Pharmaceutical Engineering Process Design
PharmOut is a professional pharmaceutical engineering consultancy. We offer engineering design and project management services to the pharmaceutical, biotechnology, veterinary and medical device industries, we always try start with the pharmaceutical engineering process design and then wrap the building around the process, not shoe horn in a process into a suboptimal building.
Our services include:
- Project & Program Management, Master Planning, Cost estimation & control, Scheduling, Procurement, Client Representation
Planning / Front End
- Site Selection, Feasibility Studies, Conceptual Design, Front End Engineering Studies, Planning / Permitting, Risk assessments
Engineering & Design
- Equipment Selection / specifications, HVAC / Mechanical Design, Piping & CAD Design (3-D), Electrical Engineering, Instrumentation, Automation
Commissioning and Qualification
- Validation Strategy Planning, Validation Master Planning, Requirements Specifications, Protocols and QMS/PQS Documentation related to validation
A complete project solution – have only one technical vendor
PharmOut offers a complete one stop project solution. We can supply individual engineers as well as project managers, technical writers and other technical professionals for your next project. These services can be offered on a fixed price basis, hourly rates or as outsourced professionals on your site.
Our flexible service offering will ensure a high level of confidence that the correct GMP standard is set. Our architects, designers and engineers design it right and our validation engineers will ensure that GMP certification is assured.
In addition, our engineers have access to the country’s leading GMP consultants to ensure that GMP’s are accurately understood and all the GMP requirements are included before you start building, not as a band-aid solution when the TGA arrives.
Our engineering process
The process starts with a feasibility study to make sure the project makes sense once all factors are considered.
After the feasibility study we do an initial engineering concept design, starting with your product and market requirements, documented in a User Requirements Specification. Our experienced pharmaceutical engineers will work closely with your team to develop the most appropriate facility design based on your process requirements, with a clear objective of achieving GMP compliance.
Our engineers are experienced with equipment selection, advantages and disadvantages of technologies and can advise on the best options, based on our industry experience.
Our complete GMP compliance, engineering and validation service will ensure a high level of confidence that the correct GMP target / standard is set, engineers design it right and our validation engineers ensure that the project quality control is done properly and GMP certification is assured.
Engineering Facility Design Review for GMP Compliance
If you already have a design for your facility our GMP Engineers can review it to ensure it complies with current GMP requirements as well as industry/engineering guidelines or standards.
It makes good financial sense to have an independent review of your design before the concrete is poured and the money starts to flow out. More information.
Lean Manufacturing, World Class Manufacturing:
Besides reviewing your design to GMP compliance, we have the experience and knowledge to ensure that your plant is designed for current manufacturing best practices such as Economic Batch Quantities (EBQ), optimal work flows, Lean Manufacturing and World Class Manufacturing.
Many of our consultants have production, quality and engineering experience, so have practical knowledge of plant designs and can ensure proper facility design reviews.
Clean room builders / design
We routinely assist with the selection and awarding contracts to clean room builders used in the manufacture of drugs and devices and are lucky enough to have the current Chair of the ISO clean rooms design standard (ISO 14644), Gordon Farquharson, on the PharmOut team. He has a wealth of experience in non-sterile and sterile facility design.
To learn more contact us.