FULLY CONTAINED LINES FOR OSD FORMS

HIGH POTENT ISOLATOR DESIGN, FUNCTIONALITY & SAFETY Nicomac Europe has focused the design of equipment under isolators to safety and technology of machinery. Standardization of transfer valves and containers, and compatibility with upstream and downstream processing can contribute significantly to the selection of a suitable containment strategy, while equipment cleaning and maintenance should also be addressed. Nicomac Europe supplies, installs and validates complete isolated lines for the production of Oral Solid Dosage Forms, with batch size from 1 kg up to 65 kg with containment level from...

TECHNICAL The isolators design ensures the correct operational ergonomics, efficiency and safety of the process. The construction of a mockup FEAIURES during early design phase gives the possibility to guarantee the best isolator's design. Full stainless construction design CFR21 Part 11 compliant control system Ergonomic study, high level finishing for best cleaning Small dispensing room, washing bin approved materials Controlled constant negative pressure Multiple transfer systems available H14 Class HEPA filters, BIBO or push-push cartridges Automatic sliding door ISO 10 648-2 to class 2 or...

Dedicated isolator units are required for preliminary and verification activities in the OSD forms manufacturing. Dispensing isolator allows proper weighting of HPAPI with excipients according to required formulation. IPC isolator hosts the necessary instrumentations for in process testing according to quality control program. Sampling devices ensure the possibility to extract product samples as process needs. DISPENSING QC-SAMPLING WASHING SYSTEM (BIN & COMPONENTS) For cleaning purposes, decision should be made regarding whether in place cleaning is implemented or not, which cleaning materials...

GRANULATION LINES Compact granulation line in a single isolator: with automatic sliding doors, built-in lights and rails for container handling. All the machines have technical part outside the isolator chamber, for an easier maintenance and better cleaning. THE LINE INCLUDES: ^ Pre-chamber with small dispensing zone ^ Unloading with continuous liner or 50 L BIN GRANULATION LINE FEATURES: g Pre-chamber and main chamber ^ Control system CFR 21 Part 11 for monitoring and controlling Stainless steel pleated ^ Ergonomic internal filters doors and safety barrier High Shear Mixer ^ Material exit: endless...

HP - FULLY CONTAINED LINES FOR OSD FORMS

COATING EQUIPMENT Nicomac Europe SWC type coating machines are designed to be easily integrated with a containment system for safe loading and unloading of tablets. The design ensures full integration with control system, semi-automatic operations and easy washing procedure. The exhaust fan of the coating machine is also used to create the negative pressure of the isolator. CAPSULE FILLING MACHINE Capsule filling machine requires special containment due to its particular operation. The isolator is typically a “hat” on the machine basement and the control systems is fully integrated. Capsules...

HANDLING SYSTEMS Lifting colums IBC or BINS Vacuum Transfer Systems TRANSFER SYSTEMS Attention to detail is of importance for successful transfer technology. At the heart of every sucessful program is a well-executed material transfer technology and the key to successfully commercialize high-potency and high performance drugs with contractmanufacturing partners.

GET IN TOUCH phone : +39 02 9542041 Nicomac Europe email : [email protected] website : www.nicomac.com Via E. Curiel 12 20050 Liscate (MI), Italy