alexa Abstract | Environmental Control for Parenteral Production


Open Access

OMICS International organises 3000+ Global Conferenceseries Events every year across USA, Europe & Asia with support from 1000 more scientific Societies and Publishes 700+ Open Access Journals which contains over 50000 eminent personalities, reputed scientists as editorial board members.

Open Access Journals gaining more Readers and Citations

700 Journals and 15,000,000 Readers Each Journal is getting 25,000+ Readers

This Readership is 10 times more when compared to other Subscription Journals (Source: Google Analytics)

Review Article Open Access

Abstract

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.

To read the full article Peer-reviewed Article PDF image

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

Recommended Journals

Share This Page

Additional Info

Loading
Loading Please wait..
 
 
Peer Reviewed Journals
 
Make the best use of Scientific Research and information from our 700 + peer reviewed, Open Access Journals
International Conferences 2017-18
 
Meet Inspiring Speakers and Experts at our 3000+ Global Annual Meetings

Contact Us

 
© 2008-2017 OMICS International - Open Access Publisher. Best viewed in Mozilla Firefox | Google Chrome | Above IE 7.0 version
adwords