Filling_ stoppering and capping machine

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Filling, stoppering and capping machine

–	 Peristaltic	aseptic	filling	from	0.1	to	100ml
–	 No	cross	contamination
–	 Disposable	Aseptic	Fluid	Path	simplifies	validation	(DAFPA)
–	 Universal	format	parts	reduce	costs	
–	 Quick	and	easy	change-over	between	batches			

                                                   WorlD	 leADers	 iN	 AsePtic	 PeristAltic	 FilliNg
FPC50 Filling, stoppering and capping machine
Fpc50 is a highly flexible aseptic     a wide range of vials, stoppers          –	 Fast	and	easy	change-over		
filling system with integrated full    and caps. thereby, compared to           	 between	batches
or partial stoppering and crimp        other automatic filling systems,
capping of vials.                      future investments in format parts       –	 Disposable	aseptic	fluid		
                                       are significantly reduced – or           	 path	ensures	simple	cleaning		
it provides a ready-to-use and                                                  	 validation
easy to validate filling system for    more likely not necessary, at all.
small batch production for vial        change-over between various vials,       –	 High	filling	accuracy
sizes between 2ml and 100ml.           stoppers and caps can be done with-
Fill volumes range from 0.1ml          in minutes by the operator, without      –	 Universal	format	parts	for		        	
to 100ml and a filling accuracy        any special tools or technical support   	 stoppers	and	crimp	caps
of ± 0.5% can be obtained.             from staff outside the cleanroom.        –	 Vial	format	parts	are	not	needed	
the entire fluid path is designed      Fpc50 is designed to be placed
for single use making cleaning         under a laF or raBs unit and all         –	 No	special	tools	needed	for		
validation extremely simple and        materials and surfaces comply            	 format	changes
permits fast change-over between       with gmp standards for aseptic           –	 Compact	unit	on	castors	with		      	
the various liquids to be filled.      filling. the Fpc50 is also available     	 small	footprint
thus, the peristaltic filling system   in a special version, Fpc50iso,
on the Fpc50 eliminates time           which is designed for integration        –	 Special	version	for	integration	into	
consuming and costly logistic          into an isolator.                        	 an	isolator	is	available	(FPC50ISO)
procedures related to having           the Fpc50 is the perfect solution
product or volume dedicated                                                     –	 IQ/OQ	documentation	can	be		        	
                                       for small batches at contract            	 provided
pumps in stock.                        fillers and for a highly flexible
the universal format parts supplied    production for clinical trials within    –	 Standard	machine	with	many		
with the Fpc50 can be used for         r&d departments.                         	 reference	customers
Watson-Marlow	Flexicon	
Frejasvej 2–6
dK-4100 ringsted
tel. +45 5767 1155
Fax +45 5767 0541

FPC50 technical speciFications                                                                        TECHNICAL	SPECIFICATIONS

a walking beam with central adjust-              operator interface is an easy-to-             Applications:
ment of guide rails transports vials             clean touch screen and keypad.                –	Filling	and	partial	stoppering	of	
                                                                                               	 lyophilisation	stoppers
from the rotary table to the different           the control panel is integrated into
work stations. thus, no format parts             a control box, which is attached to           –	crimp	capping		
are required for the entire vial range           the machine cabinet or supplied               –	Filling,	full	stoppering	of	injection		                	
between 2ml and 100ml.                           as a stand-alone unit to be placed            	 stoppers	and	crimp	capping

Format parts for stoppers consist                at a distance from the machine.               Stoppers:	
                                                                                               Ø13	mm	and	20	mm	injection	and	
only of the chute, jaws and piston.              the touch screen has self-explana-            lyophilisation	stoppers	(samples	to	be		
Format parts for crimp caps consist              tory menus for control of machine             sent	to	Watson-Marlow	Flexicon	prior		
only of the chute and crimping head.             parameters. sensors ensure no                 to	final	quotation)

the vibrator bowl for the stoppers               vial/no fill, no vial/no stopper              Caps:
can be applied for both 13mm and                 and no vial/no cap. moreover, the             Ø13	mm	and	20	mm	flip-off	aluminium		
                                                 number of stoppers and caps in                caps	and/or	plain	aluminium	caps.		
20mm injection and lyophilisation                                                              (samples	to	be	sent	to	Watson-Marlow	
stoppers. For the crimp caps the                 the chutes is monitored. errors at            Flexicon	prior	to	final	quotation)
same vibrator bowl can normally                  the stoppering or capping stations,
                                                                                               Infeed	and	outfeed	trays:
be applied for both 13mm and                     as well as at the outfeed, will stop          Width/open	end	min.	200mm/7.9”	
20mm caps.                                       the machine automatically.                    –	max.	305mm/12”

Fpc50 has integrated support of                  it is possible to store up to 20 sets         Production	capacity
                                                 of parameters as complete                     Up	to	25	units	per	minute	depending		
nozzles for gas purging before and                                                             on	fill	volume	and	vial	size
after filling of liquid. a valve for gas         programs. the programs and the
                                                 various machine functions can be              Filling	volume:
purging is optional.                                                                           0.1ml	to	100ml
                                                 password protected.
Vials can be loaded into the machine                                                           Accuracy:
from a removable infeed tray from                preparing the Fpc50 for a new vial,           ±	0.5%	can	be	obtained	on	liquids	with		
the front or from the left side of the           stopper and cap is an easy task.              a	viscosity	like	water	and	a	constant		
machine. this allows installation of             the guide rails for the vial and the          suction	level

the Fpc50 under a laF unit or inside             position of the format parts for the          Mains:
a raBs. collection of vials takes                stopper and the cap are adjusted in a         110/230VAc	–	50/60Hz

place on a removable tray.                       few minutes by turning four handles.          Power	consumption:
                                                                                               Max.	1200W
                                                                                               Air	supply	/	pneumatic	connection:
Dimensions in mm/inch
                                                                                               Min.	5	bar	clean	and	dry	air
                                                                                               Air	consumption:
                                                                                               Max.	100	litres	per	minute
                                                                                               stainless	steel	and	anodised	aluminium.	
                                                                                               Product	and	stopper	contact	parts	in	

                                                                                               2	x	rs232	serial	communication	for		
                                                                                               balance	and	printer	
                                                                                               1	x	24V	output	signal	for	nitrogen		
                                            2397/94.8                                          purge	valve	
           656/25.8                         1552/61.1                                          2	x	external	error	for	interface	with		
                                                                                                                                                            79-401-301	issUe	2	0908		·		13608	·

                                                                                               for	example	a	particle	counter		
                                                                                               communication	with	rABs		
                                                                                               (specified	by	Watson-Marlow	Flexicon)

                                                                                               Ingress	protection:
                                                                                               iP32	for	machine	base
                                                                                               iP54	for	control	panel
                                                                  Min. = 200/7.9

                                                                  Max. = 305/12

                                                                                               400	kg

                                    Max. = 305/12
                                    Min. = 200/7.9
                                                                                               Watson-Marlow Flexicon cannot be held responsible for
                                                                                               any errors or omissions. Subject to change without notice.