MARCH 17–BOSTON, Mass.–The New England Chapter of PDA, an international association for pharmaceutical science based in Bethesda, Md., will be hosting two special conference sessions in conjunction with CleanRooms East 2003 on Wed., March 19, from 9 a.m. to 1 p.m.
Edward S. Balkovic, director of the Quality Control Microbiology Technical Support Lab for Genzyme (Cambridge, Mass.), will present “Selecting the Appropriate Lab Methods for Identifying Environmental Isolates,” while Michael Sullivan, co-founder of Sullivan, Bazinet, Bongio Inc., will discuss “Real World Solutions for Early-Stage Clinical Trial Facilities.”
According to Balkovic, there are several manual and automated methods available for identifying microbial isolates encountered in biopharmaceutical cleanrooms. When selecting the appropriate methods, end-users should consider many factors including: testing volume, capital costs and technical requirements.
Balkovic’s presentation will help determine the methods appropriate for settings through the discussion of: the three phases of the microbial identification process; the various commercial methods available for microbial identification and their benefits and limitations; and the type of microbes commonly recovered at various types of environmental sites.
Sullivan’s discussion will exhibit a balance between how cost, time and quality must be decided with great impact to the finished product in early-stage clinical trial facilities. The focuses will deal with selections of walls, flooring, ceiling and mechanical systems. A balanced of discussion of architectural aspects matched with environmental aspects of a design.
Additional discussion points will include site selection requirements, time allocation for construction schedule, recent code effects that effect cost and pricing options to some of the listed points of discussion.
For more information, contact Lisa Gowern, registration coordinator, at (603) 891-9267, or e-mail at [email protected].