Fabrice-Escourrou-optima Pharma Vials Infusion Bottles v4 en
Fabrice-Escourrou-optima Pharma Vials Infusion Bottles v4 en
Member of
OPTIMA pharma –
Leading in Quality and Diversity
Optima Pharma excels in meeting the pharma- supplying lyophilization and isolation technology.
ceutical industry’s highest expectations with
the four brands Inova, Kugler, Klee and Optima Pharma is internationally recognized by
Metall + Plastic. Optima Pharma offers a diversi- the pharmaceutical industry for machine effi-
fied and innovative portfolio of filling and pack- ciency and precise realization of complex turn-
aging machines for sterile and non-sterile phar- key projects.
maceutical liquids and powders in addition to
Contents
04 Washer
06 Sterilization Tunnel
18 Closing Machines
20 Tray Loader
22 Clean Production
30 Service
31 Contact us
2 3
Washer Washer
The Perfect Solution for Wet Cleaning
f Rotary Washers
Max. height up to 104 mm up to 75 mm up to 180 mm
Spray positions 9 – 20 10 – 25 10
Rotary Washer
Technical Data:
Type VWM 218 WMR 600 WMR 1800 WMR 2400
Fully automatic
Machine type Fully automatic continuous
intermittent
Processing sequences 8 7 6
4 5
Sterilization Tunnel Sterilization Tunnel
For all Purposes
The cleaned containers are transported through nation of hot air and infrared quartz glass heat-
the infeed, which is equipped with Laminar ers. Both of the sterile systems are designed for Sterilization Tunnel Heat sterilization of the cooling zone
Flow, into the sterilization area – the heating defined applications. The tunnels are equipped
zone. The containers are heated to a defined with state-of-the-art automation and commu- Technical Data: f Automatically lockable and heated
temperature in order to ensure secure steriliza- nication systems. This ensures detailed data re- Type SHT/SHT IR gas-tight tunnel door with sealing at the
tion and depyrogenization. Sterilization can be cording and tracing of temperatures. outfeed ot the tunnel
f
Conveyor belt width 300, 450, 600, 800, 1250, 1600
performed by means of LF-hot air, or a combi- Isolation of the cooling zone
f
Transport height 900 mm +/- 25 mm
Special fans
Filter system HEPA filters - H13/H14 f Separate closed cooling circuit with
Output up to 44,000/h. bei 10H (depending on container) recirculation pump and mixing valve for
Heating temperature output 20 – 200 KW (depending on output) the sterilizable cooling zone
Cooling power 0.3 – 15 m /h
3 f Sterilization program for sterilization
implementing
Sterilizable cooling zone Optional
6 7
Filling and Closing Machines Filling and Closing Machines
Stand Alone and Complete Turn-Key Lines Compact Line VFVM 221/231
Modular and compact designed machines ac- In laboratories and R&D the demands on tech-
cording to cGMP standards with minimum nical equipment for the manufacture of sterile
space requirement – the fully-automatic Optima and aseptic products are continuously increas-
Pharma filling and closing machines are used ing.
for a wide range of applications, are designed
for your individual needs and can be easily ret- Optima Pharma has a leading position in the
rofitted. field of sterile filling technology. To meet the
market challenges a custom-made integral so-
lution for the processing steps of:
f Washing
f Sterilizing
f Filling
f Stopper insertion
f Crimping (optional)
8 9
Filling and Closing Machines Filling and Closing Machines
Large Range, Compact Design
10 11
Filling and Closing Machines Filling and Closing Machines
Flexibility by Means of a Modular Design Our Dosing Systems At a Glance
Time pressure dosing system is the most fre- Peristaltic pumps enjoy a high preference in Disposable systems mark the future trend in the
quently installed in pharmaceutical applica- biotechnological applications. world of drug manufacturing and play a huge
tions. role in the development of new processes and
products.
Self-sucking rotary piston pumps are applied Mass flow meter is usually installed in applica- Auger filling for sterile filling of powders.
for a wide range of products. tions where product viscosity is temperature-
sensitive.
12 13
Filling and Closing Filling and Closing
Sterile Liquid and Powder
f Leading position in sterile, aseptic filling, Infeed Manual onto Conveyor belt, Conveyor belt Conveyor belt Conveyor belt Conveyor belt
freeze drying and clean room technology turn table Transport scroll, Turn table Turn table Turn table Turn table
f Custom-tailored solutions for even the most From sterilization Turn table
complex projects tunnel onto
f One-stop-shop turn table
f State-of-the-art GMP compliant machines
f Reliable, goal-orientied, efficient, innovative Filling volume 0.1–100 ml 0.1–250 ml 0.2–250 ml 0.1–15 ml 0.1–500 ml 0.1– 100 ml
and flexible (4-lane)
f Comprehensive service packages 0.1 - 100 ml
(2-lane)
0.1 - 500 ml
(1-lane)
Operators 1
14 15
Loading and Freeze Drying Loading and Freeze Drying
Sophisticated Perfect Solutions Greater benefits for the user
In 2005, Klee GmbH joined Optima. Thanks to Highlights Highlights Loading and
many years of specialization, as a brand of Op- Freeze Drying Unloading Systems
tima Pharma, Klee offers a comprehensive and
technically leading product range: f Flexible and customer focused layout f Innovative solutions tailored to the
concepts customer’s requirements, e.g. a loading cart
f Sterilizable freeze drying plants for the phar- f Shelves which display an extremely even freely mobile in a room
maceutical industry – from high-tech pilot temperature distribution f Loading row by row, shelf by shelf,
plants to highly efficient production plants. f Fully automatic filter test units (WIT) frame by frame
A seamless scaled version of the pilot plant f Steam sterilization at 1.5 bar f Fully automatic handling of vials, ampoules,
to a full size production plant is guaranteed. f H2O2 sterilization syringes and magazines
f Fully automatic loading and unloading sys- f Clean In Place (CIP) with a cleaning process f Isolator or RABS technology
tems for vials, ampoules, syringes or bulk that can be validated
loading; also in connection with RABS or iso- f Visualization with Klee Lyomatic and
lator technology. standard applications
f Upgrades of machines not fulfilling state-of- f Modem support /remote control
the-art technology or those who are no lon- f Processing of solvents in compliance with
ger up to date with the current regulations. ATEX directive
f Consulting, training, service, and mainte-
nance.
16 17
Closing Machines Closing Machines
Fine Tuned for your Product and Containers
f Stopper insertion
f Crimping
f Screwing
f Insertion of droppers, spray pumps
and pipettes
f Placing of press-on caps
Technical Data:
Type VVM 211 VVM 3000 VVM 4000 VVM 7000 VVM 2400
Operators 1
Space requirements 0,7 m2 0,8 m2 (without 1,4 m2 (without 1,4 m2 (without 1,6 m2 (without
convey or belt, sorting convey or belt, sorting convey or belt, sorting convey or belt) sorting
and feeding devices) and feeding devices) and feeding devices) and feeding devices
are integrated
18 19
Tray Loader Tray Loader
Supplementary Machines to Handle Vials
Advantages
Technical Data:
Type M 2412 M 2424
Number of trays 2 4
No nesting
Traying possibilities Semi nesting
Full nesting
Output
(depending on container diameter Max. 12,000 pcs./h Max. 24,000 pcs/h
and tray coniguration)
20 21
Clean Production Clean Production
Triple Protection
To restrict the operator access to the process System description / technical module Possible operation parameters
area, our filling machines can be provided with The technical module consists of high-quality f Air speed
RABS equipment as an option. The restricted ac- stainless steel materials and is located above f Pressure regulation (option)
cess is in this case achieved by glove systems, the protection module. It contains the comple- f Air temperature (option)
and mock-up studies are used to determine in te technical air equipment, such as ventilators, f Humidity
advance the gloves‘ positions. filters, cleanroom illumination and air distributi-
on diaphragm.
Ventilation concept
The required process air is taken from the ma- Protection module
chine environment and filtered by means of a The protection module consists of high-quality
HEPA filter. Variable speed-controlled ventila- stainless steel materials. Doors, windows and
tors supply constant air volume to the unit. Air other functional elements are integrated into
distribution is achieved by means of a plastic the modular sectional framework, as required
diaphragm, which ensures uniform air distribu- for the individual machine. Intervention in the
tion in the protected area with little turbulence. protection module is achieved by means of
glove accesses that are integrated into the glass
doors (tempered safety glass (ESG)).
22 23
Turnkey Line Solutions
INOVA WM 12, SHT 12, VFVM 18000, VVM 2428 with outside washer,
KLEE Freeze dryer, M+P Isolator
Vial Ø Output
15
M+P Isolator
up to
24 mm 24.000/h 14
16
12 13
Features 13
9 11
- Cold loading via nitrogen curtain
- Empty vial inspection 7 14
- 5 double stacked peristaltic pumps
15
- Oxygen less than 1% 6 8
- Processing of toxic products 16
10
Production process
4 1 Product infeed, Vials 9 IPC
2 Washer 10 Sorting bowl for stopper
3 3 Sterilizing tunnel 11 Stopper insertion
4 Infeed turn table 12 Reject
5 Transport 13 Freeze Dryer
6 Product infeed 14 Crimp module
7 Dosing system (peristaltic pumps) 15 Outside washer
2 1 8 Filling station 16 Traying
24 25
Turnkey Line Solutions
INOVA WMR 2400, SHT 13, VFVM 18000, VVM 2428, 2 x RALUT, 2 x Klee Freeze Dryer D-30
Features
- Two Dosing systems:
- Peristaltic pumps (CIP / SIP)
- Time pressure (CIP / SIP)) 4
10
10
7 Prozessablauf
1 Rotary washer
2 Sterilizing tunnel
3 In-Process Control
6 4 CIP/SIP Cabinet
5 Dosing module: Time pressure
6 Dosing module: Peristaltic pumps
5
(optional)
3 7 Stoppering module
8 Capping machine
9 RABS
1
10 Freeze dryer, RALUT
2
26 27
Processing Line for Vials under Isolator
INOVA WMR 600, SHT 19 S, VFVVM 7042, EVK 7000
Prozessablauf
1 Rotary washer
2 Sterilizing tunnel
3 In-Process Control
4 Dosing module
5 Stoppering station Filling and Closing Machine
6 Capping module
7 Reject 1 f 4+2-lane peristaltic pump dosing
8 Vial coding unit system
9 Reject f 100% IPC
f Redosing, Restoppering,
3
10 Traying
Recapping, Repressing
3 f Rake transport system
f Disposable product path outside 10
of isolator
f Pump outside of isolator, therefore
9
M+P Isolator
Machines changeover time of product contact
parts is max. 15 minutes f Cleanliness class ISO 5
f Rotary Washer, model WMR 600 f Print verification via camera f Integrated material transfer
f Sterilization tunnel, model SHT 19 f Non-circular cap verification chamber (MTC)
f Filling and closing machine, via camera f Integrated M+P H2O2
model VFVVM 7042 f Stopper height verification generator RG 4
f Vial coding unit, model EVK 7000 via camera f Catalytic aeration process
28 29
Service Contact Us
A Comprehensive Service Program The Safety of a Strong Partner
30 31
Since we are constantly working on finding new ways to optimise our state-of-the-art machines, the texts, illustrations and figures in this prospectus are not binding and exemplar.
More information:
www.optima-pharma.com
10405381/4/EN