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O V E R V I E W 1 Veltek Associates, Inc. 15 Lee Boulevard Malvern, PA 19355-1234 Tel: (610) 644-8335 Fax: (610) 610-644-8336 Web Page: http://www.sterile.com DISP-01-2008 Rev. 5/2008 CMP Clean Garments Cut Manufactured and Packaged In a Class 1,000 (Grade B, ISO 6) Clean Room From Beginning to End Utilizing the Patent Pending

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O V E R V I E W 1

Veltek Associates, Inc. 15 Lee Boulevard Malvern, PA 19355-1234

Tel: (610) 644-8335 Fax: (610) 610-644-8336 Web Page: http://www.sterile.com DISP-01-2008 Rev. 5/2008

CMP Clean Garments Cut Manufactured and Packaged

In a Class 1,000 (Grade B, ISO 6) Clean Room From Beginning to End

Utilizing the Patent Pending

O V E R V I E W 2

Veltek Associates, Inc. 15 Lee Boulevard Malvern, PA 19355-1234

Tel: (610) 644-8335 Fax: (610) 610-644-8336 Web Page: http://www.sterile.com DISP-01-2008 Rev. 5/2008

Table of Contents Section 1 Overview of the Disposable Manufacturing Division (DPMD) of VAI Section 2 Summary of the Advantages of the CMP Clean Garments Section 3 Easy2Gown System Description Section 4 CMP Clean Garment Material Blend Construction Section 5 Cleanliness and Sterility of the VAI CMP Material Blends Section 6 CMP Garment Material Blends Section 7 CMP Manufacturing Process Section 8 PF-2 Face Mask Styles Section 9 Garment Styles Section #10: Material Blend Specifications Section #11: Customization and Availability of CMP Garments Section #12: Ordering Information

O V E R V I E W 3

Veltek Associates, Inc. 15 Lee Boulevard Malvern, PA 19355-1234

Tel: (610) 644-8335 Fax: (610) 610-644-8336 Web Page: http://www.sterile.com DISP-01-2008 Rev. 5/2008

Section #1 OVERVIEW OF THE DPMD:

Disposable Products Manufacturing Division DPMD or VAI's Disposable Products Manufacturing Division has addressed the needs of the Pharmaceutical, Biotechnology, Semi-Conductor, and Electronics industries by designing a complete range of sterile and non-sterile disposable garments, and textile products which are manufactured under the CMP Clean Manufacturing System. The CMP Clean Manufacturing System incorporates Cutting, Manufacturing, and Packaging (CMP) all products within a Class 1000 clean room facility from beginning to end. This manufacturing style assures that all products are handled in the cleanest fashion available for this type of operation. Subsequently, VAI products have tested for over 30 years as one of the lowest particulate inherent products in the marketplace. VAI's DPMD manufactures over 200 products that are designed for varying applications and clean room settings from Class 100 to Class 100,000. All DPMD products are manufactured in lot sequence, completely traceable and are tested for cleanliness by lot using our H-Y Tumble Drum Tester. This is in accordance with the Institute of Environmental Sciences Helmke Tumble Drum, IES-RP3.3. All DPMD sterile products are lot sterility tested. VAI sterility tests each by placing spore indicators (106 b. pumilis) and material swatches into each irradiation load. The spore indicators and material swatches are subsequently testing them for viability. DPMD incorporates internally designed material blends that have excellent barrier filtration capabilities, cleanliness and are designed for user comfort. DPMD also manufactures products with alternate material blends if requested. DPMD has responded and met the demands of professionals in the industry for over 30 years. Our custom manufacturing capabilities assure that the clientele will be able to request changes to our standard products and have custom items manufactured specifically for their needs. DPMD has its strongest position in the pharmaceutical and biotechnology industries. The introduction of the patent pending Easy2Gown System has revolutionized gowning by reducing the possibility of contaminating the gown due to the system’s unique folding. All sterile DPMD products are gamma irradiated. All systems are validated and appropriate documentation for products are assumed mandatory with delivery of the product. Our custom packaging provides packaging ranging from individual to bulk. Please review our product catalog on the following pages.

O V E R V I E W 4

Veltek Associates, Inc. 15 Lee Boulevard Malvern, PA 19355-1234

Tel: (610) 644-8335 Fax: (610) 610-644-8336 Web Page: http://www.sterile.com DISP-01-2008 Rev. 5/2008

Section #2 Summary of the Advantages of the

CMP Clean Garments (Each item is detailed in the following pages)

VAI is both an EPA (068959-PA-01) and an FDA (64307) registered facility. All garment products are manufactured in a batch system and are tested and released by the Quality Assurance/Quality Control Department. All products are completely traceable.

All VAI Clean Garment products are manufactured according to the CMP System requiring all Products to be Cut, Manufactured and Packaged in a Class 1,000 clean room from beginning to end.

All VAI Clean Garment products are manufactured with proprietary material blends that have been proven to be of the utmost cleanliness in particulate and shedding features tested by the Helmke-Yeich® Tumble Drum test method contained in the IEST-RP-CC003.2.

All VAI Clean Garment products are manufactured with proprietary material blends that provide a comfortable fitting gown while providing excellent barrier capabilities. This assures both end-user satisfaction and appropriate fit.

All STERILE VAI Clean Garment products are lot sterility tested. VAI sterility tests each lot by placing spore indicators (106 b. pumilis) and material swatches into each irradiation load. The spore indicators and material swatches are subsequently testing them for viability. Veltek Associates, Inc. is the only company in the industry whom sterility tests their garment products.

All STERILE VAI Clean Garment products are delivered with the:

• Certificate of Irradiation • The Dosimeter Readings from Irradiation • Lot Specific Sterility Test Report • All other documents are retained in the product batch record.

Veltek Associates, Inc. believes customization of products to meet the demands of clean room operations is a mandatory option that must be offered. As VAI is the manufacturer, all one has to do is ask and a design will be configured to meet the end-user’s needs. VAI has supplied garments to the pharmaceutical and biotechnology industry for over 30 years.

O V E R V I E W 5

Veltek Associates, Inc. 15 Lee Boulevard Malvern, PA 19355-1234

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Section #3 Easy2Gown System Description

Description: The Easy2Gown System is a patent pending folding system that is used to reduce the level of contamination that is transmitted by personnel during gowning. Easy2Gown garments are folded in such a manner so that the gown is presented in the package inside out. This provides the ability for the end user to open the sterile plastic bag and grasp any portion of the gown without concern for contamination of the exterior of the garment. Easy2Gown System garments are normally used in Class 100 (Grade A, ISO 5), Class 10,000 (Grade B, ISO 7) and in Class 100,000 (Grade C, ISO 8) areas in both aseptic and non-aseptic manufacturing and testing operations. Features and Benefits:

• Reduced exterior garment contamination while donning gowns

• Reduced time in gowning as no end user folding is required • Reduced training time • Reduced and less frequent re-qualification time periods • Soft comfortable material blends that are excellent in barrier

capabilities • Lowest particulate and shedding features in the industry (per

HY Tumble Drum Testing) • Bound and double stitch seams assure the finest barrier • Available in a multitude of styles and sizes that range from

Small to 5XL • Premier single and double bag sterile and non-sterile

packaging • Validated to 10-6 SAL for sterility • Outer packaging is designed so stacking on shelves can be accomplished with size labels

facing outward for easy user identification. Garments are also color coded per size • 5-year validated closed package expiration dating • Each gown provides the manufacturing lot number, expiration date and reorder art

number. • Sterile product is delivered with the lot specific Certificate of Irradiation and Certificate

of Sterility.

O V E R V I E W 6

Veltek Associates, Inc. 15 Lee Boulevard Malvern, PA 19355-1234

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Section #4 CMP Clean Garment Material Blend Construction

Contamination from Personnel: We know that people are the #1 source of contamination in clean room operations. We also know that airborne microorganisms are normally dispersed into the clean room from people on skin cells. People shed one outermost layer of epithelial cells every 24 hours. This amounts to 109 cells per day. The skin cells are approximately 20 um with 7-10% under 10 um and can be whole or fragmented. A small, but significant portion of these cells (with skin microbes on them) are dispersed to the air and act as a microbe-carrying particle. Almost always, they are bacteria and are a reflection of skin flora. The average diameter of a bacteria-carrying particle is 12-14 um. People disperse approximately 1,000 bacteria carrying cells per minute. When the human body becomes overheated (sweating) this number of 1,000 bacteria carrying cells per minute can triple. These parameters were the focus of VAI in design of their material blends made for pharmaceutical and biotechnology operations. Design of the VAI CMP Material Blends: In design of the PF-1®, PF-2®, PF-3®, 1300 Mitcool® (1420 Mitcool®), 1600 Mitcool® and 1700 Mitcool® material blends, VAI knew that user comfort was the key to assuring that the garments were worn appropriately. At the same time barrier capabilities were a foremost design feature to protect the wearer and the final product. In design off the material blends in 1985, VAI utilized a 2-3 inch fiber. This was different than previous theories that used a 1/4 to 1/8 inch fiber. The problem with the small fiber was that it would easily detach and would easily degrade during terminal sterilization. This mean the gown would shed and the material barrier was compromised due to the degrading effect from irradiation. As a 2-3 inch fiber was carded and oriented, heat bonded and then subsequently coated with a proprietary VAI patented acrylic binder, the material blend became stronger and provided less shedding. At the same time the material was capable of dispelling heat generated from the body. Thus a more comfortable material blend was established that shed less and had tremendous barrier capabilities.

O V E R V I E W 7

Veltek Associates, Inc. 15 Lee Boulevard Malvern, PA 19355-1234

Tel: (610) 644-8335 Fax: (610) 610-644-8336 Web Page: http://www.sterile.com DISP-01-2008 Rev. 5/2008

Section #5 Cleanliness of the VAI CMP Material Blends:

The Institute of Environmental Sciences, in their IEST-RP-CC003.3, deems the Helmke-Yeich® Tumble Tester as the recommended method for the testing of particulate and shedding features of garments products deemed suitable for controlled environments. By this testing, all VAI CMP products demonstrated significantly lower results than any product that was tested in the marketplace. This is due to the CMP System of manufacturing which requires all products to be Cut, Manufactured and Packaged in a Class 1,000 clean room from beginning to end. Product Tested Product Make-up Size Reusable Nylon Garments Separate Coverall, Hood & Boots XL Tyvek® Coverall w/ Hood & Boots Attached XXL Veltek 1600 Mitcool Coverall w/ Hood & Boots Attached XXL Veltek 1700 Mitcool Coverall w/ Hood & Boots Attached XXXL Per the IES, RP3 testing procedure a Tumble Drum manufactured by Veltek Associates, Inc. which was electopolished both inside and outside was cleaned and was purged in a laminar flow hood until background counts measured at .5 um and larger were reduced to a standardized level for each test. The exact procedure is listed in the IEST-RP-CC003.3. The results are presented below: Product Tested Average Counts measured at .3 um .5 um >5 um Reusable Nylon Garments 10, 655 7,233 579 Tyvek® 17, 584 10,559 921 Veltek 1600 Mitcool® 1, 375 909 38 Veltek 1700 Mitcool® 975 709 31 • Accumulative Total for Reusable and Disposable Garment, Hood and Boots • Tyvek® is a registered trademark of the DuPont Corporation

Sterility of the VAI Sterile CMP Products: All DPMD sterile products are lot sterility tested. VAI sterility tests each lot by placing spore indicators (106 b. pumilis) and material swatches into each irradiation load. The spore indicators and material swatches are subsequently testing them for viability. Viability testing is conducted in accordance with the United States Pharmacopoeia (USP) <71> Sterility Tests. Once irradiation treatment has been accomplished, the spore indicators and material swatches undergo Current USP Compendia, 14 day Direct Transfer Sterility Testing Method in TSB (Trypticase Soy Broth) and Thioglycollate Media. Veltek Associates, Inc. is the only company in the industry whom sterility tests their garment products.

O V E R V I E W 8

Veltek Associates, Inc. 15 Lee Boulevard Malvern, PA 19355-1234

Tel: (610) 644-8335 Fax: (610) 610-644-8336 Web Page: http://www.sterile.com DISP-01-2008 Rev. 5/2008

Section #6 CMP Clean Garment Material Blends

The Disposable Products Manufacturing Division (DPMD) has been in existence and serving the pharmaceutical, biotechnology, semiconductor and electronics industries for over 16 years. All products are Cut, Manufactured and Packaged (CMP) in a clean room from beginning to end. DPMD manufactures a complete line of disposable protective garments that includes various styles. The following materials blends are utilized in the manufacturing of our products. PF-1 Material Blend: The PF-1 material blend is manufactured into face masks and bouffant hats. This soft, comfortable and breathable material is designed to be used in Class 100-1,000. This Rayon material, coated with VAI's patented acrylic binder has very low particulate and shedding features. The filtration efficiency or retentive properties of the material measured at 0.45 microns is 96%. This material was designed for use in semiconductor or electronic operations. PF-2 Material Blend: The PF-2 material blend is designed for pharmaceutical or biotechnology operations. The PF-2 material blend is manufactured into face masks. The soft, comfortable and breathable material blend is made of Rayon and coated with VAI's patented acrylic binder . Particulate and shedding characteristics are very low while filtration efficiency or retentive properties of the material measure at 0.45 microns is 99%. PF-3 Material Blend: The PF-3 material blend is designed as a fluids barrier. The material blend is manufactured into face masks. This soft, comfortable and breathable material blend in a two-ply rayon-polypropylene that is coated with VAI's patented acrylic binder . Particulate and shedding characteristics are very low while filtration efficiency or retentive properties of the material measure at 0.45 microns is 99%. 1300-1420 Mitcool Material Blend: The 1300 and 1420 Mitcool material blends are designed for use in Class 1,000-100,000 areas. The 1300-1420 Mitcool material blends are heat bonded polypropylene that is soft, comfortable and breathable. The material blend is manufactured into coveralls, lab coats, shoe covers and bouffant hats. Filtration efficiency or retentive properties of the material measured at 0.45 microns is 91%. The difference between a 1300 and 1400 product is the 1300 products have polyknit cuffs and pockets and the 1420 do not. 1600 Mitcool Material Blend: The 1600 Mitcool material blend is designed for use in Class 100 sterile and non-sterile areas. The 1600 Mitcool material blend is a heat bonded polypropylene that is coated with VAI's patented acrylic binder . The material blend is soft, comfortable and breathable and is single stitch sewn with bound edges. Particulate and shedding characteristics are very low while filtration efficiency or barrier retention of the material measured at 0.45 microns is 99%. The material blend is manufactured into coveralls, lab coats, hoods, sleeves, and mid calf boots. This material blend is the most widely use sterile gowning material used in aseptic manufacturing operations. 1700 CleanBlend Material Blend: The 1700 CleanBlend material blend is designed for use in either Class 100 (sterile and non-sterile) or as a personal protection garment. The 1700 CleanBlend material blend is a heat bonded polypropylene that is laminated with VAI's patented laminate binding material The material blend is soft and comfortable and is single stitch sewn with bound edges. Particulate and shedding characteristics are very low while filtration efficiency or barrier retention of the material measured at 0.45 microns is 100%. The material blend is manufactured into coveralls, lab coats, hoods, sleeves, and mid calf boots. This material blend is most widely used as a personal protection gown as it has excellent chemical resistance to a variety of agents.

O V E R V I E W 9

Veltek Associates, Inc. 15 Lee Boulevard Malvern, PA 19355-1234

Tel: (610) 644-8335 Fax: (610) 610-644-8336 Web Page: http://www.sterile.com DISP-01-2008 Rev. 5/2008

Section #7: Manufacturing Process:

Fibers Carded andOriented andMaterial BlendManufacturedinto Roll Goods

Heat BondedAcrylic Latex Binder

Lot Traced

Material on Rollis Slit and doublebag packed in 60"rolls.

Lot Traced

Incoming Inspectionof MaterialBlend

Sampled/TestedQC Released

Material By Lot isCut, Manufacturedand Packagedinto Final Product

Class 10,000-100Lot TracedQA InspectedHelmke-YeichTumble Test/Lot

Sterile Productsent to Irradiator

Validated Cycle(AMMI)

cGMP Audited

Cert. of IrradiationDosimetry Record

Returned IrradiatedSterile Product is:

Material Swatches andBI (b. pumulis @ 10 )are placed into each lotand sterility tested aftergamma radiation(14-day direct)

QA Inspected andReleased

6

1 2 3

456

Batch Formula

O V E R V I E W 10

Veltek Associates, Inc. 15 Lee Boulevard Malvern, PA 19355-1234

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Section #8: PF Face Mask Styles:

The PF Face Masks provide excellent barrier capabilities. The PF Face Masks are soft, cool and comfortable and eliminate goggle fogging. Available in many styles presented below, the PF Face Masks are the choice of many pharmaceutical, biotechnology, semi-conductor and electronic organizations. Choosing a Material Blend: PF-1 is used in semi-conductor and electronic applications. PF-2 is used in pharmaceutical and biotechnology operations as a sterile mask. PF-3 is used as a personal protection where transmittal of fluids are problematic. Choosing a Packaging Option: All VAI PF Face Masks are available both sterile and non-sterile. All sterile products are packaged individually per mask, and are lot coded during manufacturing and sterilization (sterile documentation accompanies all orders). Please contact VAI Customer service for the over 100 packaging options. Ordering Instructions are presented on the last page of the DPMD section. Choosing a PF Style:

O V E R V I E W 11

Veltek Associates, Inc. 15 Lee Boulevard Malvern, PA 19355-1234

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Section #9: CMP Garment Styles:

The CMP Garments provide excellent barrier capabilities. The CMP Garment products are soft, cool and comfortable and reduce user discomfort. Available in many styles presented below, the CMP Garments are the choice of many pharmaceutical, biotechnology, semi-conductor and electronic organizations. Choosing a Material Blend: 1300 Mitcool is a material used in Class 1,000-100,000 non-sterile operations (replaces 1420 Mitcool). 1600 is used in Class 100 sterile and non-sterile operations. 1700 Mitcool is used as a product and personal protection gown where a 100% barrier is required. 1700P Easy2Gown Mitcool is the as the 1700 material with the added feature of the special fold.

Easy2Gown System utilizes the 1700 Mitcool material blend. The patent pending Easy2Gown fold includes bound seams and double stitch sewing. Easy2Gown Systems are available for use in Class 100-10,000 sterile and non-sterile operations. Choosing a Packaging Option: All VAI CMP Garments are available both sterile and non-sterile. All sterile products are packaged individually per garment, and are lot coded during manufacturing and sterilization (sterile documentation accompanies all orders). Please contact VAI Customer service for the over 100 packaging options. Ordering Instructions are presented on the last page of the DPMD section. Choosing a CMP Garment Style:

O V E R V I E W 12

Veltek Associates, Inc. 15 Lee Boulevard Malvern, PA 19355-1234

Tel: (610) 644-8335 Fax: (610) 610-644-8336 Web Page: http://www.sterile.com DISP-01-2008 Rev. 5/2008

O V E R V I E W 13

Veltek Associates, Inc. 15 Lee Boulevard Malvern, PA 19355-1234

Tel: (610) 644-8335 Fax: (610) 610-644-8336 Web Page: http://www.sterile.com DISP-01-2008 Rev. 5/2008

Section #10: CMP Clean Garments

Material Blend Specifications

O V E R V I E W 14

Veltek Associates, Inc. 15 Lee Boulevard Malvern, PA 19355-1234

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PF Facial Barrier Material 1 of 2

Specifications: PF-1 PF-2 PF-3

Electronic Class 100 Aseptic Class 100 Fluids Barrier Ingredients:

Fibers: 100% Rayon 100% Rayon 100% Rayon

Staple Cellulose Staple Cellulose Staple Cellulose

Two Ply- PF-2 & 1420

Fiber Testing: FDA Approved FDA Approved FDA Approved

Skin-Food Skin-Food Skin-Food

Fiber Length 1-2 inches 1-2 inches 1-2 inches

Binder: Non-ionic Acrylic Non-ionic Acrylic Non-ionic Acrylic

Cayalyst: USP Amoninum USP Amoninum USP Amoninum

Nitate Solution Nitate Solution Nitate Solution

Physical Properties:

Color: White White White

Tensile Strength: 10.7 lb/in MD Dry 10.7 lb/in MD Dry 10.7 lb/in MD Dry

Weight: 1.5 oz./sq. yd 2.0 oz./sq. yd 1.5 oz./sq. yd

Construction: Carded/Oriented Carded/Oriented Carded/Oriented

Absorbancy: Capacity 545% w/w Capacity 545% w/w Capacity 545% w/w

Particle Charge: Non-Ionic Non-Ionic Non-Ionic

Chemical Analysis (Water Extractables):

Sodium: Sodium Free Sodium Free Sodium Free

2.4 ppm/sq. ft. 2.4 ppm/sq. ft. 2.4 ppm/sq. ft.

Total Heavy Metals: 0.24 ppm/sq. ft. 0.24 ppm/sq. ft. 0.24 ppm/sq. ft.

Chlorine: 0.32 ppm/sq.ft 0.32 ppm/sq.ft 0.32 ppm/sq.ft

Amonium Nitrate: Not measureable Not measureable Not measureable

O V E R V I E W 15

Veltek Associates, Inc. 15 Lee Boulevard Malvern, PA 19355-1234

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PF Facial Barrier Materials 2 of 2

DOP Testing: (DOP testing conducted with an initial challenge of 10,000 particles @ 0.5 microns. Measurements below are at 0.5 um. )

Outside to Inside: 10 5 10

Inside to Outside: 11 5 11

Seam out to Seam in: No Seam No Seam No Seam

Seam in to Seam out: No Seam No Seam No Seam

Velocity Measured 300 220-235 300

Bacterial Retention: Bacterial testing conducted with an initial challenge of 10 eu3 of Staphylococcus aureus. Measurements in percentage retention from the challenge level

Test A: 53.90% 98.00% 99.00%

Test B: 56.00% 99.00% 99.00%

Test C: 60.10% 98.00% 99.00%

Helmke Tumble Drum:

Test Performed On: PF-1F-E PF-2-SM-2 PF-1F-E

5.0 um and larger 0 0 0

2.0 um and larger 0 0 0

1.0 um and larger 1 1 1

0.5 um and larger 32 36 51

Material Made into:

Facial Barriers YES YES YES

Garments NO NO NO

Wipers YES YES NO

Bouffant Hats YES YES NO

Material Used for: Class 100 Electronic Class 100 Aseptic Fluids Barrier

O V E R V I E W 16

Veltek Associates, Inc. 15 Lee Boulevard Malvern, PA 19355-1234

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Garment Material 1 of 2

Specifications: 1300 Mitcool 1600 Mitcool 1700 Mitcool Class 10,000 Aseptic Class 100 Protection Barrier General Use

Ingredients:

Fibers: Polypropylene Coated Polypropylene Laminated Polypropylene Fiber Testing: FDA Approved FDA Approved FDA Approved

Skin-Food Skin-Food Skin-Food

Fiber Length Continuous Continuous Continuous

Binder: Heat Heat-acrylic Heat Laminate Cayalyst: None None None

Physical Properties:

Color: White White White Tensile Strength: 21.4 lb/in MD Dry 21.4 lb/in MD Dry 26.4 lb/in MD Dry Weight: 1.25 oz./sq. yd 2.0 oz./sq. yd 2.5 oz./sq. yd Construction: Carded/Oriented Carded/Oriented Carded/Oriented Absorbancy: 20% w/w 20% w/w 10% w/w Particle Charge: Positive Positive Positive

Chemical Analysis (Water Extractables):

Sodium: Sodium Free Sodium Free Sodium Free

2.4 ppm/sq. ft. 2.4 ppm/sq. ft. 2.4 ppm/sq. ft.

Total Heavy Metals: 0.24 ppm/sq. ft. 0.24 ppm/sq. ft. 0.24 ppm/sq. ft. Chlorine: 0.32 ppm/sq.ft 0.32 ppm/sq.ft 0.32 ppm/sq.ft Amonium Nitrate: Not measureable Not measureable Not measureable

DOP Testing: (measured at 0.5 um)

Outside to Inside: 35 4 1 Inside to Outside: 28 3-4 1 Seam out to Seam in: 57-60 5-7 1 Seam in to Seam out: 58 5-7 1 Velocity Measured 300-320 275 90

O V E R V I E W 17

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Garment Material 2 of 2 Bacterial Retention: (measured at 0.45 um)

Test A: 25.00% 98.00% 100.00% Test B: 20.00% 98.20% 100.00% Test C: 28.00% 99.00% 100.00%

Helmke Tumble Drum:

Test Performed On: 1420-E-XXXL 1600-EHB-XXXL 1700-EHB-XXXL 5.0 um and larger 0 0 0 2.0 um and larger 5 1 2 1.0 um and larger 105 32 21 0.5 um and larger 4445 1270 1110

Material Made into:

Facial Barriers NO NO NO Garments YES YES YES Wipers NO NO NO Bouffant Hats YES YES NO

Material Used for: Class 10,000 Class 100 Aseptic Protection Applications

O V E R V I E W 18

Veltek Associates, Inc. 15 Lee Boulevard Malvern, PA 19355-1234

Tel: (610) 644-8335 Fax: (610) 610-644-8336 Web Page: http://www.sterile.com DISP-01-2008 Rev. 5/2008

Section #11 Customization and Availability

of VAI CMP Products:

Customization

Veltek Associates, Inc. believes customization of products to meet the demands of clean room operations is a mandatory option that must be offered. As VAI is the manufacturer, all one has to do is ask and a design will be configured to meet the end-user’s needs.

Availability Veltek Associates, Inc.’s Inventory Management System requires a minimum of 3 months supply that is in excess of outstanding orders to be warehoused and released for sale. Veltek Associates, Inc. suggests the use of a blanket or standing order as one’s product supply becomes secured at VAI. This also assists VAI in evaluating requirements of the future.

O V E R V I E W 19

Veltek Associates, Inc. 15 Lee Boulevard Malvern, PA 19355-1234

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Section #12 Ordering CMP Clean Garments

Veltek Hoods

Order Number Description Size Sterile/Non-Sterile Qty/Cs1600H-EO-1651 1600 Mitcool Hood, Eye Openings S/M Non-Sterile 1001600H-EO-1652 1600 Mitcool Hood, Eye Openings L/XL Non-Sterile 1001600H-EO-1653 1600 Mitcool Hood, Eye Openings XXL/XXXL Non-Sterile 1001600H-EO-S-1654 1600 Mitcool Hood, Eye Openings S/M Sterile 1001600H-EO-S-1655 1600 Mitcool Hood, Eye Openings L/XL Sterile 1001600H-EO-S-1656 1600 Mitcool Hood, Eye Openings XXL/XXXL Sterile 1001600H-UC-1657 1600 Mitcool Hood, Under Chin S/M Non-Sterile 1001600H-UC-1658 1600 Mitcool Hood, Under Chin L/XL Non-Sterile 1001600H-UC-1659 1600 Mitcool Hood, Under Chin XXL/XXXL Non-Sterile 1001600H-UC-S-1660 1600 Mitcool Hood, Under Chin S/M Sterile 1001600H-UC-S-1661 1600 Mitcool Hood, Under Chin L/XL Sterile 1001600H-UC-S-1662 1600 Mitcool Hood, Under Chin XXL/XXXL Sterile 1001700H-UC-S-1732 1700 Hood, Under Chin S/M Sterile 1001700H-UC-S-1733 1700 Hood, Under Chin L/XL Sterile 1001700H-UC-S-1734 1700 Hood, Under Chin XXL/XXXL Sterile 100

XXXX-H-UC-S-XXXX XXXX-H-EO-XXXX XXXX-H-OC-XXXX

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Veltek Masks

Order Number Description Size Sterile/Non-Sterile Qty/CsPF-2F-T-4-2010 Flat Mask with 4 Ties S Non-Sterile 500PF-2F-T-4-2011 Flat Mask with 4 Ties L Non-Sterile 500PF-2F-T-4-S-2012 Flat Mask with 4 Ties S Sterile 500PF-2F-T-4-S-2013 Flat Mask with 4 Ties M Sterile 500PF-2F-T-4-S-2014 Flat Mask with 4 Ties L Sterile 500PF-2F-T-4-S-2015 Flat Mask with 4 Ties XL Sterile 500PF-2SM-T-4-S-2020 Surgical Mask with 4 Ties One Size Non-Sterile 500PF-2SM-T-4-S-2021 Surgical Mask with 4 Ties One Size Sterile 500PF-2SM-2-S-2025 Surgical Mask with 2 Elastics One Size Sterile 500PF-2SM-2-S-2028 Surgical Mask with 2 Elastics (extra long nosepiece) One Size Sterile 500PF-2SM-2-S-2026 Surgical Mask with 2 Elastics (extra long nosepiece) One Size Sterile 500PF-2SM-2-2027 Surgical Mask with 2 Elastics (extra long nosepiece) One Size Non-Sterile 500

PF-2SM-2-S-2026 PF-2SM-T-4-S-2021

O V E R V I E W 21

Veltek Associates, Inc. 15 Lee Boulevard Malvern, PA 19355-1234

Tel: (610) 644-8335 Fax: (610) 610-644-8336 Web Page: http://www.sterile.com DISP-01-2008 Rev. 5/2008

Veltek Boots

Order Number Description Size Sterile/Non-Sterile Qty/Cs 150-SC-1501 1420 Mitcool Shoecovers Low Cut One Size Non-Sterile 150 Pair 150-SC-NS-1502 142 Mitcool Shoecover Low Cut Non-Skid Sole S/M Non-Sterile 125 Pair 150-SC-NS-1503 1420 Mitcool Shoecovers Low Cut Non-Skid Sole L/XL Non-Sterile 125 Pair 150-SC-NS-1504 1420 Mitcool Shoecovers Low Cut Non-Skid Sole XXL/XXXL Non-Sterile 125 Pair 150-SC-NS-1512 1420 Mitcool Shoecovers Low Cut Non-Skid Sole S/M Non-Sterile 125 Pair 150MC-1505 1420 Mitcool Shoecovers Standard S/M Non-Sterile 100 Pair 150MC-1506 1420 Mitcool Shoecovers Standard L/XL Non-Sterile 100 Pair 150MC-1507 1420 Mitcool Shoecovers Standard XXL/XXXL Non-Sterile 100 Pair 150MC-NS-1508 1420 Mitcool Shoecovers Non-Skid Sole S/M Non-Sterile 100 Pair 150MC-NS-1509 1420 Mitcool Shoecovers Non-Skid Sole L/XL Non-Sterile 100 Pair 150MC-NS-1510 1420 Mitcool Shoecovers Non-Skid Sole XXL/XXXL Non-Sterile 100 Pair 1600MC-NS-1663 1600 Mitcool Mid-Calf Boots Non-Skid Sole S/M Non-Sterile 50 Pair 1600MC-NS-1664 1600 Mitcool Mid-Calf Boots Vinyl Sole L/XL Non-Sterile 50 Pair 1600MC-NS-1665 1600 Mitcool Mid-Calf Boots Vinyl Sole XXL/XXXL Non-Sterile 50 Pair 1600MC-NS-S-1666 1600 Mitcool Mid-Calf Boots Non-Skid Sole S/M Sterile 50 Pair 1600MC-NS-S-1667 1600 Mitcool Mid-Calf Boots Non-Skid Sole L/XL Sterile 50 Pair 1600MC-NS-S-1668 1600 Mitcool Mid-Calf Boots Non-Skid Sole XXL/XXXL Sterile 50 Pair 1700-MC-NS-1780 1700 Mitcool Mid-Calf Boots Non-Skid Sole M Non-Sterile 50 Pair 1700-MC-NS-S-1789 1700 Mitcool Mid-Calf Boots Non-Skid Sole S/M Sterile 50 Pair 1700-MC-NS-S-1790 1700 Mitcool Mid-Calf Boots Non-Skid Sole L/XL Sterile 50 Pair 1700-MC-NS-S-1791 1700 Mitcool Mid-Calf Boots Non-Skid Sole XXL/XXXL Sterile 50 Pair 1700P-MC-NS-S-1718 Easy2Gown Mid-Calf Non-Skid Sole S/M Sterile 50 Pair 1700P-MC-NS-S-1719 Easy2Gown Mid-Calf Non-Skid Sole L/XL Sterile 50 Pair 1700P-MC-NS-S-1720 Easy2Gown Mid-Calf Non-Skid Sole XXL/XXXL Sterile 50 Pair

150MC-XXXX 150MC-NS-XXXX XXXX-MC-NS-XXXX

O V E R V I E W 22

Veltek Associates, Inc. 15 Lee Boulevard Malvern, PA 19355-1234

Tel: (610) 644-8335 Fax: (610) 610-644-8336 Web Page: http://www.sterile.com DISP-01-2008 Rev. 5/2008

Veltek Garments

Order Number Description Size Sterile/Non-Sterile Qty/Cs1300-LC-1301 1300 Mitcool Lab Coat S Non-Sterile 251300-LC-1302 1300 Mitcool Lab Coat M Non-Sterile 251300-LC-1303 1300 Mitcool Lab Coat L Non-Sterile 251300-LC-1304 1300 Mitcool Lab Coat XL Non-Sterile 251600-E-1601 1600 Mitcool Coverall, EW, EA, MC S Non-Sterile 251600-E-1602 1600 Mitcool Coverall, EW, EA, MC M Non-Sterile 251600-E-1603 1600 Mitcool Coverall, EW, EA, MC L Non-Sterile 251600-E-1604 1600 Mitcool Coverall, EW, EA, MC XL Non-Sterile 251600-E-1605 1600 Mitcool Coverall, EW, EA, MC XXL Non-Sterile 251600-E-1606 1600 Mitcool Coverall, EW, EA, MC XXXL Non-Sterile 251600-E-1685 1600 Mitcool Coverall, EW, EA, MC 5XL Non-Sterile 251600-E-S-1607 1600 Mitcool Coverall, EW, EA, MC S Sterile 251600-E-S-1608 1600 Mitcool Coverall, EW, EA, MC M Sterile 251600-E-S-1609 1600 Mitcool Coverall, EW, EA, MC L Sterile 251600-E-S-1610 1600 Mitcool Coverall, EW, EA, MC XL Sterile 251600-E-S-1611 1600 Mitcool Coverall, EW, EA, MC XXL Sterile 251600-E-S-1612 1600 Mitcool Coverall, EW, EA, MC XXXL Sterile 251600-E-S-1687 1600 Mitcool Coverall, EW, EA, MC 5XL Sterile 251600-EHB-1625 1600 Mitcool Coverall, EW, EA, Hood/Boots S Non-Sterile 251600-EHB-1626 1600 Mitcool Coverall, EW, EA, Hood/Boots M Non-Sterile 251600-EHB-1627 1600 Mitcool Coverall, EW, EA, Hood/Boots L Non-Sterile 251600-EHB-1628 1600 Mitcool Coverall, EW, EA, Hood/Boots XL Non-Sterile 251600-EHB-1629 1600 Mitcool Coverall, EW, EA, Hood/Boots XXL Non-Sterile 251600-EHB-1630 1600 Mitcool Coverall, EW, EA, Hood/Boots XXXL Non-Sterile 251600-EHB-S-1631 1600 Mitcool Coverall, EW, EA, Hood/Boots S Sterile 251600-EHB-S-1632 1600 Mitcool Coverall, EW, EA, Hood/Boots M Sterile 251600-EHB-S-1633 1600 Mitcool Coverall, EW, EA, Hood/Boots L Sterile 251600-EHB-S-1634 1600 Mitcool Coverall, EW, EA, Hood/Boots XL Sterile 251600-EHB-S-1635 1600 Mitcool Coverall, EW, EA, Hood/Boots XXL Sterile 251600-EHB-S-1636 1600 Mitcool Coverall, EW, EA, Hood/Boots XXXL Sterile 251600-EHB-S-1686 1600 Mitcool Coverall, EW, EA, Hood/Boots 5XL Sterile 25

1600-EHB-S-1687 1600 Mitcool Coverall, EW, EA, Hood/Boots, (extra long sleeves) XXL Sterile 25

1600-EHB-S-1688 1600 Mitcool Coverall, EW, EA, Hood/Boots, (extra long sleeves)

5XL Long Sterile 20

XXXX-EH-S-XXXX XXXX-E-S-XXXX XXXX-EB-S-XXXX XXXX-EHB-S-XXXX

O V E R V I E W 23

Veltek Associates, Inc. 15 Lee Boulevard Malvern, PA 19355-1234

Tel: (610) 644-8335 Fax: (610) 610-644-8336 Web Page: http://www.sterile.com DISP-01-2008 Rev. 5/2008

Order Number Description Size Sterile/Non-Sterile Qty/Cs

1600-EHB-S-1689 1600 Mitcool Coverall, EW, EA, Hood/Boots, (extra long sleeves)

3XL Long Sterile 20

1600-LC-1637 1600 Mitcool Labcoat, EW, MC S Non-Sterile 251600-LC-1638 1600 Mitcool Labcoat, EW, MC M Non-Sterile 251600-LC-1639 1600 Mitcool Labcoat, EW, MC L Non-Sterile 251600-LC-1640 1600 Mitcool Labcoat, EW, MC XL Non-Sterile 251600-LC-1641 1600 Mitcool Labcoat, EW, MC XXL Non-Sterile 251600-LC-1642 1600 Mitcool Labcoat, EW, MC XXXL Non-Sterile 251600-LC-S-1643 1600 Mitcool Labcoat, EW, MC S Sterile 251600-LC-S-1644 1600 Mitcool Labcoat, EW, MC M Sterile 251600-LC-S-1645 1600 Mitcool Labcoat, EW, MC L Sterile 251600-LC-S-1646 1600 Mitcool Labcoat, EW, MC XL Sterile 251600-LC-S-1647 1600 Mitcool Labcoat, EW, MC XXL Sterile 251600-LC-S-1648 1600 Mitcool Labcoat, EW, MC XXXL Sterile 251700-E-1747 1700 Mitcool Coverall, EW, EN L Non-Sterile 251700-E-1748 1700 Mitcool Coverall, EW, EN XL Non-Sterile 251700-E-1749 1700 Mitcool Coverall, EW, EN XXL Non-Sterile 251700-E-1750 1700 Mitcool Coverall, EW, EN XXXL Non-Sterile 251700-E-1756 1700 Mitcool Coverall, EW, EN 5XL Non-Sterile 251700-E-1762 1700 Mitcool Coverall, EW, EN XL Non-Sterile 251700-E-1764 1700 Mitcool Coverall, EW, EN 6XL Non-Sterile 251700-E-S-1726 1700 Mitcool Coverall, EW, EN S Sterile 251700-E-S-1727 1700 Mitcool Coverall, EW, EN M Sterile 251700-E-S-1728 1700 Mitcool Coverall, EW, EN L Sterile 251700-E-S-1729 1700 Mitcool Coverall, EW, EN XL Sterile 251700-E-S-1730 1700 Mitcool Coverall, EW, EN XXL Sterile 251700-E-S-1731 1700 Mitcool Coverall, EW, EN XXXL Sterile 251700-EHB-1753 1700 Mitcool Coverall, EW, EA, Hood/Boots XL Non-Sterile 251700-EHB-1754 1700 Mitcool Coverall, EW, EA, Hood/Boots 4XL Non-Sterile 251700-EHB-1755 1700 Mitcool Coverall, EW, EA, Hood/Boots XXXL Non-Sterile 251700-EHB-1756 1700 Mitcool Coverall, EW, EA, Hood/Boots XXL Non-Sterile 251700-EHB-1760 1700 Mitcool Coverall, EW, EA, Hood/Boots XXL Non-Sterile 251700-EHB-1761 1700 Mitcool Coverall, EW, EA, Hood/Boots 5XL Non-Sterile 251700-EHB-1763 1700 Mitcool Coverall, EW, EA, Hood/Boots 6XL Non-Sterile 251700-EHB-S-1735 1700 Mitcool Coverall, EH, Boots S Sterile 251700-EHB-S-1736 1700 Mitcool Coverall, EH, Boots M Sterile 251700-EHB-S-1737 1700 Mitcool Coverall, EH, Boots L Sterile 251700-EHB-S-1738 1700 Mitcool Coverall, EH, Boots XL Sterile 251700-EHB-S-1739 1700 Mitcool Coverall, EH, Boots XXL Sterile 251700-EHB-S-1740 1700 Mitcool Coverall, EH, Boots XXXL Sterile 251700-LC-1742 1700 Mitcool Labcoat L Non-Sterile 251700-LC-1743 1700 Mitcool Labcoat XL Non-Sterile 251700-LC-1744 1700 Mitcool Labcoat XXL Non-Sterile 251700-LC-S-1721 1700 Mitcool Labcoat M Sterile 251700-LC-S-1722 1700 Mitcool Labcoat L Sterile 251700-LC-S-1723 1700 Mitcool Labcoat XL Sterile 251700-LC-S-1724 1700 Mitcool Labcoat XXL Sterile 251700P-E-S-17000 Easy2Gown Coverall EW, EA S Sterile 25

O V E R V I E W 24

Veltek Associates, Inc. 15 Lee Boulevard Malvern, PA 19355-1234

Tel: (610) 644-8335 Fax: (610) 610-644-8336 Web Page: http://www.sterile.com DISP-01-2008 Rev. 5/2008

Order Number Description Size Sterile/Non-Sterile Qty/Cs1700P-E-S-17001 Easy2Gown Coverall EW, EA M Sterile 251700P-E-S-17002 Easy2Gown Coverall EW, EA L Sterile 251700P-E-S-17003 Easy2Gown Coverall EW, EA XL Sterile 251700P-E-S-17004 Easy2Gown Coverall EW, EA XXL Sterile 251700P-E-S-17005 Easy2Gown Coverall EW, EA XXXL Sterile 251700P-E-S-17006 Easy2Gown Coverall EW, EA 4XL Sterile 251700P-E-S-17007 Easy2Gown Coverall EW, EA 5XL Sterile 251700P-EHB-S-17008 Easy2Gown Coverall Elastic Hood & Boots S Sterile 251700P-EHB-S-17009 Easy2Gown Coverall Elastic Hood & Boots M Sterile 251700P-EHB-S-17010 Easy2Gown Coverall Elastic Hood & Boots L Sterile 251700P-EHB-S-17011 Easy2Gown Coverall Elastic Hood & Boots XL Sterile 251700P-EHB-S-17012 Easy2Gown Coverall Elastic Hood & Boots XXL Sterile 251700P-EHB-S-17013 Easy2Gown Coverall Elastic Hood & Boots XXXL Sterile 251700P-EHB-S-17014 Easy2Gown Coverall Elastic Hood & Boots 4XL Sterile 251700P-EHB-S-17015 Easy2Gown Coverall Elastic Hood & Boots 5XL Sterile 25