What we do - Propharmabi

What we do

Consulting and execution

Our job is to create optimal environments for technological and scientific innovation, and we are structured to carry out all the activities necessary to achieve this goal, following standards of excellence. 
Need a new cleanroom? Propharmabi doesn't just assemble the walls: depending on your needs, we can design and build an entirely new facility or refurbish existing premises, designing the systems, defining the internal layout and necessary furnishings, based on the specific activities and processes that will take place within the space. 
 
Thanks to the expertise of our in-house personnel and close collaboration with qualified external partners, we offer a wide range of services, from basic engineering of departments, production processes and systems, to construction management and coordination, civil and plant works, and validation support.
 
What we ca do - Propharmabi

What we ca do, in a nutshell

  • identification/setup of production and laboratory processes, with sizing of process equipment and assessment of regulatory requirements for proper purchase/installation 
  • general layouts and realizations from the ground up, sizing and outfitting of production areas, integration of process equipment, finishing and construction details, etc. 
  • air conditioning and filtration systems, as well as containment and extraction systems for high-tech industrial environments production and distribution of pharmaceutical utilities (purified water, distilled water, clean steam, vacuum systems, dust extraction and treatment, oil-free compressed air, pure gases, etc.) 
  • utility production plants and related distributions (industrial steam, heated hot water, chilled and cold water, compressed air, technical gases, energy reception and distribution panels, etc.) 
  • general facilities (laboratories, warehouses, offices, etc.)
Where our work is needed - Propharmabi

Where our work is needed

  • clean rooms in Pharmaceutical, Chemical, Biological, Electronic, Aerospace, Medical Devices, etc. sectors, and controlled contamination environments for a wide variety of pharmaceutical forms 
  • segregated environments for handling products with high HPAPI activity 
  • R&D laboratories (chemical, instrumental, microbiological analysis, biological)  
  • laminar flow, cross flow and dust collection hoods 
  • cold rooms 
  • temperature-controlled thermolabile product storage 
  • environments with critical humidity (low and high)
Contact us

List of Services

List of Services - Propharmabi

Design and Works Management - Feasibility Study

  • Definition of project objectives
  • Regulatory analysis (GMP, FDA, EMA, ISO 14644)
  • Site assessment and infrastructure requirements
  • Evaluation of construction costs and timelines

Basic Design

  • Objective: Define the general concept of the project, establishing the main characteristics of the building and systems.
  • Definition of production, storage, laboratory, and office areas
  • Separation of personnel, material, and waste flows
  • Rational layout to ensure linear production flow and minimize cross-contamination risks
  • Controlled contamination areas according to required ISO classes
  • Materials compatible with pharmaceutical requirements (smooth walls, joint-free flooring, easy to sanitize)
  • Clear separation between clean and dirty areas, with dedicated corridors for materials and personnel
  • Preliminary sizing of HVAC systems (Heating, Ventilation, Air Conditioning) with HEPA/ULPA filters
  • Preliminary sizing of Purified Water (PW), Water for Injection (WFI), and Pure Steam systems
  • Preliminary sizing of electrical and automation systems

Detailed Design

  • Objective: Transform the basic design into executive documentation for construction and system installation.
  • Construction and installation drawings for walls, ceilings, coatings, etc.

HVAC (Heating, Ventilation, and Air Conditioning)

  • Technical specifications and tender documents
  • Environmental parameter table
  • Layout of Air Handling Units (AHUs)
  • Floorplans and sections with ductwork routing
  • P&ID (Piping and Instrumentation Diagrams)
  • Airflow diagrams with pressure differentials between rooms
  • Area classification

Technical Utility Systems

  • Technical specifications and tender documents
  • Complete P&IDs with sampling and discharge points (chilled water, heating water, industrial steam, etc.)
  • Layouts with distribution networks (piping, pumps, tanks)

Critical Utility Systems

  • Technical specifications and tender documents
  • Complete P&IDs with sampling and discharge points (compressed air, Purified Water, Water for Injection, Pure Steam, technical gases, etc.)
  • Layouts with distribution networks (piping, pumps, tanks)

Electrical Systems

  • Technical specifications and tender documents
  • Main and secondary electrical panels
  • Layouts with cable routes and conduits
  • Single-line and multi-line diagrams
  • Area classification (ATEX, GMP, cleanroom)
  • Power continuity requirements (UPS, backup generators)
  • Lighting distribution compliant with required levels
  • Grounding and surge protection requirements

Commissioning and Qualification Services

  • Commissioning is the structured process that verifies, tests, and certifies that a pharmaceutical system (HVAC, plumbing, electrical, etc.) has been designed, installed, and operates in accordance with design specifications and industry regulations.
  • Definition of User Requirement Specifications (URS)
  • Preliminary functional tests of equipment and systems
  • System startup and HVAC/mechanical system balancing (airflows and room pressures)
  • On-site instrument calibration
  • Drafting and execution of qualification protocols (IQ, OQ, PQ) for controlled contamination environments: cleanrooms, hoods, and operating theatres, in compliance with EU GMP, standards UNIEN ISO 14644, 14698, UNI 11425
  • Audit activities and assistance during equipment FAT

Works Management

  • Works Management (Construction Supervision) is the process of supervising and monitoring the entire construction phase of a new pharmaceutical facility, ensuring that the work is executed in accordance with the approved design, industry regulations, and within expected timeframes and costs.
  • Objectives:
  • Ensure proper execution of works according to the approved project
  • Verify the quality of materials and workmanship
  • Coordinate suppliers and the various technical disciplines (HVAC, plumbing, electrical)
  • Ensure compliance with safety and environmental regulations
  • Monitor timeframes and costs, minimizing delays and unforeseen issues