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I will design pharma cleanroom systems
Mechanical Engineer Pressure Equipment and Industrial Design
Technical Director and Senior Mechanical Engineer with 25+ years of experience designing pressure equipment, autoclaves, and thermal systems. I help manufacturers and engineering firms with calculatio...
Informazioni su questo servizio
I am a Senior Mechanical Engineer with 25+ years of experience in the pharmaceutical and biotech industry, specialized in GMP-compliant Utility Systems (PW, WFI, Pure Steam, Nitrogen, Compressed Air and HVAC for cleanrooms). I design, size and document utilities following ISPE Baseline Guides, GEP, ASME BPE and USP.
I have supported FDA- and EMA-inspected facilities, delivered utility design packages for sterile manufacturing and biotech plants, and prepared audit-ready documentation for international pharma clients. My work ensures utilities are safe, efficient and compliant with regulatory expectations.
I deliver clear, structured technical documents defining capacities, design constraints, operating parameters, quality requirements and compliance needs for each system.
Services include:
URS and functional requirements
Utility capacity and sizing reports
Cleanroom/HVAC classification criteria
Integrated documentation for audits and inspections
Reliable, standards-driven engineering support for your pharmaceutical utilities.
Dominio:
Consulenza
Settore:
Biotecnologie
•
Medico e farmaceutico
Lingua:
Catalano
•
Inglese
•
Spagnolo
Il mio portfolio
FAQ
Do I need to contact you before ordering?
Yes. Utility engineering projects vary in scope, so please contact me first to confirm the systems involved (PW, WFI, PS, HVAC, CRS), required standards, and the level of documentation you need. This ensures the correct package and accurate delivery time.
What information do you need to start?
Please provide your URS (if available), process data, user requirements, layout constraints, cleanroom classification, and any existing documents or standards your company follows (ISPE, ASME BPE, USP, GEP).
Can you prepare documents for audits or regulatory inspections?
Yes. I can prepare audit-ready documents aligned with ISPE, ASME BPE, GEP, and GMP expectations, suitable for FDA, EMA, or internal QA inspections.
Do you cover multiple utilities in a single project?
Yes. I can prepare integrated documentation covering PW, WFI, Pure Steam, HVAC, CRS, compressed gases, or other plant utilities. For multi-utility projects, I usually create a custom offer.
Are revisions included?
Yes. Revisions are included to ensure the final deliverables meet your technical and compliance requirements.
