Engineering & Validations

Engineering & validation

V.T.S. Srl (Validation and Technical Services) is a company with several years of experience in the supply of GMP services and in the execution of qualifications on all types of machinery and systems in the Pharmaceutical Industry.

V.T.S. Srl, through the years, has gained a distinct specialization for operating in the Plasma and Plasma derivatives production and shipping sector.

Main validation activites with sat assistance and commissioning

  • Laboratories for the processing of skeletal muscle tissue from donation, in the pharmaceutical class.
  • Production and vial filling plants of heat treated lyophilic products.
  • Production and vial filling plants of hemo-derivatives.
  • Plasma fractionation plants.
  • Orphan Drugs production plants.
  • Laboratories with biological risk BL2 and BL3.
  • Validation of temperature controlled areas (up to 70.000 m3) for the storage of raw materials and finished product from -30 to +25 °C.
  • Validation of plasma freezing process in the plasma donation centers (Europe and USA).
  • Validation of temperature controlled transportation (Air, Land, Sea) of the finished product and of the raw materials (-30 / +25 °C) to and from Europe, the Americas, Asia, Africa.

Equipment systems and utilities

  • HVAC for clean rooms (pharmaceutical grades A/B/C/D)
  • Sterile LAF areas
  • Autoclaves
  • Depyrogenation ovens
  • Prodution, storage and distribution of pure fluids (CS,WFI,PW)
  • Thermal control units
  • Lyophilizers
  • Vial filling machines
  • Inspection machines for pharmaceutical products
  • Depyrogenation tunnels
  • Vial sealing machines
  • Ultrafiltration and nanofiltration systems
  • Reactors
  • Process tanks
  • Centrifuges
  • Filterpress
  • Cryogenic containers
  • Chromatographs
  • Inline conditioning systems
  • Cleaning systems (Cleaning In Place)
  • Biohazard Laminar Flow Hood
  • Temperature controlled areas.

Automation, management and control systems

  • Process automation system (DCS). Also with integration of third party control systems of other equipment such as filter presses, ultrafilters, chromatographs, in-line conditioning systems, nanofilters, pure fluid producers, clearing systems Cleaning in Place (CIP), sanitation system with pure steam (SIP).
  • Inline particle counters and microbial samplers.
  • HVAC BMS control system.
  • Management and monitoring of alarm systems in a Pharmaceutical Plant.

Calibrations and monitoring

  • Calibration of measurement and control equipment
  • Particle counting and clean rooms monitoring.

Engineering

  • Definition of user requirements (URS)
  • Auditing and technical counselling for plants, processes and equipment
  • Services for design review (value engineering, GMP review)
  • Translation of manuals and technical documentation

Consulting and management

  • Project Management
  • Specialized technical counselling
  • Technical plant problem solving
  • Planning of equipment maintenance and calibration
  • Supplier Audits
  • Energy Audits

Sectors and specializations

  • Process plants
  • Supply chain and Cold chain
  • Human plasma donation centers
  • Air conditioning systems (HVAC)
  • Computer System Validation
  • Critical utilities (PW, WFI, CS, etc.)

Commissioning and validation

  • Instrument calibration
  • Qualification activities (IQ, OQ, PQ) of plants and automation systems such as:
    • DCS (Distributed Control System)
    • SCADA (Supervisory Control and Data Acquisition)
    • PLC (Programmable Logic Controller)
    • BMS (Building Monitoring System)
    • ERP (Enterprise Resource Planning)
    • LIMS (Laboratory Information Management System)
  • Support to process validation
  • Preparation of Validation Master Plan
  • Execution of Design Qualification (DQ)
  • Execution of analysis on systems, processes and equipment (risk analysis, impact assessment, FMEA)
  • Coordination and execution of factory acceptance tests (FAT) and site acceptance tests (SAT) of equipment and systems
  • Assistance in the start-up and commissioning of systems and machinery