Process and Facility Engineering for the Pharmaceutical Sector: Cleanrooms, Utilities, and Critical Systems
Spike Renewables operates in the pharmaceutical sector by providing facility engineering services for highly critical environments, with particular focus on production departments, sterile areas, research laboratories, and supporting infrastructure. Over the years, the activities carried out have covered the entire plant lifecycle, from feasibility studies and definition of user requirements through to detailed design, construction support, and commissioning and qualification phases. The experience gained relates to environments governed by stringent regulations, where contamination control, operator safety, and system reliability are essential elements for production continuity and cGMP compliance.
Areas of Intervention
Projects have involved both new pharmaceutical departments and the revamping of existing areas, often while systems were in operation and under significant operational constraints. In this context, Spike Renewables has acted as a technical integrator between architectural layouts, manufacturing processes, and mechanical systems, ensuring consistency among regulatory requirements, operational needs, and the adopted engineering solutions. Activities have been mainly developed in the following areas:
HVAC Systems and Cleanrooms
A significant portion of the projects concerned the design and upgrade of HVAC systems for classified environments, with ISO classes ranging from ISO 5 to ISO 8, as well as supporting CNC and NC areas. The systems were designed to ensure control of particulate contamination both “at-rest” and “in operation,” maintenance of pressure differentials, thermo-hygrometric stability, and recovery times compatible with process requirements. Developed solutions included partial recirculation and 100% fresh air systems, modular air handling units, terminal HEPA H14 filtration, zonal post-heating coils, and automatic room pressure control systems. In several cases, redundant or segregated systems were designed to prevent cross-contamination and increase the overall resilience of the department.
Utilities and Process Fluids
Alongside HVAC systems, Spike Renewables developed the engineering design of pharmaceutical and industrial utilities, with particular attention to integration with process and laboratory equipment. Interventions included distribution networks for chilled and hot water, oil-free compressed air, nitrogen, vacuum, industrial steam, and clean steam, as well as process waste collection systems. Activities often required new tie-ins to existing systems, relocation of utilities, and the design of new stainless steel mains, in compliance with quality specifications, PED regulations, and safety requirements. Several projects also involved systems for the generation and distribution of PW and WFI, with particular focus on battery limits, service continuity, and compatibility with qualification cycles.
Safety, ATEX, and Risk Management
A specific area of intervention concerned the assessment of plant safety in the presence of potentially flammable or hazardous gases and substances. Feasibility studies and ATEX assessments were carried out on extraction and ventilation systems, including quantitative analysis of accidental release scenarios, verification of compliance with flammability limits, and the design of dedicated solutions such as ATEX-rated extract fans powered by UPS systems and independent ductwork. These activities enabled the integration of new processes or pilot plants within existing laboratories while maintaining high levels of safety for both operators and infrastructure.
User Requirements, Documentation, and Qualification
Spike Renewables has frequently been involved in the early phases of projects, supporting the preparation of User Requirements Specifications (URS) for HVAC systems, utilities, and internal finishes of pharmaceutical departments. URS documents were developed in accordance with cGMP, ISO 14644, and ISPE guidelines, providing a structured definition of technical, safety, automation, and documentation requirements. Activities also extended to support during commissioning, SAT, and IQ/OQ qualification phases, including preparation of technical documentation, verification of system performance, balancing activities, and assistance during functional testing.
Added Value of the Approach
The approach adopted by Spike Renewables is based on an integrated view of the pharmaceutical facility, where HVAC, utilities, layout, and process are considered as a single system. This enables the development of robust, flexible solutions that can be easily adapted to future process changes, reducing operational risks and improving the technical and energy sustainability of the facilities. The ability to operate in both civil-industrial environments and regulated institutional contexts has made it possible to address complex projects with high requirements for reliability, safety, and continuity of service.