Intermediate (or Intermediate Product)

20 May.,2024

 

Intermediate (or Intermediate Product)

For biotechnological/biological products, a material produced during a manufacturing process that is not the drug substance or the drug product but for which manufacture is critical to the successful production of the drug substance or the drug product. Generally, an intermediate will be quantifiable and specifications will be established to determine the successful completion of the manufacturing step before continuation of the manufacturing process. This includes material that may undergo further molecular modification or be held for an extended period before further processing.

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Partly processed material that must undergo further manufacturing steps before it becomes a bulk product
A material produced during steps of the processing of an API that undergoes further molecular change or purification before it becomes an API. Intermediates may or may not be isolated. (Note: this guidance only addresses those intermediates produced after the point that a company has defined as the point at which the production of the API begins.)

What are the Advantages of Intermediate Bulk Containers

Depending on the size of the pharmaceutical manufacturing facility, manual or continuous materials handling methods can be used to move ingredients and products along a production line. We discuss the benefits that Intermediate Bulk Containers (IBCs) offer over these materials handling methods, both in terms of efficiency and design of pharmaceutical manufacturing plant. But first…

What is an Intermediate Bulk Container (IBC)?

IBCs are specialized containers for handling in bulk, powdered or solid particle materials. IBCs are filled, then moved between and connected directly to the process equipment in a production line. This means that IBCs can be directed to whichever processing step needs material and can be cleaned offline. 

Traditional materials handling methods

Some pharmaceutical manufacturing facilities may handle materials manually using generic tubs, drums or boxes. Although this is commonplace, if you take a closer look you will see that it can be a slow process, involving a lot of physical effort for the operators, may incur health and safety hazards for staff, and creates a lot of waste.

Containers that are not completely dust-tight can introduce contaminants into your product, and if not handled carefully, segregation could occur, thus disturbing the uniformity of the blended recipe.

At the other end of the materials handling scale is continuous processing. In this type of manufacturing system, each piece of equipment needed for each processing stage of the production line is directly coupled to the next. This significantly reduces the number of people needed for materials handling and the effort involved.

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However, the specialized nature of continuous production lines makes this system costly, and inevitably, some steps of the process are slower than others, meaning the whole production line is only as efficient as the slowest step. It is difficult to modify a fixed production line to increase capacity, or to change a recipe, and if contamination or a fault occurs, then the entire line must be closed to resolve the problem, and an entire batch of product wasted.

The Benefits of Intermediate Bulk Containers

Matcon IBCs offer the benefits of both manual and continuous processing, while at the same time reducing or removing many of their drawbacks.

Unlike the boxes or drums used in manual materials handling, Matcon IBCs are completely dust-tight. This eliminates much of the potential for contamination, of paramount importance in pharmaceutical manufacture, especially GMP facilities.

Furthermore, Matcon’s precision-engineered Cone Valve technology allows complete discharge of materials from the IBC, so no residue (i.e. wasted product!) is left inside.

Compared to a fixed, continuous production line that can be subject to bottlenecks, using IBCs to move materials between processes means that each process can operate at its optimum rate, increasing efficiency and capacity. Continuous lines can only handle one product at a time, while with IBCs it is much easier to feed the outputs of one common process into multiple different lines. 

Improve your facility design with IBCs

Another, and very important advantage of IBCs, is that they are incredibly flexible – they can fit into almost any manufacturing facility, whatever size or shape and however many floors, and can even be installed alongside existing manual or continuous processes. This opens up exciting new possibilities with the design of pharmaceutical manufacturing plant or modifying your pharmaceutical OSD facility to be as ‘lean’ and profitable as possible.

Contact us to discuss your requirements of medicinal intermediates. Our experienced sales team can help you identify the options that best suit your needs.