in that area of the site. It looked OK. Joe thought, “Really, it’s just a sealed box anyway, right?” He checked that it had doors, pass through hatches and windows in the right places and that the power points were correct for the equipment that would go in there. He confirmed with the engineer that the air change overs and HEPA filters would deliver the correct air quality. Bingo! Joe did a little self-congratulatory happy dance – at least one part of this project seemed to be going right. Joe talked to the rest of the project team, and everyone was happy to sign off on the design. Joe started to daydream about the end of project party and could almost see the happy smiles on all the faces there.
The build starts
Joe could hardly contain himself (Joe doesn’t get out much). Lots of plastic-coated sandwich panels were stacked up where the clean room was being built. There were tradies EVERYWHERE – stomping around in their steel capped boots and inappropriately low hung shorts. Some of the women from Quality seemed to have decided that morning tea should be consumed on the lawn next to the building site. The new espresso machine was obviously working.
The clean room design engineer, builder and architect made numerous visits. Joe stood around with them in a hard-hatted huddle and checked that the build was going according to plan. There were the normal missed details and problems, but a solution was found for each, and Joe was pleased that most of the work would be completed by December 15th. All his Christmases really were coming at once. He might even score a pay rise out of this project when it was delivered on time and (mostly) on budget. Woo hoo!
It was late November and Joe was finally getting to see the clean room in its near finished form. It was almost as good as visiting Santa’s Kingdom at the North Pole. Minus the elves. And the reindeer.
Joe stuck his head in the clean room and liked what he saw. It was white as snow and looked so… well… clean! By December 1st, the HVAC and power would all be working, and it would be just like a real clean room. Joe hurried off to organise some tasks to be completed, like a complete clean of the room and some other GMPy stuff.
Right in time for Christmas
December rolled around and Joe was ready to start evaluating the clean room. He assembled the required team and they agreed on who was doing what.
On the 1st day, Joe went to open the clean room door and couldn’t. The pressure was too strong. ‘Hmm… some HVAC balancing is clearly needed” he muttered.
On the 2nd day, Joe managed to get the door open (after some strong words with the builder) and was instantly blinded by the bright lights. “Holy reindeer” Joe exclaimed, “I’m going to have to issue sterile sunglasses in here.”
On the 3rd day, Joe noticed some grey conduit running up the wall. He was sure it wasn’t there before. “Oh yes”, said the Particulate Counting Dude, “we realised we hadn’t run enough cable to accommodate that machine over there, so we had the maintenance guys run some more.”
On the 4th day, Joe got an email from the cleaning contractor. It had taken 10 hours for the cleaners to clean the new clean room according to the procedure. All the rivets in the walls, the sills on the windows and the new conduit needed special attention and the price of the cleaning contract would have to be revised to reflect the extra work. Joe was not looking forward to telling the Manufacturing Manager about the extra ongoing costs. He’d have to find out when the Manufacturing Christmas party was and send the email then.
On the 5th day, Joe got another email – this time from Finance. They’d had an audit of power costs done and the new clean room was costing a bomb, and the environment, to run. “Kill joy Beancounters” muttered Joe, “Don’t they know it’s Christmas”.
On the 6th day, Joe went into the clean room and noticed something hanging from the HVAC inlet. He dragged over a chair so that he could stand on it to inspect more closely. Bits of insulation were sticking out of the vent like Santa’s beard – no doubt contributing fluff and particles to the room. ‘Argh”, thought Joe, “how the hell am I going to fix that?”
On the 7th day, the Quality team tore themselves away from the espresso machine and came to do a pre-audit inspection of the clean room. After so many coffees they were pretty enthusiastic about it. They started asking lots of tricky questions about why there were smoke detectors in a clean room and why there was dirt embedded in the silicon joins on the walls. Joe’s sparkly new clean room didn’t feel so clean any more. He went home with a headache that day.
On the 8th day, Joe got the first reports from the Validation team. His temple of GMP sterility wasn’t living up to expectations and there were viable particles everywhere. Yes, living bacteria, and fungi – they were all having a boozy Christmas party in his clean room, and they’d invited their mates.
On the 9th day, the process equipment was installed. “Holy crap” said Joe when he realised the airflow was all wrong and that dirty bacteria and fungi were sweeping over the open clean vials. The Production cowboys, who’d come over for a look, started to cry. They had to run the clean room for the next 12 years and imagined the endless deviations and alarms. “How did we get that so wrong?” asked Joe. “Y’all should have asked us!” said the Production cowboys (who must be from Texas).
On the 10th day, The EMS system was fired up and it promptly died. A completely blank screen. Joe glanced at his boss. His expression was not blank. His left eyebrow had started to twitch, and his face was turning a rather unattractive shade of red.
On the 11th day, finally all was working. Sort of. The Validation team came to do their smoke and room recovery tests. Billowing smoke was everywhere and he could hardly see Bob the builder on the other side of the clean room. Joe silently prayed for the room to recover. Five minutes – still smoky. Ten minutes – not much better. At 15 minutes, Joe was losing hope, but he could now see Bob, who had a ‘what-the-#$@$%^-is happening’ expression on his face, like he was seeing something for the first time in his life. At that point Joe was convinced that Bob didn’t know the difference between a cool room a clean room.
On the 12th day, Joe realized his chances of a pay rise were slim. He started looking on seek.com at lunch time and taking the long way to his office to avoid the Quality department and their accusing, caffeine-crazed eyes. He thought he’d even overheard the Production cowboys passing a collection hat around to get a hit taken out on him.
Poor Joe – how did it go so wrong?
Our Christmas gift to you
While Joe’s story is fictitious (any resemblance to a project we’ve been called in to fix is purely coincident – honest!) there are plenty of horror stories to tell about clean rooms.
So don’t end up like Joe, our 15 point checklist has all the things you should consider for your next clean room design and enjoy a very compliant Christmas.