High Performance Clean Room Doors. When it comes to clean think Rite-Hite.

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1 High Performance Clean Room Doors When it comes to clean think Rite-Hite.

2 GMP means different things to different industries. Good Manufacturing Practices (GMP) must be used in every facility to ensure quality products are being made in a clean, safe and controlled environment. GMP Title CFR, Part 211, Subpart D, Section states Equipment used in the manufacture, processing, packaging or holding of a drug product shall be of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance There are many variations to every individual facility s GMP guidelines, but the overall principle is that all critical control points and processes are compliant to certain specifications, especially when it comes to cleaning a manufacturing facility. What s important to you?» Do you washdown frequently?» Are doors a part of your regular cleaning schedule?» Do you follow Sanitation Standard Operating Procedures?» Does your facility have specific (special) cleaning procedures?» Are aesthetics or ease of deep cleaning most important?» Does your cleaning involve harsh chemicals? 2 RiteHite.com Clean Room Doors

3 USDA 9CFR Part 416 Sanitation: 416.3(a) Equipment and utensils used for processing or otherwise handling edible product or ingredients must be of such material and construction to facilitate thorough cleaning and to ensure that their use will not cause the adulteration of product during processing, handling, or storage. Equipment and utensils must be maintained in sanitary condition so as not to adulterate product. What does clean look like? Whether you follow an HACCP program, SSOPs, or are trying to conform to your specific GMPs, cleaning a clean room can vary between industries. The contamination that should be removed may be one or more of the following types:» Particles and Fibers» Speed of Operation» Bacteria» Electrostatic Charges Pre-rinse Wash Remove Soil Rinse Sanitize Four Steps Cleaning and Sanitation» Concentration» Temperature» Time» Mechanical Force» Kill Microorganisms Good Manufacturing Practice (GMP) codes require written procedures to be established and followed for cleaning and maintenance of equipment used in the manufacturing, processing, packaging or holding of certain products. ** Generalizing GMP Title to be appropriate to all manufactured products, not just drug products Clean Room Doors RiteHite.com 3

4 Rite-Hite clean solutions SplitSecond Clean Bi-parting design and class leading speed minimizes air transfer to help prevent contamination between rooms. More speed equals more production efficiency and more control of your facility s environment. Safer work environments two large vision windows and immediate top-to-bottom visibility decreases blind spots. USDA, FDA & GMP compliant smooth curtain fabric and stainless steel components for easy wipe down and corrosion resistance. Spring tube design collects the curtain in the side frames and reduces overhead contaminants. 4 RiteHite.com Clean Room Doors

5 FasTrax Clean LiteSpeed Clean All the high-speed performance you expect from FasTrax with a total commitment to clean. This is the complete washdown door. Every part and every component is specifically engineered for deep cleaning, in washdown environments. Worry-free washdown non-corrosive materials withstand high-pressure washdown with the harshest cleaning chemicals One piece radial header machined from a solid block of UHMW plastic to exceed USDA, FDA & GMP standards. Non-corrosive Lexan & UHMW side frames stand off from the wall to minimize surface-to-surface contact, reducing pockets where bacteria can grow, and easily removable in seconds without tools for deep cleaning. From the soft bottom edge to the simple, cleanable design platform, LiteSpeed has become the new standard for reliable, productive performance in the industrial clean room door category. Tough PVC vinyl or Urethane curtain completely heat sealed. Complies with USDA, FDA & GMP guidelines. Small footprint is ideal for installation in tight spaces the compact 403B stainless steel side frames and sloped shrouds give a clean appearance and are easy to wipe down. Fewer moving parts less downtime and less maintenance, providing the most reliable door to keep your environments separated. Clean Room Doors RiteHite.com 5

6 Improving industrial safety, security, and productivity worldwide through quality and innovation. VEHICLE RESTRAINTS LOADING DOCK LEVELERS DOCK SEALS AND SHELTERS INDUSTRIAL DOORS HVLS FANS BARRIER SAFETY SYSTEMS MACHINE GUARDING SYSTEMS INDUSTRIAL CURTAIN WALLS D19CRPLB1115H North Arbon Drive Milwaukee, WI 53223, USA P ( ) F Rite-Hite, SplitSecond, FasTrax, LiteSpeed are trademarks of Rite-Hite Holding Corporation. Rite-Hite products are covered by one or more U.S. patents with other U.S. and foreign patents pending. The information herein is provided as a general reference only regarding the use of the applicable products. The specifications stated here are subject to change.