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Project
Engineering
The project engineering/management section of the company is responsible for ensuring the timely
manufacturing progress of a machine from order placement to hand over. During the project lifecycle, the
project engineer/manager is the main contact for both the customer and the sub-supplier concerning any
project issues. This ensures that continuity is maintained so that progress is as trouble free as possible.
Documentation
Throughout the project, the project engineer/manager will also expedite documents (such as drawings), or
correspondence, that are required to keep the project on schedule.
Not all documents are generated by our sub-suppliers, validation and testing documentation is generated
by the project department. This comprehensive documentation package would consist of the following
protocols:
Factory Acceptance Test Protocol
Installation Qualification Protocol
Operational Qualification Protocol
Commissioning and Validation
Another task performed by the Project Department, if required, is the site work necessary to commission
and validate the machine (using the above protocols). Within the Project Management section we have a
dedicated engineer with the task to oversee and co-ordinate all the work activities. The dedicated
engineer ensures the continuity of all site work, the completion of the validation, through to the handover
of the machine.
Performing the site work itself, we have specialist engineers with many years experience in commissioning
and validation activities.
The scope of site work that can be offered (which can consist of a combination, or all, of the following) is
as shown below:
Supervising Installation
Start-up And Commissioning
Calibration
Installation Qualification
Operational Qualification
Thermal Validation/Mapping
Closure and Handover
Closure of the project is also a responsibility of the project engineer/manager. They will ensure that there
are no outstanding issues and that the customer is happy with the final product. Once accepted by the
customer the project is deemed finished.
One last operation performed by the project engineer/manager is a handover meeting with the technical
service department. This is to ensure that there is a smooth transition of responsibility between the two
departments.
Reference Sites/Recommendations
Below are excerpts of comments from recent customers regarding the supply of machines:
From Allergan Botox Ireland, Westport, Ireland following the
successful conclusion of Botox phase 2 project: (This project involved supply, commissioning, validation of
Fedegari sterilising autoclaves, decontamination autoclaves, stopper processing autoclaves, depyrogenation
ovens and Belimed GMP tray washing equipment for a new state of the art GMP facility for manufacture of
Botox.)
"The Project Management (PM) Department at Steritech Ltd. demonstrated a way of thinking about
problems and how to identify solutions. It is seen to facilitate better understanding of the life cycle of
projects and the process through which they flow. The PM Department presented a systematic and logical
approach to achieving project objectives and is seen as a strong source of information and support to the
customer."
From Fort Dodge Laboratories, Sligo, Ireland following the successful conclusion of facility expansion
project: (This project involved supply, commissioning, validation of a large Fedegari sterilising and
decontamination autoclave and a large Stilmas pure steam generation system.)
"I wish to thank Steritech and the Project Management team in particular for the help and expertise
demonstrated in the management of our Autoclave and Clean Steam Generator projects. The projects were
expedited in a skilful and timely manner with help at hand should it be required and good backup on problem
resolution both during the project and after acceptance. Congratulations on a job well done ."
From Fujisawa, Killorglin, Ireland following the successful conclusion of facility upgrade project: (This
project involved supply, commissioning, validation of a large Fedegari sterilising autoclave for a critical GMP
facility. The work had to be carried out to a strict timetable and with minimum disruption to surrounding
production facilities.)
"It could clearly be seen from the outset and again during the commissioning & validation of the Fedegari
autoclave that Steritech supplied a professional & comprehensive project management service. If FIL had to
purchase an autoclave in the morning it would have no hesitation in purchasing a Fedegari autoclave & one
of the main reason is Steritech. Successfully projects requires effective project management, which
Steritech have" .
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