FUNDAMIX® Packaged Units and Skids
When a mixer alone is not enough
In pharmaceutical production, mixing is rarely an isolated step. Formulation and buffer preparation usually also need temperature control, dosing, filtration, cleaning and sterilisation, plus instrumentation and documentation that hold up in a GMP audit. When these parts come from different suppliers, interfaces multiply, qualification becomes more complex and responsibility for the overall system is split.
What a FUNDAMIX® Packaged Unit includes
A FUNDAMIX® packaged unit combines the vibromixer with the vessel, auxiliary equipment, instrumentation and control system on one frame or skid. DrM engineers and documents it as a single system. Depending on the process, a unit can include:
- heating and cooling via jacket or half-pipe coil
- pumps and dosing systems
- filtration units
- integrated or separate CIP/SIP skids using PW, WFI or pure steam
- load cells and instrumentation for level, pressure and temperature
Four system types from development to production
- Glass reactor laboratory units: 0.5l to 200l, for formulation trials, process development and scale-up data.
- Stainless steel process units: from pilot scale to 12 m³ production vessels, either stand-alone or as mobile or stationary skids. Pressure vessels are built to PED, ASME, EN 13445 or AD2000, with full vacuum design where needed.
- Turnkey plants: several unit operations, such as mixing, storage, filtration and cleaning, connected into one automated production line for batch or continuous operation.
- Auxiliary systems: filtration skids, CIP/SIP skids and temperature control units that complete or upgrade an existing installation.
Every system uses the same FUNDAMIX® mixing principle, so results from the laboratory unit can be transferred to production scale with confidence.
Hygienic design and qualification support
For pharma and biotech, units are built to GMP, EHEDG or ASME BPE requirements. Product-contact surfaces are 316L, finished down to Ra 0.25 µm and electropolished on request. Elastomers are available with FDA, USP Class VI or TSE/BSE-free approvals, and the membrane sealing unit of the FUNDAMIX® removes the need for a mechanical seal.
Documentation includes 3.1 material certificates, surface and passivation reports and a traceability matrix. DrM supports DQ, IQ and OQ, and carries out a factory acceptance test before shipment and a site acceptance test after installation.
Automation and data integrity
Control ranges from a stand-alone panel to full PLC and SCADA systems. Units integrate with Siemens or Rockwell plant controls via PROFINET, EtherNet/IP or OPC UA, and can connect to MES and ERP systems. Recipe management, batch reports, alarm handling, audit trail, user management and electronic records support 21 CFR Part 11 compliance.
Typical applications in pharmaceutical manufacturing
FUNDAMIX® packaged units are used for:
- insulin production
- vaccine manufacturing
- preparation of sterile media and buffer solutions
- formulation of protein-based products
- process development in pilot plants
From concept to commissioning with a single supplier
DrM handles process, mechanical and automation engineering in-house, pre-assembles each unit in its own workshop and remains the single point of responsibility through commissioning. Trials in DrM’s test facilities, or with rental units on site, can confirm the mixing parameters before the design is finalised.
To learn more, please download the brochure. To discuss your project with DrM’s engineers, send an enquiry through the DrM company profile page.
