Equipment for Pharmaceutical Manufacturing

Efficient throughput versus safe material handling, two key factors that pharmaceutical manufacturers must carefully balance.

INTRODUCTION

The Challenge - Pharmaceutical Manufacturing

Pharmaceutical manufacturing is a hugely competitive industry that is governed by strict regulations.

To succeed in this space, manufacturers need to match efficient throughput with careful materials handling, delivering products to a fast-paced market at the right price point. Any compromise made on throughput or product quality can have serious consequences.

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.

Contact one of our pharmaceutical process technicians who will be able to advise you on potential solutions.

THE CHOICES

Equipment Choices for Pharmaceutical Manufacture

No matter how experienced you are as a pharmaceutical manufacturer, at some point you will encounter production problems.

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

Matcon can save time by introducing IBCs prior to the mixing stage to feed powder to the high shear mixer. This reduces the time taken before production commences. Typically, a granulator is filled by hand from sacks however with the implementation of IBCs, this filling step can take place in parallel to the granulation process 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.

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.

MANUFACTURING PLANT DESIGN

Is Your Pharmaceutical Manufacturing Plant Designed to achieve the Best Results?

Selecting the right materials handling equipment for OSD and API manufacture is only part of the process. Careful consideration should be given to the layout of your manufacturing plant if you are to achieve the throughput and quality levels required in this industry.

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

If you are designing a new facility or adapting an 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 do you need at each of these steps, and 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

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 here or download our guide to designing a Pharmaceutical Manufacturing Plant below.

Consider how you handle materials

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 that seriously limit production capacity and the ability to expand in the long term.

The easiest way to move materials is manually 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.

Single-floor facility

Two-floor facility

Multi-floor facility