Case studies
Ampoule Manufacturing Facility and Inspection Visual Area
Bouygues Energies & Services were enlisted by a specialist pharmaceutical manufacturing company to design and build a new, sterile ampoule manufacturing facility and visual inspection area, complying with cGMP requirements for European markets.
24/7
operation capability
ISO 7
classification to cGMP
standards
21
degrees +/- 2 temperature control
Extending over a century, our client has an unparalleled track record in unlicensed and licensed specialty generics, substance misuse treatment and emergency care medicines. At its principal manufacturing facility, our client specialises in the production of sterile ampoules, sterile screw cap bottles, non-sterile liquids, non-sterile suspensions and suppositories.
Following various observations from the MHRA, Bouygues Energies & Services were enlisted by the client to aid them in the Design & Build of a new Sterile Ampoule Manufacturing Facility and Visual Inspection Area.
Our Solution
By working closely with the client team throughout the scoping stages and assisting with the development of URS and detailed facility layout, our distinctive design and build solutions encompassed:
- Construction of the Terminally Sterilised Ampoule Facility (Grade B/C/D and unclassified) into 2 distinct zones:
- Secondary change, solution prep, Ampoule filling and Autoclave loading area
- Pharmaceutical autoclave unloading, WIP CD storage and Visual Inspection
- Installation of three new autoclaves
- Transfer of existing filling and inspection machines across the existing production area
- Design & full replacement of the existing HVAC and clean utilities, incorporating energy saving measures
The new facility was also constructed within the existing footprint of the previously decommissioned Aseptic Manufacturing Facility and undertaken whilst the main manufacturing capabilities were fully operational, minimising disruption to the client.
Client Benefits
A Single Point of Contact to Boost Performance
Providing detailed design, architectural, procurement, construction, mechanical & electrical services, commissioning and validation to construct a new manufacturing facility.
Zero Downtime
Bouygues Energies & Services team developed a holistic approach based on de-risk strategies to allow the full, uninterrupted operation of the existing site, while the new facility was being built adjacently.
MHRA regulated sterile facility complying with cGMP requirements and standards for Europe, while taking into account evolving technologies and regulatory requirements.
Meeting future market requirements by introducing more products from a new production line, focused on a high value, sterile dosage for Emergency Care products.
Guaranteeing a quick and efficient response to the client's customer requirements, by developing new in-house manufactured products.
Creating an efficient and regulated working environment for the client's employees.
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Our Commitments - Pharmaceuticals & Lifesciences
Our Commitments
De-risk Project Development
Accompanying you through the whole project development from concept stage to handover
Technical Expertise
Leveraging our engineering design and construction technique to accelerate and realise the vision of our clients
Compliance Strategies Within Regulated Sectors
Ensuring MHRA and FDA regulations are met as required
Lean Operation
Ensuring greater long-term operational efficiency and productivity
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