Product category:
Manufacturing Machinery and Plant Equipment
News Release from: ABB Automation Tech (Industries)
Edited by the Engineeringtalk Editorial
Team on 15 May 2002
ABB validates AstraZeneca R and D
facility
The finishing touches for a new GBP 45 million science facility included essential work by ABB, as it completes a equipment and facilities validation project for AstraZeneca PDF.
The finishing touches for a new GBP 45 million science facility included essential work by ABB, as it completes a equipment and facilities validation project for the AstraZeneca Pharmaceutical Development Facilities (PDF) A team of up to 15 ABB consultants, engineers and technicians has been based at the Charnwood, Leicestershire, site since 1998
This article was originally published on Engineeringtalk on 27 May 2002 at 8.00am (UK)
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The AstraZeneca PDF project encompassed equipment and utilities, from initial design through installation to commissioning.
The aim was to achieve independent validation that ensured critical equipment and utilities met design briefs and complied with relevant international standards.
For software systems, for example, this required the team to confirm compliance of electronic documentation to the internationally recognised "FDA Rule 11" standard for pharmaceuticals manufacture.
ABB was selected for best meeting AstraZeneca's demanding criteria: an impartial team, independent from the Equipment Procurement Company (EPC), the main contractor; multiskilled consultants, qualified to deliver objective assessments; proven expertise in equipment and facilities validation.
Ian Johnson, AstraZeneca's validation project manager, summarised its choice: "We were impressed with the breadth and depth of expertise offered by ABB, both in the technical areas and in project management, which is essential to a project of this scope and duration".
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While the end result of the project is now visible in working systems, the team was also required to address a number of non-documentation issues.
"We benefited from ABB's experience in everything from communications to education", said Ian Johnson.
"As well as putting in an enormous effort to support and train our own people, the on-site team went out of their way to educate suppliers and other third parties, with a view to easing the progress of any similar projects in the future".
The key benefits have included high-quality standardised documentation; controlled accurate testing of validation protocols; independence of advice not only for AstraZeneca, but for the EPC and suppliers; a better understanding of the requirements for regulatory compliance and a continuity of expertise during the project.
The AstraZeneca PDF site will provide supplies of potential new medicines for worldwide clinical trials, with a focus on new treatments for respiratory and inflammatory diseases.
It will also develop the processes required for subsequent transfer to large-scale manufacture.
Believed by AstraZeneca to be unique in both concept and layout, it will deliver small-batch trial samples of solids, liquids, steriles and such products as metered dose inhalers.
In validating the site, the ABB team had to assess equipment ranging from balances, autoclaves and other everyday laboratory tools through to the most complex of systems, including ovens, coaters and freeze-dryers.
Support facilities were also under close scrutiny.
This covered such areas as environmental monitoring and gas detection, compressed air systems and heating, ventilation and air conditioning.
There have always been two or three members of the ABB team on-site at Charnwood during the three-year project.
As well the team's obvious project management, technical and documentation know-how, the critical abilities required included change control and execution experience, mentoring and coaching skills and problem solving expertise.
The team was also vital in forming an impartial interface between the EPC, suppliers and AstraZeneca, giving supportive assistance to all parties.
Ian Johnson is in no doubt of the project's success: "If ABB offered us the same people to work on another project, they would be more than welcome - and not just for their expertise and experience", he said.
"This was a dynamic project, with inevitable changes to specifications and shifting requirements which occasionally created very difficult circumstances.
At times, we just had to admire the sheer tenacity of people putting in 'above and beyond' efforts to ensure that the job was done.
An undertaking of this magnitude was never going to be the easiest of projects, but ABB has delivered what it promised".
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