FILL-FINISH

SOLUTIONS
FOR FLEXIBLE AND MULTI-PRODUCT MANUFACTURING
Table of contents
STERILE FILL-FINISH OPERATIONS
FOR READY-TO-USE COMPONENTS 2
SOLUTIONS FOR PRE-STERILIZED
PRIMARY PACKAGING HANDLING 4
INJECTA: THE QUEEN OF QUALITY 6
STERI LIF3: READY TO FILL 12
STERIFILL RS SERIES: SIMPLIFYING FILL-FINISH DESIGN 18
 ST E R I L E F I L L- F I N I S H O P E R AT I O N S

CENTRAL GOAL IS TO ACHIEVE FLEXIBLE

PRODUCTION IN A SAFE, ASEPTIC
ENVIRONMENT, IMPLEMENTING COST-SAVING
SOLUTIONS TO REDUCE TIME-TO-MARKET.

MEETING THE CHANGING DEMANDS FOR PARENTERAL PRODUCTS

The pharmaceutical industry has been progressively embracing injectables as a consistently
profitable business sector. The recent industry shift to biologics and biosimilars has further
contributed to establish a growing market for injectables and supporting technologies, leaving
injection as the only practical route for the delivery of macromolecules and biologics in particular.

For decades, injection has been largely limited to in-patient use.

The introduction of prefilled syringes and injection devices has reduced the fear factor
associated with outpatient injections and also minimized the likelihood of errors in preparing and
administering a subcutaneous injection.

With the development of new parenteral products and specialised therapies for small patient Cartridge size
populations and the increasing trend for user-friendly and safer self-administration systems, pre-
filled syringes and ready-to-use (RTU) components, are becoming the preferred solution among 3ml - 20ml
the different parenteral dosage forms.
Therefore, pre-filled syringe and cartridge-based injectables have evolved into a manageable dosing
strategy for a variety of medical conditions.

The steady growth of these next-generation, targeted therapies for parenteral delivery and relevant
dosing forms have both helped increase the demand for aseptic fill-finish operations. As fill-finish
processes represent the last step prior to product packaging, all operations are critical and failures
in the integrity of the fill-finish stage can cause potential risks regarding contamination or drug
degradation.

For these reasons, the pharmaceutical industry requires increased implementation of specialised
capabilities and of emerging robotized technologies to create a new set of sterilization, handling
and filling challenges, so as to improve product quality and manufacturing efficiency.
Vial size
2ml - 50ml
4
F O R R E A DY-TO - U S E CO M P O N E N T S

Meeting this growing demand for multi-product, fill-finish

operations, IMA Life has designed and implemented a flexible and
reliable “medium-to-low production batch” machine portfolio for
the filling and closing of a wide range of ready-to-use disposable
components:

◾◾ INJECTA, the ultimate, innovative, fully robotic fill-finish

machine for RTU components pre-arranged in nest & tub or
trays.
Syringe size
0.5ml - 20ml ◾◾ Steri Lif3, fully automatic aseptic filling, stoppering
and capping machine using robotics for handling RTU
components pre-arranged in nest & tub.

◾◾ Sterifill RS Series, automatic filling and stoppering machine

for handling RTU components pre-arranged in nest & tub.

Nest and Tub size

up to 160 pcs
5
 S O L U T I O N S F O R PR E - ST E R I L I Z E D

Tub debagging & relevant transfer to the isolated area

FULLY AUTOMATIC OPENING OF

STERILE PRIMARY PACKAGES:
A HIGH DEGREE OF AUTOMATION
At IMA Life, the fully automatic opening of sterile RTU packages is
performed by dedicated six-axis robots, which take care of all the
critical aseptic operations.
The primary packaging feeding area is usually surrounded by a
cRABS area, separating the nearby isolated processing area.

After a pincer device performs pick-up, the overwrapped tub is

automatically transferred to the cutting station, where the overbag
is opened by a robotic cutting arm.
In case the primary package is supplied in a double bag configuration
(inner + outer bag solution), a double cutting station is installed. The
cut is made by keeping the bag flaps in a closed and fixed position.

After cutting, the package is instantly transferred by an internal

transfer port to the isolated, processing area. To preserve the sterility
of the tub, the bag flaps are opened by the suction cups, only when
the tub is physically transferred to the isolated area. If required, after
unwrapping, the tub can be moved to the decontamination unit
Liner and lid disposal (e-beam sterilization). The whole tub-opening unit is completely
robotized and no operator intervention is required.

A robotic de-lidding station removes the TyvekTM covering sheet

from the top of the tub and disposes of it.
The internal liner is then automatically removed from the opened
tub, and disposed of. The tub top perimeter edge can be pre-heated
by a dedicated warming station, on request.

6
P R I M A RY PAC K AG I N G H A N D L I N G

Automatic bag-cutting Inner bag manual cutting under laminar airflow hood

SEMI-AUTOMATIC OPENING OF STERILE

PRIMARY PACKAGES: A PERFECT MATCH
BETWEEN AUTOMATION AND HUMAN
INTERVENTION
As an alternative, the primary packaging handling can be performed
semi-automatically or in part manually.
In the first case, with the semi-automatic procedure, the operator
places the sealed package on the cutting station. The overbag is
then automatically cut and the tub is automatically transferred
to the following station. The overbag is removed manually and
disposed of by the operator. Using gloves, the operator removes
the Tyvek™ lid and liner and disposes of all the scraps.
In the second case, again using gloves, the operator places the Outer bag manual cutting under Laminar airflow hood
sealed package onto the cutting station.
After positioning the overwrapped tub on the cutting station, using
gloves, the operator performs cutting manually and subsequently
pushes the tub gently onto a sloped chute towards the separate
processing area, taking care of overbag removal and disposal.
Furthermore, still with gloves, he removes the Tyvek™ lid and liner
and disposes of all the scraps.
In both cases, the surrounding area is normally confined beneath
Restricted Barrier Systems or under a laminar airflow hood,
providing a better degree of product quality assurance.

Manual de-lidding and linear removal under isolator

7
INJECTA: THE QUEEN OF QUALITY

INJECTA meets the current need to deliver a

varied product portfolio in terms of primary
packaging materials (such as vials, cartridges
and syringes for parenteral use) as expected
by the latest market requirements.
INJECTA’S FULLY ISOLATED ROBOTIC TECHNOLOGY DISRUPTS
THE CONVENTIONAL APPROACH TO ASEPTIC PROCESSING
In aseptic processing, operators are the primary source of INJECTA inbuilt “combi” configuration guarantees a whole, contained
contamination. Although human operators figure in a potentially integrated production system with no use of interchangeable
risky activity in sterile areas, pharma manufacturing remains production modules to adjust production processes. Injecta is
predominantly human. flexible and precise in terms of quality. It works with multiple primary
Therefore, one of the focal topics for pharmaceutical manufacturing packaging components. Its design is intrinsically modular and meets
today is how to improve the use of robotic automation in a gloveless, multiple requirements from small-scale clinical trial batches up to
isolated environment. The ideal outcome is the creation of a digitally medium-high production levels.
controlled aseptic process with little to no human intervention.
Single-use materials such as ready-to-use primary containers,
To achieve maximum possible improvement in safety and disposable inner/outer bags, etc. are disposed of within the system.
productivity, INJECTA’s full fill/finish process is completely Its advanced design allows faster setup and efficient product
based on robotics operating in a closed, gloveless, isolator changeover, involving therefore a faster VHP cycle development
environment. with respect to conventional isolated lines.
Whereas conventional attempts to use robots are typically confined Results are reduced filling line downtime, expanding capacity and
to just one step of production, i.e. simply for moving vials from increasing flexibility.
station to station or for removing the cover from a tub of nested
containers, INJECTA uses the full potential of its robots.

INJECTA is designed as a whole, exploiting all robotic capabilities in

an integrated system. Kawasaki’s seven-axis robot arms are designed
for the lowest particle shedding.
They are resistant to positive/negative and high pressures and fully
compatible for decontamination using H2O2 vapours.
INJECTA’s specialised robots not only provide precise, consistent
INJECTA TRACES THE ROADMAP
handling activities, but also offer a high level of flexibility: they
are completely digitally controlled with Industry 4.0 capability. FOR A REAL AND
No human intervention is required: all activities/issues are solved COMPLETE FILL-FINISH
through robot interactions. PROCESS MODERNIZATION
 INJECTA

By embracing and adopting

new robotic technologies
throughout all production
operations, from outer/inner
bag opening to the stoppering
station, INJECTA allows for
a very smooth production
process, drastically reducing
human interventions and
therefore cross-contamination
risks.

Advanced robotic handling

THE STRATEGY OF FLEXIBILITY

Benefits at a glance of INJECTA’s fully isolated robotic fill-finish operations:

◾◾ high flexibility for multi-product and multi-format handling enabling rapid switches
between different drugs and product primary packaging

◾◾ high versatility: the RTU containers can be accurately and efficiently filled and
closed in a nest or by de-nesting operations. The robotised individual component handling
solution (i.e. de-nesting configuration) is ideal for high-level quality control requirements

◾◾ improved protection of the fill-finish process and cross-contamination risk reduction

with gloveless barrier isolation systems

◾◾ perfect integration with IMA “6-sided” isolator with reduced shell width and positive
impact on space ergonomics

◾◾ asynchronous robotic movements, allowing single operation completion

◾◾ all-in-one, unique and integrated fill-finish solution: in-line lyophilisation process

and capping operations for vial handling

◾◾ compliance with industry 4.0 requirements for interconnected production data:

data accessibility, circulation and exchange by integrated automation platform.

10
Filling & 100% check-weighing Nest pick-up

ASEPTIC FILLING AND 100% STOPPERING AND REJECTION

IN-PROCESS CONTROL The stoppering process is performed using a linear stopper feeding
If flexibility is crucial for high-value and medium-low production system. Unlike conventional systems, this innovative group is
batches, INJECTA is naturally born to be flexible. It can easily made of small-sized components ideal for RTP transfer, in
combine and perform robotized fill-finish operations both in-nest compliance with Annex 1 requirements in terms of the sterilisation
and in de-nesting configurations. process.
As a de-nesting solution, INJECTA’s flexible handling units allow All adjustments regarding speed, height and stroke are ensured by
for precise removal of the components from the nest. As a result, the HMI and relevant data are stored in the recipe.
individual components (2-6 or up to 10 at a time) are filled, check- In case of individual, non-conforming products, INJECTA performs
weighed, stoppered and then replaced into the nest, in case the single rejection from the nest (in the case of a nested
of syringes and cartridges, or transferred by a conveyor belt to solution) safeguarding the whole processed nest & tub or, in de-
complete the process . nesting configuration, rejecting the single non-conformities after
In both solutions, an in-line nozzle carrier performs filling with a stoppering.
bottom-up movement. All adjustments (speed, height and stroke)
are directly arranged by HMI and all data are consequently stored
inside the recipe.
The number of loading cells used to perform 100% check-weighing
depends on the number of filling nozzles fitted to the machine.
INJECTA can be set for 1 or 2 filling groups for clinical trials of small
production batches and for 6 or 10 filling groups for high production
demands. It can be equipped with peristaltic or volumetric dosing
pumps, which are driven by the same system, ensuring a production INJECTA’s ground-breaking innovation is
speed of up to 10,000 pcs/min (referred to 1ml syringes).
The use of peristaltic pumps is becoming more common in
the 100% IPC of all processed products,
the aseptic environment as they are fitted for handling recently with single rejection of individual non-
developed biotech drugs. conformities, while ensuring high machine
performance
INJECTA

Robot overview

Stoppering

INTEGRATED (VIAL) CAPPING UNIT

AND DOWNSTREAM CONNECTIONS
WITH FREEZE DRYERS
INJECTA can be integrated with an in-line lyophilisation process,
where an automated Loading/Unloading system handles products
into and out of the Freeze Dryer.

When all filled and closed RTU containers are finally processed, the
following operations are performed automatically:
• in the case of syringes and cartridges, the filled nest is
re-inserted inside the tub and then moved to the next step.
• in the case of lyo vials, a dedicated conveyor moves
the pre-stoppered vials to a downstream automatic
Loading/Unloading System and relevant Freeze Dryer.
• in the case of liquid vials or vials coming from the Freeze
Dryer, the capping operation is carried out by a separate
alu-capper. The capped vials are transferred to a dedicated vial
collection system and then moved to the next step. The empty
nest and tub will exit the machine via a separate outfeed.
Single reject from the nest

INJECTA KEY FEATURES:

◾◾ easy access to filling and stoppering areas from both sides of
the machine

◾◾ set for 1-2 filling groups for clinical trial batches or 6 - 10

filling groups for high production demands

◾◾ operating units (filling, IPC & stoppering) situated in a remote

location away from the product path

◾◾ revolutionary 100% in-line process control, with single

rejection of individual non-conformities. Statistical IPC on
request

◾◾ use of a linear stopper feeding system, avoiding particle

generation from vibratory bowls

◾◾ full integration with robotic or semi-automatic upstream

primary package handling

◾◾ empty tub/tray transfer performed at robot base level

without the use of conveyors.

13
 STERI LIF3: READY TO FILL

STERI LIF3: READY TO FILL

STERI LIF3 is a fully automatic aseptic filling, stoppering and (vial) aseptic model and relevant handling mechanisms. As a result, it
capping machine for the processing of ready-to-use syringes, vials can offer faster and gentler processing of different products, giving
& cartridges. the flexibility to easily change the process or the type of container
Combining essential features with an innovative robotic technology, being filled, with no operator intervention. As a result, reducing
it efficiently responds to the increasing market demand for a highly the operation steps and advancing production control, STERI LIF3
variable production process. If current market trends in aseptic fill- improves production efficiency.
finish are requiring more and more agile manufacturing strategies,
STERI LIF3 allows the adoption of unique fill-finish equipment STERI LIF3 has been specifically conceived to provide for the highest
for different container formats with easy and fast change of the aseptic assurance. It can easily work under isolation technology
packaging/format (syringes, vials & cartridges). or, depending on the application requirements, be integrated
in a Restricted Access Barrier System (RABS) or even under a
Flexible and multi-product fill-finish operations are becoming more conventional room with a laminar airflow hood. Being completely
crucial due to changes in the pharmaceutical industry where most isolated from the outside, there is no human intervention, no glass-
of the new injectables require a delivery model that is patient- to-glass contact, no product conveyors or rotary tables that can
centric, safe and cost effective. That happens best with a closed generate any potential risks to the product.
robotic filling system which reduces the sources of contamination It is for all these reasons that STERI LIF3 is the ideal solution to meet
risk and consequently maintains the sterility of the equipment and the current market need for small batch flexibility.
of the finished drug product.
STERI LIF3 robotic system can offer the necessary flexibility, ease of
Inspired by the advancements in robotics, STERI LIF3 provides an use and sterility assurance required to process high-value drugs into
automated, filling and closing process overcoming the traditional multiple formats.

STERI LIF3 ROBOTIC ARMS

OFFER REPEATABILITY WITH
THE FLEXIBILITY TO EASILY
CHANGE THE PROCESS OR
THE TYPE OF CONTAINER
BEING FILLED.

14
 Fully automatic nest pick-up arm Filling station

BENEFITS AT A GLANCE OF STERI LIF3’S ROBOTIC FILL-FINISH OPERATIONS:

◾◾ increased flexibility: unique fill-finish equipment for different containers

◾◾ easy and fast change of the packaging/format with minimal/no size changeover

◾◾ increased quality: absence of glass-to-glass contact during operations

◾◾ reduction of operator intervention: minimisation of cross contamination risks

◾◾ easier and more effective maintenance and cleaning

◾◾ fewer operation steps and advanced operational control: less exposure time of the drug
product to the aseptic environment and product handling optimisation.

15
 STERI LIF3

100% In-Process Control

FILLING OPERATIONS AND IN-PROCESS CONTROL

The Ready-To-Use components are provided pre-sterilised and The dosing needles are provided with a self-centring, adjustable
configured in nests inside tubs, holding up to 120 vials/160 syringes device and servo-driven, vertical movement for bottom-up dosage.
or cartridges each. Standard-sized nest & tub configurations allow The micrometric dosage volume adjustment is servomotor-driven
for the greatest stability and product safety: all containers are and is controlled via the operator panel. All values are stored inside
securely fixed during handling and transportation. the product recipes. 

Once the nest is picked up from the tub and loaded on the nest- After filling is completed, the two RTU components are moved
holding support by the robotic arm, two single RTU components on to the two weighing cells by the robotic arm, for gross check-
are de-nested and transferred to the two loading cells to perform weighing completion. Electronically controlled scales calculate
the tare check-weighing. the effective net weight of each single component, by difference
between tare and gross weight.
The two de-nested RTU components are moved on, by the robotic The IPC system controls the automatic self-adjustment of the
arm, to the filling station. STERI LIF3 is set for 2 filling groups ensuring dosing, within the pre-set tolerance limits.
a production speed up to 1,200 pcs/hour. Multiple dosing options
are available such as volumetric or peristaltic pumps. The pumps
are fitted in line and accessible from machine operator side.  The
single-use filling systems (i.e. peristaltic pumps) are preferred in
presence of a time-intensive CIP/ SIP (cleaning in place, sterilising in
100% OR STATISTICAL
place) process, which is available on demand. CHECK-WEIGHING SYSTEM

16
Stoppering unit

STOPPERING
After In-Process Control is accomplished, the two single RTU
components are picked up and moved to the stoppering station.
STERI LIF3 is provided with a standard “venting type” stoppering
station complete with an AISI 316L vibrating bowl and a dedicated
linear chute for stopper orientation and insertion into each
component.
Stoppering is performed by a dedicated tube and pin insertion. As
optional, vacuum stoppering for RTU syringes can be installed.
An automatic discharge system, discharges the single non-
conformities due to incorrect weight or missing stopper.
 STERI LIF3

Vial transfer to the separate capping station

INTEGRATED (VIAL) CAPPING UNIT AND DOWNSTREAM CONNECTIONS

In the case of vial processing, the two stoppered RTU components When all filled and closed RTU containers are finally processed
are automatically transferred towards the integrated capping and re-arranged inside the nest, the following operations are
station, which is installed in a separate area. automatically performed:
The capping pick-up and placement onto the RTU vials is carried
• in the case of RTU syringes, cartridges or non-lyo vials,
out by the robotic arm.
the filled nest is re-inserted inside the tub and then moved to
During capping operations, the vials rotate against the idle roller to
the next step
minimise particle generation. All operations are servo-driven and
automatically adjusted by HMI. • in the case of lyo vials, a dedicated device moves the
The adjustment control of the capping force is available as an pre-stoppered lyo vials to a downstream automatic Loading/
optional feature. Unloading System and relevant Freeze Dryer. Capping operations
are subsequently carried out by a separate capping station.
The capped vials are finally collected onto a dedicated
vial-collection system and then moved to the next step, in the
secondary packaging. The empty nest and tub will exit the
machine via a separate outfeed.

18
Alu-capping

STERI LIF3 KEY FEATURES

◾◾ extremely precise filling operations for high product yield
◾◾ capping station segregated from filling and stoppering area
to avoid cross-contamination
◾◾ 100% and statistical IPC
◾◾ multiple dosing options at up to 1,200 pcs/h
◾◾ easy upgrade with fully robotic or semi-automated upstream
primary package handling
◾◾ completely brushless driven
◾◾ integrated capping station for vials
◾◾ ideal for exposure to H2O2 sanitisation
◾◾ compact design

19
 STERIFILL RS SERIES: SIMPLIFYING FILL-FINISH DESIGN

STERIFILL RS SERIES: SIMPLIFYING FILL-FINISH DESIGN

Amongst the several parenteral dosage forms available on the In order to address patient safety and dosing accuracy, as main
market for the development of a new drug product, pre-sterilised issues for injectable administration, IMA Life offers a highly flexible
syringes are on the rise and have become a preferred format. and reliable solution to meet this market demand with its STERIFILL
The ongoing biopharmaceutical boom has contributed to promote RS Series.
the growth of the pre-filled syringe market. Actually, pre-filled
syringes can address the numerous issues linked to biologic drugs as The STERIFILL RS Series has been specifically designed for the filling
they are easy to use, ensure a high dosing accuracy and contribute and stoppering of  nested, pre-filled syringes. It is also suited to
to minimising product loss, which is another major advantage handling all other pre-sterilised Ready-To-Use container formats, such
when it comes to expensive biopharmaceuticals. as vials and cartridges, for medium to small production batch sizes.
Companies targeting biologics and biosimilars face a new frontier The STERIFILL RS series allows for flexible methods of production for
in development and manufacturing, as these drugs are complex, injectable pharmaceuticals, providing the necessary agility and ability
diverse, and difficult to produce. to allow faster filling operations with minimal changeover time.
This complexity is promoting the adoption of modern methods
and more flexible technologies to improve production quality and
manufacturing efficiency.

SIMPLIFYING ITS FILL-FINISH DESIGN,

STERIFILL RS SERIES ENSURES AN EASY
AND AGILE HANDLING OF NESTED GLASS
COMPONENTS, PRESERVING STERILITY
REQUIREMENTS

Sterifill RS Series under an isolation system

20
Sterifill RS Series automatic denesting at infeed

The broader shift in the pharmaceutical market from blockbuster ISOLATORS ARE BECOMING INCREASINGLY
drugs to specialised, targeted therapies intended for small patient
COMMON AS THEY CONSISTENTLY
populations is creating a need for fill-finish operations with flexible
capabilities. Actually, a multi-product, small-batch aseptic filling
SEPARATE THE ASEPTIC AREA FROM ITS
machine must be flexible to constantly keep up with the changing SURROUNDINGS
demands for new drug-delivery systems and/or packaging types
(e.g. vials, cartridges, pre-filled syringes), offering at the same time The diverse considerations related to sterile fill-finish manufacturing
a cost-saving solution as well as reduced lead times for installation.  such as the safeguard of equipment sterility, protection against
Meeting the changing demands for sterile fill-finish operations, the contamination of the container and of the drug product itself,
STERIFILL RS Series allows for: make it especially critical to install a proper containment solution.
• increased automation in fill-finish operations, reducing many of The STERIFILL RS Series has been specifically conceived according
the potential sources of contamination risk to cGMP and FDA regulations to work under isolation technology
or Restricted Access Barrier System (RABS) or even under
• implementation of single-use technologies, such as peristaltic
conventional rooms with a laminar airflow hood.
pumps, which is cost-saving (no need to clean and validate
In a nutshell, the STERIFILL RS Series offers the highest possible
the components that come into contact with the product)
flexibility in a very compact space, handling different primary
and also a time-saving solution (no need for intensive CIP/SIP
packaging types and combining semi-automatic or fully automated
processes), both improving machine availability and reducing
processes. The primary package infeed can be either manual or
production time
semi-automated, so as to accommodate a variety of packaging
• fully automatic 100% in-process control, which definitively formats. Hence filling is fully automated.
improves the quality of the filling process
• easy integration with different containment solutions.
STERIFILL RS SERIES

In case of viscous products or in the presence

of air bubbling during dosing due to product
features, a special vacuum filling system can
be integrated. Before filling, the air is vacuum-
sucked to allow the product to reach the
bottom of the container, avoiding air bubbling.
All product contact parts are made out of
AISI 316 L STERIFILL RS is fully equipped with
servomotors to drive all machine mechanisms
in order to achieve maximum flexibility in
handling and in filling accuracy.

Fillng

BENEFITS AT A GLANCE OF THE STERIFILL RS SERIES

AUTOMATIC FILL-FINISH OPERATIONS:
◾◾ traditional filling concept combined with the highest
flexibility: unique fill-finish equipment for different
containers

◾◾ easy and fast change of the packaging/format with minimal/

no size changeover

◾◾ high degree of automation: minimum operator intervention

and reduction of cross contamination risks

◾◾ high stability and safeguard of the RTU components: all

containers are securely fixed and kept inside the nest during
the entire process

◾◾ compact, ergonomic and simple design: easy access,

maintenance and cleaning.

Fillng detail
 CIP/SIP system is available
on request. In this case, all
product contact parts can
be cleaned and sterilised
without removing them from
the machine.

Manual nozzle positioning for CIP mode

FILLING: ALL STEPS IN A HIGHLY AUTOMATED PROCESS

The ready-to-fill, pre-sterilised syringes or other components are supplied and handled in nests,
placed inside tubs, holding up to 120 vials/160 syringes or cartridges each.
The operator will manually remove the outer bags, the lid and the liner over the tubs, and then
take the syringe nest and place it on a central plateau placed outside the machine working area.
As an option, the machine can be equipped with automatic extraction and positioning of the nest
on the plateau and with the automatic re-insertion station to place the nest back in the tub. This
solution ensures easy handling of glass components, preserving sterility requirements.

Once the nests are positioned under the filling station, filling is performed at 2 or 5 units at a
time ensuring a production speed up to 4,800 pcs/hour with 2 filling pumps. The dosing station is
equipped with 2 or 5 filling groups, i.e. rotary piston pumps either in ceramics, driven by servomotor
or other single-use filling systems, typical of aseptic operations such as peristaltic pumps. The
filling volume is automatically defined by the machine, according to the recipe and the sizes stored
in the HMI.
The filling needles enter the RTU component without any contact with the container. Nitrogen
gas purging can be achieved during the filling and stoppering operations, on demand.

23
 STERIFILL RS SERIES

IN-PROCESS CONTROLS ARE

AN IMPORTANT FACTOR IN
FURTHER IMPROVING THE
QUALITY OF THE FILLING
PROCESS

100% or Statistical IPC: weighing cells detail

FULLY AUTOMATED 100% STERIFILL RS SERIES KEY FEATURES:

AND STATISTICAL
◾◾ set for 2 or 5 filling groups
CHECK-WEIGHING SYSTEM
In the case of 100% or statistical in-process ◾◾ peristaltic or volumetric pumps for dosing accuracy
control, two or five empty RTU components
(depending on the numbers of dosing units)
are automatically extracted from the nest
◾◾ fully automated 100% or statistical in-line process control
by a pushing device. Then a mechanical
arm, driven by servomotors, places them ◾◾ vacuum filling system to avoid air bubbling, for specific/
onto the individual two or five weighing viscous products
cells for tare check-weighing. After filling,
the RTU components are extracted again
◾◾ high flexibility to fill and close nested components with fast
and replaced on the weighing cells for gross
check-weighing completion. changeover times
Electronically controlled scales calculate
the effective net weight of each single ◾◾ simple and agile solution for small-scale manufacturing
component, by difference between tare and
gross weight. ◾◾ easy upgrade with a fully robotic or semi-automatic
The IPC system controls the automatic self-
adjustment of the dosing, within the pre-set upstream primary package handling.
tolerance limits.

24
Stoppering

STOPPERING STATION
The stoppers are fed by means of a vibratory bowl and a linear
chute: a pick & place arm picks the stoppers up (2 or 5 at a time)
transferring them in position, over the components. The stoppers
are then internally inserted to a depth which is automatically
defined by the machine, according to the recipe and the sizes
stored in the HMI. All stopper contact parts are made of AISI 316.
Like the filling process, the stoppering operation is performed, while
all RTU components are safely arranged and kept inside the nest.
Even during stoppering, in the event of air bubbling, the stoppering
operation is performed after air extraction by vacuum suction.

When all filled and closed RTU containers are finally processed and
automatically re-arranged inside the nest, the following operations
are automatically performed:
• in the case of RTU syringes, cartridges or non-lyo vials, the
filled nest is re-inserted inside the tub and then moved to the next
step, in the secondary packaging
• in the case of lyo vials, a dedicated device moves the pre-
stoppered lyo vials to a downstream automatic Loading/
Unloading System and relevant Freeze Dryer. Capping operations
are subsequently carried out by a separate capping station. The
capped vials are finally collected onto a dedicated
vial-collection system and then moved to the next step, in the
secondary packaging. The empty nest and tub will exit the
Stoppering detail machine via a separate outfeed.

25
 TECHNICAL DATA

INJECTA OPTIONAL UNITS: INJECTA

◾◾ peristaltic pumps or volumetric filling Automation Fully robotic automated

Footprint 3000 x 1100 x 2080 [L x W x H]
units for high dosing accuracy
IPC 100% at full speed
Format range vials Ø 16 – 42.4 mm
◾◾ Nitrogen Gas Purging Unit
Output vials up to 9800 pcs/h
Format range syringes 0.5 – 20 ml
◾◾ Vacuum Filling System for viscous
Output syringes up to 11000 pcs/h
products to avoid air bubbling Format range cartridges 3 ml
Output cartridges up to 7000 pcs/h
◾◾ vacuum stoppering

◾◾ statistical IPC

◾◾ CIP/SIP system INJECTA, Nested version for pre-filled syringes

4150

8130

INJECTA, Combi version with double bag opening, 100% IPC under isolation technology
5850
SINGLE REJECT

14900

26
 STERI LIF3 OPTIONAL UNITS STERI LIF3
Automation Fully robotic automated
◾◾ 100% and statistical IPC Footprint 3000 x 1100 x 2080 [L x W x H]

◾◾ vacuum filling and vacuum stopper IPC 100% at full speed

Format range vials Ø 16 – 42.4 mm
insertion
Output vials up to 1000 pcs/h
◾◾ CIP/SIP systems Format range syringes 0.5 – 20 ml
Output syringes up to 1200 pcs/h
◾◾ open RABS, closed RABS or isolator Format range cartridges 3 ml
technology Output cartridges up to 500 pcs/h

◾◾ 21CFR part 11 compliance

STERI LIF3, with Manual Primary Packing Feeding STERI LIF3, with Automatic Primary Packing Feeding

5350
2030

1690
7380

STERI LIF3, with Automatic Primary Packing Feeding and Lyo Loading/Unloading
7600

7900

27
 TECHNICAL DATA

STERIFILL RS OPTIONAL UNITS Sterifill RS-P5 Sterifill RS-P2

Automation Fully automated
◾◾ automatic extraction and re-insertion
Footprint 1600 x 1900 x 2080 [L x W x H] 1360 x 1785 x 2080 [L x W x H]
of the nest from/into the tub IPC 100% & Statistical
Format range vials Ø 16 – 42.4 mm
◾◾ Nitrogen Gas Purging Unit Output vials up to 8,700 pcs/h up to 4,200 pcs/h
Format range syringes 0.5 – 20 ml
◾◾ Vacuum Filling System for viscous
Output syringes up to 11,400 pcs/h up to 4,800 pcs/h
products to avoid air bubbling Format range cartridges 3 ml – 20 ml
Output cartridges up to 3,900 pcs/h up to 1,750 pcs/h
◾◾ statistical and/or 100% IPC

◾◾ CIP/SIP system

◾◾ pre-arranged for barrier technology:

easy integration with cRABS or
Isolation System

◾◾ 21 CFR Part 11 compliance

Sterifll RS-P5, with fully automated bag and tub opening, under isolation technology
3400

7520

Sterifill RS-P2, with semi-automatic bag and tub opening under cRABS
1400
750
800

1200

800 680
850 770
1900
1100
1400

1500
900

680

28
IMA LIFE IN THE WORLD

Group Headquarter:
IMA LIFE division
ASEPTIC PROCESSING & FREEZE DRYING SOLUTIONS
Via Emilia, 428/442
40064 Ozzano Emilia - Bologna - Italy
Phone +39 051 6514111
Fax + 39 051 6514821
Calenzano Production Facility:
Via Petrarca, 34/38/40
50041 Calenzano - Firenze - Italy
Phone +39 051 883231
Fax + 39 051 8879745
[email protected]

North American Regional Headquarters:

2175 Military Road
Tonawanda, NY 14150 USA
Phone +1 716 6956354

Asian Regional Headquarters:

No.3 JianAn Street, BDA - Yizhuang,
100176 Beijing,
People’s Republic of China
Phone: +86 10 59623866 899

IMA LIFE Japan K.K.:

Kuramae Sanyo Bldg. 7F 2-42-5
Kameido - Koto-ku - Tokyo 136-0071 -
Phone: +81 (0) 3 5626 9151
Fax: +81 (0) 3 5626 9158

European Service Centre:

De Leest 3
Dongen, 5107 RC, The Netherlands
Phone +31 162383500

European Service Centre:

IMA LIFE division
Via Piero della Francesca, 26
20090 Trezzano sul Naviglio - Milano - Italy
Phone +39 02 36566993

[email protected]
[email protected]

Lyomax, Lyofast, Minifast, FusionTM - Fusion PlusTM, SafeTherm HXTM

are registered trademarks of IMA Life.

For information on the IMA subsidiaries

and sales offices, visit our website:
www.ima-pharma.com (contacts section)

29
 April 2019 - 991ZS120100
www.ima-pharma.com

IMA S.p.A. reserves the right to make any changes to the described machine characteristics.

IMA S.p.A.
IMA LIFE division
Via Emilia 428-442 - 40064 Ozzano dell’Emilia (Bologna) - Italy
Tel. +39 051 6514111 - Fax +39 051 6514666
[email protected] - www.ima.it