Integration
of clean systems
Processes, clean utilities, pharmaceutical systems and the building: we make them work together, from functional analysis to safety interlocks.
Standards EMA-Annex 1 · ASME-BPE · ISPE · GAMP 5 · ATEX · NFPA · OEL · BSL
Challenges we solve
Are you at one of these stages?
01
Systems that don’t talk to each other
Purified water, clean steam, HVAC and PLCs designed separately: the interfaces are where the problems lie.
Let’s talk about this challenge
02
Purity you must guarantee
Your utilities must reach and maintain the required quality: purified water, water for injection, clean steam, compressed air.
Let’s talk about this challenge
03
Containment to control
Highly potent, biological or flammable products: operators, products and the environment must all be protected.
Let’s talk about this challenge
04
The move to Industry 4.0
PLCs, SCADA, building management and ERP have to work together, and stay compliant.
Let’s talk about this challenge
A compliant process depends on everything around it: purified water, clean steam, compressed air, HVAC, sterilization, clean-in-place. We analyze these systems together, verify purity, sterility and risk level, then select the right technologies.
We also integrate PLCs, SCADA, building management and enterprise systems (ERP, SAP) to pave the way for Industry 4.0, along with containment equipment and effluent treatment.
Clean systems
A skid, piece by piece.
Frame, tank, pump, piping and valves: each component is specified, then tested at the manufacturer (FAT) and on your site (SAT).
What you get
Results you can show.
Functional analysis of your systems and their interfaces
Technology selection: purified water, clean steam, compressed air, HVAC, sterilization, clean-in-place
Assessment of purity, sterility and risk level
Integration of PLCs, SCADA, building management and enterprise systems
Containment equipment and effluent treatment
Safety interlocks between systems
What the service includes
The common core for every industry we serve.
Service sheet
Clean systems integration
Page 1 of 1
- 01EMA-Annex 1 complianceRABS and isolator barriers, filter integrity testing before and after use (PUPSIT)
- 02Functional analysis of processes, clean utilities and pharmaceutical systems
- 03Verification of purity, sterility and risk level
- 04Cross-matrix of equipment, utilities, systems, production rooms and infrastructure
- 05Biological containment (BSL-1 to BSL-3) and biotechnology, continuous and autoclave thermal effluent decontamination
- 06Selection and layout of manufacturing equipment and systems
- 07Risk management, impact assessment and mitigation (RAPA, GAPA)ICH Q9, FMEA, ATEX
- 08Design of the warehouse, push-back racking, vaults, cold rooms and quality control (QC) laboratory equipment: physicochemical testing, microbiology, R&D
- 09Support with environmental certificate of authorization (CA) applications
- 10Energy efficiency, energy, water and material balances, renewable energy integration (trigeneration)
- 11Gowning and personal protective equipment (PPE)
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.
Pharmaceutical4 items
- Choice of sterilization technology: aseptic, filtration, steam, depyrogenation
- Chemical containment of highly potent, toxic, oncology and cytotoxic products
- Techno-economic assessment of single-use technologies
- Treatment of hazardous chemical and biological effluents (OEL, BSL): gaseous, liquid and solid
Biotechnology and vaccines4 items
- Functional analysis of processes, clean utilities, clean systems and biological containment
- Choice of sterilization technology: aseptic, filtration, steam, depyrogenation
- Techno-economic assessment of single-use technologies
- Treatment of hazardous biological effluents (BSL): gaseous, liquid and solid
EU-GMP therapeutic and medical cannabis8 items
- Specifications for storage areas, the THC vault, cold rooms and quality control (QC) laboratories
- Analysis of flows, contamination and cross-contamination (CCC) risks
- Functional and technical program (PFT)
- Specifications for personal protective equipment (PPE), explosion-proof equipment and containment
- Preserving the integrity and asepsis of rooms, equipment and products (THC, CBD…)
- Design of the warehouse, push-back racking, THC vault, cold rooms and quality control (QC) laboratory equipment: physicochemical testing, microbiology, R&D
- Treatment of hazardous chemical effluents (OEL): gaseous, liquid and solid
- Support with certificate of authorization (CA) applications and environmental impact studies
Hospitals and pharmacies2 items
- Choice of sterilization technology: aseptic, filtration, steam
- Chemical containment of highly potent, toxic, oncology and cytotoxic products
Fine chemicals and APIs5 items
- Functional analysis of processes, clean utilities and clean systems
- Verification of purity and risk level
- Preserving the integrity and cleanliness of rooms, equipment and products
- Design of the warehouse, push-back racking, cold rooms and quality control (QC) laboratory equipment: physicochemical testing, microbiology, R&D
- Treatment of hazardous effluents (ATEX, NFPA): gaseous, liquid and solid
Food7 items
- Functional analysis of processes, utilities and clean systems
- Choice of aseptic treatment and pasteurization technology
- Flow and critical control point (CCP) hazard analysis
- Specifications for personal protective equipment (PPE) and for gowning and safety procedures
- Capital (CAPEX) and operating (OPEX) cost optimization
- Energy, water and material balances, and their optimization
- Energy efficiency, renewable energy integration (trigeneration)
In practice
One project as an example.
Frequently asked questions
What people ask us.
Which systems do you integrate?
Clean utilities (purified water, water for injection, clean steam, compressed air), HVAC systems, sterilization and clean-in-place, PLCs, SCADA, building management and enterprise systems.
Do you work with containment?
Yes: chemical containment (OEL), biological containment (BSL) and explosive atmospheres (ATEX), to NFPA standards.
Are computerized systems validated?
Yes. Our validation team qualifies them to GAMP 5 and 21 CFR Part 11.
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.