How to clean enteric polymers; picture rights: chematic

How to Clean Enteric Polymers – Basics Article

Why Common Approaches Are Not Effective

The mechanism of action for cleaning enteric polymers is straightforward. Because enteric polymers are chemically acidic, their solubility and therefore their release is pH dependent. As a result, one would assume that they can be easily cleaned with alkaline chemistry or detergents.

 

The wrinkle to this simplistic view is that the polymers are rarely used on their own. They are formulated with other excipients to improve their processing efficiency, to improve film or matrix properties, or to extend their shelf life. Furthermore, coloring pigments such as titanium or iron oxide are frequently added into the enteric coating formulation.The result is often a tough and sticky residue bonded to the stainless steel.

Enteric Polymer before Cleaning 2Similar to how a hammer will put a screw into the wall, traditional approaches to cleaning enteric polymers will get the job done, but it won’t be pretty and there will be repercussions down the road.

 

infographic about cleaning enteric polymers
Clean Enteric Polymers – Why Common Approaches are not Effective

Efficient Cleaning of Enteric Polymers

Let´s revisit the hammer and the screw analogy. There are thousands of different shapes and sizes of screws, and depending on if you are screwing into drywall, plaster, or concrete, you will need to make sure you match the right tool with the unique project at hand. The case at hand is a great example of requiring a detergent and process that target not only the enteric polymer, but the other ingredients too.

If you want your equipment to look like this without manual scrubbing, then read on!

Here is the 3-step process we recommend for cleaning enteric polymers:

 

1. Select the Right Detergent

  • Enteric Polymer: Methyl acrylate-methacrylic acid copolymers (Eudragit® L 30 D-55, L 100-55, L 100, L 12.5, S 100, S 12.5, FS 30 D, Acryl-EZE and similar polymers)
    • Recommended detergent/cleaner: Chematic® L/S Plus
  • Enteric Polymer: Eudragit® FL 30 D-55
    • Recommended detergent/cleaner: Chematic® FL Cleaner
  • Enteric Polymer: Cellulose Acetate Pthalate
    • Recommended detergent/cleaner: Chematic® 454
  • Enteric Polymer: Shellac
    • Recommended detergent/cleaner: Chematic® 1

2. Follow Recommended Cleaning Procedure:

Step 1: Pre-rinse with Water

    • Temperate: Ambient temperature
    • Time: 5 – 10 minutes
    • Note: if formulation contains pigments, do not use water above 50° C

Step 2: Apply Cleaning Agent

    • Cleaning Temperature:
      • If manual soak and agitate: 20 – 50° C
      • If CIP/automatic: 50 – 65° C
    • Cleaning Time:
      • If manual: as required
      • If CIP/automatic: Soak the equipment (soiled portion) for 30-60 minutes with mild agitation*
        • *blade rotation for RMG
        • Pan rotation for coater
        • Recirculation through Spray balls in CIP for equipment like FBE/ stirring for lab scale
      • Additional Notes:
        • Ensure that the entire residue is soaked for the given time period as un-soaked residue doesn’t easily get cleaned even with scrubbing
        • For this polymer, soaking / detergent contact time is more important than scrubbing
      • Post-rinse is to be done immediately after the detergent solution is drained to prevent the drying of detergent solution on to the surface of the equipment. For manual cleaning, gentle scrubing/wiping is to be done before rinsing.
    • Cleaning Action: This process is a good starting point for CIP, WIP, blade rotation, or pan rotation

Step 3: Optimize

      • The process steps outlined are meant to be starting points for cleaning cycle development. Depending on the exact residue and thickness, we often test dilution ranges from 2-8% and vary other variables listed above. To discuss a cleaning process based on your coating process and cleaning capabilities please contact Dober’s Chematic Division

Efficient Cleaning of Enteric Polymers

Efficient cleaning of Enteric polymers requires targeting the entire soil, not just the polymer. Our laboratory can replicate your soil and evaluate different cleaning detergents and processes. The image below is a representation of a coupon study that has simulated an enteric polymer with iron oxide in order to ensure we provided a solution for their soil, and not just the enteric polymer.

The industry trends of improving production efficiencies and increasing the safety of the environment and the processes for employees gives cleaning optimization an opportunity to play a key role in helping production teams reach their goals.

More about Enteric Polymer Cleaning

Author: Priya Poduval from Chematic

For over 30 years, Chematic has been developing and manufacturing unique detergents for regulated industries. Chematic provides you with solutions and support needed to find the right cleaning process no matter what the challenge.