Coating optimization: equipment features to prevent defects • Pharma

1. Introduction

The process of coating pharmaceuticals must be carefully controlled to obtain a high-quality end product. This article highlights some equipment features can help you reach that goal.

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The first consideration before coating begins is core shape. A flat profile, for example, is a poor choice because it will allow many of the tablets to stick together, a defect called twinning. The next consideration is the coating itself, which must comprise the appropriate ingredients at the specified percentages. Ideally, the coating optimizes wettability and elasticity while delivering solids at the maximum rate without having an impact on viscosity.
Producing high-quality coated tablets also requires identifying the optimal process parameters, which must be in harmony and kept under control. That means combining efficient spray technology with the appropriate mixing baffles and a high-performance drying system. Also critical is a user-friendly control system to manage the process parameters, along with proper maintenance and calibration. Doing so ensures not only coating quality, but minimizes coating losses.
Below are some brief examples of how customizing a coating system’s hardware and software can help you obtain a high-quality result.

2. Foam

Anyone with coating experience knows that the presence of foam in the coating suspension can lead to problems with the final product. Most of today’s coating systems prevent foam by combining the coating powder and liquid usually water using a method that minimizes air entrainment.
Nevertheless, as you near the end of a batch run, it’s possible that the agitator in the coating tank will breach the surface, entrain air, and generate foam. To avoid that, place a level sensor in the tank and connect it to a switch that shuts off the agitator automatically when the suspension is no longer in contact with the sensor.

3. Gun Position

The improper orientation of the spray guns and/or the distance between them and tablet bed can have a big impact on results, including overly wet tablets and tablets with surface defects.
In many cases, operators must monitor the process and adjust the guns manually. If that’s how you operate, consider using a system that adjusts the guns automatically, such as the one our company offers. It uses a laser to detect the orientation of the guns and the gun-to-bed distance throughout the process and adjusts them as needed to keep prevent defects.

4. Number of guns

How many guns you use depends primarily on batch size. But what if the size varies over the course of the batch run.
In one such case a powder layering process the batch grew from 30 to 240 kilograms over a 7-hour run, an eightfold increase. The process was a continuous sequence of spraying a binder onto neutral spheres and then applying a powder API.
Because the batch size would grow over time, the manufacturer opted for a system that automatically varied the number of guns used between 2 and 4 in this case in tandem with the length of the screw feeder that conveyed powder to the process. This ensured the liquid binder and API powder were properly distributed over the full 7 hours without operator intervention. The resulting pellets were uniform in size, smoothness, and shape, and free of defects.

5. Sampling

It’s important to sample tablets from time to time to see whether the operation is under control and the tablets are free of defects. If you operate a contained system, consider specifying equipment that allows you to take samples without breaking containment.
One approach uses a telescopic sampling thief that you guide from outside the pan into the tablet bed, where it gently captures the samples using suction. Once extracted, the tablets are released with a small burst of compressed air. The operation has no impact on the tablets.

6. Loading and discharging

For tablets that break or are easily damaged, adjust how you load and discharge them to and from the coating pan. When loading, for example, position the pan so that the flow of uncoated tablets gently reaches the unloading blade. This prevents the tablets from falling to the bottom of the coater too fast, which could damage them.

7. Other factors

3D printing has matured as a manufacturing technology over the past decade, inching closer to becoming a mainstream manufacturing technology. This is in large part because 3D printing technology has gotten more sophisticated, leading to more consistent, durable, and complex prints that match its counterparts made with injection molding and CNC machining.

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With this continued acceptance, more industries are exploring the use of 3D printing as a part of their manufacturing strategy. One of these is the food industry, where food packaging, utensils, or spare parts for food production lines can all become important 3D printed parts. The food industry has strict regulations regarding safety which must be considered when planning on using a new manufacturing technology. This article will discuss how to design and implement food-safe 3D printing and clarify the responsibilities of the client and manufacturer when it comes to ensuring the printed parts meet strict requirements.

In order to make a part food-safe, it is important to review the relevant regulations in the region where the part is to be distributed or used. This section will focus on the challenges of implementing food-safe 3D printing by basing the analysis on the 3-A Sanitary Standards that were developed to help companies comply with FDA and USDA regulations. In general, there are three factors that determine if a part is safe for use with food: its design, the materials used, and the manufacturing process.

1. Food-Safe 3D Printing Design

In terms of food safety, parts are divided into two categories according to the 3-A Sanitary Standards:

1. Product Contact Surfaces - “Essentially any part surface which is exposed to the product as well as any surface onto which other food material can splash or drain onto the product.” In short, any surface of the part that can contact food.
2. Non-Product Contact Surfaces - “Any part surface that does not come into contact with the product or areas such as structural supports or other external components.” In short, this is any surface of the part that does not contact food.

When evaluating a component for food-safe 3D-printing, it is important to focus on the product contact surfaces. Listed below are some key points that need to be considered in the design phase.

• Free of Crevices or Voids - Parts should not be designed with crevices or voids. This will create areas that cannot be adequately cleaned, and thus will allow bacterial growth. If these types of voids are necessary for the item’s functionality, the areas should be easily accessible when the device is disassembled so that they can be cleaned regularly.
• Smooth Corners and Radii - It is important to eliminate any sharp corners in a design and instead use large-radius fillets wherever practical. Sharp corners are difficult to clean and should therefore be avoided.
• Robustness - Food-grade parts must be robust enough to withstand their intended application without breaking down, corroding, or cracking. Each of these failure modes can introduce areas for bacteria to grow. In general, 3D printed parts and materials can withstand corrosion and breakdown if designed correctly.

2. Additive Materials for Food Safe 3D Printing

Another critical factor in determining the food safety of parts is the material. Listed below are some key material-specific factors that product designers should consider.

• Non-contaminating and Non-toxic - The base material, plus any post-processing additives like dyes or coatings, must be food safe. In terms of 3D printed plastics, it is possible for the bulk material to be food-safe initially, but get rendered unsafe by pigments and other additives. It is important to consult the Material Safety Data Sheet (MSDS) for everything that will go into the item.
• Corrosion-Resistant - A key factor in maintaining a smooth and clean surface is choosing an inert material or one that is resistant to corrosion. Some examples of corrosion-resistant materials for food-safe 3D printing include plastics such as polycarbonate or polypropylene, and metals like stainless steel. A corroded surface can become a breeding ground for bacteria because it is more difficult to adequately clean. Cleaning chemicals must also be considered.
• Smooth, Non-porous, and Non-absorbant - A surface profile of 32 Ra or better should be achieved for food-safe 3D printed products. Most 3D-printing technologies build parts up layer by layer. Each of these layers interfaces to generate microscopic crevices into which food products can collect and promote dangerous bacterial growth. Porous and absorbent materials are difficult to clean and therefore promote bacteria growth. This is one of the largest challenges with food-safe 3D printing, and often requires post-process polishing or food-safe coatings to create a non-porous, smooth surface.

Which 3D Printed Materials are Sterilizable?

It is important to understand that sterilizable does not necessarily mean food-safe. Sterilizable simply means that the material can be effectively purged of all bacteria. However, the factors mentioned above can determine whether the part is ultimately food-safe. An example of this in the list below is ABS; while it is sterilizable it is not food-safe. Listed below is a summary of various sterilizable 3D printed materials.

Food-safe 3D printing relies on many factors. Together, the materials, design, manufacturing method, and application will help a certifying body determine whether a product adheres to all safety standards. While Xometry cannot guarantee a product will be food-safe, our team of application engineers can provide expert guidance on which materials, design principles, and manufacturing techniques will put you on the best possible path to achieve the necessary level of food safety. Xometry offers eight different additive manufacturing technologies through its on-demand 3D printing service. To learn more about the options for food-safe 3D printing manufacturing, contact a Xometry representative today.

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