VAPOR COMPRESSION DISTILLER MANUFACTURING – WFI from Vapor Compression Distillation

In industrial machinery manufacturing, different terms refer to the “vapor compression distiller” (the most correct diction in relation to STMC still). For example: thermocompressor, thermocompression distiller, mechanical vapor compression or recompression system, … Technically, it is an evaporation technology used in many areas, from desalination to the separation of hydrocarbons. Also air-conditioning and refrigeration system use compressed vapor, in different ways.

set of 7 Bram-Cor STMC in construction — DEC 2019, Bram-Cor main factory, Parma (Italy). Set of seven STMC distiller in construction. It’s a formidable battery producing WFI for Large Volume Parenterals.

However, unlike all other areas, only the construction of a pharmaceutical “thermocompressor” for the production of Water for Injection claims the most extreme care. It’s due to the “purity” required throughout the transformation process, from raw water to WFI. In this page we show the BRAM-COR GMP reference standards, in supporting the quality of its STMC VC distiller.

Bram-Cor STMC Vapor Compression still — BRAM-COR STMC Vapor Compression Distiller

THERMOCOMPRESSION DISTILLER CONSTRUCTION: FULL UNDERSTANDING OF THE STAINLESS STEEL PROCESSING

The experience and passion for stainless steel processing enable BRAM-COR to care for quality in vapor compression distiller manufacturing. Therefore, the construction of each STMC distiller 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).

Welding a condenser of a Vapor Compression Still — BRAM-COR qualified and skilled welders – Welding a VC Still condenser

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.

Bram-Cor STMC - Testing a Thermal Compression still — BRAM-COR STMC – Testing a “Thermal” Compression still in Parma

Functional testing is ensured by automation experts, with special care for monitoring of critical parameters. Our project management includes documentation, inspection and field testing.

BRAM-COR STMC condenser. A detail of the mirror polished stainless steel surfaces, which reflect the tube bundle

BRAM-COR VAPOR COMPRESSION DISTILLER MANUFACTURING – GMP REFERENCE STANDARDS

– 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

BRAM-COR ASME S U stamp - Certificates — Vapor Compression Distiller Manufacturing – BRAM-COR ASME S U stamp – Certificates

– 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)

STMC vapor compression Distiller - Construction detail — BRAM-COR STMC vapor compression distiller – Construction detail

Click here to see other Bram-Cor pharmaceutical lines (water treatment, processing, filling and packaging systems).