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                      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

				
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