The goal of manufacturing is to create many of something with as little variability as possible. Mistakes, if they occur at all, should be very infrequent. This past semester, the Biomanufacturing Club at Skyline College saw just how hard it is to be a Contract Manufacturing Organization (CMO) in the life sciences or pharmaceutical space.
The Skyline College biomanufacturing group has volunteered to produce petri dishes for BABEC, a nonprofit that supplies biotechnology lessons to local high schools. The biotechnology club followed cGMP, biopharmaceutical industrial standards, making these plates.
The group learned that having the correct materials, planning and communicating with all members of the group is required for good manufacturing. Originally, the group had planned to pour 2000 plates. However, there was a backlog in the media prep room and our members were not able to get into the autoclave on time (which takes an hour to work), starting at 2:00 p.m. rather than noon.
The group found out that the medium would boil over in the autoclave, so instead of having three liters, we now only had two liters of medium. The group decided to press ahead and still manufacture what they could.
We experienced problems with our pump (which filled the plates with 10 ml of medium), stacking our plates and clotting of the agar, a thickening agent, in one pump and dribbling in the other. After an hour, we found that we could only make 120 plates in an hour and that even with two groups manufacturing plates, we would still be in lab on a Friday evening.
To top it all off, the group discovered that the media prep team did not add agar to one set of the media so the 120 plates they poured would never solidify and have to be thrown out.
A disaster, but maybe not. The group sat around for their last hour and did what industry calls a CAPA, Corrective and Preventative Actions, and listed all the things that went wrong with the 2k pour and how we can prevent those things in the future.
The day was full of learning from our mistakes.
On a side note, the biomanufacturing group will be demonstrating some of the innovative teaching labs that our students came up with at the Bay Area Makers Fair held at the San Mateo Fairgrounds on Saturday, May 18, 2019 and Sunday, May 19, 2019. This is a fun fair for DIY and Makers of all kinds, so if you are near downtown San Mateo this weekend you should check us out.
Article and Photo by Nick Kapp
