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

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

GMP Title CFR, Part 211, Subpart D, Section 211.

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

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.

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

Rite-Hite Clean Solutions Rite-Hite Doors Graphic User Interface FasTrax Clean SplitSecond Clean Rite-Hite Door s unique Graphic User Interface (GUI) offers the industry s only 7" LCD touch screen

All the high-speed performance you expect from FasTrax with a total commitment to clean. This is the complete washdown door.

Worry-free washdown Non-corrosive materials withstand highpressure washdown with the harshest cleaning chemicals.

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

4 Rite-Hite Clean Solutions Rite-Hite Doors Graphic User Interface FasTrax Clean SplitSecond Clean Rite-Hite Door s unique Graphic User Interface (GUI) offers the industry s only 7" LCD touch screen operator that provides increased safety by allowing an individual to simply access the control box settings without wearing the necessary PPE often required for accessing a live electrical panel. 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 highpressure 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. 4 RiteHite.com Clean Room Doors SplitSecond high performance 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 A smooth curtain fabric and stainless steel components for easy wipe down and corrosion resistance. Spring tube design Simply collects the curtain in the side frames and reduces overhead contaminants. Replaceable seals Replaceable bottom seals for easy maintenance.» 7" (178mm) Color LCD Touch Screen» State of the art low voltage controls designed to provide complete control» Simple troubleshooting screens» Useful insights such as cycle times and average time the door is spent open and closed» Supports multiple languages» Supports network connectivity» Ability to communicate with building management systems» Wireless interlock capabilities» NEMA 4X enclosure

LiteSpeed Cleanroom LiteSpeed Washdown From the soft bottom edge to the simple, cleanable design platform, LiteSpeed Cleanroom has become the new standard for reliable,

Its tapered surfaces minimize dust collection points better than flat surfaces and it is designed with no exposed fasteners to allow quick and easy cleaning.

Complies with USDA, FDA & GMP guidelines.

down. TRUE Auto Re-feed For automatic re-feeds, on the fly, with no human interaction. Impacts won t impact production.

cgmp, FDA & USDA compliant The simple design of the LiteSpeed Washdown has non-exposed fasteners and stainless steel side frames and shroud options to most clean

5 LiteSpeed Cleanroom LiteSpeed Washdown From the soft bottom edge to the simple, cleanable design platform, LiteSpeed Cleanroom has become the new standard for reliable, productive performance in the industrial clean room door category. LiteSpeed Cleanroom helps maintain the integrity of clean environments with ease. Its tapered surfaces minimize dust collection points better than flat surfaces and it is designed with no exposed fasteners to allow quick and easy cleaning. The tight seal maintains pressure differentials from room-to-room and can withstand pressures up to 0.2 InWC. Tough PVC vinyl or Urethane curtain Completely heat sealed. Complies with USDA, FDA & GMP guidelines. Small footprint This 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. TRUE Auto Re-feed For automatic re-feeds, on the fly, with no human interaction. Impacts won t impact production. The LiteSpeed Washdown is a fast, roll-up door with speeds up to 65" per second (1.65 m/ sec) designed to help keep contaminants from entering clean, interior environments. cgmp, FDA & USDA compliant The simple design of the LiteSpeed Washdown has non-exposed fasteners and stainless steel side frames and shroud options to most clean applications. Cleaner overall application experience The recessed control options available to have next to the door opening. No coil cords or wires Which helps with safety anywhere in or around any part of the fabric door opening. Fewer moving parts Which means less downtime and less maintenance, providing the most reliable door to keep your environments separated. Clean Room Doors RiteHite.com 5

Arbon Drive Milwaukee, WI 53223, USA P 414-355-2600 (800-456-0600) F 414-355-9248 Rite-Hite, SplitSecond, FasTrax, LiteSpeed, Soft Breakaway Technology are trademarks of Rite-Hite Holding

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 D20CRPLB0518H North Arbon Drive Milwaukee, WI 53223, USA P ( ) F Rite-Hite, SplitSecond, FasTrax, LiteSpeed, Soft Breakaway Technology 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.

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