CASE STUDY. PCI Pharma. Gerteis Roller Compactor for Highly Potent Contained Manufacturing Facility

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1 CASE STUDY PCI Pharma Gerteis Roller Compactor for Highly Potent Contained Manufacturing Facility

2 BACKGROUND CHALLENGE PCI Pharma Services Tredegar (formerly known As part of their state-of-the art facility, PCI had as Penn Pharma), provides an outsourced two manufacturing suites; one with equipment contract and manufacturing formulation designed for capacities of 1-120kg for formulation development service to many of the world s development and small batch production, and leading pharmaceutical companies. PCI has another with equipment designed for a capacity invested extensively in expanding their of 300kg for commercial batch production. In capabilities and their service offering order to maximise the value of the investment, completing the design and build of one of the the new roller compactor would need to be made most advanced contained manufacturing available to both manufacturing suites. This facilities for highly potent products in the World. meant the materials handling system for the new roller compactor would need to be specified and Clients were impressed with the new facility allow adaption to interface with different types of the building, the equipment, the infrastructure IBCs and different sizes of containment valves. and the early adoption of continuous manufacturing methods, however there appeared to be an increasing interest in dry granulation. PCI quickly recognised the market trend and the need to increase capabilities to include roller compaction technology into their existing contained manufacturing facility satisfying growing customer demand and maintaining their market leading position. In order to seamlessly integrate with both process lines, the roller compactor would need to be ideally situated between the two existing manufacturing suites. There was only one room that was suitable, but it was very small and located in the middle of the facility with limited access not only was this a challenge for the installation, but this proved a challenge in terms of equipment layout and materials handling for day-to-day operation. Having previously worked with PCI during the 1 development of their containment strategy, Every aspect of this project needed to be S3 Process were re-engaged to design an meticulously designed and managed the user effective strategy to install a new Gerteis requirement specification, the software design, Mini-Pactor into a potent manufacturing facility the mechanical and electrical design, room that was purpose built for the processes it layout, handling requirements and every step of already contained. S3 Process were involved the installation, from how to lift the equipment from the very beginning, from initial conceptual in, to how to manoeuvre the equipment in such layout designs, through to project execution a constrained space. There was only one installation, acceptance testing and qualification. opportunity to get this right. Continuously Improving Process Manufacturing

3 SOLUTION Layout Being involved from the start enabled S3 Process There was only one room between the two to provide the full benefit of their experience and manufacturing suites that could feasibly be used, add value throughout the entire project. and it was very small, but very tall requiring an Approaching the problem with a clear strategy to innovative design. The ideal layout was achieved, integrate a new piece of equipment, optimise the considering how materials would flow in and out value of the investment, minimise disruption to of the room, how materials would flow through the business and improve the manufacturing the equipment, how materials would be handled process wherever possible. From the outset, a and with what handling equipment all while dedicated S3 project manager was appointed to keeping the process as efficient as possible. ensure the project ran smoothly. Specification The user requirement specification highlighted that it was critical for the new roller compactor to interface between processes, with configurable components and the ability to quickly change from one product to another in a highly potent contained suite. Technical, environmental and health & safety concerns were highlighted and during a comprehensive specification process, each of the concerns were systematically and thoroughly addressed. To make most efficient use of the available space, the roller compactor was designed in a top-down configuration lifting materials in an IBC to 6m and, with a single vertical column of powder flow, collecting the granulated material into the receiving IBC at ground level. The design of the suite included a mezzanine platform with stairs leading to an elevated operating area, a post hoist and a dual-purpose mobile platform for accessing the top of the equipment as well as safely lifting disassembled machine components to ground level for cleaning. Due to the unusual layout, particular attention was paid to ergonomics for day-to-day operation, as well as considering any potential risks and the health & safety of the operator utilising the post hoist for all lifting and installing multiple exits from the platform. 2 s3process.co.uk

4 Installation The new dry granulation process suite was right in the middle of the manufacturing facility. Due to narrow and winding corridors, there was no access for a forklift truck and dismantling other rooms in the facility was not an option. The only way to install the new roller compactor and the mezzanine platform was to lift the roof, drop the equipment through and assemble everything in the room. Having devised a meticulous step-by-step installation methodology, the roller compactor was attached to a custom designed lifting rig, the roof was lifted and the equipment, including all the components of the mezzanine platform, systematically craned into the room. The roller compactor was then detached from the lifting rig and attached to the mezzanine floor, before being lifted again by the crane, so the mezzanine platform legs could be attached. The complete structure, now weighing in excess of 3 tonnes, was then skidded into its final position on the other side of the room. Once the equipment was installed, it was a matter of days before acceptance testing was underway, snagging complete and processes improved. Qualification was completed to schedule and the new roller compactor was fully operational within 10 days of being installed. Sounds simple, but PCI is located on a windy hill top in South-Wales, the equipment on skids had just a few millimetres clearance from the ceiling, and all manoeuvring was done manually whilst protecting a brand new GMP finish floor. There was a great deal to be concerned about, and apart from one failed attempt due to bad weather, the installation went without issue. The training and support we received on the new equipment was outstanding. The process for resolving issues during our acceptance testing was really professional. It was clear that both S3 Process and Gerteis had a lot of experience and everyone in the acceptance team felt they couldn t have done more to help us. Kevin Howells Process Manager PCI Pharma Services 3 Continuously Improving Process Manufacturing

5 Due to the complexity of the challenge, we needed multiple contractors to work together. We asked S3 Process to manage the whole project, including install, acceptance testing and qualification. S3 Process worked exceptionally well with the other parties and the installation went very well. PCI Pharma Services Engineering Department 4 s3process.co.uk

6 Batch Development Parameters such as mixing speed, drying temperature, drying time and so on cannot be changed once the development batch has been started; a batch will need to be completed before being ready to sample. As new parameters are used as part of the DoE, then the process starts over, using up expensive API and valuable time. Continuous Process Development Parameters are easily changed; a small residence time in the granulation zone means that the result from a parameter change is seen within seconds, allowing a sample to be immediately taken. Multiple experiments can be achieved within a very short period of time, saving valuable API. The result is significantly lower development costs and a reduction in the time it takes to take new products to market. Why the Gerteis Roller Compactor? Gerteis has earned a reputation within the industry as having the most advanced roller compaction technology available. The Gerteis roller compactor has several unique patented features which allows for a far greater range of formulation to be dry granulated, up to 90% of formulations that can be wet granulated can be dry granulated on Gerteis. Rapid DoE with no scale up from R&D work to production scale, the Mini-Pactor can process from 10g up to 100kg/hour. High-containment designs allowing OEB5 APIs to be handled, with proven Wash-in-Place and Clean-in-Place designs. 5 Continuously Improving Process Manufacturing

7 RESULTS Since building their contained manufacturing facility, formulation development had become a more substantial part of PCI s service offering. With the latest addition of the Gerteis Mini-Pactor roller compactor, PCI has improved their R&D capabilities now conducting more experiments with smaller quantities of materials, not only saving on expensive API and research time, but improving the depth and quality of research. Continuous flow production means there is no traditional scale up from formulation development to commercial manufacturing once formulations are approved, the parameters used for batches of 1kg are the same as they are for batches of 100kg. This has resulted in PCI being able to manufacture products of a commercial standard far sooner, enabling their customers to bring products to market potentially years earlier maximising the revenue customers can generate from Commercial Supply. Having invested in the most advanced roller compactor available on the market, PCI has maintained their position at the forefront of contract manufacturing and is able to continue to offer operational excellence in the development and manufacture of higher 6 We provide a very high calibre service to our clients and expected the same from S3 Process. At the time we were demanding, especially around requirements, drawings, documentation. S3 Process were very good at responding to challenges and helping us resolve issues quickly. There never seemed to be a hurdle too big. potency products and continue to satisfy the PCI Pharma Services demands of a growing market. Engineering Department s3process.co.uk

8 Talk with us today to see how the combination of our expertise and the world s leading process technologies can help drive efficiencies and improve your process. S3 Process is very experienced and has good process manufacturing knowledge. They work with various pharmaceutical equipment suppliers to provide complete manufacturing solutions. They re diligent, friendly and very easy to work with. PCI Pharma Services Engineering Department T + 44 (0) S3 Process Limited, East Cartshed Barn, Borough Hill Farm, Catton Road, Walton-on-Trent, Derbyshire, DE12 8LL, UK E info@s3process.co.uk s3process.co.uk S3 Process Limited Registered in England & Wales: