Engineering
solutions for
pharmaceutical
industry
Your partner for turnkey projects
Our solutions
Specialized in the realization of pharmaceutical production units, we offer
solutions tailored to your needs in France and abroad.
Turnkey Production
Units
NTS designs and manufactures all types of complete, ready-to-use pharmaceutical production units.
Project engineering
NTS carries out the design, planning, subcontractors and provider monitoring, and implementation of pharmaceutical construction projects.
APS/APD - URS - FAT/SAT - CQ/IQ/OQ/PQ
Integration
NTS can integrate all types of equipment or infrastructure into your project.
Innovative solutions for industry
Expertise in pharmaceutical
engineering
NTS is a company created to meet the various engineering needs of customers wishing to invest in the pharmaceutical industry.
NTS offers all types of services (Technical studies, Training, Project engineering, integration and commissioning of utilities or production equipment, Qualifications, etc.) up to the creation of complete pharmaceutical production units on a “turnkey” concept
Why choose us?
+ The advantages of the Turnkey concept => 1 single point of contact, finalized solution "all inclusive"
+ Ability to intervene everywhere (France, Europe, World)
+ Technology transfer => expertise of more than 20 years in this field, especially in the pharmaceutical industry in France and export (Europe, Africa, Middle East, Asia)
+ Ability to handle pharmaceutical projects of all types :
• Sterile and aseptic injectable forms (IV bags, IV ampoules, syringes, Vias, etc.)
• Dry forms (tablets, capsules, sachets, syrups, etc.), traditional formulation or repackaging of antibiotics
• Pasty forms (creams, gels, etc.)
• Medical devices (compresses, sutures, etc.)
+ Integration of multiple solutions (new, second hand, etc.)
+ Numerous partnerships with experts
+ Possibility of reasoning in Modular construction (specific modules or modified shipping containers)
Services
Feasibility studies
Technical and financial feasibility studies:
• Pre-Project Studies for the elaboration of a bankable dossier for Funding corporations
• Budget evaluations
• Execution and financing planning
• Implementation of a Projected Income Statement evaluation
• Environmental impact assessment
Technical studies
Study and design of infrastructures:
- Study of the existing (existing building or land topography)
- Design of production units (lines, buildings, access)
- Civil engineering guide plans for local operations (building, traffic, ground loads, location of various evacuations, buried fluid networks, tanks, etc.)
- Technical support for the construction of the wastewater treatment plant (if necessary)
Assessment of energy requirements (utilities) and location of their delivery points
- Requirements for Water (extraction/supply + upstream storage)
- Total electrical power requirement
- Thermal power requirements (Cold and Hot)
- Air Handling Requirements - HVAC
- Estimate of effluent to be treated (volume, category)
Pharmaceutical support
- Edition of Pharmaceutical Manufacturing files, Marketing Authorization Files
- Edition of Standards Operating Procedures (SOPs) for Production and Control
Detailed technical studies
- Design studies of production premises, control laboratories and technical areas
- Study and definition of civil works to be carried out on site
- Design study of manufacturing and packaging processes, PIDs, layouts
- Preparation of specifications for equipment to forecast (Calculations and edition of the User Requirement Specifications) + call for tenders
- HVAC and aeraulic design (ducts layout, filtration, etc.)
- Electrical study (HLTT + distribution)
- Fluids study (Purified water, WFI water, compressed air, compressed nitrogen, steam, cooling, etc.)
- Piping network design
- Study and design of warehousing areas (surfaces, capacities, flows, etc.)
- Study and design of Quality control areas (laboratory equipment, etc.)
Engineering
- Monitoring of suppliers / purchases / subcontracting
- Design Qualification
- Factory Acceptance Tests (FAT)
Regulatory support
- Production Flowchart
- HVAC Zoning
- Qualification protocols DQ/IQ/OQ/PQ
- FAT/SAT protocols
Construction / Installation / Commisionning
Pre-installation in France (depending on projects)
- Construction/assembly of various sub-assemblies (mechanical, electrical, fluids)
- Validation tests for mechanical, electrical, thermal, automation, etc.
- Installation Qualifications for sub-assemblies that will no longer be disassembled
- Preliminary tests and provisional acceptance of the installation by the customer – SAT France
- Block disassembly, packing and preparation for shipment
Monitoring of on-site work through periodic visits
Periodic on-site visits prior to equipment shipment to monitor:
- Progress of road works
- Progress on construction of buildings, slabs, buried networks, etc.
- Progress of electrical and fluid works (including boiler fuel)
- Progress on construction of wastewater treatment plant
Installation on site
- Receipt of materials, wood boxes and/or containers, unloading and opening
- Installation of equipment or modules
- Construction of production rooms (partitions, ceilings, lighting, openings, floor covering, etc.)
- Installation of utilities + electricity and fluid connections
- Construction of HVAC networks (ducts) + thermal insulation
Logistic & Freight
Monitoring of logistic operations
- Handling operations
- Road, marine, rail freight, …
- Edition of the Customs Nomenclature of the project (if export)
Commisionning
- Running of the various subsets
- Functional tests and validations
- Room metrology (particularly HVAC)
- IQ/OQ Qualifications
Operators training
In France
- Technical theoretical training + validation of knowledge on equipment
- Maintenance and Production Management Training
- General pharmaceutical training (GMP standards)
- Specific training on equipment (laboratory, sterilization, manufacturing, packaging)
- Quality Management Training
On site
- Acquisition Control
- Practical technical training on equipment
- Maintenance and Production Management Training
- General pharmaceutical training (GMP standards)
- Specific training on equipment (laboratory, sterilization, manufacturing, packaging)
- Quality Management Training
- Production management training
- Training of production operators on built lines
- Training of laboratory technicians for quality control of drugs produced
- Logistic and purchase training
• Technical documentation (use and maintenance) for each equipment
• Regulatory documentation (pharmaceutical)
• Quality Management supports
• Qualifications protocols QD/IQ/OQ/PQ
• FAT/SAT protocols
• Technical and maintenance (Hotline or on site during periodic visits)
• Production, purchase and HR management
• Pharmaceutical and Quality Control