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Pharmaceutical Manufacturing and Packing Sourcer
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The term 'cleaning validation' has been known to make grown men cry, or at least shake with fear! It is a much misunderstood process yet can be relatively straightforward if tackled correctly and methodically. Cleaning validation can be defined as 'documented evidence that has a high level of assurance, where a cleaning process will consistently produce equipment and products meeting pre-determined quality specifications.' There are many approaches to establishing a rugged, documented, validated cleaning programme. Here we will discuss just one option of approaching cleaning validation in a systematic way, to achieve the final cleaning goal.
Step 1
In this initial step, there are four tasks to accomplish before being able to move to Step 2.
1. Identify and keep a record of all manufacturing and filling equipment, which is dedicated to one product or used for multiple products. Equipment used for multiple products may be considered (provided it is qualified) for product grouping as an alternative to individually validating all the products processed with the same equipment. Similarly constructed equipment is defined as having a different size, but built with the same material of construction when compared to the equipment train in the specific group.
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Industry Events |
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7th Annual Pharma Packaging and Labelling conference
17 September - 18 October 2008, Barcelona
7th Annual Pharma Packaging and Labelling conference will bring
together experts from leading pharma manufacturers to present case study driven
presentations on critical industry-wide issues.
Attending this event will give you an opportunity to discuss with fellow
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matters.
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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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