BRAM-COR WATER FOR INJECTION – LOCATION & STANDARDS

BRAM-COR WFI systems work all over the world! Our project drivers are aimed at satisfying all pharmaceutical regulatory and QA requirements, aligning the WFI equipment to the international Pharmacopoeias and capitalizing upon a careful, customer-oriented project management.

To directly request information and quotations related to Bram-Cor WFI equipment, please note that we can not provide costs or other without the necessary URS from the customer (credentials and location, .. quality of water, …type of product desired, etc).

CONTACT US TO REQUEST A QUOTE

BRAM-COR GMP REFERENCE STANDARDS

• United States Pharmacopoeia (USP)
• European Union Pharmacopoeia (EP)
• EudraLex – The Rules Governing Medicinal Products in the European Union – Vol. 4: Good Manufacturing Practice-Medicinal Products for Human and Veterinary Use
• Sterile Manufacturing facilities – ISPE Guideline
• Water & steam systems – European Pharmacopoeia 8th edition USP 37 – ISPE Guideline
• Testing GXP – ISPE Guideline
• Commissioning and Qualification , Vol.5 – ISPE Guideline
• Commissioning and Qualification of Water and Steam Systems – ISPE Guideline
• Approaches to Commissioning and Qualification of Water and Steam Systems, 2014 – ISPE Guideline
• Calibration Management, 2nd Ed. 2010 – ISPE Guideline
• 2006/42/CE European Directive for Machinery
• 2014/68/UE Eur. Directive for Pressure Vessels (repl. PED 97/23/CE)
• ASME BPVC Boiler and Pressure Vessel Code – S / U stamp certified
• GAMP 5: “A risk-based approach to compliant GXP computerized systems”
• CFR 21 Part 11: FDA guideline for electronic records and electronic signatures
• ASME BPE “Bioprocessing Equipment”
• UNI EN 9606:2013 – “Qualification of welders” – Manual welding
• UNI EN 14732:2013 “Qualification of welders” – Automatic welding
• A270 ASTM – “Standard Specification for Seamless and Welded Austenitic Stainless Steel Sanitary Tubing
• A269 ASTM – “Standard Specification for Seamless and Welded Austenitic Stainless Steel Tubing for General Service
• A479 ASTM “Standard Spec. for Stainless Steel Bars and Shapes for Use in Boilers and Other Pressure Vessels”
• A967 ASTM – “Standard Specification for Chemical Passivation Treatments for Stainless Steel Parts”
• CEI EN 60204-1:“Electrical safety of machinery”
• IEC 1131-1: “Programmable Controllers – General Information”
• UNI 10893: “Technical Documentation of Product”
• UNI EN 10204: “Metallic products – type of inspection documents”
• ASTM C-795 “Standard Specification for Thermal Insulation for Use in Contact with Austenitic Stainless Steel”
• UNI 5634 “Identification of piping for fluids”
• ASTM A380 “Standard Practice for Cleaning, Descaling, and Passivation of Stainless Steel Parts, Equipment and Systems”
• EN 285 “Sterilization, steam sterilizers, large sterilizers (related to Bram-Cor CPSG/Pure Steam Generator)

FULL SERVICE & FULL SUPPORT

Moreover, top quality cGMP equipment from BRAM-COR is integrated through a proper high level of professional services including: Technical Documentation, Factory Acceptance Test, Installation, Commissioning, Site Acceptance, Test& Start-up, Training, Validation, After Sales Service.

As a result, most our businesses is with long term Clients; a close partnership with our Customer is therefore the core of our work philosophy. Thus, the direct contact with the End User ensures full commitment in any long term relationship.

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