BioPharmaceuticals
High Purity Pipework Systems for Clean Utilities and Process Applications
High purity pipework for research through to clinical trials and cGMP manufacturing.
HEES has the capability and experience to undertake projects in the following industries:
We design, install, commission and qualify:
- Water for Injection (WFI) storage & distribution systems
- Purified Water storage & distribution systems
- Highly Purified water
- Pure Steam
- Demineralised water
- CIP/SIP
- Product process lines
- Specialist gases
Research & Development Applications
- DI / RO water distribution systems
- Specialist gases
- Contained waste systems
- Electrical mains (HV & LV) & sub-mains (LV) power distribution
- Design of lighting & installation
- Small power
- Safety & security systems – fire, security & access control
Proven Compliance
Our modular systems provide flexible solutions that are compliant with all of the cGMP guidelines for the US & European Pharmacopoeia, including the International Committee on Harmonization. European Compliance Academy
Hydro Dynamics Modelling
All of our systems are compliant with the International Society of Pharmaceutical Engineers design guides and we pride ourselves in our ability to balance design and cost of ownership to provide a flexible, low risk solution with sustainable utility demand.
Our distribution systems are designed to meet the flow rates, pressures and diversity of use as indicated by our customers.
We have proven compliance & design solutions with prestige reference sites.
Mechanical
All mechanical engineering work is compliant with the latest ASME BPE 2005 protocols.
Electrical
We can offer the electrical expertise to provide complete renewal, refurbishment or modification to clients’ electrical services.
All electrical installations are fully compliant with the Institute of Electrical Regulations BS7671:2008 and we are a National Inspection Council for Electrical Installation Contracting (NICEIC) registered contractor.
This provides clients with the comfort of knowing that all the electrical installations are backed up with a guaranteed standard by the NICEIC.
Our electrical control panels and distributed I/O are all constructed according to IEC & EN Standards, UL 508 & 544 NEMA and NEC or CSA.
Our installation services include:
- Design & installation
- Electrical mains (HV & LV) & sub-mains (LV) power distribution
- Data communications infrastructure & systems
- Process automation and control infrastructure & systems
- As-built drawings & client operating manuals
- IEE regulations & NICEIC compliant testing & certification
- Staff training
Control System Design
Our control philosophy is to utilise standard, commercially available Programmable Logic Controllers (PLC) to maximise flexibility and reliability.
All systems are cGAMP compliant and typical systems include:
- Siemens Simatic S7 PLC with touch screen & SCADA
- Paperless Chart Recorders
- On Line Monitoring
- TOC
- Mass Flow
- Temperature
- Conductivity
Documentation
Our cGAMP documentation packages includes:
- Risk Assessment (Support)
- Validation Master Plan (Support)
- User Requirement Specification (Support)
- Technical and Commercial Specification
- Design Qualification
- Functional Design Specification
- Detailed Design Specification
- Software Design Specification
- Hardware Design Specification
- STS
- Installation Qualification
- Operational Qualification
- Performance Qualification (Support)
Specialist Gases
Being an active member of the British Compressed Gases Association we are accredited to design, install & qualify specialist gases applications.
This key utility is vital for both upstream and downstream Biopharmaceuticals where the quality of installation and delivery of high purity gases to the point of use, has a direct impact on product yield.
Key to the UK is scientific research with applications in genetic & DNA research.
Gases include:
- Nitrogen
- Carbon Dioxide
- Oxygen
- Argon
- Helium
- Hydrogen
- Liquified Petroleum
- Methane
- Specialist mixed gases