Pharmaceutical Engineering & Design Capability
DIALOG Fitzroy are a New Zealand leader in the engineering & design of pharmaceutical facilities. We specialise in integrated design, construction, and validation of cleanrooms, laboratories, containment facilities and process plant - manufacturing facilities.
We recognise the importance of investing time and money wisely and efficiently by following a Lean Approach in the execution of pharmaceutical projects. Work is phased so that each step builds on the foundations from the previous step. Each phase culminates in a gate review in which the project is tested against the business case, GMP, HSE, operational & engineering requirements, confirm fitness for purpose and capability to proceed. In general terms, project phasing is as follows; Initiation – Concept – Developed – Detailed – Construction – Qualification – Handover.
Design is challenged at each phase, through
- Good Manufacturing Practice (GMP) Review – fulfilment of those fundamental requirements (eg, for the Animal Health Medicine for NZ in the NZFSA, ACVM Standard and Guideline)
- Design Qualification
- Engineering Design Review - specification and capability,
- Safety Review – typically HAZOP, HAZID for process plant
The Pharmaceutical Facility
Like no other industry the “Facility” for pharmaceutical manufacture is an integration of not only process plant - stainless steel pipework, hygienic valves, UF and Centrifuge unit operations – but the trained staff and building itself – the clean rooms and the associated pharmaceutical Grade HVAC to provide the full “manufacturing process”. The integration of the building with the process plant is key.
Control of people and materials movement from the “street” environment through to progressively more stringent cleanliness zones must be built into the facility design, and is achieved through the use of closed systems (pipework), material airlocks, and personnel changing rooms.
Integration of the process services is key – High Purity Water (WFI, PW), Pure Steam, Clean Compressed Air, Process Gases – along with the Building Services – HVAC, Power, Drainage, Plant Steam, Glycol, Chilled Water, Cooling Water, Fuel Gas.
Attention to cleanability of the process is key. CIP systems provided for process plant, with SIP on systems requiring this approach – parenteral products. Similarly, the building fabric itself must be easily cleanable, and sanitised as required.
Specialist Validation staff at Fitzroy, with in-depth knowledge of cGMP, industry standards (ASME BPE) and guides (ISPE Baseline and Good Practice), and the competence to pragmatically apply them, ensure that the requirements of Process Validation are supported by the integrated Qualification andEngineering effort, “built in” – not “bolting on” – the requirements to facilitate equipment qualification.
DIALOG Fitzroy staff provide comprehensive validation support, through planning, protocol production, execution and reporting, and full integration with the engineering team.
Procurement & Construction Management
In addition to our specialised pharmaceutical engineering & design capability, our extensive in-house procurement, fabrication and construction management experience enables us to deliver projects seamlessly and cost effectively to meet client requirements.