An essential component to Bioserv is the Heating, Ventilation and Air Condition (HVAC) systems. The HVAC systems that support pharmaceutical operations, especially cleanrooms and aseptic manufacturing, are complex and extensive. The heating and cooling functions are needed for operator comfort and environmental control. Ventilation function provides the necessary circulation and “air turns” to maintain environmental control. The HVAC is designed and operated to maintain the aseptic core by the use of positive pressure that extends away from the core.
Within Bioserv’s cleanrooms, the ducts terminate at High Efficiency Particulate Air (HEPA) filters. For the HVAC that supports the aseptic processing operations, including the preparations area, there are a series of pre-filters prior to the HEPA filters. The HEPA filters are rated 99.95% effective for microbial retention and facilitate unidirectional air flow.
As with the aseptic filling process, Bioserv’s cleanroom sanitization process requires documentation, personnel training and qualification. Bioserv conducts Environmental Monitoring (EM) to ensure that the cleanrooms are under control for potential viable and non-viable contamination.