Facility

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.

Other utilities that are used to support Bioserv’s aseptic fill/finish operation include Water for Injection (WFI) in preparation for rinsing of vials, stoppers and equipment change parts.

I. Facility Overview

  • Total Area 36,467 sq ft
  • Manufacturing Area 11,235 sq ft
  • Laboratory Area 253 sq ft
  • Warehouse Area 16,235 sq ft
  • Office Area 8,851 sq ft

II. Three (3) Clean Room Suites

  • One (1) Class 10,000 (Class 7 or Class C)/Class 100 (Class 5 or Class A) Aseptic Suite
    • Aseptic HULL-48 lyophilization equipment
  • Two (2) Class 10,000 (Class 7 or Class C) Clean Rooms with Class 100 Filling Hoods

III. One (1) Class 100,000 Room

IV. Five (5) Uncontrolled Laboratory Areas


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