We can provide you with the following services and expertise;
- Design of Planned Preventative Maintenance Systems
- Project management of system installation
- Resource for routine and demand maintenance and calibration activities
- Equipment validation support
- Development of Policies and Procedures
Project Management of System Installation
We provide engineers who have the experience to project manage system installation covering; the generation of specifications, commissioning through to final qualification, evaluation and supervision of contractors, planning and progress reporting.
Design of Planned Preventative Maintenance Systems
We will work closely with you to develop planned preventative maintenance systems. We manage the conceptual scheme, equipment assessments, instrument categorisation and population of data through to final implementation. The maintenance scheme is fully proceduralised. We can also carry out gap analysis on existing maintenance systems in order to ensure compliance, improve manufacturing efficiency and reduce production downtime.
With our expertise we will improve your plant compliance and efficiency by;
- Targeting critical equipment
- Reducing, maintenance on non-critical items
- Streamline calibrations for product critical instrumentation
- Documenting evidence of maintenance and instrument assessments
- Creating a periodic schedule for maintenance and calibration activities
- Developing maintenance and calibration job plans
Routine and Demand Maintenance and Calibration Activities
Our engineers are experienced in mechanical and electrical maintenance and instrument calibrations, working on pharmaceutical process equipment and utilities. Familiar with current regulatory requirements meeting cGxP, FDA (CFR21), EMEA and the GAMP guidelines, we are comfortable working alongside permanent staff to support production deadlines. Our extensive engineering knowledge enables effective troubleshooting of plant breakdowns.
We offer a comprehensive calibration service to ensure that your organisation remains compliant. Our service provides calibration of a wide range of operational parameters which are integral to the processes utilised within a wide range of industries, including:-Temperature, Pressure, Flow, Speed, Time, Volume. All calibrations are performed to national standards, with the aid of calibrated test equipment by our team of highly trained technicians. We provide on-site services that are tailored to suit the needs and requirements of our customers and fully recognise the production constraints of industry; our aim is to function as a genuine partnership service within our customer's organisations.
Equipment Validation Support
We can provide expertise in the writing, execution, reviewing of validation specifications and protocols (URS, FAT, SAT, IQ, OQ), raising deviations and final report writing.
Development of Policies and Procedures
We offer a wealth of experience and knowledge in the creation, development and improvement of engineering procedures which will satisfy pharmaceutical regulatory requirements. We have produced bespoke policies and procedures for calibration and maintenance systems that have passed both FDA and MHRA audits.
Examples of Previous Projects
- Project management to implement a new qualified IMS system and improvements to existing BMS system for a leading Biopharmaceutical manufacturer.
- Installation of a new PLC cabinet and 84 new temperature sensors, transmitters, cabling with containment and termination for a manufacturing Biotechnology facility in the East Midlands, including project management and commissioning.
- Implementation of maintenance systems and calibration schedules requiring full instrument categorisation and equipment maintenance assessments, including a suite of new procedures for a number Biotech facilities that achieved MHRA audit approval.
- Calibration and maintenance engineering support for a manufacturing Biotechnology facility in the Midlands during routine shutdowns.
- Writing of engineering calibration SOPs and policies for a Biotechnology company which achieved FDA approval.
- Annual ongoing service contract for maintenance and calibration of clean room isolators for the NHS.