ERGONOMIC HIGH TECH DESIGN HSM and FBD

High Shear Mixer NicoMix is manufactured with “Tulip”

design with AC frequency control for Impeller and

chopper, perfect mixing, uniform granulation. The FBD

container is moving in a rail to allow easy unloading

from HSM and from FBD to NicoMill. The NicoBed Fluid

Bed Dryer and Top Spray Processor is an high tech

equipment able to dry and process uniform granule.

Designed to withstand 18 bar of pressure, shock

resistant execution with PED 12 bar stamp. PTFE

cartridge filters with automatic lowering system, State

of the art design according to cGMP, integrated WIP CIP syetms.

The RTP Rapid Transfer Port is the heart of Isolation

Technology. RTP is made with an active valve and a

passive valve which can be connected with stainelss steel

canister or plastic bag. Bectochem-Nicomac manfucture

and install their own rapid transfer valves.

NCS Nicomac COATER

At the end of granulation line, Nicomac designed a new

air tight coater, 5 kg capacity for potency product.

Loading and automatic unloading systems are under

isolator through RTP technology. Nicomac Coating

technology with patented Blow Master and automatic

unloading systems.

Nicomac s.r.l. - Via Curiel, 12 – Liscate – MI – Italy - Ph. +39 02 95 42 04.1

sales@nicomac.it www.nicomac.com

CONTAINMENT ISOLATOR SYSTEMS

Nicomac and Bectochem joined

their experiences, know how and their talent to

design, develop, manufacture and supply

Isolation Technology to all pharmaceutical companies all over the world.

Bectochem and Nicomac: the leaders in Isolation Technology.

• Nicomac is the World Leader Manufacturer Company in Clean Room,

Granulation Machinery, Film and Sugar Coating Equipment with cemented

working relations with Bectochem since January 2004.

• Bectochem Machinery, the Leader Company in Indian Pharmaceutical market

for many years, started isolators production in 2004.

• High Expertise & Exceptional Skill on Isolation Technology for both Containment

& Sterile Applications.

• Manufactured and installed more than 150 isolators for various applications.

Nicomac and Bectochem success is due to the proven

ability to produce advanced tailor-made solutions that

meet client individual containment needs. Based on

European technology, Bectochem started designing and

manufacturing Isolators in 2004 and by the end of 2007

the results were:

97 Isolator Installed and Commissioned

44 Isolators under manufacturing

Isolators for high containment designed for OEL up to

0.1μg/m3

Glove Box – Sterile Isolator in over pressure

Material Transfer Technology - Pass Box - Split Butterfly

Valve - RTP

GRANULATION LINE UNDER ISOLATORS

A completely contained granulation line with 2 or 5 kg capacity, for high potency

products under isolator - OEL level of 0.1 µg/m3 in 8 Hours. RTP technology. An

ergonomic and high tech solution for:

Dispensing ● HSM NicoMix ● FBD NicoBed ●NicoMill ●Tumbler NiCO Mixers ● NCS Coater

CONTROL SYSTEM

PLC-PC control for all line with user friendly Software designed with Proficy i.Fix

CFR21 part 11 complaint. It controls and monitors the isolator and each single

process equipment in manual or automatic mode with stored recipes. It is possible to

record and print a batch report for all machinery monitoring a trace of all production

batches from dispensing to the blender. 15 air changes with push in out push out

filter. Technical area is enclosed in the framework.

PASS BOX – DISPENSING Only one Isolator to produce high potency granules

protecting operator and product.

Raw material is loaded through a pass box, dispensed

and loaded into the bowl of NicoMix.

CALIBRATOR AND TUMBLER A NiCoMill performs the best calibration for wet or

dry granule. Nico tumbler 5 kg capacity optimizes the

blendig operation.