Once a business plan has been determined and a conceptual design completed, you then need to decide the next stage forward. You may prefer to choose basic & detailed engineering, which will allow you to choose various other strategies like EPCM or your own project management with multiple subcontractors. The other option is to go straight to the design & built stage.
Whichever route you decide to take you will need to choose a company that has vast experience in designing, purchasing, installing, starting up and performing qualifications of pharma and biotech plants. You must fully trust that the company is up to date with all relevant Pharma GMP regulations in relation to all of the above services.
Telstar Pharma Services can help you through the whole process and partner you. Having more than 30 years’ experience developing fit for purpose pharmaceutical regulated plants, Telstar is a unique company in the market which join together it’s engineering team, in house matter experts in pharma manufacturing equipment, its pharmacist consultants with extensive knowledge in pharma regulation and its specialised engineers dedicated exclusively to tailor your plant, offering all your requirements with advanced operational and GMP compliance solutions.
With office locations on three continents (Spain, Brazil, India and Bangladesh), Telstar’s teams of experienced engineers and construction supervision experts execute complex and challenging projects throughout the globe. The individual and collective project and technical expertise of our Subject Matter Experts (SMEs) and our associated process, clean utility and pharmaceutical expert engineers enable Telstar to deliver appropriate, cost-effective fit-for-purpose solutions to our clients. Telstar is a Life Science design specialist company with leading edge in-house technical equipment experts who provide input on equipment sizing, selection and cycle analysis.
Telstar’s engineering capabilities comprise of proven processes and best practices which guarantee Quality by Design implementation from the outset and looks to provide integrated design, construction and GMP compliance. Telstar can also provide clinical trial expertise if required. More importantly, Telstar executes all projects ensuring that the following key objectives are fully met; health and safety, environmental stewardship, cost and schedule control and risk mitigation.
During the initial discussions your user requirements are examined alongside the pharma and biotech regulations and what local engineering and construction companies can offer. The engineering & design output will be a complete set of deliverables build up after a BIM model which will allow you to justify decisions (GMP, industrial, cost, lead time, operations and maintenance) and to proceed with the next stage of your investments such as local permits, procurement, materials & contracting works and scheduling different qualification stages).
Though the engineering and design is done with the latest tools in BIM modelling, its development follows the classic strategy of Basic Design and Detail Design, where different decisions and stages are consolidated with the users before proceeding to the next level of design.
The methodology is easy to understand but still requires an experienced project management team to conduct the whole process smoothly and efficiently. The process requires the following to ensure success:
We will design all the installations required in your facility: HVAC, clean utilities, process reactors, transfer lines, Cip/SIP, integrated control systems (from PLC to MEs & other industrial management systems), clean room partitions, chill & hot water for process and for HVAC, compressed air for process or industrial, de-dusting, vacuum cleaning system, electrical system , IT and other communication systems. Telstar will coordinate with your civil work contractor from the beginning to the end of the whole project.
Conceptual DesignGMP ComplianceTelstar Value Services
We work alongside our customers in close partnership, supporting them throughout the full life cycle of their plant and equipment to ensure lasting business success.
Read More