alexa Abstract | Environmental Control for Parenteral Production

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Parenteral dosage form differs 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. Environmental control is a major concern in potential drug manufacturing. There is substantial evidence establishing a direct relationship between the level of environmental control and the final quality of the product. Environmental control zone groupings consist of sevean zones and environmental design concepts include personal flow, welding screens, employee services, warehousing, utilities, quality control, wall and floor treatment, glass bead sterilizer, change room, handwash station, apparel storage cabinet, shoes, air shower, air curtains, air tight door, pvc flap/swing doors, washer, laminar flow unit, sampling booth, filling suites, communication, pass box which control contamination and maintain aseptic condiation effectively. Effective monitoring of the conditions in the system must be carried out from time to time to ensure that the right conditions are being created for the manufacturing process. It is important to understand that the design and function of the pharmaceutical manufacturing area forms a significant part of Good Manufacturing Practices (GMP), these being the requirements by governmental agencies like the FDA, WHO, ISO. Good environmental monitoring program is one of the most important laboratory controls. Environmental monitoring programs, when appropriate, should include quantification of microbial content of room air, compressed gases, and surfaces. Personnel contamination control, cleaning and dispensing procedure plays important role in environmental monitoring with quality assurance test.

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Author(s): Parag V. Ingle, Vivekanand K. Chatap, N. M. Bhatia

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