The definitive guide to selecting the right materials handling solution for OSD and API pharmaceutical manufacture, including best practice advice on feeding powders to roller compaction, tablet compression, capsule filling, tablet handling and what the ideal manufacturing plant would look like.
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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.
Problems usually occur due to inadequate or unsuitable equipment or errors due to manual intervention or manual operations. These can lead to issues in areas such as segregation of blended material, lack of containment or reduced/no flow of powder from a container. In worse case scenarios this can lead to a cease in production while the problem is being fixed.
Typically, there are two methods of feeding powders to processing and each has its inherent issues.
Although this is the quickest and most straight forward process the following issues often occur:
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.
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.
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.
Compared to butterfly valve IBCs, the Cone Valve provides superior discharge control preventing the traditional powder handling issues such as bridging, rat-holing and blend segregation.
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.
Bridging, rat-holing, and blend segregation. These will be terms that you are all too familiar with, but what steps can you take to mitigate these issues?
Learn more about Matcon Cone Valve technology and how Cone Valves are the optimum solution for manufacturers processing anything from cohesive to free-flowing powders.
If you can accommodate a single coating batch in one IBC you will naturally see production efficiencies through reduced manual handling, fewer fewer repeated operations and less downtime.
This is just one way in which IBCs can improve the way in which you handle tablet manufacture, download our guide to discover more.
Not considering how things like powders, granules, tablets, and capsules are handled and moved from one stage of the production process to another can cause inefficiencies which seriously limit production capacity and the ability to expand in the long term.
The easiest way to move materials is a manual one via tubs, drums or boxes, this can, however, lead to a waste of product, time and energy and ultimately a quality control issue.
One way to remove the handling of materials is to couple all the processes together which eliminates waste but this process relies on the operational speed of the slowest step.
The ultimate handling solution is to use Intermediate Bulk Containers (IBCs) to move materials between processes.
If you are designing a new facility or adapting existing space, it is vital to think about the steps involved in production:
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.
Discover how a change in the way materials are handled can give manufacturers of pharmaceutical oral solid dosage (OSD) products an ‘edge’ over their competitors. Assembling a factory is not simply a question of ‘fitting it all in’ read the guide to learn how the design of a pharmaceutical manufacturing plant brings efficiencies and a competitive advantage to your business.
Complete with factory layouts and insights on how to avoid common process flow problems, this is a must have guide for anyone consider an operational change to their pharmaceutical manufacturing facility.
By installing a number of Matcon IBC blenders you can eliminate the waiting time for your blender to become free to make identical batch sizes in parallel.
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).
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.
Upon discharge, all the material in the container moves at the same rate across the whole container, creating uniform flow – no stagnant material, no rat-holing and a first in-first out sequence of material movement.
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.
Avoid damaging equipment and stock with the correct manufacturing methods.
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.
At Matcon we don't just build and supply powder handling systems - we consider your business needs and design systems specifically to meet those objectives.
Powder Handling - our unique Cone Valve provides a reliable way to feed powders and granules into tablet compression or roller compaction. These are available in a range of sizes from 50L to 3500L.
Tablet Handling - if you are currently using multiple drums, consider using a single IBC which completes the same job with its fast, automated filling capabilities.
API - our Cone Valve IBCs ensure your product does not degrade at any stage of the manufacturing process ensuring that the solvent rich 'wet cake' solids are handled with care between the centrifuge and drying processes.
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.