STERILE TECHNOLOGIES

• Clean rooms
• Pure, pyrogen-free steam generators
• Water treatment (demineralizers, reverse osmosis)
• Sterile water distillators (multiple effects, thermocompression)
• WFI (Water For Injection) loops
• Sterile dissolvers
• Sterile filters
• Air conditioning for clean rooms
• Complete pharmaceutical factories

STERILE PRODUCTION
The plant is suitable to obtain any kind of sterile products by dissolution and or filtration of products. Before to start a SIP (sterilisation in place) treatment is required. Then the charge of solvent and solids is made. After dissolution by heating the solution is filtered in absolute filters and after re-crystallised. Finally the crystals are filtered to obtain final product which will be tried and packed.
Dissolutors and crystallizers are completely manufactured in stainless steel AISI 316L or equivalent (DIN 1.4435 BN2).
Pure, sterile and pyrogene-free steam generators are natural convection type, with double tube sheets, tube nest with clamp connections for an easy and quick disassembling and inspection, special design drain valve with plunged bellow seal to avoid impurities stagnation zones. For small production electric heated generators have been developed.
WFI distillers are multiple effects or thermo-compression system; both systems have been studied to minimise the energy costs.
WFI loops at 80 °C are complete with coolers and samplers.
The circulation, heating and cooling system is completely controlled with PLC.
We provide also for installation with DQ, IQ, OQ and PQ procedures and FDA validation documents.

THE TYPICAL WFI LOOP CONSISTS OF:
A pure pyrogene-free steam generator to sterilise
A pure water distiller
A tank in which purified water is maintained at 80°C
N° 2 sanitary centrifugal pumps for water circulation
Some coolers for cold water using points
A heater to maintain the temperature at the prefixed value
Some sampling points and temperature probes on the circuit
The plant is controlled by a PLC system.

PURE, STERILE, PYROGEN-FREE STEAM GENERATORS
The pure, sterile, pyrogen-free steam generators, natural convection, VPV vertical series are CE marked according to 97/23/CE PED Directive and are in accordance with cGMP and FDA rules.
We remember the main characteristics:
- double tube sheets with closed air chamber to convoy leakages to a signaling system;
- tube nest with clam connections for an easy disassembling and quick inspection;
- circular level gauge with self draining sight glass permitting the continuous sight of generator internal;
- automatic drain valve without stagnation zone.

The VPH horizontal series with U tube bundle and extractable double tube sheets is suited for sterile ambient humidification.
The VPE electrical series trailer mounted are particularly studied for little productions as research laboratory, biotechnologies and hospitals.

PURE WATER DISTILLERS
On the basis of the experience on the solvents distillation plants MFC has developed a new range of distillers for pure water (PW and WFI) for pharmaceutical and electronic uses.
The technologies employed are multiple effect and thermo compression system.
In the multiple effect the distilled condensation latent heat is used to distillate the water in the following effect operating at lower pressure. Each effect is realized with internally and externally electro polished tubes and double tube sheets.
In the thermo compression always the condensation latent heat is used increased with the thermal energy by the mechanical compressor. The heart of the plant is the compressor expressly studied for this application.
The distillers are CE marked according to 97/23/CE PED Directive and are in accordance with cGMP and FDA rules.
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