samedan logo
 
 
 
spacer
home > pmps > winter 2003 > aseptic pharmaceutical manufacturing: the design and validation of water for injection systems
PUBLICATIONS
Pharmaceutical Manufacturing and Packing Sourcer

Aseptic Pharmaceutical Manufacturing: The Design and Validation of Water for Injection Systems

In pharmaceutical manufacturing, water is an invaluable resource. It is used in the production, processing and formulation of drug products and is subject to review, monitoring and approval by government bodies. This article contains a conservative approach to evaluating and qualifying water systems used for aseptic pharmaceutical manufacturing as regulated by the US Food and Drug Administration (FDA).

Specification Requirements

As with all manufacturing processes, evaluation of a water system entails three distinct specifications: a user requirement, functional requirement and design requirement. The user requirement defines the quality of water required by the type of pharmaceutical production process. The functional requirements specification describes how the water system will operate. Functional requirements are identified with the goal of identifying system capacity and meeting chemical and microbial limits. Several references are available to aid in the design, development, installation and validation of WFI systems. Most notable are the US Pharmacopoeia Convention (USP) (1), Parenteral Drug Association (2) and ISPE (3). Design requirements detail how the system will be built including system components, construction materials and methods.


Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer
By Hank Hicks, Validation Director, and David Bosch, Validation Manager, at Pharmaceutical Systems

Hank Hicks is Director of Validation at Pharmaceutical Systems Inc, USA. He has over 15 years' experience specialising in the areas of equipment, critical utilities and process validation. He has managed validation projects for installation of new process equipment, including facility construction/qualification, equipment installation/qualification, and process validation. He has had responsibilities to manage the interface with the FDA during inspections.


David J Bosch is Validation Manager at Pharmaceutical Systems Inc, USA. He has over 10 years' technical experience in equipment, process, and critical utilities validations. He also has experience in calibration of laboratory, manufacturing and data collection equipment, as well as commissioning, cycle development, IQ, OQ and PQ for autoclaves, depyrogenation equipment, washers, temperature controlled units, environmental chambers, laboratory, manufacturing equipment and critical utilities. He has also had direct interface with the FDA during inspections.


spacer
Hank Hicks
spacer
spacer
spacer
David J Bosch
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Carterra Announces Successful Immunity Monitoring of COVID-19 Patients Using a SARS-CoV-2 Label-free Assay

Carterra Inc., the world leader in high-throughput antibody screening and characterization, has announced the availability of a highly accurate assay for simultaneously measuring the concentration and binding of IgG, IgM, and IgA antibodies to the Receptor Binding Domain (RBD) of SARS-CoV-2.
More info >>

White Papers

Working Towards a Standardised Identification Solution

PCI Pharma Services

The security of the pharmaceutical supply chain is an issue of growing concern, with recent reports addressing its vulnerability to counterfeiting. The complexity of the European supply chain is one of the key factors of this counterfeiting pandemic, with millions of medicine packs being moved around the EU, annually. Aside from this, fragmentation has resulted in decreased transparency in the supply chain and increased difficulties to track and trace medicines, leading to significant threat from counterfeiting. As a key source of income for the European economy, it is essential that the supply chain remains safe and free of counterfeits. A significant stumbling block within the industry remains to be the lack of a unified, single‐source pan‐European or indeed global database where scanned bar codes on drug packaging can be verified at point of dispense. At some point in the future the pharmaceutical industry, regulatory bodies, clinicians and retailers will need to join forces to overcome this.
More info >>

 

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement