Document wKRgGM72KaabrB2go2a0QBx43

Fluororesin products for various pharmaceutical and pharmaceutical intermediate manufacturing processes Lining tank (PTFE), lining piping (PTFE, PFA), lining valve (PTFE, PFA), insertion tube (PTFE, PFA), gasket (PTFE), bellows (PTFE, PFA) Flexible hose (PTFE, PFA), pliable hose (PTFE, PFA) PFAS used in the products is PTFE and PFA, which are polymer materials, and there is no concern about exposure, leakage, or environmental release of eluates. (Reference: SDS of PTFE in Daikin Industries, SDS of PFA in Daikin Industries) This product is to be used under the following conditions. Subject to use: Piping, storage, and reaction systems in the manufacturing process of various pharmaceuticals and pharmaceutical intermediates. Wetted parts Fluid to be used: The medicines themselves are diverse and cannot be identified. Usage Environment: RT180 Use Conditions: Not to be affected by fluids in the use environment and no leakage. No elution of metal ions in chemicals Not to contaminate medicines. Due to batch production, it must have excellent cleaning properties after manufacturing Due to batch production, many different products are manufactured on the same line. For this reason, chemical resistance to various chemicals is required. Required to meet the above specification conditions, and no perfect alternative product is considered to be available at this time, (Reference:Kogyo Chosakai Publishing Co., Ltd. Plastic Data Handbook, VALQUA Handbook Technical Section As mentioned above, the presence of Fluororesin products is essential for chemicals used in various pharmaceutical and pharmaceutical intermediate manufacturing processes We propose a regulatory exemption for the above reasons. Attachment 1: PTFE Safety Date Sheet Safety data sheet Page 1/6 Printing date 06.02.2023 Version number 1 Revision: 06.02.2023 SECTION I: Identification of the substance/mixture and of the company/undertaking 1.1 Product identifier Trade name: POLYFLON PTFE M-12, 18, 18F, 391S, 392, 393 Article number: M 1.2 Relevant identified uses of the substance or mixture and uses advised against: No further relevant information available. 1.3 Details of the supplier of the safety data sheet Manufacturer/Supplier: DAIKIN INDUSTRIES, LTD. CHEMICALS DIVISION: OSAKA UMEDA TWIN TOWERS SOUTH 1-13-1 Umeda, Kita-ku, Osaka-shi, Osaka, 530-0001, Japan Phone: Fax: Further information obtainable from: http://www.daikin.com/ 1.4 Emerrencv telephone number: Japan: China: +86-21-34151689 South Korea: Americas: CHEMTREC (Outside US/Canada: Europe: +49-211-179 225-0 SECTION 2: Hazard identification 2.1 Classification of the substance or mixture Classification according to Regulation (EC) No 1272/2008 The substance is not classified, according to the CLP regulation. 2.2 Label elements Labelling according to Regulation (EC) No 1272/2008: Not applicable Signal word: Not applicable SECTION 3: Composition/information on ingredients Information on ingredients: CAS: 9002-84-0 Polytetrafluoroethylene SECTION 4: First aid measures 100% 4.1 Description offirst aid measures General information: Seek medical treatment. After inhalation: In case of inhaling decomposed gases: supplyfresh air and consult a doctor in case of complaints. After skin contact: Immediately wash with water and soap and rinse thoroughly. After contact with the molten product, cool rapidly with cold water. Do not pull solidified product off the skin. After eye contact: Rinse opened eyefor several minutes under running water. Consult an ophthalmologist in case of complaints. After swallowing: If symptoms persist consult a doctor. 4.2 Most important symptoms and effects, both acute and chronic: Nofurther relevant information available. 4.3 Indication of any immediate medical attention and special treatment needed: No further relevant information available. SECTION 5: Firefighting measures 5.1 Extinguishing media Suitable extinguishing agents: Usefire extinguishing methods suitablefor surrounding conditions. For safety reasons unsuitable extinguishing agents: Nofurther information available. 5.2 Special hazards arisingfrom the substance or mixture: Formation of toxic gases is possible during heating or in case offire. Attachment 2: PFA Safty Date Sheet DAIKIN Printing date 06.02.2023 Safety data sheet Version number 1 Page 1/6 Revision: 06.02.2023 SECTION I: Identification of the substance/mixture and of the company/undertaking 1.1 Product identifier Trade name: NEOFLON PFA AP-201, 202, 210, 220, 230, 201SH, 2I1SH, 215SH,221SH, 230SH, 231SH Article number: AP2 STD 1.2 Relevant identified uses of the substance or mixture and uses advised against: Nofurther relevant information available. 1.3 Details of the supplier of the safety data sheet Manufacturer/Supplier: DAIKIN INDUSTRIES, LTD. CHEMICALS DIVISION: OSAKA UMEDA TWIN TOWERS SOUTH 1-13-1 Umeda, Kita-ku, Osaka-shi, Osaka, 530-0001, Japan Phone: Fax. Further information obtainable from: http://www.daikin.com/ 1.4 EmerRencv telephone number: Japan: China: +86-21-34151689 South Korea: Americas: CHEMTREC (Outside US/Canada: Europe: +49-211-179 225-0 SECTION 2: Hazard identification 2.1 Classification of the substance or mixture Classification according to Regulation (EC) No 1272/2008 The product is not classified, according to the CLP regulation. 2.2 Label elements Labelling according to Regulation (EC) No 1272/2008: Not applicable Signal word: Not applicable SECTION 3: Composition/information on ingredients Information on ingredients: CAS: 26655-00-5 Perfluoro(alkoxy alkane) Additional information: For the wording of the listed hazard phrases refer to section 16. SECTION 4: First aid measures 100% 4.1 Description offirst aid measures General information: Seek medical treatment. After inhalation: In case of inhaling decomposed gases: supplyfresh air and consult a doctor in case of complaints. After skin contact: Immediately wash with water and soap and rinse thoroughly. After contact with the molten product, cool rapidly with cold water. Do not pull solidified product off the skin. Consult a doctor in case of complaints. After eye contact: Rinse opened eyefor several minutes under running water. Consult an ophthalmologist in case of complaints. After swallowing: If symptoms persist consult a doctor. 4.2 Most important symptoms and effects, both acute and chronic: No further relevant information available. 4.3 Indication of any immediate medical attention and special treatment needed: Nofurther relevant information available. SECTION 5: Firefighting measures 5.1 Extinguishing media Suitable extinguishing agents: Usefire extinguishing methods suitablefor surrounding conditions. For safety reasons unsuitable extinguishing agents: Nofurther information available. 5.2 Special hazards arisingfrom the substance or mixture: Formation of toxic gases is possible during heating or in case offire. Attachment 3: Chemical resistance of various resins Attachment 4: Heat resistance of various resins Attachment 5: Purity of fluororesin VALQUA Handbook Technical Section