Engineering
your processes
Sanitary design and process engineering to ASME-BPE, basic and detailed: PFDs, P&IDs, 3D drawings and performance specifications.
Standards EMA-Annex 1 · ASME-BPE · ISPE · ATEX · NFPA · OEL · BSL
Challenges we solve
Are you at one of these stages?
01
A process to design
A new formulation or a scale-up: the process has to be designed right from the start.
Let’s talk about this challenge
02
Hard-to-clean equipment
Your equipment retains product or is hard to clean: the sanitary design needs a fresh look.
Let’s talk about this challenge
03
Equipment to specify
Tanks, skids, filling lines: your suppliers expect clear specifications.
Let’s talk about this challenge
04
A hazardous product
Highly potent, biological or flammable product: containment must be built into the process.
Let’s talk about this challenge
Processes, clean utilities and pharmaceutical systems are designed to ASME-BPE and ISPE standards from the outset. We develop the requirements (PURS, URS), the basis of design and detailed design, the diagrams (PFD, P&ID) and the critical process parameters.
Our engineers produce 3D designs of tanks, transfer lines, clean-in-place and sterilization-in-place skids, filling and packaging machines and containment equipment, minimizing dead legs and optimizing slopes and velocities.
From design to qualification
A water for injection loop, line by line.
- 01
Design & P&ID
The process is drawn as a P&ID: equipment, piping, valves and instruments.
- 02
Production and storage
Water for injection is produced, then kept hot in a stainless steel tank.
- 03
The loop
A sanitary pump keeps it circulating continuously, with no dead legs.
- 04
Points of use
Diaphragm valves, as close as possible to the equipment that uses it.
- 05
Instruments
Temperature, pressure, velocity and conductivity, monitored continuously.
- 06
Construction and qualification
Piping orbital-welded to ASME-BPE, then qualified through IQ, OQ and PQ.
What you get
Results you can show.
User requirements (PURS, URS), basis of design and detailed design
Process flow diagrams (PFD) and piping and instrumentation diagrams (P&ID)
Critical process parameters
3D drawings of tanks, transfer lines, and clean-in-place and sterilization-in-place skids
Equipment performance specifications
Sanitary design to ASME-BPE: fewer dead legs, optimized slopes and velocities
What the service includes
The common core for every industry we serve.
Service sheet
Process engineering (ASME-BPE)
Page 1 of 1
- 01EMA-Annex 1 complianceAseptic processes designed for sterility, from design to qualification
- 02Sanitary design and process engineering (ASME-BPE), basic and detailed, 3D drawings and performance specifications
- 03Development of PURS, URS, BOD, detailed design, PFD, P&ID and critical process parameters (CPP): material and interior finish specifications
- 04Sanitary designFewer dead legs, optimized slopes and velocities
- 05Specifications for valves (diaphragm, block-and-bleed), tri-clamp (TC) fittings, pumps, filters and heat exchangers
- 063D design of manufacturing equipment and process skids
- 073D design of formulation, mixing and filling tanks
- 083D design of filling, freeze-drying, and primary and secondary packaging machines
- 093D design of clean-in-place (CIP), sanitization and sterilization-in-place (SIP) skids
- 103D design of process transfer lines (orbital welding)
- 113D design of containment equipmentIsolators, RABS, IBCs, biosafety cabinets
- 123D design of protective equipmentLaminar airflow hoods, weighing booths (UDAF), LEV
- 13Interlocks between process equipment, systems and building safety systems
- 14Automation, PLCs, SCADA, integration, BMS, BAS, ERP, SAP, Industry 4.0
- 153D design of clean-in-place (CIP) and sanitization skids
Approved by
The PBE Expert team
By industry
Every industry adds its own requirements. Here is what comes on top of the common core, industry by industry.
Pharmaceutical2 items
- 3D design of clean utilities, generation and distribution: PW, WFI, PS, PCA, N2
- 3D design of pharmaceutical systems: HVAC, FFU, CIP, SIP, autoclave, freeze-drying, vacuum, drainage…
Biotechnology and vaccines3 items
- 3D design of clean utilities, generation and distribution: PW, WFI, PS, PCA, N2, CO₂
- 3D design of clean systems: HVAC, FFU, CIP, SIP, autoclave, freeze-drying, vacuum, drainage…
- 3D design of protective equipment: laminar airflow hoods, weighing booths (UDAF), RABS, LEV
EU-GMP therapeutic and medical cannabis7 items
- Development of PURS, URS, BOD, detailed design, PFD and P&ID, critical process parameter (CPP) specifications, 3D drawings and performance specifications
- 3D design of cannabis extraction and THC and CBD ingredient purification technologies
- 3D design of filling and primary and secondary packaging machines
- 3D design of clean utilities, generation and distribution: PW, PCA, N2, CO₂
- 3D design of pharmaceutical systems: HVAC, FFU, CIP, vacuum, drainage…
- 3D design of cannabis drying and milling systems, ATEX safety, energy efficiency
- 3D design of supercritical CO₂ cannabis oil extraction, THC and CBD ingredient purification and dewaxing
Hospitals and pharmacies4 items
- 3D design of clean utilities, generation and distribution: PW, WFI, PS, PCA, N2
- 3D design of pharmaceutical systems: HVAC, FFU, CIP, SIP, autoclave, depyrogenation, vacuum, drainage…
- Design of the warehouse, push-back racking, vaults, cold rooms and quality control (QC) laboratory equipment: physicochemical testing, microbiology, R&D
- Selection and layout of manufacturing equipment and systems
Fine chemicals and APIs4 items
- 3D design of filling and primary and secondary packaging machines
- 3D design of clean utilities, generation and distribution: PW, PCA
- 3D design of clean systems: HVAC, FFU, CIP, vacuum, drainage…
- Design of the warehouse, push-back racking, cold rooms and quality control (QC) laboratory equipment: physicochemical testing, microbiology, R&D
Food4 items
- 3D design of clean utilities, generation and distribution: PW, WFI, PS, PCA, N2, CO₂
- 3D design of clean systems: HVAC, FFU, CIP, microwave, freeze-drying, vacuum, drainage…
- 3D design of protective equipment: laminar airflow hoods, weighing booths, LEV
- Design of the warehouse, push-back racking, cold rooms and quality control (QC) laboratory equipment: physicochemical testing, microbiology, R&D
In practice
One project as an example.
Frequently asked questions
What people ask us.
What is the ASME-BPE standard?
It is the reference for designing equipment and piping for bioprocessing and pharmaceutical manufacturing: materials, surface finishes, slopes, dead legs and cleanability.
Do you handle both basic and detailed engineering?
Yes, from preliminary requirements (PURS) to 3D drawings and performance specifications.
Do you design for containment?
Yes: containment equipment for highly potent (OEL), biological (BSL) and flammable (ATEX) products.
Let’s talk about your project.
A new site, an expansion, an inspection to prepare for: describe your project and one of our experts will get back to you.