SOLUTION PREPARATION COMPLETE WITH ISOLATOR

REMOIN Srl among the other things, is also specialized in designing, constructing and installation of Solution Preparationcomplete with Isolator, on proper skid, suitable to be in Sterile Areas Class A, B and C. Isolators are used in the production of oncological and injectable medicines; they are structured to operate both in positive and negative pressure, depending on the type of product to be treated.

The plant can be made with both fixed and mobile preparation tanks, complete with all the utilities at their service: WFI, clean steam, nitrogen, sterile air, thermostating, product lines. Isolators are designed to be able to handle products in a safe and controlled environment and can be sterilized with Hydrogen Peroxide (VHP). The material of Construction for all components is stainless steel AISI 316L ASME BPE SF1 or SF4. All welds are executed with automatic procedures and controlled by borescopes. Allpipes and fittings are passivatedaccording to ASTM 967.

The system is supplied complete with an electro-instrumental system and, on request, it can be monitored with SCADA; it complies with the CFR21 PART 11 Directives and the USP, cGMP and FDA Prescriptions.

maincharactestistics:

• Internal Design studied to facilitate cleaning and prevent accumulation of dirt;
• Integratedejectionsystem;
• HEPA H14 filters on intakes;
• Filtri Hepa H14 o outlets;
• System of holding and controlling Inflatable seals;
• Preccure control on Chamber and pre-chamber;
• Filtersobstruction control;
• Doors made of crystalline PMMA ( different materials on request);
• Oval Flanges for better ergonomics.

optionals:

• Inertizationsystem
• Continuous particles control
• CIP/SIP