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Feasibility and Concept studies
Determining which projects to proceed with, how much to invest and which product lines to prioritise are just some of the main challenges facing Pharmaceutical and Life Sciences manufacturers.
Here are some of the benefits our clients in this sector have received from RB Pharma’s expertise in this area:
- Evaluate project viability at the outset using a structured early stage gate process.
- Define project scope and review alternative options.
- Estimate capital and operating costs at an agreed level of accuracy.
- Identify key technological and commercial risks that could affect viability of each option.
- Propose various execution strategies with pros and cons for each, for example EPCM.
- Present CAPEX justifications to stakeholders with more confidence.
Key to our success is pitching the right level of detail in each study. Too much detail incurs higher fees, insufficient detail makes it more difficult to navigate between the various options.
The demands of upgrading, extending or building a new Pharmaceutical facility call for a coordinated approach and a single point of contact.
RB Pharma have provides our clients with all the requisite disciplines under one roof thereby facilitating continuity and cross-fertilisation of ideas between each discipline. This avoid leaving any gaps in scope execution and seamless working between critical path deliverables.
Our disciplines cover the following:
- 3D modelling and Navisworks design
- Civil, structural and architectural
- HVAC and building services
- Electrical, control and instrumentation
Keeping up-to-date with ongoing changes in safety and legislative compliance can be a challenge to manage along with day-to-day operations. As well as the in-depth expertise and track record amongst our process safety engineers, we rigorously keep abreast of changes in legislation so our clients can rest assured that RB Pharma will deliver any solutions that are fully compliant and stand up to scrutiny in front of any regulatory bodies.
We offer the following services either in isolation or as part of a wider project:
- What-If Studies
- Functional safety (TUV certified); FSMP, SRS, O&M plan, Proof test & inspection procedures
- Environmental Risk Assessments
- Process scale up and technology transfer
- Design of DOE to inform design and optimisation for process development
- Business modelling and CAPEX justifications including Value/cost benefit, risk mitigation and constructability analysis.
- Continuous improvement to improve quality, productivity and efficiency.
- MHRA and FDA audit preparation
- SOP / BMR rationalisation and redesign
- Sustainability including:
- Reduction of process waste by utilising Lean Manufacturing principles
- Energy efficiency optimisation/recovery
Having the necessary resourcing structure to see a project through successfully from concept to completion can seem daunting. RB Pharma have worked with a variety of clients with diverse project team structures and developed an execution approach tailored to the needs of each client.
Our project, procurement, contract and CDM managers all have an engineering background meaning they have the technical and practical experience to work seamlessly with all technical disciplines and liaise at all levels on the client side.
We can provide a complete project service as follows:
- Scheduling and program management
- Cost control
- Planning guidance
- Procurement of equipment and vendor bid analysis
- Contract Management
- Construction management and CDM
- Installation supervision and FATS/SATS
- Commissioning and validation protocols (i.e. IQ/DQ/OQ/PQ, URS, VP, IA, CCA)
- Operator training
The following is an overview of the kinds of technologies, services and successfully accomplished projects that RB Plant can support you with. Please note the following list isn’t exhaustive.
- Aseptic/sterile processing
- Wiped Film Evaporator (WFE)
- Condensers/heat exchangers
- Fluid Bed Dryer
- Filter Dryer
- High Shear Mixer/Granulator
- Mobile Blister Packaging machines
- Medical device assembly Jigs
- WFI system (including Highly Purified Water)
- Purified Water systems
- Clean steam
- Capsule vacuum filling machines
- Cryogenic processes
- CIP systems
- VHP low temperature sterilisation
- Neuroscience/neurological disorders
- Gene therapies Monoclonal antibodies (mAbs)
- MRNA vaccines and antibody drug conjugate medicines
- Neurodegenerative and cardiovascular disease
- Immune system suppression
- Viral infections anti-sense oligonucleotides