Targeted Cleaning

SCIENCE
CLEANING
Achieve significant time and cost savings by using
Chematic ® for effective cleaning processes.
Equipment cleaning after processing Eudragit ® L, FS & S and Eudragit ®
RL/RS, Eudragit ® NE/NM formulations is now an efficient and safe process.
Custom formulated detergents have been developed by Dober, in close
cooperation with Evonik. Chematic ® Cleaners provide optimized cleaning
results with minimum efforts. Chematic Cleaners take advantage of a special
detergent system, which targets removal of both the Eudragit polymers and
associated excipients.
strategic partnership
Evonik and Dober have a strategic partnership
combining Evonik’s know-how in functional
polymers and drug delivery systems with
Dober’s unique approach to cleaning science.

CLEANING EFFICIENCY
The optimal combination of Time, Action, Chemistry and Temperature
in all Chematic Cleaners provides best in class cleaning results.
Time
Less Time
No scrubbing, less cleaning cycles
No haze from TiO 2
or iron oxides
action
chemistry
temperature
Less Action
Automated WIP/CIP processes
Mild Chemistry
Optimized for Eudragit polymers
Cost saving
Regulatory Compliant
Low Temperature
Cleaning at temperatures below 50˚C
Applicable for manual processes
Efficiency
• Cleaning time reduced by more than 65%
• Energy savings of about 70%
• Equipment down time minimized
• Reduced labor costs
• Simplified procedures
• Maximize use of assets
Reliability
• Consistent results
• GMP compliant
• Robust cleaning process

Applications
Chematic ® NE/NM cleaner
Eudragit ® polymers
Eudragit ® NE 30 D
Eudragit ® NE 40 D
Eudragit ® NM 30 D
Recommended
process parameters
Application
concentration /
temperature
Physico-chemical
properties
WIP/CIP
4 – 8% v/v
50 – 60˚ C
pH (10% v/v solution) 11.0 – 12.0
Transparent, amber liquid
Manually
Chematic ® rl/rs cleaner
Eudragit ® polymers Eudragit ® RL 100
Eudragit ® RS 100
Eudragit ® RL 30 D
Eudragit ® RS 30 D
Eudragit ® RL PO
Eudragit ® RS PO
Eudragit ® RL 12,5
Eudragit ® RS 12,5
Recommended
process parameters
Application
concentration /
temperature
Physico-chemical
properties
WIP/CIP
Cold water pre-rinse,
20˚C
4 – 8% v/v
55 – 70˚ C
pH (10% v/v solution) 2.0 – 3.0
Transparent, water-white liquid
Manually
4 – 8% v/v
50 – 60˚ C

Chematic ® l/S cleaner
Eudragit ® polymers Eudragit ® L 100-55
Eudragit ® L30 D-55
Eudragit ® L 100
Eudragit ® L 12,5
Eudragit ® S 100
Eudragit ® S 12,5
Eudragit ® FS 30 D
Recommended
process parameters
Application
concentration /
temperature
Physico-chemical
properties
WIP/CIP
Cold water pre-rinse,
20 – 30˚C
4 – 6% v/v
50 – 60˚ C
Cold water post-rinse,
20 – 30˚C
pH (6% v/v solution) 10.60 – 11.60
Manually
Cold water pre-rinse,
20 – 30˚C
4 – 6% v/v
20 – 50˚ C
Clear, light yellow to amber liquid
Cold water post-rinse,
20 – 30˚C

APPLICATION CLEANING
METHODOLOGY
We are experts in building business efficiencies through the research,
testing, application and training of a proper cleaning process. As a
result of our Application Cleaning Methodology (ACM) process, we are
able to deliver not only cleaning benefits, but bottom line improvements.
With every ACM study we perform, we look to achieve a validated state
and cost savings through maximized use of assets, improved operator
safety, reduced cleaning time and eliminated need for re-cleaning.
Client Provides
Data to Chematic
Lab
Application
Chemists Analyze
Data
Chematic Lab
Hypothesizes a
Cleaning Plan
Chematic Lab
Performs
Cleaning Study
Chematic Lab
Optimizes
Cleaning Study
Chematic Lab
Delivers Cleaning
Recommendations
=
WE ASSIST YOU IN ACHIEVING
$ YOUR TARGETED GOAL:
Our cleaning process recommendations and formulated
detergents are proven to reduce operating costs.

DELIVERING & SUPPORTING
ANALYTICAL CLEANING
VALIDATION RESULTS
WITH THE ANALYTICAL TECH TRANSFER PACKAGE
We go above and beyond in helping our clients achieve a validated state.
As part of our customer offering, we provide our clients an analytical
technical transfer package that includes everything your lab needs to
validate Chematic formulated detergents are effectively removed from
process equipment after a high performance clean.
Adhere to regulatory guidelines
Dober has determined the last to leave
components in our formulated detergents
Chematic detergents have validated HPLC and
TOC analytical test methods including ADE/PDE values
Train customer on how to execute analytical
cleaning process, if needed
Test method transfer protocol performed
simultaneously at Dober’s lab and at customer’s lab
Post test methods transfer, the customer will
receive the test method, transfer data and results package
as part of the Technical Data Package
Achieve validation

CASE STUDY | EUDRAGIT ® NE 30 D -
60” Coating pan
PROBLEM
Time
action
2 - 6 hours manual cleaning
2 hours WIP/CIP cleaning
Inconsistent cleaning impacts scheduling
Labor intensive; resulting in ergonomic issues
chemistry
Residue peels off & blocks perforations
temperature
60°C hot water rinses
CASE STUDY | EUDRAGIT ® RS 30 D -
Fluid Bed
PROBLEM
Time
24 hours manual cleaning
action
Labor intensive; manual process involves power
washing hand scrubbing & disassembly
chemistry
Complicated cleaning procedure with hazardous
detergents
temperature
70-80°C hot water rinses

One production run, dirty hold time 24 hours
Goals
Reduce cleaning time
Improve operator safety
Decrease manual labor
More consistent cleaning
process using CIP
RESULTS
15 - 30 minutes Manual
Under 2 hours WIP/CIP
Significant time and cost savings
Safer process for operators
Improved capacity
Chematic ® NE/NM Cleaner
Detergent dissolves residue
50-60°C rinsing & washing
Cooler water temps
Goals
Reduce down time
Improve safety
Decrease manual labor
Eliminate scrubbing by using
chemical spray wands
Less complex process
Save 20 hours
Significant time and cost savings
Safety improved
No scrubbing
Increased capacity
RESULTS
Chematic ® RL/RS Cleaner
Detergent dissolves residue
20˚C Cold water pre-rinse
50-60°C rinsing & washing
Cooler water temps

CASE STUDY | EUDRAGIT ® L/S Series -
PROBLEM
Coating pan
Time
action
2 - 6 hours manual cleaning
30 minutes - 2 hours WIP/CIP cleaning
Inconsistent cleaning impacts scheduling
Labor intensive; resulting in ergonomic issues
chemistry
temperature
Polymer dissolves completely but pigments
settle back; 2 chemistries needed
Re-cleaning needed - Haze visible on surface
70-80°C hot water rinses
Eudragit ® L , FS & S-Polymer
• Enteric
• Challenging
Detergent:
CHEMATIC L/S
Eudragit ® NE- & NM-Polymer
• pH-independently insoluble
and permeable
• Challenging 1
Detergent:
CHEMATIC NE/NM
PRODUCT
OFFERINGS
Eudragit ® E-Polymer
• Taste masking and
protective coating
Detergent: Contact Evonik
for a specific solution
Eudragit ® RL- & RS-Polymer
• pH-independently insoluble
and permeable
• Challenging 1
Detergent:
CHEMATIC RL/RS

One production run, soil at 40% solids
Goals
Reduce cleaning time
Eliminate scrubbing
Decrease manual labor
No haze from TiO 2
or
Iron Oxides or Talc
20˚C Cold water pre/post-rinse
45-55°C rinsing & washing
RESULTS
Under 30 minutes Manual
1 hour WIP/CIP cleaning
Significant time and cost savings
No manual scrubbing
Improved capacity & scheduling
Chematic ® L/S Cleaner
(single detergent)
Detergent dissolves residue
Pigments best removed with
cold pre and post rinse
OUR COMPREHENSIVE SUPPORT FOR
YOUR CLEANING OPTIMIZATION
Combining the deep formulation and process understanding of Evonik,
with the high cleaning expertise of Dober, we offer technical and regulatory
support to ensure both fast and effective cleaning as well as processes and
documentation accepted by the authorities.
BASIC
SUPPORT
1L Samples
with standard
recommendations
Information
Exchange
Requirements
and Needs
Process
Description
STANDARD
SERVICE
ACM Study
Optimization
Trials at
Evonik/
Dober
Process
Transfer
Cleaning
Report
Technical
Transfer to
Production
Site (optional)
REGULATORY
SUPPORT
Assistance for test
methods & process
descriptions (SOP)
regulatory advise

OUR COMMITMENT TO OUR
CUSTOMERS
RIGOROUS STANDARDS
Chematic production meets cGMP standards
Complete lot traceability
All inbound raw materials are QC tested
Product C of A’s provided
Change control policy
ADDITIONAL SERVICES & SUPPORT
A cleaning process optimized for your equipment
Analytical test methods provided under confidentiality
Controlled formulation and detection method for all
formulated Chematic detergents
Cycle development assistance
Committed to continuity of supply for the life of your product
11230 Katherine’s Crossing | Woodridge, IL 60517
Phone: 630.410.7300 | Toll Free: 800.323.4983
chematic@dober.com
www.dober.com
Disclaimer
This information and all further technical advice is based on our present knowledge and experience.
However, it implies no liability or other legal responsibility on our part, including with regard to existing
third party intellectual property rights, especially patent rights. In particular, no warranty, whether
expressed or implied, or guarantee of product properties in the legal sense is intended or implied. We
reserve the right to make any changes according to technological progress or further developments. The
customer is not released from the obligation to conduct careful inspection and testing of incoming goods.
Performance of the product described herein should be verified by testing, which should be carried out
only by qualified experts in the sole responsibility of a customer. Reference to trade names used by
other companies is neither a recommendation, nor does it imply that simliar products could not be used.
® = registered trademark
Eudragit = reg. trademark of Evonik Industries AG and its subsidiaries
Chematic = reg. trademark of Dober, Woodridge, IL, USA
Dober = reg. trademark of Dober Chemical Company
D
BER