Case Study 1
Potent Manufacturing Facility, 8966
Aesica (Queenborough) Ltd
RBPC was awarded Front End Study contract in May 2010 RBPC was awarded Design and Manage Contract in August 2010. The Building was completed to IQ stage in April 2011 Pharmaceutical Formulated Product Facility to manufacture a Potent Schedule 2 controlled drug with an OEL of 700 nanograms/m3 Feasibility Study, Front End study, Detailed design, construction management, Validation, CDM
Requirements
- The requirement was to convert an unused office into a stand-alone facility within a short as possible time period.
- This facility includes change rooms, airlock, Blender, Tablet press, Blister packer, Analytical laboratory, safe room.
- HVAC system where air is HEPA filtered in and out of each room.
- The main driver for this project was programme with a supply agreement of 6 million tablets agreed for delivery in 2011.
Scope
- The initial layout concept was developed by Aesica. Aesica also scoped and purchased all major production equipment.
- RBPC costed the facility and utilities to house this concept in 3 separate design stages (30% feasibility, 10% front end and detailed design stages).
- RBPC then managed the construction of the facility.
- RBPC completed all facility and utility validation Delivery.
- The building was delivered on time despite major construction activates (steelwork erection and cladding installation) occurring during a harsh winter.
Outcome
- The building completion was achieved within the same month that was originally targeted at feasibility stage.
- The final cost of the facility and utilities was only 8% higher than the price estimated at feasibility level (30% design stage), and only 0.5% higher than that estimated at detailed design level.
Mike Battrum, Head of Engineering commented:
R B Plant delivered a class leading potent manufacturing facility to budget on time.
RBPC was awarded design works November 2012 Facility shutdown for the start of upgrade May 2013. Partial handover to make product 1, July 2013. Final handover to make product 2, December 2013 API Potent Drug Facility Equipment, facility and utility upgrades to make products for a new customer Detail design, HAZOP, Construction Management, Validation.
Requirements
- The requirement was to upgrade an existing Potent drug facility such that it could make a new product which is both a Schedule 3 controlled drug and also is a potent drug with an OEL of 1.5 µg/m³ 8 hour TWA (Safebridge level 3 potent compound).
- Materials of construction of equipment had to be compatible with HCL. The existing stainless steel Filter dryer had to be removed in a sympathetic way such that it could be sold on the second hand market and replaced with a new Hastelloy Filter dryer.
- Containment systems were to be upgraded to handle a product with an OEL of 1.5 µg/m³.
- HVAC systems were upgraded to meet ISO 14644-1 class 7.
- Installation of a new HTF package.
- Works to be carried out such that there was minimum impact to other production operations.
Scope
- The initial concept including the purchase of the new Filter dryer was completed by Aesica.
- RBPC designed and costed the remaining equipment, facility and utility upgrade.
- HAZOP assessment.
- RBPC then managed the construction of the upgrade.
- RBPC completed all equipment, facility and utility validation.
Delivery
- The upgrade was delivered in a 2 stage process. Initially a shutdown was required to relocate existing equipment and a contained construction area was created. The remainder of the facility was then handed back over to manufacture existing products.
- The remaining upgrades and validation were then completed as planned
Outcome
- The upgrade was delivered on time and within budget
Mike Battrum, Head of Engineering commented:
R B Plant delivered a logistically difficult project in a flexible and professional manner.