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2 2 TECHNICAL BULLETIN STERalloy FDG - FOOD & DRUG GRADE LIQUID MOLDING POLYMER ALLOYS - STERalloy FDG is the first Liquid Molding Polymer Alloy Series that has been specifically designed for food and drug applications. All of the products in the STERalloy FDG Series exhibit unique physical and chemical properties, are manufactured with FDA approved material, and have been used in countless applications where FDA approval is required. STERalloy FDG Series fills the high current demand for products that are used in food and drug applications. KEY ADVANTAGES: Manufactured using FDA approved materials Wide range of hardnesses Very high physical properties ROHS compliant Moisture insensitive Easy to use The food, drug, pharmaceutical, wine, beer, juice, dairy, hospital equipment, and prosthetic industries are just some examples of applications that require special products such as STERalloy FDG. There are two STERalloy FDG Series: STERalloy FDG Elastomeric Series various hardness elastomers, shore 20A - 72D clear in color available in 2 speeds - fast and slow STERalloy FDG Rigid Series rigid, tough polymer alloy plastics high heat distortion high physical properties STERalloy FDG products may be customized to fine tune project/specific properties. (Please contact a Hapco Representative)

3 3 Here are just a few parts made using STERalloy FDG materials: Applications such as biomedical, pharmaceutical, surgical, food processing, hospital equipment, and anatomic models can now be market places for the Liquid Molders. Surgical - retraction claw, instrument grip, endoscope part - Food Processing - roller, food masher - Biomedical - fluid container - Test Models - bone/ligament model, knee cartilage, artery model - Ultrafiltration Applications pharmaceutical, blood, beer/wine filters and more! Clean Room Applications - filters, instruments, hardware-

4 4 STERalloy FDG 2000 SERIES Elastomeric - FOOD & DRUG GRADE LIQUID MOLDING COMPOUNDS - PHYSICAL PROPERTIES PRODUCT PROPERTIES PROPERTIES Mix Ratio by volume A:B by weight A:B Gel time C Color (cured) Hardness Shore Scale Viscosity 25 C cps Specific Gravity 25 C Shrinkage inch/inch See shrinkage paragraph Demold 70 F 1/8 thick Weight per cubic inch (lbs.) Tensile Strength (psi) Elongation % Tear Strength (pli) Modulus of Elasticity METHOD Calculation 100: :200 D-2971 Visual D-2240 D-4878 D-4669 D-2566 HAPCO : : : : : : : : min. ± 2 5 min. ± 2 16 min. ± 2 5 min. ± 1 18 min. ± 2 5 min. ± 1 clear / translucent clear / translucent clear / translucent colorless / slightly cloudy colorless / slightly cloudy 25 A 25 A 35 A ± 5 35 A ± 5 55 A ± 5 55 A ± 5 2,500 2,500 3,000 3,000 4,500 4, hours 2-4 hours 6-8 hours 2-4 hours 4-6 hours 1-2 hours Calculation Die C Izod Impact (Ft.lbs/inch) notched D-256 unnotched Heat Distortion Temperature ( C) 66 psi 264 psi Flexural Strength (psi) Flexural Modulus D : :200 clear / translucent >1,200 >1,200 1,000 1, NA NA NA NA NA NA No Break No Break No Break No Break No Break No Break NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA Available in Flame Retardant (FR) 94V NA NA NA NA NA NA FDA Status (components may appear in one or more of these sections) Uses all FDA approved components per: CFR CFR CFR CFR NOTE: Before use, reference material handling, processing, and safety notes located at the end of this brochure.

5 STERalloy FDG 2000 SERIES Elastomeric - FOOD & DRUG GRADE LIQUID MOLDING COMPOUNDS - FOOD DRUG GRADE LIQUID MOLDING COMPOUNDS 5 PROPERTIES METHOD Mix Ratio by volume A:B by weight A:B Calculation 100:20 100:20 100:20 100:20 100:15 100:15 100:15 100:15 100:32 100:32 100:32 100:32 PHYSICAL PROPERTIES Gel time C D min. 5 min. 20 min. 5 min. 20 min. 5 min. Color (cured) Visual clear clear clear clear clear clear Hardness Shore Scale Viscosity 25 C cps Specific Gravity 25 C Shrinkage inch/inch See shrinkage paragraph D-2240 D-4878 D-4669 D A 65 A 80 A 80 A 90 A 90 A 4,000 4,000 3,000 3,000 4,000 4, min. clear 72 D 4, min. clear 72 D 4, Demold 70 F 1/8 thick HAPCO 6-12 hrs. 2-4 hrs. 5-8 hrs. 1-2 hrs. 5-8 hrs. 1-2 hrs. 1-3 hrs min. Weight per cubic inch (lbs.) Calculation Tensile Strength (psi) ,150 2,150 3,530 3,530 3,700 3,700 Elongation % Tear Strength (pli) 624 Die C PRODUCT PROPERTIES Modulus of Elasticity Izod Impact (Ft.lbs/inch) notched unnotched Heat Distortion Temperature ( C) 66 psi 264 psi Flexural Strength (psi) Flexural Modulus D-256 NA NA NA NA NA NA No Break No Break No Break No Break No Break No Break D-648 NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA NA C 44 C 2, C 44 C 2, Available in Flame Retardant (FR) 94V NA NA NA NA NA NA NA NA FDA Status (components may appear in one or more of these sections) Uses all FDA approved components per: CFR CFR CFR CFR NOTE: Before use, reference material handling, processing, and safety notes located at the end of this brochure.

6 6 STERalloy FDG 2000 SERIES Elastomeric - FOOD FOOD & DRUG DRUG GRADE GRADE LIQUID LIQUID MOLDING MOLDING COMPOUNDS COMPOUNDS - PROPERTIES Mix Ratio by volume A:B by weight A:B METHOD Calculation 100:20 100: :17 100:14 PHYSICAL PROPERTIES PRODUCT PROPERTIES Gel time C D min. 16 min. Color (cured) Visual transparent / hazy transparent / hazy Hardness Shore Scale Viscosity 25 C cps Specific Gravity 25 C D-2240 D-4878 D-4669 Shrinkage inch/inch See shrinkage paragraph D-2566 Demold 70 F 1/8 thick Weight per cubic inch (lbs.) Tensile Strength (psi) Elongation % Modulus of Elasticity Izod Impact (Ft.lbs/inch) notched unnotched Heat Distortion Temperature ( C) 66 psi 264 psi Flexural Strength psi Flexural Modulus Available in Flame Retardant (FR) FDA Status (components may appear in one or more of these sections) HAPCO 65 D 90 A 40,000 ± 5,000 50,000 ± 7, hours 2-4 hours Calculation D-256 2,000 1, No break D C 47 C No break 50 C NA 3,100 NA 63.7 NA 94V NA NA Uses all FDA approved components per: CFR CFR CFR CFR NOTE: Before use, reference material handling, processing, and safety notes located at the end of this brochure.

7 STERalloy STERalloy FDG FDG SERIES SERIES Rigid Rigid - FOOD & DRUG GRADE LIQUID MOLDING COMPOUNDS - - FOOD & DRUG GRADE LIQUID MOLDING COMPOUNDS - 7 PHYSICAL PROPERTIES PRODUCT PROPERTIES PROPERTIES Mix Ratio by volume A:B by weight A:B Gel time C Color (cured) Hardness Shore Scale Viscosity 25 C cps Specific Gravity 25 C Shrinkage inch/inch See shrinkage paragraph Demold 70 F 1/8 thick (For faster demold times contact Hapco) Weight per cubic inch (lbs.) Tensile Strength psi Elongation % Modulus of Elasticity Izod Impact (Ft.lbs/inch) notched unnotched Heat Distortion Temperature ( C) 66 psi 264 psi Flexural Strength psi Flexural Modulus Available in Flame Retardant (FR) FDA Status (components may appear in one or more of these sections) METHOD Calculation 100:20 100:18 D-2971 Visual D-2240 D-4878 D-4669 D-2566 HAPCO :15 100:15 100:20 100:20 100:22 27 min. 25 min. 25 min. 20 min. 32 min. clear / slight haze clear / slight haze clear / cloudy clear / cloudy clear / cloudy 85 D 77 D 76 D 80 D ± 3 80 D ± 3 7,500 ±500 8,500 ±1,500 9,000 ±1,500 6,700 ±1,000 30,000 ±5, hrs. or ºC 6-12 hrs. or ºC 6-12 hrs. or ºC 6-12 hrs. or ºC Calculation D-256 8,000 4,000 3,500 7,500 4, D C 94 C C 64 C C 52 C C 93 C 6-12 hrs. or ºC C 80 C 10,500 4,850 4,300 10,300 7, V NA NA NA NA NA Uses all FDA approved components per: CFR CFR CFR CFR NOTE: Before use, reference material handling, processing, and safety notes located at the end of this brochure.

8 8 PD COLOR DISPERSION SERIES OPAQUE COLOR DISPERSIONS PD-6 M RED PD-15 M ORANGE PD-3 M YELLOW In Ultralloy 206/207 PD-25 M YELLOW PD-4 M GREEN PD-9 M BROWN PD-1 M DARK BLUE PD-26 M BLUE PD-8 M LIGHT GREY PD-11 M DARK GREY PD-2 M CARBON BLACK 0.02 (2%) by weight PD-512 M BLACK OXIDE 0.02 (2%) by weight PD-7 M WHITE 0.05 (5%) by weight PD - Mix Ratio: Add 1-5% ( ) by weight to Part B, mix well. In above results, ratios were added by weight to Ultralloy 206/207 Part B, then mixed and cured. Color Dispersions are compatible with most Hapco Resin Systems except those listed under the MP Color Series. Read product list for MP Color Series. All of Hapco Color Dispersions are appropriate for standard and/or Food and Drug applications. Weigh the color additions accurately for batch to batch uniformity. The above colors may be blended to form additional colors. NOTES: All above Ratios are % added by weight to Ultralloy 206/207 Part B, then mixed and cured. Packaging Available: 1/2 pint cans, 1 quart cans, 1 gallon pails, and 5 gallon pails.

9 9 TD COLOR DISPERSION SERIES * TRANSLUCENT COLOR DISPERSIONS TD-22 M RED TD-24 M YELLOW TD 20 M VIOLET 0.005(1/2%) by weight TD-21 M ORANGE TD-23 M BLUE TD-28 M BLACK TD - Mix Ratio: Add 1/10-2% ( ) by weight to Part B, mix well. In above results, ratios were added by weight to Ultralloy 206/207 Part B, then mixed and cured. Less than 1/10% (0.001) by weight may be added to the Part B for very translucent colors, 1/2% (0.005) to 2% (0.02) may be added to Part B to form opaque colors. Color Dispersions are compatible with most Hapco Resin Systems except those listed under MP Color Series. Read product list for MP Color Series. All of Hapco Color Dispersions are appropriate for standard and/or Food and Drug applications. Weigh the color additions accurately for batch to batch uniformity. The above colors may be blended to form additional colors. NOTES: All above Ratios are % added by weight to Ultralloy 206/207 Part B, then mixed and cured. Packaging Available: 1/2 pint cans, 1 quart cans, 1 gallon pails, and 5 gallon pails. *Translucent color dispersions are not translucent in some Liquid Molding Systems. Consult your Hapco Representative for more details.

10 10 MP COLOR DISPERSION SERIES TRANSLUCENT* and OPAQUE COLOR DISPERSIONS for Hapflex 1021, 1036, , 1056, Steralloy 2021, , 2036, , 2056, Di-Pak 4021, 4036, , 4056, TD-22 MP RED TD-24 MP YELLOW TD-23 MP BLUE TD-21 MP ORANGE PD-3 MP (Opaque) YELLOW In Ultralloy 206/207 PD-7 MP (Opaque) WHITE 0.05 (5%) by weight PD-2 MP (Opaque) BLACK 0.02 (2%) by weight TD-28 MP BLACK TD - Mix Ratio: Add % by weight to Part B, mix well. Less than 1/10% or less than by weight can be added to the Part B for very translucent colors, 1/2% (0.005) - 2% (0.02) may be added to the Part B, by weight, for opaque coloring. PD - Mix Ratio: Add 1 5% ( ) by weight to Part B, mix well. Weigh the color additions accurately for batch to batch uniformity. The above colors may be blended to form additional colors. NOTES: All above Ratios are % added by weight to Ultralloy 206/207 Part B, then mixed and cured. Packaging Available: 1/2 pint cans, 1 quart cans, 1 gallon pails, and 5 gallon pails. *Translucent color dispersions are not translucent in some Liquid Molding Systems. Consult your Hapco Representative for more details.

11 11 STERALLOY MATERIAL HANDLING & SAFETY NOTES POSTCURE: Postcure Heat: F (38-80 C) for 8-24 hours. Properties increase with heat acceleration. Izod impact and heat distortion properties increase with postcure heat. The lower the temperature the longer the post-cure (8-24 hrs). It is suggested to post cure ºF and ºF. DEMOLD & CURE TIMES: Demold and final cure time can be accelerated with the addition of postcure heat F (38-79 C). To retain working life, heat the mold not the material for best results. Increasing the mold temperature to F (26-38 C) will accelerate demold and cure times by up to 50%. For full cure polymers require at least 7-10 days. Final cure for faster gel materials (3-6 minute gel) is 3-7 days. Please be aware that size and mass effect demold and cure times. Many Steralloy materials are used at 85-90ºF to lower viscosity, but gel time is reduced. The customer and geometry will ultimately determine demold time. HARDNESS NOTE: The hardness progresses more slowly in the longer working life systems. The hardness progression can be accelerated by using the faster version or by curing with mild heat. Hardness and cure progress will be retarded, slowed down, when the temperature falls below 70 F. SILICONE MOLDS: Silicone molds should be post cured overnight, hours, in an oven at 120 F (48 C). When using a tin based silicone mold, make sure the mold is open when it is in the oven during postcure. Improperly cured silicone can cause a sticky surface on E-Series Steralloy parts. This process extends mold life. STERALLOY 2700/2800 Series products may have a negative reaction to silicone rubber molds. RELEASE FOR FOOD & DRUG GRADE MATERIALS: To maintain / obtain the food and drug grade level, Steralloy must be used with GREASE-IT WAX P, GREASE-IT WAX LT, GREASE-IT II, or Grease-It FDG mold release. It is up to the customer to obtain FDA approval for the finished product. FDA STATUS OF STERALLOY PRODUCTS The FDA requires the submission of the final product made up of all its components. It is the customer s responsibility to have their final product submitted and approved from the FDA for its particular use. Hapco s Steralloy products have been successfully used to manufacture products that have passed various levels of biocompatibility testing, however, the process of submission and approval must be followed by the customer. Hapco uses ingredients that are listed in the guidelines outlined in CFR 21 as shown in the Hapco brochures. SURFACE PREPARATION TO PREVENT ADHESION: To prevent adhesion to the mold, use a GREASE-IT release agent. The following are recommended: GREASE-IT II or GREASE-IT FDG when a Food & Drug grade release is required. For best results, apply in a few thin coats, drying between coats. Porous surfaces, i.e. wood, plaster, etc, must be sealed thoroughly before release is applied. Use multiple coats of a good coating, such as: a high grade lacquer or urethane lacquer. SURFACE PREPARATION FOR ADHESION: For applications where adhesion is desired, the surface must be cleaned, abraded and dried. Sandblasting and mechanical roughing are the preferred ways of abrading surfaces to be bonded. For added adhesion to metals, use Primer 200 and for added adhesion to plastic, use Primer 810. Make sure all surfaces are clean, dry, and free from moisture. COLD TEMPERATURES: CAUTION - The STERALLOY E-2000 ELASTOMERIC SERIES Part A may freeze or crystallize in cold temperatures. Part A may appear to be striated, thicken, or solidify. This situation can easily be corrected. Place the cover loosely on the Part A (do not seal). Place in an oven set at F (51-65 C), for 3-8 hours or 8-12 hours for drums. Reseal, allow to cool and then mix thoroughly before using. CAUTION - STERALLOY 2501, 2503 and 2505 Part A may freeze or crystallize in cold temperatures. Part A may appear to be striated, thicken, or solidify. This situation can easily be corrected. Place the cover loosely on the Part A (do not seal). Place in an oven set at 100 F (38 C), for 3-8 hours or 8-12 hours for drums. Reseal, allow to cool and mix thoroughly before using. CAUTION - The STERALLOY RIGID SERIES Part A may freeze or crystallize in cold temperatures. Part A may appear to be striated, thicken, or solidify. This situation can easily be corrected. Place the cover loosely on the Part A (do not seal). Place in an oven set at 100 F (38 C), for 3-8 hours or 8-12 hours for drums. Reseal, allow to cool and then mix thoroughly before using.

12 12 MIXING: IMPORTANT: Before each use, mix Part B thoroughly before proportioning out the required amount. Components may separate and should be mixed before each use. Mix, only when ready to use, by adding the curing agent to the resin portion and blending together thoroughly. Be sure to scrape and stir in all material sticking to the sides and bottom of the mixing container. Do not use paper containers or wooden mixing sticks. They may contain moisture. For best results, use plastic or coated containers, and metal or plastic sticks. MACHINE MIXING AND DISPENSING: Use Hapco s RAPIDFIL, MINIFIL, and/or RAPIDSHOT dispensing machines for fast, reliable, and efficient mixing without the air entrapment, measuring, or mess associated with hand processing. CASTING: Pour in a thin unbroken stream into the lowest point in the cavity or mold. This will help break up some of the air entrapped during mixing. For best results, Hapco recommends meter mix dispensing, vacuum degassing and/or pressure casting at PSI. SHRINKAGE: Shrinkage or dimensional variation is largely influenced by 5 factors: 1. Mass (total volume and thickness) 2. The temperature of the material 3. Maximum temperature reached during the exotherm (reaction). The faster the gel time, the higher the exotherm, the greater the shrinkage. 4. The temperature of the mold 5. The thermal properties of the mold material.(insulator vs. Conductive) Geometry, part thickness, and total volume vary in each design, therefore, the customer is responsible to test and determine the shrinkage factor to be used. The values in the brochures are for comparative reference only, using testing procedures. AIR RELEASE: Use Hapco s ANTI-AIR to aid in air release (see Technical Bulletin). In some products, ANTI-AIR can cause a slight haze to cloudiness. This has no effect on properties. CLEAN UP: Cured polymers are difficult to remove. It is best to clean tools and equipment immediately after use. For best results use Hapco s A-TAK. STORAGE: Store both components in an area with a temperature range of F (20-32 C). Store in a dry place off of cement floors and on shelving if possible. Containers should be kept tightly closed. SHELF LIFE: The shelf life on Hapco products begins from the date of invoice for that product shipment. Hapco s shelf life only pertains to containers that are unopened and in their original condition. Once the container is opened Hapco has no control or responsibility for the shelf life. RESEALING: Many polymers are moisture sensitive, reseal, using one of the following two (2) methods: blanket with nitrogen or use a hair dryer for 30 seconds to cover with dry air. PRECAUTIONS: CAUTION: The MSDS should be read thoroughly before using this product. Skin or eye contact with any glass filler should be avoided. The use of gloves, eye protection, and face masks are strongly recommended. All polymers, as a general practice, should be used in well-ventilated areas. Spot ventilation is most effective. Contaminated clothing should be removed immediately and the skin washed with soap and water or waterless skin cleaner. Should accidental eye contact occur, wash thoroughly with water and consult a physician. The information presented here is based on carefully conducted laboratory tests and is believed to be accurate. However, results cannot be guaranteed and it is suggested that customers confirm results under their conditions and in their applications before production use. Important: Hapco Inc. makes no warranty, whether expressed or implied, including warranties of merchantability or of fitness for a particular purpose. Under no circumstances shall Hapco Inc. be liable for incidental, consequential, or other damages from alleged negligence, breach of warranty, strict liability, tort contract, or any other legal theory, arising out of the use of handling of this product. The sole remedy of purchaser and sole liability of Hapco Inc. shall be for the purchase price of the product which is the subject of the claim. 8/10/10