Design Considerations for Parenteral Production Facility
Rational of this review article is to maintain principal of design, facility design, building a clean room is a complex exercise carried out in order to assure the product quality within the overall guidelines of FDA, WHO, ISO and Good Manufacturing Practices in the pharmaceutical industry. Poor cGMP conditions at a manufacturing facility can ultimately pose a life-threatening health risk to a patient. Parenteral dosage forms differ from other dosage form. Parenteral product directly enters into systemic circulation. Parenteral preparation should be free from any type of pyrogen, micro-organisms and particulate matter. In parenteral industry control of contamination and cross contamination plays important role by design consideration. Design of room, sterile processing department, air handling system, environmental contamination control system like HVAC system, RTRH, aerosol behavior, ventilation, entry and exit procedure, and their design methodology, equipments like high efficiency particulate air (HEPA) filter remove at least 99.97% of airborne particles 0.3 micrometers (μm) in diameter. A laminar air flow (LAF) system is combination of HEPA filters and lamination of air flow. It has 99.97% efficiency with offering uni-directional flow in aseptic area. There are various types of class HEPA filter and LAF system used in aseptic area depends upon their need they classify and with their optimum parameters, applications, specifications. So it is imperative to ensure that the design is undertaken in a systematic and organised manner so that on completion, the clean facility meets with the specifications and requirements of the end-user and regulatory authorities.