During the planning stage of a new pharmaceutical facility, you have a fresh slate; anything is possible. You have time to carefully consider the layout of your facility, time to ensure it has the leanest manufacturing processes, using space in the most efficient way. You also have the opportunity to ensure the new facility meets the approval standards of GMP and will yield efficient OSD manufacturing cycles, which will in turn positively impact the profitability of your business.
One of the biggest considerations during this planning process is whether to build a single or two-floor pharmaceutical facility. When space is at a premium and budgets are tight it is important that the decisions you make now are the right ones as they have far-reaching implications. Even if budget and space are not constraining factors, being informed now will help you make better decisions later.
In this blog, we look at the advantages and disadvantages of single versus two-floor facilities and what each offers your business.
When planning a single floor facility, the primary advantage is cost. Typically a single floor facility is less expensive to build/rent than a two-floor building. But with less cost there is also less space so you need to plan how to use the space effectively. A particular disadvantage in single floor facilities is in the GMP production area where
Single-floor facilities are also great for improving productivity, especially with the implementation of IBCs where batch transfers can be closed. But for all the advantages there is one primary disadvantage to only having one floor and that is production capacity. While you can achieve multiple batches on a single floor, it’s not as efficient due to the limited amount of space. Scaling up from a single-floor facility to meet increased demand can also be costly and quite an upheaval. It is worth considering planning for growth now and building in that extra capacity in readiness for the future.
Although construction or rental costs of a two-floor facility are often higher than smaller (single-floor) facilities, the overall gain in ‘lean’ efficiency can potentially be much greater, especially if you use IBCs. With a two-floor facility, you can use a multi-batch production process, which offers greater potential for scalability and ultimately profitability. One floor can be dedicated to material handling alone. With the benefit of increased space, production areas don’t get as crowded as in single-floor facilities.
The greatest benefit of a two-floor pharmaceutical facility is the ability to separate processes by using the divide between the two floors. ‘Clean’ processes can be kept physically separate from ‘unclean’ areas, eliminating possible sources of contamination that might otherwise cause a company to fail regulatory inspections. An example of a two-floor building layout using the best use of height and space could be:
Upper Floor – Raw material handling and mixing of ingredients, then transferred through the floor to the lower floor.
Lower Floor – Pressed tablet or capsule packing processes.
Whether you choose to design your pharmaceutical facility on a single or two-floor layout very much depends on your budget, the space available and your aspirations for business growth. For more information on the best facility design read our other blogs in this series. The key to getting it right is planning and planning early before a building is commissioned. Whichever route you take, using an IBC based production system is the most flexible and efficient way of using the space available while achieving GMP regulations.
For more information about planning pharmaceutical production lines and the best way to shape the space you have, download our whitepaper ‘Better Buildings for Better Pharmaceutical Production’.