Equipment for Pharmaceutical Manufacturing

Whether manufacturers are handling oral solid dosages (OSD) or solvent rich 'wet cake' solids (API) it is hugely important to get the materials handling system right. Bottlenecks, slow throughput, tablet damage, product inconsistencies and inefficient processes are inherent in this space, so what can you do as a pharmaceutical manufacturer to mitigate these issues? We've collated a number of resources to help you solve these issues and plan a better manufacturing process.

Often the structure of API systems can vary and tends to be quite bespoke, if the resources detailed on this page don't address your specific API use case click here to contact one of our pharmaceutical process technicians who will be able to advise you on potential solutions.

Typically, there are two methods of feeding powders to processing and each has its inherent issues.

Feeding to Compression

Issues feeding powder to direct compression

Although this is the quickest and most straight forward process the following issues often occur:

• Segregation of ingredients is a big concern when feeding to direct compression as this will affect the uniformity of the finished tablet and risks the expense of failed batches.
• Tablets are often created by a powder product, so if the powder can't flow to the compression hopper at the correct rate this results in a slower process restricting the capacity of the factory.

Issues feeding granulated material to compression

Currently, the most common methods of tablet manufacture are either via wet granulation or roller compaction and due to the wide use of butterfly valves the material is expected to be 'free-flowing', but this method does increase the risk of segregation and results in poor tablet quality.

Wet granulation

Whilst the products are not yet mixed, Matcon can save time by introducing IBCs at this stage to feed powder to the high shear mixer, this reduces the time taken before you can start production. Typically when a granulator is filled from sacks by hand – this step can take place in parallel to cleaning or production with an IBC filled in a separate dispensary and then brought to the granulation suite when needed.

Feeding to Roller Compaction

In our experience, the materials handling part of the manufacturing process can get overlooked at this stage. If you have opted to conduct ‘dry granulation’ using a roller compactor as your manufacturing method, it is vital to get the feed of material correct as this is the last point at which you lock the chemistry into the powder. 

As we are feeding pre-blended material into the roller compactor the need to maintain the mix is crucial, any differences in homogeneity will be present in the finished product. Worse still inconsistent feed to the compactor could influence the finished product due to variations in density of the material at the inlet – either caused by poor flow or by inconsistent “lumps” of product entering the inlet.

Find out what equipment options you have for each feed method.

What initially looks like a cheaper option is usually cheaper for a reason and may not give you the performance you need. It is worth researching to understand the benefits and limitations of different types of IBC. As well as production quality, the key difference in systems is in the valve outlet itself. Some manufacturers opt for IBCs fitted with a butterfly valve, others supply IBCs with cone valves. 

Learn more about IBC discharge valves and how the Cone Valve is particularly suited to pharmaceutical manufacturing.

• Unlike boxes, tubs or drums in manual materials handling, IBCs are completely dust-tight. Eliminating much of the potential for contamination.
  
  
• Cone Valve technology enables complete discharge of all materials from the IBC, leaving no residue (wasted product) inside.
  
  
• Using IBCs to move materials between processes removes bottlenecks so each process can operate at its optimum rate increasing efficiency and capacity.
  
  
• With IBCs it is much easier to feed the outputs on one common process into multiple lines so multiple products can be processed at the same time.

But where do you start when designing a pharmaceutical OSD facility?

If you are designing a new facility or adapting existing space, it is vital to think about the steps involved in production:

• Do you blend ingredients? Press tablets? Undertake quality control procedures? Package SKUs in different ways?
• What equipment you need at each of these steps, how much space does it take up?
• How do you move materials between the different steps in the production process?
• How to decide the most efficient location of internal Zoning areas and product flow to external logistics

Consider the space available

Whether your building from scratch or adapting existing space, how you configure your production area will influence what equipment you choose and how the manufacturing process will flow. 

Typically, pharmaceutical production facilities fall into three categories:

1. Single-floor facilities

2. Two-floor facilities

3. Multiple floor facilities 

Each scenario has its advantages and disadvantages, find out more at this link or download our guide to designing a Pharmaceutical Manufacturing Plant below.

Careful consideration needs to be made to cover all eventualities of batch size. How are you accommodating your smallest batch and your largest batch? If you're not careful you could end up needing to buy 3 or 4 blenders, each of which will need its own space within your facility.

Failing to get a balance between the size and number of blenders could mean increased quality control checks (and cost).

Read our guide to blending different batch sizes.

Many companies have understood the conceptual advantages of using a decoupled IBC system, yet use conventional butterfly or slide-valve IBC technology. This works well for some companies, but for others that have particularly free-flowing powder blends that are difficult to handle, they are hugely disappointed with the performance achieved.  The cost implications of a failed or recalled batch can be huge. 

Explore discharge valve choices and how to control free-flowing powders in your pharmaceutical equipment.

As you start to investigate which IBC is the better option for you, don't be driven by price alone.  What initially looks like a cheaper option may not give you the performance you ultimately need.  It is worth doing your research and understanding the benefits and limitations of the different types of IBC on the market today.  We have created a handy checklist of the types of questions to ask when making that selection.

Choosing the right type of IBC for your business depends upon a number of factors, follow this link to learn about key equipment considerations, especially if you have a product that is prone to segregation.

In addition to 'Bin-rash', we've also seen operators fully clothed in hazard suits rodding the product out through the container inlet to get it all out.

These issues can be avoided completely when you've got the right powder flow. Find out how to get better powder flow with Cone Valve technology.

Choosing the ideal IBC system to meet your pharmaceutical needs can be difficult. Get it wrong and you potentially face many of the powder handling issues discussed above.

To help you ask the correct questions of your IBC provider, we've developed the 'Ideal IBC System Checklist'. Use the guide to help you validate your equipment procurement process and ensure the IBC meets all your needs.

Reduce labour costs - use large IBCs to feed to pharmaceutical equipment - For some of our customers we are seeing a trend towards scaling up and using very large IBCs up to 3500L. These big bins are useful to reduce the amount of handling needed to move materials around the production line and reduce the amount of QA testing required.  We are seeing a trend towards scale-up within the Generic Pharmaceutical market. If this is your requirement too, or you are looking into scaling up your Pharmaceutical manufacturing process, click on the link above for some words of advice.

Single vs. two-floor pharmaceutical facility - which should you choose? - During the planning stage of a new pharmaceutical facility, you have a clean 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. 

How can I use IBCs in a two-floor pharmaceutical facility? - Flexible, cost-effective, and one of the ‘leanest’ types of materials handling system around, Intermediate Bulk Containers (IBCs) makes perfect sense for any manufacturing industry that needs to move powders, granules or tablets between processes. We explain how a two-floor pharmaceutical facility can make the best use of IBCs. 

Why materials handling matters, design of pharmaceutical manufacturing plant - In pharmaceutical OSD manufacturing facilities, the ways in which powders, granules, tablets, and capsules are moved between production processes can significantly affect productivity. We discuss how taking a lean approach to materials handling can reduce waste, save costs and improve product quality.