Pharmaceutical Process

In-depth knowledge of the life sciences sector.

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  • Inspiring our clients with proven solutions while also providing them with innovative designs to address their future challenges,

  • Supporting our business development efforts with our clients from the very beginning,

  • Providing expertise to our internal and external clients,

  • Expanding our global order book.

Processes

  • Containment systems for highly toxic products (in accordance with EPO standards)

  • Biological hazard containment (in accordance with BSL)

  • Preliminary zoning of areas at risk of explosion (ATEX)

  • Storage of raw materials (API and excipients under controlled conditions)

  • Weighing (booth, RABS, isolator)

  • Preparation of buffer solutions and culture media

  • Preparation/sterilization of non-filterable products

  • Fermentation / Cell culture

  • Virus inactivation

  • Fine chemical reactions

  • Purification (filtration/chromatography/ultrafiltration and diafiltration)

  • Oral solid dosage forms / Spray drying, freeze-drying, granulation, coating

  • Formulation of injectables (solutions and suspensions) - Standard processes using stainless steel tanks and/or single-use equipment.

Clean utilities

  • Production/Distribution of softened water (SW) for the production of process water and initial CIP stages

  • Production/Distribution of purified water (EP)

  • Production/Distribution of water for injectables (EPPI)

  • Production/Distribution of clean steam (including compliance with EN285/HTM2010 testing)

  • Production/Distribution of process compressed air

  • Storage/Distribution of liquid nitrogen

  • Storage/Production/Distribution of gaseous nitrogen

  • Storage/Distribution of gaseous nitrogen, oxygen, and CO₂

  • Storage/Distribution of other gases required for QC laboratories (argon, helium, etc.)

Our Deliverables

  • Block/Process Module Diagram

  • Process Flow Diagrams & Operational Flow Diagrams (PFD/OFD)

  • Utility Flow Diagrams (UFD)

  • 2D/3D equipment layout concepts, personnel, material, product, and waste flow

  • PID diagrams

  • Capacity analysis, batch modeling, production schedules

  • Process simulation

  • Equipment list, consumption data sheets, mass and utility balances

  • Equipment specifications

Regulations

  • European GMP / Eudralex Vol. 4 for human and veterinary products

  • cGMP CFR Parts 210 and 211

  • European Pharmacopoeia and USP (other pharmacopoeias if necessary)

  • ICH Q7 to Q11

  • ISO 14644 (cleanrooms), NFS 90351, ISO 13485 (medical devices)

Group presence

The Snef Group operates across four continents—the Americas, Europe, Africa, and Oceania—in 30 countries and 80 cities, with a network spanning more than 100 international locations.