Isolation Technology

Product catalog summary

Overview
Nicomac Europe specializes in designing and supplying fully contained lines for Oral Solid Dosage (OSD) forms, focusing on safety and technology. The company provides complete isolated lines for OSD production with batch sizes ranging from 1 kg to 65 kg and containment levels from OEB3 to OEB5.

Company Background
Founded in 1977 in Milan, Italy, Nicomac Europe has completed over 1800 projects in 65 countries. The company is renowned for its clean rooms, coating systems, and granulators, often used under isolators. Nicomac Europe emphasizes quality and customer satisfaction, with many clients being FDA/EMA approved.

Design and Safety Features
The isolators are designed for operational ergonomics, efficiency, and safety. Key features include full stainless construction, CFR21 Part 11 compliant control systems, FDA/EMA approved materials, and controlled constant negative pressure. The design also includes ergonomic studies and high-level finishing for optimal cleaning.

Technical Features
- Full stainless construction design
- CFR21 Part 11 compliant control system
- ISO 10 648-2 to class 2 or AGS-2005 leak test
- FDA/EMA approved materials
- Controlled constant negative pressure
- Ergonomic design for easy cleaning
- Automatic sliding doors
- H14 Class HEPA filters
- Multiple transfer systems

Washing Systems
Decisions on cleaning methods are crucial, with options for clean-in-place or wash-in-place techniques. Ergonomics, accessibility, and ease of cleaning are important considerations.

Granulation Lines
The granulation line is compact, featuring automatic sliding doors, built-in lights, and rails for container handling. Machines have technical parts outside the isolator for easier maintenance and cleaning.

Coating Equipment
Nicomac Europe’s coating machines integrate easily with containment systems, ensuring safe loading and unloading of tablets. The design supports semi-automatic operations and easy washing procedures.

Capsule Filling Machine
Special containment is required due to the machine's operation. The isolator is typically a "hat" on the machine basement, with integrated control systems.

Tablet Press
The tablet press turret is enclosed in an isolator chamber, with utilities HEPA filtered and integrated into the isolator pressure control system.

Transfer Systems
Successful transfer technology is crucial for commercializing high-potency drugs. Nicomac Europe emphasizes well-executed material transfer technology.

Handling Systems
Includes lifting columns, vacuum transfer systems, and IBC or BINS.

Contact Information
For further inquiries, Nicomac Europe encourages getting in touch for more details.

Catalog excerpts

FULLY CONTAINED LINES FOR OSD FORMS

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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...

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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...

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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...

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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...

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HP - FULLY CONTAINED LINES FOR OSD FORMS

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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...

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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.

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