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Strategies for efficiency and quality.

Process Engineering

Precis delivers process engineering solutions that help clients bring therapies to market safely, efficiently, and compliantly.

We support clients through every phase of process implementation and modification from development through commercialization.

Our process engineers translate user requirements into fully functional manufacturing facilities by defining process controls, selecting and sizing equipment, and designing layouts that meet cGMP and regulatory requirements. Our manufacturing optimization expertise includes reducing non-value-added activities – such as cleaning and product changeovers – to help clients minimize downtime, improve throughput, and increase production efficiency.

Process development and characterization are complex, critical activities essential to ensuring that manufacturing processes are robust, scalable, and capable of meeting current and future demand. Our process engineers apply an Operational Excellence (OpEx) approach and Critical‑to‑Quality (CTQ) and Critical Process Parameter (CPP/CPM) methodologies to define operating windows and establish process understanding, positioning our clients for successful validation or rapid commercialization. Regardless of the technology, product, or challenge, Precis offers expertise to help clients bring processes online and operate with confidence.

process engineering services:

  • Process flow diagrams (PFD)
  • Process scope development
  • Process + instrumentation diagrams (PID)
  • Process instrumentation + automation
  • Operational excellence + optimization
  • Highly potent API containment
  • Capacity analyses + scale-up planning
  • Superskid + module design
  • Equipment + user requirement specifications (URS)
  • Cell culture + microbial fermentation
  • Downstream recovery
  • Building information modeling (BIM)
  • 3D piping design
  • Single-use + continuous processing
  • Chemical synthesis, solvent handling + recovery
  • Aseptic fill/finish
  • Oral solid dosage (OSD) (tablets, capsules)
  • Semi-solids (creams, ointments)
  • Biosafety Level (BSL) facilities
  • Animal Biosafety Level (ABSL) facilities
  • Risk assessments
  • Hazard + operability (HAZOP) reviews
  • Energy modeling + conservation strategies
  • Deionized (DI) water
  • United States Pharmacopeia (USP) water
  • Reverse osmosis (RO) purified water
  • Process development
  • Process characterization + pre-validation prep
  • Process validation