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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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Industry-First Cancer Screening Technology Boosted by Biomedical Grant Funding
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White Papers |
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High-tech Packaging for High-tech Medicine
West Pharmaceutical Services, Inc.
As more biologics and biosimilars come on to the global pharmaceutical market, they can and will present unique packaging and containment challenges. For materials that are sensitive to glass or that may require larger-dose volumes or custom configurations, cyclic olefin polymers may offer a solution. These novel materials for drug container closure systems can provide a needed alternative to traditional glass containment systems for advanced therapeutics.
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Industry Events |
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The Pharmaceutical Manufacturing and Packaging Congress 2023 (PHARMAP 2023)
12-13 June 2023, Hilton Geneva Hotel & Conference Centre, Geneva, Switzerland
The Pharmaceutical Manufacturing and Packaging Congress 2023 (PHARMAP 2023) gathers top-level management from pharmaceutical
companies of manufacturing, primary and secondary packaging, purchasing,
and supply chain and procurement sectors, CMOs and CDMOs leaders, heads
from government and institution on 12-13, June, 2023 in Geneva,
Switzerland.
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