Apparel for Bioburden Monitored Environments

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2 2 Apparel for Bioburden Monitored Environments

3 Eliminate an Entire Category of Biological Contamination in Your Production Environment Stop taking chances with contaminated reusable and disposable garments that can lead to unacceptable high levels of contamination within your production environment. The Alpha Pro Tech Assurance apparel line can help you end worries about bioburden levels in your monitored, non-sterile environments. The Assurance apparel line's pioneering mix of best-inclass materials, stringent manufacturing process, patented packaging system and Method 1 validated SAL10-4 eliminates this category of risk to your environments. Stringent Processing Eliminates a Source of Bioburden Contamination Garments are gamma irradiated to yield a minimum Sterility Assurance Level (SAL) of This exponentially reduces or eliminates the bioburden and diversity of genome entering your environment on garments. Assurance garments are processed and certified to contain one or fewer colony forming units in 10,000 garments. Alpha Pro Tech s Patented* Packaging System Stops the Contamination of the Outside World at the Loading Dock The unique, patented Alpha Pro Tech packaging system guarantees contamination will not cross between areas. Garments are packaged in a primary vacuum heat sealed bag and/or secondary heat sealed bag, carton liner and outer corrugated carton to assure bioburden and contamination do not migrate between environments. Outer carton has a Certificate of Irradiation with indicator dot eliminating the need to quarantine product awaiting documentation. All open seams on the outer carton are tape sealed to further prevent contamination. Four-sided carton labeling allows quick, easy identification and error-free inventory management. Sealed carton with corner labels, and Certificate of Irradiation Twist-sealed carton liner has an additional Certificate of Irradiation with indicator dot. The carton liner holds the primary or secondary bag. Carton Liner holds Primary Bag(s) Secondary bags contain 25 each or pair of individually bagged garments (coverall, hoods, and boot covers) stacked within a heat sealed 3 mil bag to permit efficient storage with or without bins. Bouffants and beard covers are bulk packed in a 1 mil primary bag, 100/bag, 10 bags per secondary 3 mil bag. Primary bag is a 1 mil bag. All garments are precision folded for easy donning. Shoe covers are bulked packed in a 3 mil primary bag. Carton Liner with Certification of Irradiation Quality Assurance The irradiation facility is certified by TUV. This certification covers Provision of Irradiation sterilization for single use medical devices in compliance with EN 552/A1:1999 and ISO 11137:1995 and the facility s Quality Management System is certified to EN ISO 9001:2000. Processed to ensure 1 or fewer colony forming units in 10,000 garments Secondary bag holds primary bag(s) Primary Bag 3

4 Cover All Your Protection Needs ComforTech Assurance Coveralls Features & Benefits: Eliminate bioburden risks to your manufacturing and R&D areas with the exceptional containment performance, 10-4 SAL processing and ultra low particle count of these coveralls. The ComforTech Assurance fabric contains 99.9% of all particles 0.3 microns and larger transmitted from the wearer, eliminating contamination concerns. The strong, lightweight, static dissipative material also exhibits a high vapor transmission rate to dispel perspiration for cool, comfortable, all-day wear. Protects the wearer from particles and biologicals, too. Sterility Assurance Level: Method 1 validated and terminally sterilized using gamma irradiation to yield a minimum SAL of Construction Details: Available with or without attached AquaTrak boots. Both feature serged seams, front zipper, inset sleeves, elastic wrists and ankles. For industrial use only. Packaging Details: Each coverall is sealed in a 1 mil primary bag with 25 garments vacuum heat sealed in a 3 mil secondary bag. This is surrounded by a 1 mil carton liner surrounded by a carton. A Certificate of Irradiation with confirming dot is affixed to the carton liner and carton. Coveralls Part No. CVA-J CVA-J CVA-J CVA-J CVA-J CVA-J CVA-J CVA-J S M L XL 2X 3X 4X 5X Elastic wrist & ankle, serged seams, white, individually bagged 25/case Coveralls Part No. CVA-J4C92-1 CVA-J4C92-2 CVA-J4C92-3 CVA-J4C92-4 CVA-J4C92-5 CVA-J4C92-6 CVA-J4C92-7 CVA-J4C92-8 S M L XL 2X 3X 4X 5X Elastic hood, wrist, ankle & AquaTrak boot, serged seams, white, individually bagged 25/case Dimensions Body Chest (B) Sleeve (C) Leg (D) S 36 ½ ½ 28 M 37 ½ 24 ¼ ½ L 38 ¾ ½ XL ½ 30 2X 40 ½ 29 ¾ X X ½ ½ 5X 43 ½ 33 ½ Bioburden Free Coveralls shown with AquaTrak UltraGrip Assurance Shoe Covers, sold separately. Processed to ensure 1 or fewer colony forming units in 10,000 garments. 4

5 Unobstructed View ComforTech Assurance Hoods Features & Benefits: The ComforTech Assurance hood is made of a low particulate material manufactured using the latest techniques to help protect your manufacturing environment. The hood gives workers full range of motion and vision while acting as a barrier to particles, biologicals, fluids and a wide variety of chemicals. One-size-fits-all securely and comfortably thanks to easy-to-use crown ties. As an added measure of protection, the longer cowl length keeps the hood securely tucked into the coverall. Sterility Assurance Level: Method 1 validated and terminally sterilized using gamma irradiation to yield a minimum SAL of Construction Details: Bound seams, an attached crown and ties. For industrial use only. Packaging Details: Each hood is sealed in a 1 mil primary bag with 125 hoods vacuum heat sealed in a 3 mil secondary bag. This is surrounded by a 1 mil carton liner surrounded by a carton. A Certificate of Irradiation with confirming dot is affixed to the carton liner and carton. Hood Part No. SDA-J1533-B Univ. Open face, attached crown, ties, bound seams, white, individually bagged 125 case Full Coverage Dimensions Length Top Width (B) Opening Width (Relaxed) (C) Opening Width (Stretched) (C) Opening Length (Relaxed) (D) Opening Length (Stretched) (D) Tie Length (E) Univ. 17 ½ ¾ 6 ½ 9 ¾ 17 5

6 AquaTrak UltraGrip Assurance Boot Covers Protect Against Slip and Fall Accidents Features & Benefits: The combination of the UltraGrip sole with our AquaTrak upper material offers the ultimate in safety. The AquaTrak material is durable, clean and impervious to fluids, particulates and several chemicals. For protection against slip and fall accidents, the UltraGrip non-skid sole exhibits outstanding traction on a wide range of smooth to highly textured surfaces. The sole also works well on many surfaces contaminated with silicone. When you combine these performance properties with the SAL 10-4 processing, you have the ultimate boot cover for monitored environments. Sterility Assurance Level: Method 1 validated and terminally sterilized using gamma irradiation to yield a minimum SAL of Construction Details: Non-conductive, anti-skid, serged seams. Different thread colors around the opening for convenient size identification. For industrial use only. Packaging Details: A pair of boot covers is sealed in a 1 mil primary bag with 100 pair vacuum heat sealed in a 3 mil secondary bag. This is surrounded by a 1 mil carton liner surrounded by a carton. A Certificate of Irradiation with confirming dot is affixed to the carton liner and carton. Boot Covers w/ultragrip Sole Thread Part No. Colors BTA-T1815-B M Yellow BTA-T1816-B L Orange BTA-T1812-B Univ. White BTA-T1813-B XL Black Elastic ankle and top, anti-skid sole, serged seams, white, individually bagged in pairs 100 pair/case Long Wear Dimensions Length Height (B) Top (Relaxed) (C) Top (Stretched) (C) Ankle (Relaxed) (D) Ankle (Stretched) (D) Sole Width (E) M 11 ¼ 17 5 ¼ ¾ 4 ¼ L 12 ¼ 17 ½ 5 ½ 9 ½ 6 9 ¾ 4 ¼ Univ 13 ½ 17 ½ 5 ¾ 9 ½ 6 ½ 11 4 ½ XL ½ 6 ¾ 12 ½ 4 ¾ 6

7 Stop Slip and Fall Accidents AquaTrak UltraGrip Assurance Shoe Covers Features & Benefits: The AquaTrak material used in the manufacture of these shoe cover uppers is durable, clean and impervious to fluids. For protection against slip and fall accidents, the UltraGrip non-skid sole exhibits outstanding traction in dry and damp conditions. When you combine these performance properties with the SAL 10-4 processing, you have the ultimate shoe cover for monitored environments. Sterility Assurance Level: Method 1 validated and terminally sterilized using gamma irradiation to yield a minimum SAL of Construction Details: Non-conductive, anti-skid sole, serged seams. Different thread colors around the opening for convenient size identification. For industrial use only. Packaging Details: These shoe covers are bulk packed 100 pair vacuum heat sealed in a 3 mil primary bag. This is surrounded by a 1 mil carton liner surrounded by a carton. A Certificate of Irradiation with confirming dot is affixed to the carton liner and carton. Shoe Covers w/ UltraGrip Sole Thread Part No. Colors SHA-T1315-BH M Yellow SHA-T1316-BH L Orange SHA-T1312-BH Univ. White SHA-T1313-BH XL Black Non-skid sole, serged seams, white, bulk packed 100 pair/case Barrier Protection Dimensions Length Height (B) Top Relaxed (C) Top Stretched (C) Sole Width (D) M 11 ½ 5 4 ½ 8 ¾ 4 ¼ L 12 ¾ 5 4 ¾ 9 ¼ 4 ½ Univ ½ 4 ½ XL 15 ¼ 6 ½ 6 ½ 12 4 ¾ 7

8 GenPro Assurance Bouffants Perfect for Dry, Non-Hazardous Environments Features & Benefits: The cool, comfortable GenPro Assurance bouffant provides a limited barrier to particulates and contamination. The durable yet lightweight, breathable material keeps workers clean and comfortable all day and acts as a moderate barrier or containment solution for particles and bioburden. A non-binding latex-free elastic band holds the bouffant securely in place without binding or scratching. The unique application of 10-4 SAL processing eliminates one of your largest sources of incoming bacteria, virus, mold and algae contaimination. By processing a contact plate of your current bouffant cap, you will see the reason to select GenPro as your bouffant of choice. Sterility Assurance Level: Method 1 validated and terminally sterilized using gamma irradiation to yield a minimum SAL of Construction Details: Latex-free elastic band. For industrial use only. Packaging Details: These bouffant caps are bulk packed 100 each in a 1 mil primary bag, 10 bags of 100 (1,000) vacuum heat sealed in a 3 mil secondary bag. This is surrounded by a 1 mil carton liner surrounded by a carton. A Certificate of Irradiation with confirming dot is affixed to the carton liner and carton. Bouffants Part No. BOA B 21 BOA B 24 Lightweight material, latex-free, serged elastic, white, bulk packed 1,000/case Lightweight Dimensions Diameter Relaxed Diameter Stretched ½ 24 8

9 Get Contamination Under Wraps GenPro Assurance Beard Covers Features & Benefits: The soft, comfortable, lightweight GenPro Assurance beard cover helps keep biological and particulate contamination under control. The material also acts as a moderate barrier to fluids. A latex-free elastic band holds the cover securely in place. The unique application of 10-4 SAL processing eliminates one of your largest sources of incoming bacteria, virus, mold and algae contamination. By processing a contact plate of your current beard cover you will see the reason to select GenPro as your beard cover of choice. Sterility Assurance: Method 1 validated and terminally sterilized using gamma irradiation to yield a minimum SAL of Construction Details: Latex-free elastic band. For industrial use only. Packaging Details: These beard covers are bulk packed 100 each in a 1 mil primary bag, 10 bags of 100 (1,000) vacuum heat sealed in a 3 mil secondary bag. This is surrounded by a 1 mil carton liner surrounded by a carton. A Certificate of Irradiation with confirming dot is affixed to the carton liner and carton. Beard Cover Part No. MSA Univ. Lightweight material, serged elastic headband, white, bulk packed 1,000/case Breathable Dimensions Diameter Relaxed Diameter Stretched Headband Stretched (B)

10 Seam Construction Bound Seams Bound seams deliver extra durability and strength, as well as, reduce particulate shedding and provide extra protection against fluids. Serged Seams This seam is produced when the threads are interlocked around the material edges for a strong, stress-resistant seam. Ultrasonically Welded Seams There are no thread or needle holes with this seam. The material is welded together creating a superior particle and fluid barrier. Apparel Sizing Charts Please contact us for other sizing. UltraGrip Sole Physical Properties C Standard Applied Test Method Results Electrostatic Decay Rate Surface Resistivity ASTM D257 Fed Std 101C Method 4046 ASTM D257 Inner Outer Pass 4.84E+09 ohms/sq in. 4.50E+09 ohms/sq in. Coefficient of Friction ASTM 1894 >1 Taber Abrasion Resistance ASTM D cycles CAll test data is pre-irradiation 10

11 Standard Applied Test Method ComforTech AquaTrak Ball Burst Strength ASTM D3787 (Puncture Strength) 21 lbs 23 lbs BFE (Bacterial Filtration Efficiency) MIL-M-36954C 99.90% 99.90% COF (Coefficient of Friction) ASTM D1894 (Film to Metal Test) N/T Static Kinetic Physical Properties Testing C Delta P (Differential Pressure) ESD (Electrostatic Decay Rate) Grab Tensile Properties MIL-M-36954C Fed. Std. 101C Method 4046 ASTM D257 ASTM D751 MD-Tensile Strength TD-Tensile Strength mm H 2 O/cm 2 >122 Pass 30 lbs 32 lbs mm H 2 O/cm 2 >119 N/T 28 lbs 40 lbs Helmke Drum IEST-RP-CC003.3 Category II Category I Hydrostatic Resistance ASTM D751 N/T 20 psi Mass/Unit Area ASTM D oz/sq yd 1.77 oz/sq yd Mullen Burst Strength ASTM D psi 146 psi Puncture Propagation Tear Resistance ASTM D2582 MD-Tensile Strength TD-Tensile Strength 5 lbs 6 lbs 10 lbs 9 lbs Trapezoid Tearing Strength ASTM D4533 MD-Tensile Strength TD-Tensile Strength 9 lbs 8 lbs 12 lbs 17 lbs Water Resistance Impact Penetration AATCC Method 42 No Visible Penetration No Visible Penetration Water Vapor Transmission ASTM E oz/yd 2 /hr oz/yd 2 /hr MD - Machine Direction CAll test data is pre-irradiation TD - Transverse Direction N/T - Not Tested WARNING: These garments and associated materials are not suitable for use in some environments containing certain chemicals and/or hazardous agents. It is the responsibility of the user to determine the level of risk in a particular environment and the proper personal protection equipment needed. Garments manufactured from synthetic non-woven material may generate static electricity. Garments that contain an anti-stat treatment are not intended to be used as a safety feature. These garments are not recommended to be used in a flammable and/or explosive environment. If you have any questions, contact your distributor or Alpha Pro Tech for garment/fabric safety data. The use of this product is out of Alpha Pro Tech s control. Therefore, Alpha Pro Tech makes no warranties, expressed or implied, and assumes no liability as to the performance of these products for a particular use. CAUTION: AVOID HEAT AND/OR OPEN FLAME. UCC Limited Warranty and Exclusions Limited Warranty; Disclaimer and Limitation of Remedies: The products shall be free from defects in material and workmanship. ALPHA PRO TECH HEREBY EXPRESSLY DISCLAIMS ALL WARRANTIES, EITHER EXPRESSED OR IMPLIED, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. Buyer s remedy is expressly limited to replacement of any defective product and Alpha Pro Tech shall have no responsibility for any incidental or consequential damages. Any claims under this warranty must be made in writing to Alpha Pro Tech and must be made with 90 days of the purchase. Alpha Pro Tech, Inc. reserves the right to change any prices, terms and conditions of sale at any time without any notice. *Roundup is a trademark of Monsanto Technology LLC. *Vesphene is a trademark of E.R. Squibb and Sons, Inc. *Spor-Klenz is a trademark of Steris Corp. AquaTrak, Assurance, ComforTech, GenPro and UltraGrip are trademarks of Alpha Pro Tech, Inc. 11

12 Alpha Pro Tech is committed to protecting people, products, manufacturing and healthcare environments to optimize process effectiveness and customer profitability. Ordering Information: To place an order, receive a sample or obtain more information, please contact our Customer Service Department toll-free from 9:00 a.m. to 5:00 p.m. Eastern Time at: Phone: Fax: sales@alphaprotech.com International customers please use the following contact information: Phone: Ext. 201 Fax: ccrespo@alphaprotech.com Visit us at: APT-3054D 04/12