Robust
table
S
Validateable
Pharmaceuticals
The Measure of Quality™
Pharmaceutical Processing
NDC Analysis for Process Control Achieving Process Understanding
Europe
NDC In-Process Analytical Control Quality by Design initiatives help to
Solutions are utilized in large numbers develop science-based understanding
in industrial manufacturing processes to of the chemical and mechanical
consistently achieve yield and quality properties of all elements of the
specifications. proposed drug product.
COMANY OVERVIEW
As an in-process alternative to off-line The understanding of the properties of
Active in over 50 countries
methods, these solutions output drug product components enables
worldwide, NDC Infrared
measurements to control the process identification of the process variables
Engineering is a UK & US based
within the desired design space, and which control or determine these
manufacturer of measurement
provide feedback for adjustment. properties.
and control solutions for a wide
range of process industries,
Additive returns achieved over a NDC’s in-process measurement systems
including:
relatively short period of time enable enable control of these critical
users to realise significant financial parameters and can be integrated into
■ Pharmaceuticals
benefits, such as: the production plant control systems and
■ Foods
incorporated into standard procedures.
■ Chemicals & Minerals
■ Optimal material usage
■ Paper
■ Time Savings
■ Extrusions
■ Improved Labour Utilization
■ Packaging
■ Lower Manufacturing Costs
■ Nonwovens
■ Calendering
Our in-house engineering
development team has specialists
from a wide range of disciplines,
with access to world-class
optical materials from our
With NDC Technology,
NDC Optics business unit.
there is no need for an
NDC customers also benefit Analytical Chemist to
from the support offered by our
project engineering team, constantly adjust,
applications engineering
laboratory and a Customer Care
operate and maintain
organization with resources in the system
key locations around the world.
NDC
USA
Keeping an eye on Moisture
Optics
Bringing NIR Measurement to the
Plant
Process
Moisture content is a critical param-
eter for ensuring product quality and
performance in tablet manufacturing.
Currently this is measured at intervals
off-line, providing only limited snapshots NDC OPTICS
of the process. NDC Infrared Engineering
manufactures its own opti-
On-line NIR alternatives can help achieve cal components to ensure that
more efficient drying and better process every analyzer achieves optimal
visualization by delivering, for example, performance for its application.
absolute moisture content in real time for
The company’s NDC Optics
optimal control. It also allows operation
Division is a world-class supplier
with reduced operator exposure to
Key system features include: of coated substrates, establisehd
product by eliminating the need for
as a design and manufacturing
off-line testing.
■ automatic cleaning of the sensor-to- service for Analytical and Process
product measurement interface to Control applications for a diverse
Operations that can benefit from this
avoid unreliable readings due to foul- range of end uses including:
approach include:
ing ■ Astronomy
■ Fluid Bed Systems ■ simple calibration to the compendial ■ Medical
■ Tablet Coating Systems method ■ Research
■ multi-wavelength algorithms to ■ Industrial
Connectivity with Your Process desensitize the measurement to
Designed for robustness and optical product variations, such as particle
The NDC Optics facility uses
stability, and supported by patent, NDC’s size and colour
coating technologies such
solutions have been fully incorporated ■ fieldbus and analogue connectivity
as E-Beam Evaporation and
into drug manufacturing. for reliable inrterfacing to PLCs,
Magnetron Sputtering systems,
SCADA compliant software and other
which achieve high-precision and
common control arrangements
long-term stability to Aerospace
standards such as: MIL-C-675C
and MIL-M-13508C, within an
ISO9001:2000 framework to
rigorous standards.
Real-time moistuRe output in Fluid Bed dRying
Drying Profile: Lactose/MCC/PVP
16 70
NDC moisture
14
60
profile showing
Actuator
Outlet % RH / Product Temperature
12
correlation with Powder Line 50
MOISTURE
10
LOD tests made at 40
Source Lamp 8
intervals during the 6 30
batch run 20
4
Mounting Boss
10
2
0 0
14:09:36 14:16:48 14:24:00 14:31:12 14:38:24 14:45:36 15:00:00
14:52:48
“Eye”TIME
Filter
Filter Wheel Samples
Contact Us
Next Steps...
To establish viability of incorporating an Fax to: +44 1621 856 180
NDC Pharmaceutical Control Solution
for moisture and other constituents into
Attn: Pharmaceutical Market Manager
your process, including validation
templates, we would welcome the
From:
opportunity to meet at your premises,
present our offering in more detail and
Name:
match your requirements to our
capabilities. Ideally we should also view
Company:
the production area to establish
feasibility as early as possible.
Address:
Please photocopy and complete this
form and send by fax, or email us at:
pharma@ndcinfrared.com Telephone:
Fax:
Email:
Comments:
www.ndcpharma.com
NDC Infrared Engineering is NDC Infrared Engineering Ltd NDC Infrared Engineering Inc NDC China NDC France
Bates Road, Maldon 5314 North Irwindale Avenue Tel: +86 20 8666 2790 Tel: N° Azur: 0810 600 400
represented in over 60
Essex, CM9 5FA Irwindale, CA 91706 Email: info@ndcinfrared.com.ch Email: info@ndcinfrared.fr
countries worldwide United Kingdom United States of America NDC Germany NDC Japan
Tel: +49 1801 977112 Tel: +81 3 3255 8157
Tel: +44 1621 852244 Tel: +1 626 960 3300 Email: info@ndcinfrared.de Email: info@ndcinfrared.jp
Fax: +44 1621 856180 Fax: +1 626 939 3870 NDC India NDC Brazil
www.ndcinfrared.com Email: ndcindia@ndc.com Tel: +55 11 5188 8172 / 8175
ISO9001:2000 Email: sales@ndcinfrared.co.uk Email: info@ndcinfrared.com Tel: +91 20 2543 5768 Email: info@ndcinfrared.com.br
In line with its policy of continuous improvement NDC Infrared Engineering reserves the right to revise published specifications and details of this equipment without prior notice. 00/14245-01 Iss 1 11/08