A RELIABLE PROCESS TECHNOLOGY FOR A STRONG, LASTING, EFFICIENCY.
BRAM-COR CPSG, pharmaceutical Pure Steam Generators, produce dry, saturated steam, suitable for sterilization of pharmaceutical production plants, for direct contact with active pharmaceutical ingredients, for parenteral and non-parenteral dosage form applications.
The steam, when condensed, meets USP requirements for Water for Injection. The steam is purified using centrifugal and gravity separation methods.
cGMP, ASME and PED standards are baseline criteria in BRAM-COR Pure Steam Generator design and construction: material and instruments are certificated and all welds are made by qualified welders. In detail:
– The evaporation column is designed to minimize steam speed to avoid the entrainment of water droplets, which are separated from the steam by means of a special separator.
– A Double Tube Sheet Heat Exchanger provides heating of pre-treated feed water above the boiling temperature, generating pure steam which expands into the evaporation column. Heating medium in the DTS Heat Exchanger is typically industrial steam at 100 to 120 psig (6 to 8 barg).
– Pure steam pressure is maintained by an electronic control system, modulating the supply steam control valve and monitoring the evaporator feed water.
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)