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References & Case Studies

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By products

- Chose - Reinräume Edelstahlmöbel Arbeitsplatzlösungen Dekontamination Laminar-Flow-Lösungen Isolatoren & RABS

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TIMOTEC s.r.o. - Weighing Isolator

Weighing Isolator

Customer: Synthon, s.r.o.

Details: The isolator workplace with turbulent air flow will be used for weighing of high active substances. The isolator will be operated both in standard atmosphere and it will be possible to switch to nitrogen atmosphere with low relative humidity. The aim of the isolator workplace is to protect the personnel when working with highly active substances, as well as to protect the materials being handled from atmospheric moisture and oxygen. The device works in negative pressure mode. Leak tightness class 3 pursuant to ČSN EN ISO 14 644-7 (ISO 10648-2).

TIMOTEC s.r.o. - Isolator for sterility test

Isolator for sterility test

Customer: NOVAVAX CZ a.s. / Praha Vaccines a.s.

Details: Isolator workplace is designed for the sterility test Positive interior pressure for product protection Laminar flow “A“ Class cleanliness according to EU GMP Leak tightness class 3 according to ISO 10648-2

TIMOTEC s.r.o. - RABS

Customer: Zentiva, k.s.

Details: The RABS (Restricted Access Barrier System) serves as a barrier between the product and the operator. In a RABS, theproduct is processed on an IWK filling line. The RABS is located according to GMP in a cleanroom of the Cleanliness Class B Inside the RABS there is according to GMP the required Cleanliness Class “B” EU GMP Grade “A”

TIMOTEC s.r.o. - Laminar Flow Cart

Laminar Flow Cart

Customer: Bioveta, a.s.

Details: Laminar carts are used to protect the material transported from the filling line to the lyophilizer. After the subsequent comple-tion of the lyophilization process, the cart is used to transport the material from the lyophilizer to the closing line. The cart is used for transporting material between positions of different working heights therefore the cart is equipped with aheight-sliding shelf on which two product cassettes are placed. For product protection, the cart is equipped with a laminar vertical flow circulation unit with a velocity of 0.36 - 0.45 m/s in “A”purity class, which is located above the working chamber of the cart. In order to transport material between positions, the cart has a back-up power supply (UPS) installed to supply the systemwith electricity. The cart works in an over-pressure mode in relation to the ambient surroundings and is designed in accordance with EN12469:2000.

TIMOTEC s.r.o. - Decontamination Pass-through Cabins

Decontamination Pass-through Cabins

Customer: Bioveta, a.s.

Details: Two decontamination pass-through cabins were supplied within the order These decontamination pass-through cabins are used for the transfer of materials between rooms with different purity classes The material is decontaminated with H2O2 vapours These devices prevent cross-contamination or spread of infection while maintaining biological safety Leak tightness 3 according to EN ISO 14 644-7 (ISO 10648-2) “D” purity class inside the working chamber according to EU GMP

TIMOTEC s.r.o. - Isolator for Aseptic Works

Isolator for Aseptic Works

Customer: Bioveta, a.s.

Details: The isolator workplace is intended for aseptic works (inoculation from cryo-tubes into Roux bottles, inter-operational sterility control,seeding, counts) at BSL3 level. The appliance is of a single chamber layout The appliance is in vacuum mode Leak tightness 3 according to EN ISO 14 644-7 (ISO 10648-2) “A” purity class inside the isolator according to EU GMP Body material: stainless steel AISI 316L