We have been working successfully with companies in the BioTech / Pharmaceutical sector for many years. Over that time, we have become very familiar with the issues and challenges faced by companies wishing to install new systems and modernise existing ones. Our deep experience in this sector puts us in a strong position when bidding for new work in this area.
Our speciality is in the design, installation, commissioning and qualification of high purity pipework systems for clean utilities and process applications used in research, clinical trials and in cGMP manufacturing. In addition, we have considerable experience in the design and installation of medical gas systems which are often required by pharmaceutcial companies.
Alongside the mechanical engineering work, our electrical department are experienced and available to carry out any necessary electrical work that may be needed – renewal, refurbishment or modification.
As you would expect, we carry out all project installations in accordance with the latest comprehensive Quality Assurance Systems and comply with all legislation, protocols and standards.
Examples of the types of work we regularly carry out are given below.
Mechanical
We design, install, commission and qualify:
- Water for Injection (WFI) storage & distribution systems
- Purified water (PW) storage and distribution systems
- Ultrapure water
- DI/RO water distribution systems
- Pure steam / clean steam
- Demineralised water
- CIP/SIP
- cGMP product process lines
- Specialist medical gases
- Contained waste systems
Electrical
Our electrical services include:
- Design & installation
- Electrical mains (HV & LV) & sub-mains (LV) power distribution
- Lighting design & installation
- Small power
- Safety & security systems – fire, security, disabled alarm & access control
- Data communications infrastructure & systems
- Electrical Controls and instrumentation (EC&I)
Proven Compliance to Quality Standards and Procedures
Designing and installing compliant systems and proving their compliance is essential in the pharmaceutical industry. We have proven compliance & design solutions with prestige reference sites.
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 and European Compliance Academy.
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.
All mechanical engineering work is compliant with the latest ASME BPE 2012 protocols.
All electrical installations are fully compliant with the Institute of Electrical Regulations BS7671:2018 (Amendment A1:2020) 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.
All control systems are cGAMP compliant.
Being an active member of the British Compressed Gases Association (BCGA), we are accredited to design, install & qualify specialist gases applications.
Specialist medical gases are a key utility, vital for both upstream and downstream Biopharmaceuticals where the quality of installation and delivery of gases to the point of use, has a direct impact on product yield.
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)