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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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News and Press Releases |
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New NoriZite™ Nasal Spray launches in the UK
Birmingham, UK, 28th October 2022 / Sciad Newswire / Birmingham
Biotech LTD, an innovator in diagnostic tests, protective nasal sprays
and mobile medical facilities, today announces that NoriZite™ Nasal
Spray, an easy-to-use nasal device designed to block and trap inhaled
virus particles, is now available to buy in the UK.
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White Papers |
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Quality of Steel
Natoli Engineering Company, Inc.
Steel quality is the summation of how well a steel meets its specified chemistry, the cleanliness of the steel or degree to which it is free of impurities or inclusion, homogeneity of the microstructure, grain/carbide size and in some instances if it meets the mechanical requirements for that particular steel. In the design and manufacture of tablet compression tooling, nothing is more important than the quality of the materials being used. The best manufacturing principals maintaining the tightest tolerances will result in tool failure if the initial material quality is poor. Material quality is the fundamental building block upon which all successive value added steps are laid. The majority of all tablet compression tooling is produced from steel and steel quality is the subject of this article.
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