Full Services

BRAM-COR PROFESSIONAL SERVICES

Top quality cGMP equipment must necessarily be integrated through a proper high level of professional services including:

Technical Documentation
FAT (Factory Acceptance Test)
Endotoxin Test
Installation (see related page in this site)
Commissioning, SAT (Site Acceptance Test)
Start-up and Training
Validation (Equipment Qualification)

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.

ENGINEERING & TECHNICAL DOCUMENTATION

All Pharmaceutical Facilities need to be up-dated, competitive and efficient in operation, to diversify production programs, to reduce life-cycle costs and, above all, to comply to the appropriate pharmaceutical GMP regulation. BRAM-COR project drivers are aimed at satisfying all pharmaceutical regulatory and QA requirements, aligning the final product to the international Pharmacopoeias and capitalizing upon a careful, customer-oriented project management. Equipment and process flow are designed to allow a logical flow in order to avoid mix-ups of components, drug product, closures, labeling, in-process materials or cross contamination achieved through the development of

Conceptual Design describing the general project organization

Detailed Engineering, considering all process flows (raw materials, finished products, personnel, waste, etc.) and detailed project specifications

A complete technical documentation is part of our machines and includes:

General Documentation and Constructive Specification
Components Documentation
Valves Documentation
Instruments Documentation
Electrical/pneumatic Documentation
Hardware and Software Documentation
Piping, Fitting and Welding Documentation Non-destructive test certificate
Operating and Maintenance Instructions
Spare Parts

DQ - DESIGN QUALIFICATION

During the initial phases of the process we assist our Clients with a feasibility study and an engineering support due to optimize the entire project from the overall investment point of view, considering operational costs reduction. In case of Critical Fluids Systems (PW, WFI, PS), we usually ask to provide us with following basic data:

Raw water analysis

Table of concurrent uses in the 24 hours (ask for more information)

Lay-out with location of each user point, as well as of the equipment (we are ready to assist the Clients in defining the most suitable layouts)

Through our software we can perform all necessary simulations and recommend the best solutions. Either counting or not on our initial engineering support, we provide a complete set of specifications in our DESIGN QUALIFICATION protocols, which are submitted to our Customer for approval before starting the equipment construction.

COMMISSIONING

Commissioning includes factory testing, site testing and start-up activities, ensuring that the system is correctly running and that the final product meets all specified requirements within the operating range.

FAT & SAT PROTOCOLS

BRAM-COR systems are first pre-tested in our facility, tested in the presence of the Customer during FAT, and finally tested on site (SAT) under real operating conditions by professional and competent BRAM-COR technicians. Product critical parameters are carefully monitored, as well as fluid flows, pump duties, alarms, valves, emergency power and software modules. Our FAT and SAT protocols provide a complete documentation of testing activities.

PROFESSIONAL INSTALLATION

Professionalism in installation is a basic requirement in all pharmaceutical technologies. We provide installation teams composed of qualified supervisors, patented welders and skilled piping assemblers working in accordance to BRAM-COR sanitary piping procedures all over the world.

BRAM-COR water treatment equipments are thus integrated to state-of-the-art, GMP-compliant distribution systems, which are inspected during construction, passivated and tested. Isometric drawings of the “as built” loops are supplied as part of the loop documentation, together with the relevant material certificates.

VALIDATION PACKAGES / EQUIPMENT QUALIFICATION

Validation of a pharmaceutical systems implies careful verification of functional and design specifications, to make sure that the final product meets all regulatory standards. BRAM-COR standard validation package includes:

INSTALLATION QUALIFICATION The documented verification of the system design is achieved by checking the as built equipment versus the design specification. IQ protocols include as built drawings, part lists, electrical schemes, software documentation. Our IQ protocols provide easy-to-fill check lists.

OPERATIONAL QUALIFICATION The documented verification of the functional design is achieved by checking functional data against the functional specification. OQ protocols are conceived for easy recording of critical parameters and provide full support for effective system validation.

TELESERVICE

Our Customer Service provides effective after sales assistance, focusing on quick problem solving. The direct communication with our Customers and the full traceability of all system components enables us to easily detect the problem cause and to suggest the most suitable corrective action. Teleservice can be also configured on Bram-Cor systems to ensure quick feedback by our Automation Dept. Special care is given to safe remote access policy for compliance with 21 CFR PART 11.