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Construction Services

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Test Phase

From the earliest stage of the project a customer can run simulation tests; thorough testing ensures that we can guarantee final machine performance right from the start of the machine manufacture.

IMA has Class 10.000 test rooms available on site, with facilities for production simulation with controlled temperature and humidity and under aseptic conditions: technology transfer, scale-up, production start-up, product feeding into pockets can be replicated in a real operating environment.

These test rooms, for customer trials, are available in Italy, Germany and US, together with expert qualified engineering assistance. In this way the final performance of the machines is assured right from the construction phase and prior to delivery, another factor contributing to optimum quality performance.

Calibration

Component control and calibration technicians are all highly qualified personnel in the following tasks:

  • Systematic quality control of components and units sent to customers
  • Modification of components and units to enable rapid installation
  • Adjustment and calibration of product quality control systems to ensure that they remain 100% efficient at all times
  • Functional testing of all components to be installed on IMA production machines that affect final product quality
  • Support to customers for activities relating to recalibration

Project Management and Installation

The essential pre-requisite for successful project management is an in-depth knowledge of the disciplines of planning, organizing, securing and managing resources to achieve specific targets:
a challenging goal that IMA has pursued and achieved over the years to now boast core skills, expertise and experience to design and manufacture solutions, able to deal with complex and large scale customized projects and meet the special requirements of the end-user.

The services offered range from the technical-commercial approach to the design and proposal of line configurations with a high number of options (including contingency planning and simulation techniques) to the technical-functional aspect (capacity to prefigure, program and organize the production and integrated commissioning of several machines from several production sources) to the efficient centralized advisory service that provides the pharmaceutical partners with a unique reference point.

The IMA Project Managers’ thorough knowledge of machine integration and line functioning logic is totally at the disposal of our customers to outline thorough project cost-management policies and checklists and to ensure that end-user’s time to market deadlines are met.

 

 

 

Large projects require space for equipment manufacture, integration and line FAT execution.
Here, too, IMA is considered the number 1 partner with its more than 160,000 square meters of workshops.

IMA’s turn-key solutions include the appropriate documentation for line qualification, installation, setting-up and start-up as well as training and assistance during production.

Our not just keeping pace but also moving ahead with innovations in pharmaceutical technology and processes is attributable to our teams of highly motivated personnel radically rethinking what was once considered standard and taking it to a superior level.

IMA is the One-Stop-Supplier.

 

Documentation and Validation Support

IMA is an ISO 9001 certified company and part of a group of manufacturers playing a major role in the ongoing revision of GAMP. The IMA quality system, implemented throughout the company, ensures that IMA operates in accordance with GAMP procedures and is a guarantee that the production quality assurance specifications will always be met.

Where requested, IMA will provide customers with a comprehensive package of documentation for on-site validation procedures; various packages are available to meet two primary purposes:

  • To provide documented evidence of IMA production quality through the Quality Plans.
  • To provide a comprehensive package of documentation to support the customer validation activity on site.

“IMA can also offer dq, iq, oq and pq support by specialists and documentation packages to help validate the packaging process.”

 

 

Different packages are available according to customer needs.

By applying its Quality System with appropriate Quality Plans, IMA is able to prove the correct operation of its equipment in compliance with customer requirements and specifications. The documentation and records issued by IMA during the equipment life cycle, allow the customer to reduce validation costs and times.

All machines are delivered with full detailed technical documentation including:

  • Spare parts catalogue for rapid part identification and easy ordering
  • Instruction manuals for machine groups and commercial units, each manual contains separate sessions for operators and technicians
  • Electrical documentation including functional drawings, I/O tables, PLC and microprocessor cards lists