Lubricant & Releasing Spray Sterile Pharmaceutical Clean Room Formula ssil-01 Rev. 17 September 2012

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1 Lubricant & Releasing Spray ssil-01 Rev. 17 September 2012, 15 Lee Boulevard, Malvern, PA USA T: F:

2 1 of 6 PRODUCT DESCRIPTION STERI-SILICON Sterile Lubricant and Releasing Spray is another innovation from VAI to assure the use of a sterile lubricant silicone within the aseptic manufacturing area. Machinery lubrication is essential for trouble-free equipment operation during manufacturing of a product. At the same time, the use of a sterile silicone lubricant is equally important to assure environmental conditions. STERI- SILICON is colorless with excellent thermal stability and is inert. The product is specifically designed to speed processing in heat sealing, packaging and process machinery. This product is aseptically filtered, double bag packaged, and then gamma irradiated. The product is delivered each time with lot specific Certificate of Conformance, Certificate of Irradiation and Certificate of Sterility. This innovation represents another significant breakthrough for clean room operation. Product Description Filtration Filled In Flash Pt SSIL-02 Emulsion Based Silicone 0.2 µm ISO 5 ISO F (61 0 C) ORDERING INFORMATION Order# Description Quan/cs. SSIL-02 STERI-SILICON, 8 oz. Aerosol Spray Sterile 24 Available Technical Data Supplements (Upon Request) Validation: STERI-SILICON LUBE-1002

3 2 of 6 SPECIFICATIONS STERI-SILICON: CHEMICAL: CAS # OSHA PEL ACGIH TWA OTHER RANGE Aliphatic hydrocarbon n/a n/a 400 ppm 90 % Napthenic oil mg/m3 5 mg/m3 10 mg/m3 5% Carbon dioxide ,000 ppm 5,000 ppm 30,000 ppm <5 % RIGHT TO KNOW COMPOSITION: This product contains the following non-hazardous components in sufficient quantity which require identification: Polydimethylsiloxane ( ). General Product Packaging/Filling Specifications: REFRACTIVE INDEX: DENSITY: FILLING: FILTRATION: PRODUCT LOT NUMBER: IRRADIATION: CAN: PACKAGING: STERILITY TESTING: EXPIRATION: PROPELLANT: APPLICATIONS: Product is filled in ISO 5 - ISO 7 conditions. Filtration designated per product is accomplished and integrity of the filter assured by prior and post bubble point testing Product Lot Number and expiration date is placed on the bottom of each can, and on the exterior of the case. Dosage is Min: 25.0 kgy Max: 50.0 kgy Seamless Aluminum exterior wiped with sterile IPA before packaging. Product is double bagged per can in 4 mil polyethylene bags and placed into a linered case. The entire contents are irradiated. Once exposed to the validated gamma irradiation cycle, every lot undergoes 14 day current USP Direct Transfer Method in TSB (Trypticase Soy Agar) and Thioglycollate Media. 3 years from DOM for analytical and sterility. Carbon Dioxide (CO 2 ) or Liquefied Petroleum Gas (see MSDS) Spray on parts to stop squeaks, lubricate, protect and prolong life. Use on chains, rollers,

4 3 of 6 delivery chutes, hinges, latches, belts, rubber moldings, drawers and more. DIRECTIONS: DANGER: CAUTIONS: Thoroughly clean surface to be lubricated. Spray silicone lightly over area. For sticking objects, work back and forth until parts move freely. Repeat process if necessary. Keep away from heat, sparks, open flame, heated surfaces and any other source of ignition. Disconnect electrical tools and appliances before spraying. Keep away from electrical sources or battery terminals. Contents under pressure. Do not puncture, incinerate or store where temperature is above 120 degrees F/49 degrees C. Prolonged exposure to heat may cause bursting. Use only in a well ventilated area. Avoid prolonged breathing of vapors or contact with skin.

5 4 of 6 PRODUCT LABELING All product labels are available upon request.

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7 6 of 6 Lot Specific Sterile Documentation (received with each shipment) Certificate of Conformance Certificate of Sterility Certificate of Irradiation (Please contact VAI for a sample of this documentation)