References & Case Studies
Isolator technology for working with hazardous materials
Customer: CARBOGEN AMCIS AG
Details:
Isolator designed for working with hazardous materials which are sensitive to oxygen
Negative interior pressure
Turbulent flow
Leakage class 3 according to ISO 10648-2
“C“ Class cleanliness according to EU GMP
Custom designed for the customer
Mehr anzeigen
VHP Decontamination Lock
Customer: Seqirus – A CSL Company
Details:
Three types of decontamination pass-through cabins for Seqirus - A CSL Company, to which a total of five decontamination pass-through cabins were delivered.
Decontamination Pass Through Cabinet is used for material transfer between rooms with different cleanliness classes and todecontaminate the material by H2O2 vapors and it is suitable for PC3.
Tightness class 2 according to ČSN EN ISO 14 644-7 (ISO 10648-2)
Cleanliness class inside the chamber EU GMP Grade „B“
The device is equipped with a integrated hydrogen peroxide vapor generator which serves to evaporate the H2O2 solution and totransport the resulting vapors by means of compressed air with the required concentration to the decontamination cabinet.
Mehr anzeigen
Safety Weighing Box
Customer: Teva Czech Industries s.r.o
Details:
The two-chamber isolator workstation is used for handling intermediate and finished HAPI products
The main activities at this workstation are weighing, dissolving, sampling and packaging of HAPI products classified up to OEB4-6. • The equipment is operated in vacuum mode.
Tightness class 4 according to ČSN EN ISO 14 644-7 (ISO 10648-2).
Cleanliness class “C” inside the chamber according to EU GMP
Housing material: steel AISI 304 + powder coating white RAL 9016 smooth matt
Mehr anzeigen
BSH - Bioveta Serum Hall: supply of cleanroom systems
Customer: Bioveta
Details: Refurbishment, completion, and superstructure implementation of the building. The structure is a part of a building complex serving administrative, production, quality control, and pharmaceutical veterinary product development purposes. Our scope of supply included the delivery of cleanroom facilities for production and auxiliary areas, with a total area of 300 m².
Timotec Reinraumsysteme a.s. supplied cleanroom systems under contracts executed by the BLOCK Group (now SPIE Central Europe).
Mehr anzeigen
Weighing/Containment Isolator
Customer: ICM Farmak S.L.U.
Details:
The purpose of the isolator is to ensure operator safety when handling hazardous substances and also to protect the product fromcontamination during aseptic operations.
Laminar flow
The device operates in two pressure modes - positive pressure and negative pressure
Tightness class 2 according to ČSN EN ISO 14 644-7 (ISO 10648-2)
Purity class “A” according to EU GMP
Mehr anzeigen
Isolator for Spray Dryer
Customer: Synthon (IZV 11108)
Details:
This turbulent flow isolator workplace is used for complete handling of solid materials, including HP API category (OEB 4). This includes the following operations:
weighing of materials (API, adjuvants and polymers) for use in production,
collection and preparation of samples for AO during production or SDD final product,
distribution and packaging of the SDD final product.
The aim of the isolator workplace is to protect personnel when working with highly active substances and also to protect materials being handled against air humidity and oxygen.
The device is in vacuum mode.
Leak tightness class 3 according to ČSN EN ISO 14 644-7 (ISO 10648-2).
Mehr anzeigen