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Cleanrooms

BIOTECHLAB - PROVIDER OF TOTAL CLEANROOM SOLUTIONS

Despite the rather short biography of Biotechlab Ltd. (est. 2010) as a company the core team involved in cleanroom constructions and cGMP matters has about 17 years of experience in the field.
The key to our success is the gathered theoretical and practical knowledge and qualifications on the one hand and the continuous exploration and adopting of the useful novelties and recent developments appearing on the international forums and markets on the other. The combination of both enables us to introduce variety of modular cleanroom concept to one project in order to achieve optimal results in terms of flawless quality, customer satisfaction and cost efficiency.
Together with our carefully selected proven through the years reliable partners we are capable of providing complete turn-key solution for practically any need requiring clean environment with controlled parameters.


REFERENCE LIST OF ACCOMPLISHED CLEANROOM PROJECTS


1.    Tchaikapharma Inc. Plovdiv, Solid dosage forms shop, 2011
Scope of activities performed: design, delivery and installation of complete cleanroom system, qualification of cleanrooms.
Class: 100 000             Approx. area 820 m 2        www.tchaikapharma.com

2.    GE Pharmaceuticals Ltd. Botevgrad, Compete reconstruction and enlargement of Primary packing shop and QC laboratories, 2011
Scope of activities performed: general contracting incl. design works, complete reconstruction, delivery and installation of cleanrooms, delivery and installation of the HVAC equipment and BMS w. operator’s station, qualification of cleanrooms, HVAC system and BMS.
Classes: 100 000, 10 000, 100        Approx. area 1300 m 2    www.ge-ph.com

3.    Adipharm Jsc. Sofia, Partial reconstruction of production and ancillary premises, 2012-2015
Scope of activities performed: step-by-step complete renovation of cleanroom ceilings incl. light fixtures and air grilles. Delivery and installation of dedicated cleanroom partitions.
Class: 100 000            Approx. area 92 m2            www.adipharm.com

4.    Fortex Nutraceuticals Ltd. Sofia, Delivery and installation of cleanroom doors for the new production shop, 2012-2013; reconstruction of Microbiology lab and Sampling room, 2014-2015
Scope of activities performed: design revision, general project management and GMP consultation, delivery and installation of dedicated cleanroom element – doors, glazing, air shower interlock systems. Delivery and installation of pass-boxes, air-showers, laminar-flow cabinets, soft-wall clean booth complete w. FFU.
Class: 100 000            Approx. area 120 m2 + 45 m2        www.fortex.bg

5.    Balkanpharma-Razgrad Jsc., Unguents and Ointments Shop, 2013-2014; Microbiology lab, 2015-2016
Scope of activities performed: delivery and installation of dedicated cleanroom elements – doors, glazing, air-shower interlock systems.
Class: 100 000        Approx. area 142 m2 + 84 m2        www.antibiotic.bg

6.    Ceratizit Bulgaria Jsc. (Plansee MW GmbH) Gabrovo, Delivery and installation of cleanroom for final QC and primary packaging of semiconductor base plates, 2014
Scope of activities performed: consulting, design concept, general contracting incl. design works, complete reconstruction, delivery and installation of soft-wall cleanroom and ancillary premises, air-shower interlock systems delivery and installation of the HVAC and controlling equipment, qualification of cleanroom and HVAC system.
Class: 100             Approx. area 135 м2            www.plansee.com

7.    R1 Suture Ltd. (MZKRS) Burgas, Construction of surgical suture kits primary and secondary packing shop, 2014
Scope of activities performed: leading consultant and project manager, pre-design studies, design supervision, election of contractors, coordination and monitoring of construction and finishing works, delivery, installation and qualification of specialized production and QC equipment.
Class: 100 000            Approx. area 360 m2        www.mzkrs.ru

8.    GE Pharmaceuticals Ltd. Botevgrad, Construction of new production facility for solid dosage forms primary and secondary packing and high bay storage warehouse, 2014-2015
Scope of activities performed: pre-design studies, evaluation and election of general contractor, monitoring and coordination of HVAC and Technology design works, delivery and installation of complete cleanroom system, HVAC and cleanroom validation procedures consulting.
Class: 100 000        Approx. area 560 м2                www.ge-ph.com

9.    Texsan Medical Ltd. (Sengewald Klinikprodukte GmbH) Sandanski, Complete reconstruction of facility for medical devices production, 2014-2015
Scope of activities performed: consulting, pre-design studies, general contracting incl. two-stage design works, complete reconstruction, delivery and installation of complete cleanroom system, delivery and installation of the HVAC equipment and BMS w. operator’s station, qualification of cleanrooms, HVAC system and BMS.
Class: 100 000            Approx. area 1080 m2        www.texsan.eu

10.    Optix Co. Panagyurishte, Optical coatings QC facility, Strelcha site, 2015-2016
Scope of activities performed: technological flows and HVAC consultating, delivery and installation of dedicated cleanroom element – pass-boxes, air-showers, laminar-flow cabinets, N2 cabinets.
Class: 100 000            Approx. area 64 m2        www.optixco.com

11.    Tchaikapharma Inc. Varna, Ampoules filling shop, 2015-2016
Scope of activities performed: design, delivery and installation of complete cleanroom system, qualification of cleanrooms.
Classes: 100 000, 10 000, 100        Approx. area 228 m2    www.tchaikapharma.com


Currently we are accomplishing nearly 800 m2 of dedicated cleanrooms for manufacturing of medical devices (bandages and plasters) in the village Katunci near Sandanski. The project is realized by appointment of the new owner and on the territory of the former production site of Medica Jsc.
We are glad to announce that none of our a.m. customers have ever had any regulatory problems concerning the infrastructure installed by us (for instance one of our customers near the capital passes 20 to 30 profound audits by various authorities and clients annually).
We would be delighted to have the opportunity to place our know-how and practical experience in designing and erecting cleanrooms at your service.