Technical/Engineering Consultancy
- Plant design and revision
- Creating architectural and cleaning class flow layouts in line with process flow and GMP concept
- Designing ail flow directions, pressure values in line with WHO, ISPE and FDA Regulations
- Designing and projecting of raw material, semi finished goods, personnel, packaging, finished goods and waste flows in line with GMP and related regulations
- Sterile process, oral process designs (Manufacturing, transfer, filling, control and packing)
- Defining infrastructural requirements by making utility consumption analysis
- Machnine/equipment qualification (IQ+OQ+PQ), validation works and consultancy services concerning with these
- Providing required GMP and technical trainings
- Preparing for inspection, GAP analysis, making and observing action plans
- Creating capacity analysis, capacity optimization, machine, equipment choosing tables, feasibility analysis
- Making cost reduction programs
- Laboratory designs
- Project management and consultancy
- Creating related UGS’s and risk analysis
- Reviewing computerized system validation, inspection, interoffice expertise training, making validation activity documents
- Reducing and optimization of process and manufacturing costs in line with GMP rules
Construction Works
- Making calculations suitable for designed architecture
- Making static calculations and static project
- Side works and designing visuals
- Planning and performing of excavation works
- Conducting building audit works
- Making foundation manufacturing
- Building conventional and prefabricated reinforced concrete constructions
- Building storm water and infrastructure canalization
- Doing trim works and completing the building
Design and Application of Mechanical Systems
- Three-directional system designing, reporting and applying in HVAC and mechanical installation (heating, cooling, ventilation, steam, fire, pressured air, vacuum cleaning systems etc.)
- Manufacturing, applying and mounting, starting them, doing and reporting all required performance tests
- Maintaining, repairing and operating all started systems, increasing their sustainability and productivities
Design and Application of Electric Installation
- Electric installation calculations, reports
- Electric installation project services required for performing strength, lighting, reactive power compensation plants, protection, communication, fire informing, security, data etc. systems withing scope of Domestic Installation Regulations in line with technical requirements
- Manufacturing, applying and mounting in line with electric installation project, starting them, doing all necessary performance tests and reporting them
Other Design and Applications
- In line with the process, loop system, water tanks’ capacity calculations by calculating hourly and daily consumptions of water pre-treatment, PW, WFI, PS
- Project and application of pre-treatment, PW, WFI, PS P&ID drawings
- By calculating sterile air, nitrogen consumptions which contact with the product, designing loop line and filtration system and projecting and applying line P&ID drawing
Other Projecting and Applying
- Clean room aluminum, laminated plastic/melamine, division panel wall, walkable ceiling floor, hygienic aluminum door, interlock systems, UV/ heap pass-box systems’ design, projecting, manufacturing and mounting
- Clean room aluminum baseboard, corner, oval end pieces, accessories manufacturing and mounting and delivery
Treatment and Filtration Systems
- In line with specification and capacity of the plant, exhaust filtration, solid waste collection, calculations of liquid wastes’ pre and final treatment systems, projecting and applying them
Computerized System Applications And Validation
- Computerized system validation, data integrity, ERP, BMS, PMS project and applications
Pharmaceutical Manufacturing Machines
- With optimum cost, manufacturing of required pharmaceutical manufacturing machine and equipment, doing FAT, SAT, mounting and starting