Eudragit Polymers
- Page 2 and 3: SCIENCE CLEANING Achieve significan
- Page 4 and 5: Applications Chematic ® NE/NM clea
- Page 6 and 7: APPLICATION CLEANING METHODOLOGY We
- Page 8 and 9: CASE STUDY | EUDRAGIT ® NE 30 D -
- Page 10 and 11: CASE STUDY | EUDRAGIT ® L/S Series
- Page 12: OUR COMMITMENT TO OUR CUSTOMERS RIG
SCIENCE<br />
CLEANING<br />
Achieve significant time and cost savings by using<br />
Chematic ® for effective cleaning processes.<br />
Equipment cleaning after processing <strong>Eudragit</strong> ® L, FS & S and <strong>Eudragit</strong> ®<br />
RL/RS, <strong>Eudragit</strong> ® NE/NM formulations is now an efficient and safe process.<br />
Custom formulated detergents have been developed by Dober, in close<br />
cooperation with Evonik. Chematic ® Cleaners provide optimized cleaning<br />
results with minimum efforts. Chematic Cleaners take advantage of a special<br />
detergent system, which targets removal of both the <strong>Eudragit</strong> polymers and<br />
associated excipients.<br />
strategic partnership<br />
Evonik and Dober have a strategic partnership<br />
combining Evonik’s know-how in functional<br />
polymers and drug delivery systems with<br />
Dober’s unique approach to cleaning science.
CLEANING EFFICIENCY<br />
The optimal combination of Time, Action, Chemistry and Temperature<br />
in all Chematic Cleaners provides best in class cleaning results.<br />
Time<br />
Less Time<br />
No scrubbing, less cleaning cycles<br />
No haze from TiO 2<br />
or iron oxides<br />
action<br />
chemistry<br />
temperature<br />
Less Action<br />
Automated WIP/CIP processes<br />
Mild Chemistry<br />
Optimized for <strong>Eudragit</strong> polymers<br />
Cost saving<br />
Regulatory Compliant<br />
Low Temperature<br />
Cleaning at temperatures below 50˚C<br />
Applicable for manual processes<br />
Efficiency<br />
• Cleaning time reduced by more than 65%<br />
• Energy savings of about 70%<br />
• Equipment down time minimized<br />
• Reduced labor costs<br />
• Simplified procedures<br />
• Maximize use of assets<br />
Reliability<br />
• Consistent results<br />
• GMP compliant<br />
• Robust cleaning process
Applications<br />
Chematic ® NE/NM cleaner<br />
<strong>Eudragit</strong> ® polymers<br />
<strong>Eudragit</strong> ® NE 30 D<br />
<strong>Eudragit</strong> ® NE 40 D<br />
<strong>Eudragit</strong> ® NM 30 D<br />
Recommended<br />
process parameters<br />
Application<br />
concentration /<br />
temperature<br />
Physico-chemical<br />
properties<br />
WIP/CIP<br />
4 – 8% v/v<br />
50 – 60˚ C<br />
pH (10% v/v solution) 11.0 – 12.0<br />
Transparent, amber liquid<br />
Manually<br />
Chematic ® rl/rs cleaner<br />
<strong>Eudragit</strong> ® polymers <strong>Eudragit</strong> ® RL 100<br />
<strong>Eudragit</strong> ® RS 100<br />
<strong>Eudragit</strong> ® RL 30 D<br />
<strong>Eudragit</strong> ® RS 30 D<br />
<strong>Eudragit</strong> ® RL PO<br />
<strong>Eudragit</strong> ® RS PO<br />
<strong>Eudragit</strong> ® RL 12,5<br />
<strong>Eudragit</strong> ® RS 12,5<br />
Recommended<br />
process parameters<br />
Application<br />
concentration /<br />
temperature<br />
Physico-chemical<br />
properties<br />
WIP/CIP<br />
Cold water pre-rinse,<br />
20˚C<br />
4 – 8% v/v<br />
55 – 70˚ C<br />
pH (10% v/v solution) 2.0 – 3.0<br />
Transparent, water-white liquid<br />
Manually<br />
4 – 8% v/v<br />
50 – 60˚ C
Chematic ® l/S cleaner<br />
<strong>Eudragit</strong> ® polymers <strong>Eudragit</strong> ® L 100-55<br />
<strong>Eudragit</strong> ® L30 D-55<br />
<strong>Eudragit</strong> ® L 100<br />
<strong>Eudragit</strong> ® L 12,5<br />
<strong>Eudragit</strong> ® S 100<br />
<strong>Eudragit</strong> ® S 12,5<br />
<strong>Eudragit</strong> ® FS 30 D<br />
Recommended<br />
process parameters<br />
Application<br />
concentration /<br />
temperature<br />
Physico-chemical<br />
properties<br />
WIP/CIP<br />
pH (5% v/v solution) 11.0<br />
Cold water pre-rinse,<br />
20˚C<br />
2 – 5% v/v<br />
45 – 55˚ C<br />
Cold water post-rinse,<br />
20˚C<br />
Transparent, amber liquid<br />
Manually<br />
Cold water pre-rinse,<br />
20˚C<br />
2 – 5% v/v<br />
20 – 55˚ C<br />
Cold water post-rinse,<br />
20˚C
APPLICATION CLEANING<br />
METHODOLOGY<br />
We are experts in building business efficiencies through the research,<br />
testing, application and training of a proper cleaning process. As a<br />
result of our Application Cleaning Methodology (ACM) process, we are<br />
able to deliver not only cleaning benefits, but bottom line improvements.<br />
With every ACM study we perform, we look to achieve a validated state<br />
and cost savings through maximized use of assets, improved operator<br />
safety, reduced cleaning time and eliminated need for re-cleaning.<br />
Client Provides<br />
Data to Chematic<br />
Lab<br />
Application<br />
Chemists Analyze<br />
Data<br />
Chematic Lab<br />
Hypothesizes a<br />
Cleaning Plan<br />
Chematic Lab<br />
Performs<br />
Cleaning Study<br />
Chematic Lab<br />
Optimizes<br />
Cleaning Study<br />
Chematic Lab<br />
Delivers Cleaning<br />
Recommendations<br />
=<br />
WE ASSIST YOU IN ACHIEVING<br />
$ YOUR TARGETED GOAL:<br />
Our cleaning process recommendations and formulated<br />
detergents are proven to reduce operating costs.
DELIVERING & SUPPORTING<br />
ANALYTICAL CLEANING<br />
VALIDATION RESULTS<br />
WITH THE ANALYTICAL TECH TRANSFER PACKAGE<br />
We go above and beyond in helping our clients achieve a validated state.<br />
As part of our customer offering, we provide our clients an analytical<br />
technical transfer package that includes everything your lab needs to<br />
validate Chematic formulated detergents are effectively removed from<br />
process equipment after a high performance clean.<br />
Adhere to regulatory guidelines<br />
The Dober lab performs testing to isolate the<br />
detergent components that are “last-to-leave”<br />
during cleaning<br />
Chematic detergents have validated analytical<br />
test methods including ADE/PDE values<br />
Train customer on how to execute analytical<br />
cleaning process, if needed<br />
Test method transfer protocol performed<br />
simultaneously at Dober’s lab and at customer’s lab<br />
Post test methods transfer, the customer will<br />
receive the test method, transfer data and results<br />
package as part of the Analytical Tech Transfer Package<br />
Achieve validation
CASE STUDY | EUDRAGIT ® NE 30 D -<br />
60” Coating pan - One prod<br />
PROBLEM<br />
Time<br />
action<br />
2 - 6 hours manual cleaning<br />
2 hours WIP/CIP cleaning<br />
Inconsistent cleaning impacts scheduling<br />
Labor intensive; resulting in ergonomic issues<br />
chemistry<br />
Residue peels off & blocks perforations<br />
temperature<br />
60°C hot water rinses<br />
CASE STUDY | EUDRAGIT ® RS 30 D -<br />
Fluid Bed<br />
PROBLEM<br />
Time<br />
24 hours manual cleaning<br />
action<br />
Labor intensive; manual process involves power<br />
washing hand scrubbing & disassembly<br />
chemistry<br />
Complicated cleaning procedure with hazardous<br />
detergents<br />
temperature<br />
70-80°C hot water rinses
uction run, dirty hold time 24 hours<br />
Goals<br />
Reduce cleaning time<br />
Improve operator safety<br />
Decrease manual labor<br />
More consistent cleaning<br />
process using CIP<br />
RESULTS<br />
15 - 30 minutes Manual<br />
Under 2 hours WIP/CIP<br />
Significant time and cost savings<br />
Safer process for operators<br />
Improved capacity<br />
Chematic ® NE/NM Cleaner<br />
Detergent dissolves residue<br />
50-60°C rinsing & washing<br />
Cooler water temps<br />
Goals<br />
Reduce down time<br />
Improve safety<br />
Decrease manual labor<br />
Eliminate scrubbing by using<br />
chemical spray wands<br />
Less complex process<br />
Save 20 hours<br />
Significant time and cost savings<br />
Safety improved<br />
No scrubbing<br />
Increased capacity<br />
RESULTS<br />
Chematic ® RL/RS Cleaner<br />
Detergent dissolves residue<br />
20˚C Cold water pre-rinse<br />
50-60°C rinsing & washing<br />
Cooler water temps
CASE STUDY | EUDRAGIT ® L/S Series -<br />
PROBLEM<br />
Coating pan - One produ<br />
Time<br />
action<br />
2 - 6 hours manual cleaning<br />
30 minutes - 2 hours WIP/CIP cleaning<br />
Inconsistent cleaning impacts scheduling<br />
Labor intensive; resulting in ergonomic issues<br />
chemistry<br />
temperature<br />
Polymer dissolves completely but pigments<br />
settle back; 2 chemistries needed<br />
Re-cleaning needed - Haze visible on surface<br />
70-80°C hot water rinses<br />
<strong>Eudragit</strong> ® L , FS & S-Polymer<br />
• Enteric<br />
• Challenging<br />
Detergent:<br />
CHEMATIC L/S<br />
<strong>Eudragit</strong> ® NE- & NM-Polymer<br />
• pH-independently insoluble<br />
and permeable<br />
• Challenging 1<br />
Detergent:<br />
CHEMATIC NE/NM<br />
PRODUCT<br />
OFFERINGS<br />
<strong>Eudragit</strong> ® E-Polymer<br />
• Taste masking and<br />
protective coating<br />
Detergent: Contact Evonik<br />
for a specific solution<br />
<strong>Eudragit</strong> ® RL- & RS-Polymer<br />
• pH-independently insoluble<br />
and permeable<br />
• Challenging 1<br />
Detergent:<br />
CHEMATIC RL/RS
ction run, soil at 40% solids<br />
Goals<br />
Reduce cleaning time<br />
Eliminate scrubbing<br />
Decrease manual labor<br />
No haze from TiO 2<br />
or<br />
Iron Oxides or Talc<br />
20˚C Cold water pre/post-rinse<br />
45-55°C rinsing & washing<br />
RESULTS<br />
Under 30 minutes Manual<br />
1 hour WIP/CIP cleaning<br />
Significant time and cost savings<br />
No manual scrubbing<br />
Improved capacity & scheduling<br />
Chematic ® L/S Cleaner<br />
(single detergent)<br />
Detergent dissolves residue<br />
Pigments best removed with<br />
cold pre and post rinse<br />
OUR COMPREHENSIVE SUPPORT FOR<br />
YOUR CLEANING OPTIMIZATION<br />
Combining the deep formulation and process understanding of Evonik,<br />
with the high cleaning expertise of Dober, we offer technical and regulatory<br />
support to ensure both fast and effective cleaning as well as processes and<br />
documentation accepted by the authorities.<br />
BASIC<br />
SUPPORT<br />
1L Samples<br />
with standard<br />
recommendations<br />
Information<br />
Exchange<br />
Requirements<br />
and Needs<br />
Process<br />
Description<br />
STANDARD<br />
SERVICE<br />
ACM Study<br />
Optimization<br />
Trials at<br />
Evonik/<br />
Dober<br />
Process<br />
Transfer<br />
Cleaning<br />
Report<br />
Technical<br />
Transfer to<br />
Production<br />
Site (optional)<br />
REGULATORY<br />
SUPPORT<br />
Assistance for test<br />
methods & process<br />
descriptions (SOP)<br />
regulatory advise
OUR COMMITMENT TO OUR<br />
CUSTOMERS<br />
RIGOROUS STANDARDS<br />
Chematic production meets cGMP standards<br />
Complete lot traceability<br />
All inbound raw materials are QC tested<br />
Product C of A’s provided<br />
Change control policy<br />
ADDITIONAL SERVICES & SUPPORT<br />
A cleaning process optimized for your equipment<br />
Analytical test methods provided under confidentiality<br />
Controlled formulation and detection method for all<br />
formulated Chematic detergents<br />
Cycle development assistance<br />
Committed to continuity of supply for the life of your product<br />
11230 Katherine’s Crossing | Woodridge, IL 60517<br />
Phone: 630.410.7300 | Toll Free: 800.323.4983<br />
chematic@dober.com<br />
www.dober.com<br />
Disclaimer<br />
This information and all further technical advice is based on our present knowledge and experience.<br />
However, it implies no liability or other legal responsibility on our part, including with regard to existing<br />
third party intellectual property rights, especially patent rights. In particular, no warranty, whether<br />
expressed or implied, or guarantee of product properties in the legal sense is intended or implied. We<br />
reserve the right to make any changes according to technological progress or further developments. The<br />
customer is not released from the obligation to conduct careful inspection and testing of incoming goods.<br />
Performance of the product described herein should be verified by testing, which should be carried out<br />
only by qualified experts in the sole responsibility of a customer. Reference to trade names used by<br />
other companies is neither a recommendation, nor does it imply that simliar products could not be used.<br />
® = registered trademark<br />
<strong>Eudragit</strong> = reg. trademark of Evonik Industries AG and its subsidiaries<br />
Chematic = reg. trademark of Dober, Woodridge, IL, USA<br />
Dober = reg. trademark of Dober Chemical Company<br />
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