White Clean Rooms - Biological Safety Cabinets and Laminar flow - Laminar flows - GMP Services

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ingeclima

Technology

TURNKEY CLEAN ROOM PROJECTS

INGECLIMA proposes a comprehensive solution. Our definition of comprehensive solution:
Supply.
We accompany the businesses that need to "produce in a specific, controlled environment," from the birth of their project to its realization.
Scope of the comprehensive solution.
Provision of the comprehensive solution may bring together the following matters:
Turnkey clean rooms.
Turnkey biosafety laboratories.
Air treatment and filtration.
Production and distribution of energy.
Production and distribution of fluids.
Assembly and integration of production equipment.
Collection and treatment of biocontaminated effluents.

At INGECLIMA, we offer solutions and improvements for companies in the industrial and service fields. Our great capacity comes from ongoing documentation work, research, development and training in each and every one of their product lines.

Our solutions are based on the interrelationships between:

Consulting and supervision: In collaboration with other companies in the ALBIAN group, we can provide consulting and supervision services for the implementation of GMP and BPL good manufacturing practices and laboratories.
3D Room Design: From basic engineering to detail engineering, developing practical projects that meet our clients' technical and economic needs and requirements.
Purchasing Management: Collaborating with the client to select equipment that will later be integrated with the rest of the facilities.

Supply and Installation of Critical Systems:

Project Steering: Through rational management of the work, guaranteeing the development and commissioning of the project in the execution times, costs and quality that we have committed to.
Automation and Control: In collaboration with IRATI CONTROL, we introduce Data Supervision and Acquisition systems, to visualize the statuses and conditions of the facilities and their equipment, to monitor readings and record the data in a date base designed following GAMP standards and 21 CFR annex 11 requirements for electronic records of the data generated.

Validation Master Plan:

Commissioning:

Qualification.
Training.


n accordance with the project's architectural design, we make enclosures for the classified rooms with free-standing brand panels specially created for this purpose. These panels are finished with phenolic resin, lacquered steel sheets or stainless steel sheets, and with polystyrene core or rock wool.
Doors and profiling for frames have been designed in curved form in order to avoid dust accumulation and to allow easy cleaning.
Modular ceilings or continuous ceilings allow access for convenient maintenance of the facilities

FACILITIES

Innovation must be constant in "turnkey" installation projects. Providing them with greater perfection is a matter of applying resources and research. This is one of the main means we use to continuously improve our know-how and to thus be able to develop facilities with increasingly stringent requirements, including:

Air Treatment and Filtration.
Control of the temperature, humidity and internal pressure of the classified premises.
Modular enclosures with special panels.
Metal continuous ceilings or modular ceilings that are easy to access.
Continuous floors without cracks.
Special doors with curved profiling that are easy to clean or watertight for "LSB - 3" laboratories.
Special integrated lighting for clean rooms.
Integrated electrical facilities.
Loops of osmotic water and deionized water.
Computerized control of the entire system.
Assembly and integration in the room of production machines and equipment.
Continuous counting of particles.
Other facilities (treated water, vapor, compressed air, vacuum etc...).
Final and periodic validation.
"D.Q." "I.Q." "O.Q." Protocols.

COMPLEMENTARY EQUIPMENT

For clean areas to function properly, we must study their interrelationship with the outside and the flow of people and materials, so that at no time are the established conditions compromised.

INGECLIMA designs and manufactures customized equipment for full integration with architecture, facilities and production process.

* SAS for materials or wastes to pass through, with sterile filtration.
* SAS with biological decontamination by nebulization of biocides in a way that is automatic and programmable.
* SAS for cleaning with air blowing to make the product enter clean areas.
* AIR SHOWERS at staff access points.
* INTEGRATED LAMINAR FLOWS to occasionally obtain ISO -5 class (Grade-A).
* GMP pass through bank with jump.
* Phenolic resin work benches and shelves. Integrated with the enclosures' panels.
* Lockers and other locker room furniture with phenolic resin.

APPLICABLE SECTORS

Pharmaceutical.
Veterinary Medicine.
Microelectronics.
Food.
Hospital (Operating Rooms and biocontamination).
Biotechnology.
Chemical.
Optics.
Research.
Precision Mechanics.

 

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INGECLIMA BILBAO· Dr. Díaz Enparanza, 39 - A · 48002 Bilbao · Tel: +34 944 424 800 · Fax: +34 944 424 808 · INGECLIMA MADRID · Avda. Camino de Cortao, nº 6-8-Nave 22 28.700 San Sebastián de los Reyes - Madrid · Tel: +34 911 960 845
INGECLIMA BARCELONA • Avda. PRAT de la Riba 191, nau 5 - Pol. Ind. Camps d´en Ricart - 08780 Pallejà • TEL. +34 936 634 232

e-mail:info@albian.es