Design for a Client's Business

Design should vary to suit the client’s business drivers.  Designs for the same technical purpose may vary from the client to client.
For example a start-up business might prefer to use a contract manufacturer even though that is in the long term more expensive, than build their own facility.  If they do build by the capital cost has to be kept to minimum.  The design must be expandable or flexible, so the future changes and growth can be accommodated.
A plant making a high revenue product might be designed to reduce risk of production stoppages or quality failures, by adding standby equipment and gold-plating systems.
For examples of projects that we have done with the focus on the client’s business needs for given below.

Middle East Client:  The client was considering bringing a small range of sterile products into their plant from a contractor.  The volume was small and so keeping the initial capital cost low was important.  
But once the sterile manufacturing suite existed other products might to added or the suite used for contract manufacturing.
The initial design consisted of a compounding and filling room.  The process used closed ampoules to avoid adding an expensive glass washing and sterilisation tunnel [probably about a million dollar saving].
* The design could add the glass washing and tunnel later so it could handle vials and also a greater throughput,
* The design also allowed the compounding area to feed a future syringe filling suite.
These two features cover the majority of the formats used to fill sterile material.
* The environments were designed to allow terminally sterilised products and aseptic [products that are not sterilised after they are filled into their containers] products.
* The facility would have had either a second autoclave for future terminal sterilisation
* The facility was designed to allow visibility into the working areas

.

Drivers:  

• Low initial costs, 
• Expandability to other formats.

Halo:  Halo is a contract manufacturer [CMO] based in the US.  As part of a proposal win the manufacture of potent products, designs were made for the manufacturing facility.  
Clients of such a business are always concerned about the quality of such facilities and also about cross-contamination of their products by anything else being handled in the facility at the same time.
* Contained process equipment was used which could be cleaned in place.  
* Each unit is self-contained and could be dedicated to a specific product.  This minimising clients fears of cross contamination and is a selling point in a CMO market
* As the business grew additional units could be added to the core, minimising the initial capital investment, and lastly,
* The facility has a visitor’s gallery that allows visitors, potential new customers, to view the facility without entering it, supporting the sales effort.

Drivers: .

• Obvious cross contamination control.
• Attract future business
  
• Ability to grow quickly as contracts are won.

Vicdoris:  Vicdoris is a successful distributer of pharmaceutical products in Western Africa.  This is a tough environment in which to do business.  A proposal to manufacture in country to EU standards has been discussed over time – it has tax advantages as imports are taxed.  
Starting a such a business requires a lot of capital and well trained staff.  To make this easier the initial step is to import product in bulk and pack it locally.
There is little design or construction experience locally to construct the required cleanroom facilities.
The proposal is to manufacture a pre-fabricated facility.  Some companies will ship complete facilities in sections [so called three dimensional pre-fabrication].  This works well for process plant or process skids but the size of the sections is always limited by transportation issues, usually in the las mile to the site.  Too large and they cannot be easily delivered to site, too small and the joints get in the way.
So a pre-fabricated building was designed with all the components prefabricated and ready to be fitted together but all the components would fit inside regular container.  The containers are ubiquitous all over the world and are secure and easily transported.
An assembly team with key craftsmen sent from the fabricators in Europe together with local labour, is to assembled the project.

Drivers:

• Ability to achieve international standards
•  Ability to control project delivery and costs
• Abitity to obtain export finance
• Low initial cost