Sterile Processes - Sterile Verfahrenstechnik

17 Qualitätssicherung / Quality Assurance Certificate Manufacturer and Welding Shop acc. to AD 2000-Code Certificate no.: 01 202 LU/A-19 0001 Name and address of the certificate holder: SISTO Armaturen S.A. 18 rue Martin Maas L-6468 Echternach Luxembourg It is hereby certified that the manufacturer has furnished proof of the quality requirements. The above-mentioned company: - has facilities permitting manufacturing and inspection in conformity with the present technical standard, - operates a quality system which guarantees that manufacturing and inspection of the products stated in our report are in conformity with the technical codes and regulations, - employees qualified supervisory and inspection personnel. Specifications: AD 2000-Merkblatt HP 0 under the Directive 2014/68/EU Annex I, Para. 3.1 Test Report no.: PRE-561508/22 Scope: Manufacturing of Pressure Equipment, see report Manufacturing Plant: see certificate holder Validity: This certificate is valid until 2025-05-31. Cologne, 2022-05-25 Dipl.-Ing. Achim Makowka Certification body for welding manufacturers ® TÜV, TUEV und TUV sind eingetragene Marken. Eine Nutzung und Verwendung bedarf der vorherigen Zustimmung. TÜV Rheinland Industrie Service GmbH Certification body for welding manufacturers Am Grauen Stein, D-51105 Cologne M-010-Rev24 www.tuv.com Certificate Standard ISO 9001:2015 Certificate Registr. No. 01 100 187121/030 Organization: KSB SE & Co. KGaA Johann-Klein-Str. 9 67227 Frankenthal (Pfalz) Germany Site: c/o SISTO Armaturen S.A. 18 Rue Martin Maas L-6468 Echternach Luxembourg Scope: Development, production, marketing and service of pumps, valves, additional components and systems Proof has been furnished by means of an audit that the requirements of ISO 9001:2015 are met. Validity: The certificate is valid in conjunction with the main certificate 01 100 187121 from 2022-07-13 until 2025-07-12. 2022-07-22 TÜV Rheinland Cert GmbH Am Grauen Stein · 51105 Köln www.tuv.com ® TÜV, TUEV and TUV are registered trademarks. Utilisation and application requires prior approval. Certificate Quality Assurance System acc. to Directive 2014/68/EU Certificate no.: 01 202 L/Q-04 0004 Name and address of the certificate holder: SISTO Armaturen S.A. 18 rue Martin Maas L-6468 Echternach Luxembourg Herewith we certify that the above -mentioned manufacturer operates a quality system according to the European Directive 2014/68/EU. The manufacturer has the permission to affix the following CE marking to pressure equipment described and manufactured in accordance to the scope covered by this QualityAssurance System: Test basis: Directive 2014/68/EU: QA-System (Module H) (the QS-Modules E1, E, D1, D are covered by Module H) Audit report no.: 01 202 L/Q-04 0004 Scope: Valves, valve actuation, elastomer and plastic technologies, surface treatment and joining technologies, see annex, 15.11.2022, Re.: 02, to certificate Manufacturing plant: see certificate holder Validity: This certificate is valid until 2025-12-31. Cologne, 2022-12-08 Dipl.-Ing. (FH) Vera Ruff www.tuv.com ® TÜV, TUEV und TUV sind eingetragene Marken. Eine Nutzung und Verwendung bedarf der vorherigen Zustimmung. TÜV Rheinland Industrie Service GmbH Notified Body for Pressure Equipment, ID-No. 0035 Am Grauen Stein, D-51105 Cologne MS-0037317 E-008-Rev01 Zulassungen FDA – Code of Federal Regulations (CFR), Titel 21, Paragraph 177.2600/177.1550 VDI2440, TRB610 – Technische Anleitung zur Reinhaltung der Luft (TA Luft 2000) USP – U.S. Pharmacopeia Guideline 87, Guideline 88 EU 1935 – Konformität gemäß Verordnung (EG) Nr. 1935/2004 ATEX – Herstellererklärung im Sinne der EG Richtlinie 2014/34/EU Approvals FDA – Code of Federal Regulations (CFR), Titel 21, Paragraph 177.2600/177.1550 VDI2440, TRB610 – Technical Instruction for Environmental Protection (TA Luft 2000) USP – U.S. Pharmacopeia Guideline 87, Guideline 88 EU 1935 – Conformity according to regulation (EC) No. 1935/2004 ATEX – Declaration by the manufacturer as defined by EC Directive 2014/34/EU 1

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