BRAM-COR QUALITY MANUFACTURING
The experience and passion for stainless steel processing enable BRAM-COR to care for quality in each multiple effect distiller. Therefore, the construction of the SMPT follows cGMP procedures. In Parma, the location of BRAM-COR headquarters, qualified welders perform regularly BRAM-COR Sanitary Piping procedures (we use AISI 316L Stainless steel for piping and AISI 304 for the frameworks only). Non-destructive tests are performed during construction. A single tag identifies each component, engraved on metal plate, for the total traceability in the relevant technical documentation. Functional testing is ensured by automation experts, with special care for monitoring of critical parameters. Our project management includes documentation, inspection and field testing.
GMP REFERENCE STANDARDS
(data can change without notice; Bram-Cor works with current certifications)
- United States Pharmacopoeia (USP)
- European Union Pharmacopoeia (EP)
- EudraLex – The Rules Governing Medicinal Products in the European Union – Volume 4 : Good Manufacturing Practice-Medicinal Products for Human and Veterinary Use
- ISPE Guideline: “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
- 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
- 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
- ASTM A270 “Standard Specification for Seamless and Welded Austenitic Stainless Steel Sanitary Tubing”
- ASTM A269 “Standard Specification for Seamless and Welded Austenitic Stainless Steel Tubing for General Service”
- ASTM A479 “Standard Specification for Stainless Steel Bars and Shapes for Use in Boilers and Other Pressure Vessels”
- ASTM A967 “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 & SUPPORT
BRAM-COR top quality cGMP equipment are 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.
BRAM-COR worldwide network of skilled agents and our affiliated companies ensure assistance to our Clients in over 50 countries, from the very beginning of a pharmaceutical project throughout decades after start-up. BRAM-COR After Sales Dept. grants punctual and quick deliveries of spares and ongoing technical support.
