AWS AND BRAM-COR PARTNERSHIP
AWS is the exclusive North American distributor for Bram-Cor’s Water Purification Systems and Linear Filling Systems for bags and bottles. All Bram-Cor systems are designed and manufactured in accordance with cGMP regulations, completely validatable, and are suitable for use in FDA and EMA regulated facilities.
THE ROOTS OF BRAM-COR
Bram-Cor provides customized pharmaceutical equipment; our goal for design, manufacturing, documentation, testing and validation activities is the overall compliance of our equipment to the needs of the pharmaceutical and biotechnology industry. Further, we dedicate to the production of parenteral solutions for any application.
WATER PURIFICATION OVERVIEW
We design Water Purification System to produce compendial water for any pharmaceutical application. We offer a variety of equipment including: Pre-Treatment Systems, Reverse Osmosis Systems, Vapor Compression Distillers, Single or Multiple Effect Distillers, Generators and Tankage.
Our Pharmaceutical Water Systems produce compendial:
PW – Purified Water
WFI – Water for Injection
PS – Pure Steam
In this composite outlook, we give special care to the choice of sanitary materials of our equipment. Moreover, our systems feature product contact surfaces composed of certified AISI 316L SS EPDM or PTFE gaskets for perfect sealing. In addition, our Advanced Process Analytical Technologies are applied for monitoring issues and professional GAMP compliant automation is provided for system control.
Key points in our design of all processing steps, from feed water to the point of use, include:
- pre-treatment options
- critical parameter monitoring
- regulatory requirements
- consumption, microbiological control
- operation/maintenance requirements
- life-cycle costs.
PRODUCING WATER FOR INJECTION
To obtain compendial Water For Injection for pharmaceutical purposes, Bram-Cor employs two main technologies producing hot WFI and a third way producing cold WFI:
- WFI from Vapor Compression Distillation (VC) System
- WFI from Multiple Effect Distillation (ME) System
- WFI from Reverse Osmosis + Ultrafiltration (RO+UF) system
Note: we do not think that RO system is the safest method to produce Water for Injection (WFI), unless the feed water is really excellent. Theoretically, above all, with the availability of more technologically advanced membranes, we can produce cold WFI with the addition of ultrafiltration (UF). Techniques such as water softening, descaling, pre filtration, degasification, nanofiltration, electro-deionisation, ozonation, UV treatment and micro-filtration should all be considered, too, in relation to the feed water quality. Cold WFI from RO+UF meets all the parameters required (USP, EP, JP, …). However, producing WFI with Reverse Osmosis systems requires special attention, since in RO there is not a water changing state (from liquid to vapor, a natural microbiological barrier).
In the case of low capacities and of budget constraints, Bram-Cor also offers the Single Effect Distiller (DPSG), that is both a Still and a Pure Steam Generator. The production process consists of Purified Water evaporation followed by Pure Steam separation and condensation. The steam is purified using centrifugal and gravity separation methods. The DPSG System produces dry, saturated steam to be used as a sterilizing agent. The Pure Steam, when condensed through a Double-Tube Sheet condenser, meets the requirements of international pharmacopoeias for Water-for-Injection. Therefore, the system can provide a simultaneous production of Pure Steam and Water for Injection.
PRODUCING WFI – NOTE ON PHARMACOPOEIAS
USP 27 (2004) revised USP WFI monograph. It admits WFI from “Distillation or a purification process that is equivalent or superior to distillation in the removal of chemicals and microorganisms”. In 2008 EMEA (European Medicines Evaluation Agency, now EMA) issued a Reflection Paper to explain why the use of membrane technology was not considered acceptable for the production of WFI. From 2010 EDQM (European Directorate for the Quality of Medicines & HealthCare) works on surveys to collect industry data on: “Preparation WFI grade water using Reverse Osmosis (RO)”. During 2011 EDQM (Expert Workshop) examines potential uses of the membrane systems for the WFI production. In 2014, EDQM works to allow non-distillation technologies to be included in EP, in addition to distillation for WFI production. In recent years, documents (EMA Q&A EMA / INS / GMP / 489331 / 2016) and related issues are again examined. As a consequence (EP 9.1 publication), HPW monograph will be deleted.