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Pharma

A significant proportion of our team has worked in the pharma industry for many years, delivering projects across many UK and European sites. We can help you to achieve your pharma based scopes, from project work, advising/consultancy to qualification and beyond....

Two Syringes

Our team have worked in some of the largest life science companies in the UK for decades. We are therefore well placed to support your work, and skillsets include: 

 

  • Pharma Consultancy – for example, you may need equipment or a facility delivering, and want to better understand the ways in which you can do that. We can support you to better understand what is needed. Regulatory consultancy is a big part of what we offer – for example having delivered over 28 autoclaves and 12 washers into the pharma industry, we are well placed to advise on your quickest and most compliant routes to first use.  

 

  • Commissioning, Qualification and Validation – we can support you, or take full control of qualifying and bringing into use a facility or equipment, working to your processes, or working to an end clients. We can seamlessly integrate into a team to provide the skills needed to bring your system(s) into service. We can act as CQV and/or CSV roles as required. We have extensive experience of the delivery of equipment, facilities and laboratories – including the delivery of HVAC, cleanroom facilities and lab fitouts.  

 

  • Computer Systems Validation (CSV) - In conjunction with our Automation team, we deliver Computer Systems Validation – with extensive experience across UK sites. We work to GAMP standards, and can also provide consultancy and guidance for your systems as required – such as Data Integrity and Cyber Security to regulatory requirements. Our work includes: 

    • PLC, PCS/DCS, Scada based systems 

    • Control Systems for Purified Water, Water for Injection, Pure Steam, and other such utilities.  

    • Lab Based Equipment, such as UV Cells, Spetrophotometers, Vi-Cells, Integrity Testers.  

    • Production Lines – fill/finish, packing, dispensing.  

 

  • Design Stage – We can integrate into a team or deliver a project independently from the first stages, ensuring your projects and CAPEX investments are delivered on time and on budget. Our teams will aim to ensure your equipment and facilities are delivered effectively, efficiently and economically – allowing you to focus on other aspects of your work. 

 

  • Temperature Control Systems – Fridges, freezers, liquid nitrogen based storage systems, warehouses, walk in cold rooms, autoclaves, washers – we are able to provide services to qualify and bring into use these types of systems, inclusive of temperature mapping via an in house service. We can provide consultancy for existing systems too, inclusive of problem solving and fault finding.  

 

  • Documentation – we can create all your documentation throughout your project lifecycle, starting at a suitable and solid URS allowing you to procure against and be one of your critical documents to validate your system against. We can generate all the documentation needed from Validation Plans, to Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ). We can ensure other activities are written in a suitable way to reduce duplication, such as ensuring commissioning documents such as FAT and SAT documents are leverageable to avoid tests being performed twice.  

 

  • Building Information Modelling (BIM) - we partner will BIM providers, so can act as a conduit to allow you to achieve BIM designs.  

 

Avoid the need for finding individual contract resource, work with us cradle to grave, and we'll deliver your whole project – avoiding the need for time consuming status determinations of contract resources.  

 

Reach out via our Contact Us page to find out if we can help with your requirement..... 

 

Examples of our work: 

  • Utility installs and modification – WFI Systems, Puri Systems, Air Systems, Steam Systems (electrical and steam driven)

  • Cleanroom projects

  • Autoclaves/Steam Sterilisers (Fedegari, Steris, Steelco, Getinge),  

  • Washers,  

  • Centrifuges (Alfa Laval, GEA),  

  • Build, Commission & Validation of Sterile Vial Fill Finish Modules including in line washers, depyrogenation tunnels, fillers and cappers..... 

  • Packaging and Inspection Equipment Lines for pre-filled syringes, ampoules and vials including Groninger, Bosch, Sortimat, Marchesini 

  • Walk in fridge / freezers, product and raw material stores 

  • Temp Mapping 

  • Pharma grade / cleanroom utility generation - including WFI, Purified Water, Pure Steam (PSG), Process Air systems.  

  • Cleanroom upgrades 

  • Cleanroom lifting equipment 

  • Project Managing and Commissioning of HVAC to class A, B & C areas, including AHU Filter Integrity Testing, Pharmagraph Environmental Monitoring Systems, Pressure Differential Balancing 

  • A full range of Lab Equipment - bringing into GMP use.. 

  • Lab Installs

  • Inspection equipment Bosch KLD HV Crack detection systems, Brevetti vision systems, Nikka Densok vac systems, bespoke vision systems including inter-departmental production reconciliation systems  

  • Building Management Systems (BMS) - Carradon Trend - upgrade of outstations and supervisors, system network rationalisation GMP/Non-GMP 

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