Advanced CIP/SIP solutions. .Premium Equipment. Processes & Equipment Solutions for Cleaning and Sterilization

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1 Advanced CIP/SIP solutions.

2 Advanced CIP/SIP solutions. Profile McFlusion is a highly specialized life-cycle supplier of advanced processes and equipment solutions for cleaning (CIP) and sterilization (SIP) as well as a wide array of cleaning related services to the FDA regulated life science, pharmaceutical, and specialty food industries. At McFlusion, we specialize in providing innovative technology solutions and quality craftmanship - we develop the best, most pragmatic, and sustainable process solutions, source the right equipment and components as well as manage project deliverables from A-Z - making sure that you are satisfied with the outcome. We are recognized as experts within our field, and through our extensive process knowledge and practical experiences we assist you in understanding and developing the best possible solutions to meet your specific challenges and needs. We consider each project a continuous close partnership with you, and will actively strive to earn your trust and confidence every day by offering value added, high quality, services and equipment.

3 Process Advanced Areas CIP/SIP solutions. Process Areas McFlusion has successfully designed, manufactured and qualified cleaning-inplace (CIP), cleaning-out-of-place (COP) and sterilization-in-place (SIP) solutions for numerous FDA regulated life science, pharmaceutical and specialty food facilities. Some examples of our installed base: Sterile & Vaccine Manufacturing CIP/SIP of filling lines w/isolator technology CIP of formulation tanks CIP/SIP of fill vessels & transfer lines COP of disassembled fill apparatus COP of portable compounding vessels Solid (Oral) Dosage Form Manufacturing CIP of fluid bed driers & granulators CIP of cone, slant & V-blenders CIP of hi- & low shear mixers CIP of coating pans COP of drums, tools & utensils Chemical API Manufacturing CIP of reactors CIP of condensers & pipe lines COP of IBC containers COP of parts, tools & utensils COP of drums & bins Specialty Foods Manufacturing CIP of cone & V-blenders CIP of hi- & low shear mixers CIP & sanitization of product transfer & fill lines COP of drums & bins CIP of holding tanks

4 The Advanced McFlusion CIP/SIP Difference solutions. CIP/SIP Equipment McFlusion offers modular, customized, CIP/SIP process systems that are engineered, manufactured, tested and qualified in our facility prior to delivery. Our CIP/SIP equipment program includes, but is not limited to, the following: MEC-series CIP units High impact CIP cleaning units that are perfectly suited for stand-alone process equipment within solid (oral) dosage form, cosmetics and specialty foods facilities. Portable Parts Racks & CIP/SIP modules C- and S-series, decentralized, CIP equipment Modular, decentralized, CIP equipment for high-end cgmp drug manufacturers within sterile, vaccine and biotech industry segments - providing full TACCT performance, maximum process control, monitoring and batch reporting. Customized, specialty engineered, modules for various process applications, such as portable parts racks for disassembled filling apparatus, CIP/SIP docking stations for portable vessels, stand-alone or integrated process modules for gas purging & drying, vacuum and sterilization. CIP/SIP Accessories & Parts Various accessories and parts required for your cleaning and sterilization processes, such as flexible hoses, process adapters, spray devices and others.

5 The Advanced McFlusion CIP/SIP Difference solutions. Cleaning Services A major part of our offering lies within cleaning services, where we combine a scientific & analytical approach with hands-on, practical, tests & experiments. We always encourage our clients to take advantage of our cleaning services to define, test and validate the feasibility of your project goals - this approach enables us to guarantee the overall performance of each cleaning & sterilization system that we deliver. Our cleaning services for both process / manufacturing equipment and utility systems are structured and divided into three segments, as follows: McBASE Bench scale to full scale evaluation & tests of cleaning process (-es) in our laboratory and facility to establish optimal CIP programs/recipes. McCIP Cleaning feasibility studies, or CIP cycle (recipe) development, and process optimization trails conducted on-site on your production equipment. McCLEAN On-site cleaning of production equipment and utility systems - as per regulations and SOPs.

6 The Advanced McFlusion CIP/SIP Difference solutions. Support CIP/SIP expertise At McFlusion, we offer our unique knowledge and expertise within specific process areas to our clients in well-defined packages. We can act as Subject Matter Experts, as part of our client's organization, to perform CIP/SIP benchmark, assessment and feasibility studies - herewith practical bench scale and full scale CIP/SIP testing to provide proof-of-concept. Hardware / Software Upgrades Hardware and software upgrades to keep your cleaning and/or sterilization system up to date, stay in compliance with latest trends and user requirements, add functionalities, etc. Process Automation Integration GAMP and S88 automation integration with manufacturing equipment, as per our Interface Agreement document... Training & Seminars Off- and on-site training sessions in the use and operation of our CIP/SIP equipment as well as educational seminars on cleaning and sterilization related topics.

7 Advanced CIP/SIP solutions. Parts Parts Catalogue McFlusion provides sale of parts for our CIP/SIP equipment, modules, and accessories. Coming soon, we will launch our web based parts catalogue containing specialty CIP/SIP components, regular wear parts, etc. Preventive Maintenance Periodic inspections, adjustments and preventive maintenance - tailored to meet your specific needs and requirements - to ensure safe, accurate and consistent operation of your process cleaning and sterilization unit. Emergency Repair/Parts Replacement Services Emergency, on-site, repair and expedited replacement part delivery services to assist you in resolving your issues as correctly and quickly as possible. 24/7 Phone or Web Support Hotline with 24/7 access to an application specialist for immediate assistance over the phone and/or via the internet.

8 The Advanced McFlusion CIP/SIP Difference solutions. Contact us McFlusion Corp. (headquarters) 1480 Sandhill Drive Ancaster, ON L9G 4V5 Canada Phone: Fax: Sales, Engineering, Consulting, Manufacturing, Assembly, Test, Services & Support. McFlusion, Inc. 113 Sunset Drive Hudson, OH USA Phone: Fax: Sales, Engineering, Consulting, Services & Support. Find McFlusion on Facebook. Follow CIPClean on Twitter. Watch our videos at CIPClean on YouTube.