References & Case Studies
Production Facilities for the Packaging and Storage of Medical Cannabis
Customer: Geschur Medical
Details: The project involved the refurbishment of an existing building to establish a facility for the cultivation, drying and packaging of medical cannabis. The building has two floors. Scope of supply by Timotec Reinraumsysteme a.s.:
Cleanroom installations for the processing, drying and packaging of medical cannabis
Stainless steel cleanroom furniture
Cleanroom area (according to ČSN EN 14644 and US Federal Standard 209E): 135,05 m2
ISO CLASS 8 (100 000): 51,4 m²ISO CLASS 9: 83,65 m²
Timotec Reinraumsysteme a.s. supplied cleanroom systems under contracts executed by the BLOCK Group (now SPIE Central Europe).
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Reconstruction of API Production
Customer: Cayman Pharma s.r.o.
Details: The reconstruction of the API production facility, carried out while the building remained fully operational, included the construction of cleanrooms for handling highly active pharmaceutical ingredients (HAPI), the supply of isolator workstations, HVAC systems, pharmaceutical utilities and technical gases. The project also included the complete validation of cleanrooms, technologies and isolator workstations.
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Aseptic Filling Isolator
Customer: Carnamedica Sp.z o.o.
Details: ▪ Laminar flow isolator for aseptic filling of products and transfer of sterile bags, designed for handling non-toxic materials.▪ Semi-automatic aseptic filling using a bag holding and sealing device with an integrated dosing system. ▪ The purpose of the isolator is to protect the product from contamination.▪ The unit operates in positive pressure mode under a standard atmosphere.▪ Three-chamber design supplemented with a laminar flow box (C4) for the removal of filled bags.▪ Leakage class 2 in accordance with ISO 10648-2.
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Cleanroom for an ISO 8 Drying Filter, Pilot Unit
Customer: Synthon
Details: The scope of work includes the supply and installation of cleanrooms for an ISO 8 drying filter and the installation of an isolator workstation. Existing premises were adapted to meet process requirements and the innovative HAPI production solution. The system enables product processing in a closed system and its transfer from the drying filter to the isolator. The isolator workstation was supplied by TIMOTEC. The implementation took place while the building remained in operation.
Purity class: ISO 8
Cleanroom area: 20 m2
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Isolator for Work with Tissues
Customer:
Details:
The isolator consists of 4 working chambers and 2 airlocks.
It is used for working with sterile material, primarily processing tissues, tendons, eye corneas and other similar products.
The line is equipped with a VHP generator to ensure the sterilization of the interior spaces.
The isolator has an integrated vacuum dryer and an ultrasonic bath for cleaning.
In addition, a special saw and cutter for processing bones and joints is integrated in the line.
The outlet of the line is secured by an airlock and enters the “A” cleanliness class space where a freeze dryer is located for thesubsequent processing of the products.
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Isolator technology for working with mammalian cells and tissues
Customer: BIOCELTIX
Details:
Isolator designed for working with mammalian cells and tissues (tissue preparation, tissue separation, cell incubation, etc.)
Laminar flow
Positive interior pressure inside for product protection
“A“Class cleanliness according to EU GMP
Leak tightness class 3 according to ISO 10648-2
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