Published Oct. 14, 2014
A team of industry professionals devoted to exploring the issues associated with using closed systems housed in non-classified environments has contracted BTEC to generate data to demonstrate feasibility of closing connections between dissimilar equipment. The team, part of the BPOG (BioPhorum Operations Group), is sponsoring the studies to test the ability to clean connectors that have been exposed to the environment while joining disposable equipment and stainless steel equipment. The data from the BPOG’s studies, including the ones performed at BTEC, will be used to support decisions on using these connectors in non-classified spaces without negatively affecting product quality. Currently, regulatory expectations only allow steaming connectors after addition or making the open connections in a classified clean room. Steam cleaning disposable equipment can adversely affect its performance. In addition, clean steam and classified clean rooms are costly and not always available.
About BioPhorum Operations Group (BPOG)
Since its inception in 2004, the BioPhorum has become an open and trusted environment where senior leaders of the biopharma industry come together to share and discuss the emerging trends and challenges facing their industry. The BioPhorum Operations Group (BPOG) was the first of its collaborations. Begun in 2008, it now has 19 member companies with over 500 participating representatives. The community consists primarily of experts from biopharma drug substance operations, who meet and work together at face-to-face meetings in the USA and Europe, on regular teleconferences and via webconferencing. The group has established best practices on a wide range of quality, engineering and organizational subjects, all central to the challenge of mastering a biotech drug substance operation. For more information about the BPOG, visit BioPhorum’s website at www.biophorum.com.