Our cleaning science gets you back to business faster Chematic Cleaners
Chematic Cleaners Achieve significant time and cost savings by using Chematic for effective cleaning processes. Clear view on the advantages Chematic Cleaners can be applied for manual WIP and CIP processes. Due to their mild chemistry and low process temperatures they are highly suitable for manual cleaning procedures as well. Equipment cleaning after processing EUDRAGIT RL/RS, EUDRAGIT NE/NM and EUDRAGIT L, FS & S formulations is now an efficient and safe process. Special detergents have been developed by Dober, USA, in close cooperation with Evonik. Chematic Cleaners provide optimized cleaning results with minimum efforts. Chematic Cleaners take advantage of a special detergent system which aids in the removal of both the EUDRAGIT polymers and associated excipients. 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. Safety Minimized need for operator intervention Not irritating High compliance by personnel Reduced disassembly No solvent usage and exposure Efficiency Cleaning time reduced by more than 65 % Energy savings of about 70 % Equipment down time minimized Reduced labor costs Simplified procedures Reliability Consistent results GMP compliant Robust cleaning process
Product offerings Our cleaning science gets you back to business faster, automatically! Cleaning efficiency The optimal combination of Time, Action, Chemistry and Temperature in all Chematic Cleaners provides best in class cleaning results. EUDRAGIT L, FS & S-Polymer enteric challenging EUDRAGIT E-Polymer taste masking and protective coating T Less Time No scrubbing, less cleaning cycles No haze from TiO 2 or iron oxides Detergent: Chematic L Detergent: contact Evonik for a specific solution A Less Action Automated WIP / CIP processes EUDRAGIT NE- & NM-Polymer Detergent: Chematic NE/NM EUDRAGIT EUDRAGIT RL- & RS-Polymer ph-independently insoluble and permeable challenging 1 Detergent: Chematic RL/RS C T Mild Chemistry Optimized for EUDRAGIT polymers Cost saving Regulatory Compliant Low Temperature Cleaning at temperatures below 60 C Applicable for manual processes 1 Pigmented formulations
Applications Chematic RL/RS Cleaner Chematic NE/NM Cleaner Chematic L 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 EUDRAGIT polymers EUDRAGIT NE 30 D EUDRAGIT NE 40 D EUDRAGIT NM 30 D EUDRAGIT polymers EUDRAGIT L 100-55 EUDRAGIT L 30 D-55 EUDRAGIT L 100 EUDRAGIT L 12,5 EUDRAGIT S 100 EUDRAGIT S 12,5 EUDRAGIT FS 30 D Recommended process parameters WIP/CIP Manually Recommended process parameters WIP/CIP Manually Recommended process parameters WIP/CIP Manually Application concentration/ temperature pre-rinse, 20 C 4 8 % v/v 55 70 C 4 8 % v/v 50 60 C Application concentration/ temperature 4 8 % v/v 50 60 C Application concentration/ temperature pre-rinse, 20 C 2 5 % v/v 45 55 C post-rinse, 20 C pre-rinse, 20 C 2 5 % v/v 20 55 C post-rinse, 20 C Physico-chemical properties Transparent, water-white liquid Physico-chemical properties Transparent, amber liquid Physico-chemical properties Transparent, amber liquid ph (10 % v/v solution) 2.0 3.0 ph (10 % v/v solution) 11.0 12.0 ph (5 % v/v solution) 11.0
Before cleaning After cleaning Case study EUDRAGIT NE 30 D EUDRAGIT RS 30 D EUDRAGIT L Series Coating Pan (60 inch O Hara) One production run, soil sat 24 hours Original Process: Labor intensive; resulting in ergonomic issues Residue peels off & blocks perforations Inconsistent cleaning impacts scheduling Manual cleaning: 2 6 hours WIP/CIP cleaning: 2 hours Goals of New Process: Improve operator safety Decrease manual labor Allow for more consistent cleaning process using CIP Reduce clean time Results: Chematic NE/NM Cleaner Manual cleaning: 15 30 minutes WIP/CIP cleaning: ~2 hours Benefits: Safer process for operators Less manual labor intensive process Detergent dissolves residue Significant time and cost savings Consistent cleaning process allows improved scheduling Improved capacity Fluid Bed (Glatt WSG 200 with 46 inch Wurster) Multiple batches Original Process: Labor intensive; manual process involves power washing, hand scrubbing & disassembly Complicated cleaning procedure with hazardous detergents Manual cleaning: 24 hours Goals of New Process: Improve safety Decrease manual labor Eliminate scrubbing by using chemical spray wands Less complex process Reduce down time Results: Chematic RL/RS Cleaner Manual cleaning: 4 hours Benefits: Safety improved Manual labor significantly reduced, no scrubbing Greatly reduced clean time by robust cleaning process Increased capacity Reduced labor costs Significant time and cost savings Coating Pan (Glatt GMPC II (75cm)) One production run, soil at 40% solids Original Process: Labor intensive; resulting in ergonomic issues Polymer dissolves completely but pigments settle back Haze visible on surface Re-cleaning was required due to haze Manual cleaning: CIP cleaning: 2 6 hours 30 minutes 2 hours Goals of New Process: Decrease manual labor Eliminate scrubbing No haze from TiO 2 or Iron Oxides or Talc Reduce cleaning time Results: Chematic L Cleaner Manual cleaning: 0 30 minutes WIP/CIP cleaning: 1 hour Benefits: No manual scrubbing No haze from TiO 2 or Iron Oxides or Talc post cleaning Pigments best removed with cold pre and post rinse Significant time and cost savings Consistent cleaning process allows improved scheduling Improved capacity
Our service offerings 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 Standard service Regulatory support 1L samples with standard recommendations Information exchange Requirements and needs Process description ACM study Optimization trials at Evonik/Dober Process transfer Cleaning report Technical transfer to production site (optional) Assistance for test methods & process descriptions (SOP) regulatory advise Watch Chematic RL/RS Cleaner perform in real time
Europe, Middle East, Africa Evonik Nutrition & Care GmbH Kirschenallee 64293 Darmstadt Germany PHONE +49 6151 18-4019 fax +49 6151 18-3520 eudragit-germany@evonik.com North America Evonik Corporation 2 Turner Place, PO Box 365 Piscataway, NJ 08855 USA PHONE +1 732 981-5021 fax +1 732 981-5484 eudragit-usa@evonik.com Latin America, Mexico Evonik Degussa Brasil Ltda Alameda Campinas 579-5 andar CEP 01404-000 - São Paulo Sao Paulo Brazil PHONE +54 11 3146 4138 fax +54 11 3146 4140 eudragit-latinamerica@evonik.com India, Bangladesh Evonik India Pvt. Ltd. Krislon House, Saki Vihar Road, Sakinaka, Andheri(East) Mumbai 400072 India PHONE +91 22 6624 6908 fax +91 22 6624 6996 eudragit-india@evonik.com South East Asia Australia & New Zealand, Pakistan Evonik (SEA) Pte. Ltd. 3 International Business Park #07 18 Nordic European Centre Singapore 609927 Republic of Singapore PHONE +65 6809 6666 fax +65 6809 6663 eudragit-sea@evonik.com China Evonik Specialty Chemicals (Shanghai) Co. Ltd. 55 Chungdong Road Xinzhuang Industry Park Shanghai 201108 People s Republic of China PHONE +86 21 6119 1032 fax +86 21 6119 1473 eudragit-china@evonik.com Japan, Taiwan Evonik Japan Co. Ltd. Shinjuku Monolith 12 F 2-3-1, Nishi-Shinjuku Shinjuku-ku Tokyo 163-0938 Japan PHONE +81 3 5323-7357 fax +81 3 5323-8789 eudragit-japan@evonik.com South Korea Evonik Korea Ltd. #601~603 CCMM B/D 101 Yeouigongwon-ro, Yeongdeungpo-gu, Seoul 150-869 Korea PHONE +82 2 320 4792 fax +82 2 783 2530 eudragit-korea@evonik.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 similar 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 Evonik Nutrition & Care GmbH Pharma Polymers & Services Kirschenallee 64293 Darmstadt Germany PHONE +49 6151 18-4019 fax +49 6151 18-3520 Chematic@evonik.com www.eudragit.com/cleaning www.evonik.com May 2016, V 1.2