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Pharmaceutical Manufacturing and Packing Sourcer
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The control of airborne, non-viable particles is fundamental to the design and operation of a cleanroom. Cleanrooms are defined (whether by ISO14644, EU GMP, USP <1116> or the former FS209E) by their ability to control a defined level of particles in different occupancy states. Controlling the level of particles in the air is arguably the most challenging aspect of contamination control.
This article examines some approaches to the monitoring of particles, including techniques and monitoring regimes, and examines some of the areas associated with particle control. The emphasis of this article is upon aseptic filling, but many aspects are also applicable to other cleanroom operations.
Why Monitor?
The measurement of particles is indicative of the cleanliness of a cleanroom. A cleanroom is a room with a specially designed heating, ventilation and air-conditioning (HVAC) system that is designed to control the level of contamination. Although it is the totality of the different physical checks that go towards contamination control, it is the measurement of particles that provides the best indicator of the level of control.
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Industry Events |
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EMBALLAGE 2008. World Packaging Exhibition
16-21 November 2008, Paris-Nord Villepinte - France
“Business, Innovation, Outlook” are the watchwords for the 38th World Packaging Exhibition which opens in Paris from 17 to 21 November 2008. Fifteen months before the key packaging event of the end of 2008, EMBALLAGE displays its differences to offer you a new edition that is even more representative, international and rich in new features.
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News and Press Releases |
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Azopharma Product Development Group, Inc
HOLLYWOOD, Fla. – Azopharma Product Development Group, Inc. (“Azopharma”) announced today the addition of innovative state-of-the-art equipment at its formulation and manufacturing division, ApiCross Drug Delivery Technologies in Hollywood, Florida. The most recent acquisition is the MG Futura Capsule Filler which delivers the latest in capsule filling technology. The company has also added a Bausch & Strobel Aseptic Filling Isolator, equipment that is ground-breaking in the powder filling process. These additions support our previously implemented XcelodoseTM powder micro-dosing system. With these technologies, Azopharma is able to provide its clients with all forms of the capsule filling process. The new equipment is part of Azopharma’s recent manufacturing expansion which includes 17 new manufacturing suites for GMP, cytotoxic and aseptic products...
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