WHAT WE DO
Compounding PREPARATION SUITES With Fixed Or Mobile Vessels
Compounding system for pharmaceutical, biotech, parenteral, cytotoxic formulation and vaccine production. Preparation suite with fixed or mobile vessels, mixing tanks and bioreactors.
Preparation system with fixed or mobile tanks and process transfer and filtration lines; equipped with valves, instruments, accessories and process piping.
Fixed or mobile tanks (on wheels) with capacities from 50 to 2,000 litres, vertical design, tri-clamp connections and control instrumentation; AISI 316L stainless steel and PED/ASME certification. Spray ball for complete wetting of all internal parts of the tanks and safety valves and burst disc to control the risk of overpressure during pressurisation are included.
In-line integrated pressurisation/ventilation filters and process accessories; including process control instruments such as pressure transmitters, temperature transmitters, level indicators, weighing cells, flow meters and pH meters.
Dedicated filtration and transfer line with sanitary piping and certified welds, including sterilising filters and integrity control circuit. The piping is passivated, the construction ensures complete drainability and the absence of dead spots. Safe platforms and ladders are provided to reach the entire system area for inspection or manual process operations.
Preparation system with fixed or mobile tanks and process transfer and filtration lines; equipped with valves, instruments, accessories and process piping.
Fixed or mobile tanks (on wheels) with capacities from 50 to 2,000 litres, vertical design, tri-clamp connections and control instrumentation; AISI 316L stainless steel and PED/ASME certification. Spray ball for complete wetting of all internal parts of the tanks and safety valves and burst disc to control the risk of overpressure during pressurisation are included.
In-line integrated pressurisation/ventilation filters and process accessories; including process control instruments such as pressure transmitters, temperature transmitters, level indicators, weighing cells, flow meters and pH meters.
Dedicated filtration and transfer line with sanitary piping and certified welds, including sterilising filters and integrity control circuit. The piping is passivated, the construction ensures complete drainability and the absence of dead spots. Safe platforms and ladders are provided to reach the entire system area for inspection or manual process operations.
Multipurpose Compounding, evolution of preparation plants with an equipped wall dedicated to the pharmaceutical sector, which can be used with mobile tanks or pallet tanks for any type of product and process.
Preparation system for solutions or suspensions comprising mobile preparation or storage tanks and/or pallet tanks for storage inside disposable bags, filtration and transfer lines – fixed or disposable -, utility panels, temperature control units, on-site cleaning and sterilisation stations – CIP/SIP – and/or off-site cleaning and sterilisation stations – COP/SOP -, CIP skid units for preparation of water and cleaning media.
Where possibile compounding plant are done with SKID approach and engineering desing, skid approach allow pre-installation in factory and faster installation on site. Wherever possible, compounding plants are built using a SKID approach and engineering design. The skid approach allows for factory pre-installation and faster on-site installation. Engineering considers all design and functional aspects for construction and functionality requirements such as minimum product loss, pressure and temperature control, filter integrity testing and process steps. The control system via PLC/HMI or PANEL PC is integrated to manage all stages, critical parameters and record all data according to CFR 21 Part 11 requirements. The control system via PLC/HMI or PANEL PC is integrated to manage all phases, critical parameters and record all data according to CFR 21 Part 11 requirements. The complete system documentation provided consists of the mechanical booklet, electrical and software documentation, including all validation documents from design qualification, factory acceptance tests, site acceptance tests, installation qualification protocols, operational qualification protocols and performance qualification protocols.
Preparation system for solutions or suspensions comprising mobile preparation or storage tanks and/or pallet tanks for storage inside disposable bags, filtration and transfer lines – fixed or disposable -, utility panels, temperature control units, on-site cleaning and sterilisation stations – CIP/SIP – and/or off-site cleaning and sterilisation stations – COP/SOP -, CIP skid units for preparation of water and cleaning media.
Where possibile compounding plant are done with SKID approach and engineering desing, skid approach allow pre-installation in factory and faster installation on site. Wherever possible, compounding plants are built using a SKID approach and engineering design. The skid approach allows for factory pre-installation and faster on-site installation. Engineering considers all design and functional aspects for construction and functionality requirements such as minimum product loss, pressure and temperature control, filter integrity testing and process steps. The control system via PLC/HMI or PANEL PC is integrated to manage all stages, critical parameters and record all data according to CFR 21 Part 11 requirements. The control system via PLC/HMI or PANEL PC is integrated to manage all phases, critical parameters and record all data according to CFR 21 Part 11 requirements. The complete system documentation provided consists of the mechanical booklet, electrical and software documentation, including all validation documents from design qualification, factory acceptance tests, site acceptance tests, installation qualification protocols, operational qualification protocols and performance qualification protocols.
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SEE ALSO
PW/WFI, Storage and
Distribution Loop new systems or revamping
CIP-WIP-SIP SKID and DISTRIBUTION LINES
N2, CA, PURE STEAM COMPOSITION Distribution and Modification
PROCESS AUTOMATION
with PLC/SCADA/Panel PC control system
