— Expertise
Equipment & URS
Covering the entire field of engineering procurement — from writing precise specifications and User Requirement Specifications (URS), through supplier comparison and acceptance testing, to obtaining the best equipment at optimal cost.
The URS Development Process
A User Requirement Specification is the foundation of every successful equipment procurement. It defines precisely what the system must do — in technical, operational, and regulatory terms — before any vendor is contacted.
Arnan’s URS documents are recognized for their thoroughness and precision, drawing on decades of experience with the actual operational realities of sterile manufacturing environments. This prevents the costly discovery of unmet requirements during FAT, SAT, or worse — during qualification.
1
Requirements Gathering
Stakeholder interviews, process requirements, regulatory constraints
2
URS Drafting
Technical specifications, performance criteria, compliance requirements
3
URS review by site principals and formal approval
Internal review by key stakeholders before release to vendors
4
Vendor RFQ preparation and evaluation using structured comparison tables
Formal RFQ package preparation and vendor comparison
5
Vendor selection based on technical, quality, and commercial criteria
Decision support focused on the best overall value and compliance fit
Equipment Categories
Filling Lines
Liquid, lyophilized, and powder filling systems for all container types.
Bosch/Syntegon, Optima, B+S, Groninger, IMA, Dara
Isolators & RABS
Barrier systems for aseptic processing environments.
Skan, Franz Ziel, Ravona, Comecer
Autoclaves
Steam sterilizers for components, media, and equipment.
Fedegari, Bosch-SBM, De-Lamma, Tuttnauer
Lyophilizers
Freeze-drying equipment from lab to production scale.
IMA, Klee, Hull, Martin Christ
Visual Inspection
Automatic inspection machines for particles and cosmetic defects.
Eisai, Körber (Seidenader), Brevetti
Special Equipment
Homogenizers, process equipment, and custom machinery.
Harro Höfliger, Nicro, GEA Niro Soavi, Netzsch
The Cost of Poor Specification
An incomplete or imprecise URS leads to equipment that does not meet operational needs, costly change orders, delayed qualification, and potential regulatory findings. Expert specification writing is the most cost-effective investment in any equipment procurement project.
