The following areas of focus are included in this category:
- Cell-factory and biobanks for advanced therapies
- Hospital pharmacy departments (ufa and radifarmaceuticals)
- Patient isolation wards
- Operating rooms and sterile blocks
- Laminar flow systems
- Special intensive care units
A comprehensive package of services tailored to your needs
Studies ofFeasibility
Analysis of the production process and specifications for achieving the required degree of protection for the product and the operator
Identification of process lay outs and analysis of critical points
Determination of contamination classes of affected areas according to international standards (GMP - FDA - ISO)
Planivolumetric study of the building and determination of energy requirements
Analysis of machinery and utilities needed
Preliminary project development and investment economic analysis
BasicEngineering
Analysis of production processes
Definition of material and personnel flows
Process layout
Identification of air contamination control issues according to the required classes
Study and sizing of air conditioning and air filtration (HVAC) systems and utilities
Study of electrical, control, supervisory and security systems
Definition of suitable materials for civil finishes with low particle release infrastructure
DesignExecutive
Detailed executive design of air conditioning systems, electrical systems, automation and supervision systems, civil infrastructure
Issuance of technical specifications and material requirements
Planning, control and order management
Construction Management
.Construction
Supply and implementation of turnkey facilities
Planning, coordination and management of contract and site work
Technical supervision and construction management
Resource management and job order cost control
Startup &Commissioning
Plant startup and balancing
Tests
"As built" documentation
Electrical and HVAC system certifications
Class certifications according to ISO 14644
Performance of IQ-OQ-PQ Validation Tests.
Management &Maintenance
Preparation of operation manuals
Conducting service and scheduled preventive maintenance
Technical support and spare parts
Staff training courses on cleanroom operations and behavior
Consulting in the drafting of SOPs
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