Integrated Solutions Pharma offer you services that go far beyond our broad portfolio of machines and process equipment.
Whatever business case you are facing, a green field project or an extension of your building or production area, you will either receive complete plant engineering solutions, or consulting in all matters that effect your production environment.
Our services include feasibility studies, conceptual, basic and detailed designs as well as construction management and validation services for the GMP area. Furthermore, GMP reviews and assessments can be executed for existing installations.
As leading provider of process technology and packaging solutions, we also provide all necessary equipment for manufacturing liquid as well as solid pharmaceuticals. This includes process and bio-process systems, primary and secondary packaging technologies, high purity media systems, equipment for sterilisation, automation systems, as well as HVAC and clean room technologies.
With our expert team of Integrated Solutions Pharma, you will have one single point of contact for all your endeavours!
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Process Consulting
A fast input for your business plan.
OUR DELIVERABLES
- Process step overview
- Process description
- Factory output overview
- Cost overview
- Time schedule overview
YOUR BENEFITS
- Fast delivery < 1 week
- Solid starting point for further steps
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Conceptual Design
The first step to realize your project, firm planning.
OUR DELIVERABLES
- Process flow diagrams
- GMP-layout development
- Equipment and room lists
Determination of:
- Space requirements
- Investment costs
- Time schedule
YOUR BENEFITS
- GMP compliant workflow, layout and environment
- One partner with in-depth knowledge of pharmaceutical processes
- Structured planning process with defined delivery date
- Reliable basis for investment decisions
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Basic and Detailed Design
Time to order equipment!
OUR DELIVERABLES
- Final design and specification of all trades in scope
- Validation master plan
- Risk analysis of critical systems
- Proposal evaluation
- Refinement of investment cost values and time schedule
YOUR BENEFITS
- One partner with combined in-depth knowledge of pharmaceutical processes and machine engineering
- Consistent planning
- Complete GMP production area out of one hand!
- Immense reduction of implementation risks
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Manufacturing and Construction Management
One partner with full responsibility for realization.
OUR DELIVERABLES
Dedicated project manager for
- Regular progress reports
- Procurement support
- Quality assurance inspections
- Time schedule supervision for all trades of scope
- In-house and on-site trade supervision
YOUR BENEFITS
- One partner with full responsibility for scope, function and price
- One project manager / contact person for all trades
- Steer and manage one partner instead of multiple
- Realization of suppliers interfaces in one hand
- Major reduction of implementation risks!
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Qualification and Validation
GMP compliance, your success factor!
OUR DELIVERABLES
- Qualification
- Documentation and execution of DQ / OQ
- Support of PQ activities
- Validation of
- Manufacturing and cleaning processes
- Analytical methods
- Computer-based systems and automation
YOUR BENEFITS
- Fast track execution due to in-depth machine knowledge
- Efficient approach to design, installation and operational qualifications
- Advanced staff trainings
- Reduction of time to market
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Contact
Syntegon Technology is one of the leading providers of process technology and packaging solutions for the pharmaceutical industry.
Customers of Syntegon Technology can rely on a comprehensive service portfolio and local support.Syntegon Technology GmbH
Address:
Blaufelder Stra?e?45
D-74564 Crailsheim
Phone: +49 79 51/4 02-0
Fax: +49 79 51/4 02-258
E-Mail ?Google Maps Link