Elettracqua

Compounding Areas

Compounding Areas

Pharmaceutical Compounding Areas and Systems

At Elettracqua, we design and manufacture turnkey compounding areas and process skids for the preparation of pharmaceutical and biotechnological products. Each system is custom-engineered to ensure maximum process reliability, flexibility, and full compliance with GMPand FDA requirements.

Process Overview

The compounding area represents the core of pharmaceutical manufacturing, where active ingredients, excipients, and solvents are precisely weighed, mixed, and dissolved to create homogeneous bulk solutions or suspensions.

Elettracqua systems are designed to guarantee:

  • Accurate gravimetric or volumetric dosing
  • Efficient mixing and homogenization
  • Complete automation and data traceability
  • Seamless integration with CIP/SIP systems for cleaning and sterilization
System Configuration

Each compounding installation can include:

  • Jacketed stainless steel vessels (AISI 316L or higher grades) with mechanical or magnetic agitation manufactured in our own dedicated manufacturing site.
  • Load-cell weighing modules for high-precision dosing
  • Inline homogenizers, filters, and transfer pumps
  • Automated control systems based on PLC/SCADA architecture with recipe and batch management
  • Sanitary piping and valves designed in accordance with ASME-BPE standards

All systems are compatible with Purified Water (PW), Water for Injection (WFI), Clean Steam, and Compressed Air utilities, ensuring full process integration.

Cleanroom Integration and GMP Compliance

Elettracqua compounding areas are engineered for installation within classified cleanrooms, maintaining:

  • Controlled temperature, humidity, and pressure differentials
  • Proper air classification (Grade C or D)
  • Full compliance with EU GMP Annex 1 & 15, FDA 21 CFR Parts 210–211, ISPE Baseline Guides, and GAMP 5 principles.
Validation and Documentation

Each project is delivered with complete DQ/IQ/OQ/PQ documentation, FAT/SAT protocols, and full traceability of materials, instruments, and welds.
Our qualification and validation philosophy ensures total regulatory compliance, product safety, and long-term process reliability.

Key Advantages
  • Turnkey engineering and installation
  • Fully automated, validated, and documented systems
  • Hygienic design for easy maintenance and cleaning
  • Global technical support and after-sales service
Discover the Perfect Solution for Your Needs!

Our pre-treatment systems are custom-designed to align with your chosen purification method and specific water quality requirements

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