Life Science industry is continuously challenged to comply with upcoming new strict quality and safety standards and to increase output and efficiency.
In turn, to design break ground processing and packaging lines, we are committed to maintain an in-depth knowledge of the product, and of its manufacturing and packaging principles.
Project Management and Installation
Community style approach.
We believe End User-Supplier Teamwork to be the key to develop made-to-measure solutions for our Clients’ production necessities, both present and future ones.
Yes, indeed, also the future ones! With our Customers we keep the dialogue going uninterrupted lifelong, like we were in a community: innovation through brainstorming.
We foster our innate aptitude to deal with complex and large scale customized projects:
To start the technical-oriented commercial approach: the line is designed and proposed with an high number of options, including contingency planning and simulation techniques.
A dedicated centralized advisory service provides the Customer with a unique reference point also in the case of integration and commissioning of machines from different production sources.
Share of project management policies, activities and checklists to ensure that time to market deadlines are met.
Space availability for equipment manufacture, integration and line FAT execution.
Specialists of our Validation Departments draw-up the appropriate documentation for line qualification.
Installation, setting-up and start-up as well as training and assistance during production is then followed-up by our skilled engineers.
First: test it.
From the earliest stage of the project our Customer can run simulation tests to verify the final machine performances.
IMA has Class 10.000 test rooms available on site (Italy and US) managed by expert qualified engineers and scientists, 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.
Documentations and Validations Support
IMA quality system (ISO 9001 certification), implemented throughout the company, ensures that the design and manufacturing is carried out in accordance with the quality assurance specifications and with GAMP procedures.
Where requested, our teams of specialists can provide comprehensive packages of documentation (DQ, IQ, OQ and PQ) to support Customer validation activities on site.
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.
Qualified component control and calibration technicians take care of:
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 Customers for activities relating to recalibration.