guaranteed reliability optima equipment for pharmaceutical · optimized operation costs f assurance...
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EXCELLENCE IN PHARMA
OPTIMAGuaranteed Reliability
Equipment for Pharmaceutical Freeze Drying
For the most stringent pharmaceutical requirements
More security for your product
Sensitive pharmaceutical products
often need to be freeze dried to extend
shelf life. The Klee brand provides
solutions for all requirements with its
broad range of machines. From high-
tech pilot plants up to high efficiency
production plants for vials, syringes,
ampoules as single units or in bulk.
Optima Pharma’s modern
manufacturing site is state of the art.
All the required media for the different
processes are available: Clean steam,
CIP water and liquid nitrogen. The
construction, commissioning and FAT of
the freeze drying unit takes place in our
split level facility. Freeze drying units
can be installed, tested and operated
under real conditions, saving time and
money for qualification (IQ/OQ) and the
final site installation (SAT).
Innovative forward-looking technologies
With a policy of continuous improvement
in quality management, (EN ISO9001) Op-
tima Pharma commits to the high stan-
dards set by the pharmaceutical industry.
Optimized and standardized processes
ensure professional project handling. As
a technology leader, Optima pharma uses
the latest simulation and calculation
tools to optimally design and construct
the units to your specific requirements.
Respective tests are carried out by our
technology department. Close
cooperation with leading universities and
technical colleges gives us edge on train-
ing, research and development which is
actively supported by Optima.
OPTIMA pharma
For over 25 years, Optima pharma has been providing one of
the world’s most diverse and innovative range of machines for
filling and packaging of pharmaceutical and diagnostic
products. Filling of sterile and non-sterile liquids and powders,
pharmaceutical freeze drying and isolator containment
technologies are the core competencies.
The broad spectrum of technical design details in the
equipment cater towards optimal solutions for human and
veterinary medicine, clinical diagnostics, pharmaceuticals
and biotech products.
Optima pharma is a constituent part of the OPTImA packaging
group GmbH, which operates worldwide and with over 1900
employees and 13 foreign subsidiaries.
Process based
3D engineeringTurnkey
integrationQuality assurance
IQ/OQ/PQ
Phase-oriented
project managementOn-site support
MIlesTOnesMIlesTOnes
1993 Founding of Klee GmbH
2005 Klee GmbH becomes part of the Optima Group
2007 Construction of the new manufacturing and administration facility in Gladenbach–mornshausen
25 years
Process development
µbar
2 3
Optional. Built for the future. secure investment.
f Pre-configured for performing controlled nucleation
f Wireless temperature measurement (TEmPRIS)
is possible
f ATEX / High potency drugsmass spectrometry
f H2O
2 sterilization
f CFD simulation
(Computational Fluid Dynamics)
f Smoke studies
f Individualized tests
Integrated sCADA system
f Extendable to the complete production line
f multiple PC stations possible
f Flexible recipe management via SImATIC Batch
for freeze dryers
f Audit Trail
f Autodidactic interface
f Easy to understand batch reports
f Comfortable review of historic trends and alarms
f High scalability
f Simple connection to on-site IT-systems
f GAmP 5
f Programming according to ANSI/ISA-88
f FDA ZI CFR Part II compliant
f Tailored to the high expectations in the
pharmaceutical industry
shelves – „The contact to the product“
f Solid construction in 316L
f Highest quality surfaces finishes
f Narrow tolerance
f Save and ergonomic construction
f mesh reinforced stainless steel flexible
hoses “mADE IN GERmANY”
f Highly accurate guidance and positioning system
of the shelves
f mass reduced pressure table in
“frame structure” design
f Homogenous temperature distribution
Process technology
for effective freeze drying
f Optimized cooling coils for compressors,
liquid nitrogen (LN2) and oil
f Effective CIP cleaning in accordance
with the stringent VDmA guidelines
f modern and environmentally friendly
cooling media
f Effective vacuum systems (dry and oil sealed),
also for ATEX applications
f Sterilizable aeration system, including
automated filter test (2 filters)
f High output CIP system with frequency
controlled pump technology
f Heat exchanger in the drain system
to reduce the waste water temperature
and shorten the sterilization time
f Heating and cooling system for the shelves
f Individually adjusted units
secure. efficient. Fast.
f Optima proven technology for a secure product
f Guaranteed quality with comprehensive
“all-in” testing prior to shipment
f Reduced energy consumption
f Reduced process time with experienced
and intelligent process engineering
f Shortening of the cleaning procedure
(turnaround time)
Guaranteed safety
Pharmaceutical Freeze Drying
4 5
Type CCompact
Type s Single Floor
Type DDouble Floor
Modular designHigh degree of flexibility with standardized modules
shelves
Surface area
(m²)< 2 2–10 10–20 20–30 > 30
Shelf
dimensions
(mm) 620 × 620
620 × 920 920 × 1220 1220 × 1520
1520 × 1820920 × 920
1220 × 1220 1520 × 1520
1220 × 1520 1520 × 1820
Temperature
range-60°C to +80°C
Temperature
distribution
1°C per shelf (-40°C / +40°C)1,5°C per shelf package (-40°C / +40°C)“
Heating rate 1,5°C/h (0°C / +40°C) 2,0°/h (-55°C / 0°C)h
Cooling rate 1,0°C/h (+20°C / -40°C)
Chamber / Condensation Unit
Type P C,s C,D,s C,D,s D,s
Codes PED, ASME U-Stamp, SELO (China), KOSHA (Korea)
CIP Nozzles and spray heads – ribolavin test according to VDMA guidelines
SIP 1,5–2,0 bar(g) / 127–134°C
Surface Area < 2 m2 2–10 m2 10–20 m2 20–30 m2 > 30 m2
Ice Capacity
(kg/24h)< 50 50–150 150–300 300–500 > 500
min.
condenser
temperature
-75°C (compressor) / -120°C (LN2)
Cooling rate +20°C to -40°C in < = 20 min
Flexible Chamber Design
f Chamber and condenser in a
single casing or vessel
f Space saving
f Integrated intermediate valve
f Optimized for “multiples” concept
f Capable of push/pull and pass
through loading
f Optimized for installation in
existing facilities
f manual or automatic loading
possible
f Condenser separated from
chamber
f Intermediate valve as separate
component
f Flexible arrangement of
components
f manual or automatic loading
possible
f Customization and integration
into building architecture
f Intermediate valve as
independent component
f 2-floor installation
f Service door on the side is
possible (in case of pass through
loading/unloading)
f Customization and integration into
building architecture
Service door
Door-in-Door
Subdoor
Top view
1 × Service door for loading
and unloading
Principle: manual and semi-automatic
Use: Vials and frames
1 × Door-in-door for loading
and unloading
Principle: manual and semi-automatic
Use: Vials and frames
1 × Service door,
1 × Subdoor for loading and unloading
Principle: Semiautomatic,
fully automatic
Use: Vials and frames
1 × Door-in-door,
1 × Subdoor for loading and unloading
Principle: Fully automatic
Use: Vials
1 × Service door on the side
2 × Subdoor for loading and unloading
Principle: Fully automatic
Use: Vials
f manual loading
f Up to 2m² shelf space
f Customizable for
integration to site
architecture
f Configurable for
future technologies
(mass Spectrometer,
Controlled Nucleation)
f Optional CIP / SIP
Type PPilot Plant
6 7
VWM VFVM
GT GT
VVM
VWM
sHT
Freeze Dryer
Your needs are our focus
The design of new plants and the
refurbishment or upgrading of
existing plants is dependent on
many factors. Process requirements,
product characteristics and your spatial
limitations are all being considered
during design. The desired level of
automation (manual, semi-automatic
or fully automatic) is a key factor in
the selection of the loading system.
Optima pharma ofers exactly the
right solution for your requirements.
manufacture, test, installation and
commissioning of loading and
unloading systems and freeze drying
units can be performed at the facility in
mornshausen.
loading and Unloading system
loading and unloading systems to meet your unique requirements
Row-based systems
Loading and unloading take place row
by row. The items are fed and a row of ×
number of items is prepared and then
pushed in its entirety into the freeze
drying system. During unloading, each
row is individually removed and then
transferred to the next machine.
Frame-based systems
Loading and unloading take place
frame by frame. The items are arranged
into vial packs and loaded into frames,
which can then be loaded and
unloaded in the machine. During
unloading, the frames are removed, the
vial packs are unloaded and the items
are fed to the next machine.
shelf-based systems
The items are pregrouped in a large
pack with exactly the same dimensions
as a mounting plate in the freeze drying
system. This pack is then loaded into
the machine in a single step and then
unloaded again in a single step. The
packs are then removed and fed to the
next machine.
Toolless format changeFully automatic removal of empty vialsLoading row by row ATEX design Loading of the freeze dryer from one side
ADVAnTAGesADVAnTAGes
f modular construction f Toolless format changes f Standardized software modules f Turnkey
sample facilitiesLinear – double L-shape configuration
Vial-Washing Maschine Vial Filling and Stoppering Machine Freeze Dryer Loading System
Freeze Dryer Unloading System
Vial Sterilization and Depyrogenation Tunnel
Vial Capping Machine
Vial Outside Washing Machine
8 9
2 31 4
service
Contract
service
Process reliability is also a question of
service. Even the best machines and
lines are subject to a certain extent of
wear. With our team of experts and the
worldwide available service network of
the Optima Pharma, you will reduce the
risk of machine downtime to a
minimum. Additionally, a 24-hour
hotline as well as an extensive spare
parts supply within a very short time
are at your disposal. Electronic spare
parts catalogs, comprehensive technical
documentation and operating
instructions as well as
the teleservice,
facilitate the
competent handling
of trouble-shooting.
Service already starts
when commissioning
the machine.
The Optima Pharma offers you training
specifically adapted to your
requirements. Incidentally, it is not
always necessary to invest in new
machinery. Innovative machine
upgrades and individual retrofitting
packages of the Optima Pharma
upgrade your machines to the state-of-
the-art. Ask us for a service package
meeting your requirements.
It will be our pleasure to assist you.
A Complete service Program
service Contract
Training
service contract
shelf temperature
distribution
measurement
sterility assurance
distribution
measurement
Remote support
Calibration of
pressure, vacuum,
temperature and
conductive sensors
Training
Modiications,
modernization,
retroits
spare parts
service Activities
spare p
artsTraining
Preventive
24
/7 s
erv
ice In
spe
cti on
f Tailored service package
f Flexible – from basic service, to mo-
difications, online monitoring, and
complete process optimization
f Maximum output with
optimized operation costs
f Assurance and control
of the service budget
f Advance planning of service
f On-time execution of service
Inspection and service
of the freeze dryer,
PC systems and loading
and unloading
f General freeze drying
process and process
boundaries
f Training on automation
f Customer specific
properties
f Creation of specific
maintenance plans
and SOPs
f Process optimization
and adjustment of
process parameters
f Workings of the freeze
dryer in-situ
f Service and preventive
maintenance
f Corrective measures
f Learning the main
functions of the
freeze dryer (SCADA)
f Batch and recipe
management
(Batch Control Center)
f Using the HmI
f Fault analysis corrective
measures
f Preventive maintenance
according to the
operation manual
f Basics of freeze drying
and equipment
f Basic training of
equipment operation
f Error diagnosis
f Basic service and
maintenance
f Safety features
leVel 4
Expert Training
leVel 3
Technician Training
leVel 2
Operator training
leVel 1
Basic training
EFFICIENCY THROUGH TRAINING
f Increasing uptime with specially trained machine operators
f Faster fault analysis with trained technicians
f Effective communication through knowledge base
f Reduced cost thanks to planned preventive maintenance
maintenance
10 11
MAINTENANCE FREEZE DRYER
MASCHINE NO.: PR2250096 YEAR OF MANUFACTURING: 2015
VERSION 1.0 Summary Seite 1 von 37
Plan created / adapted by: Optima Pharma Date:
Work executed by: Optima Pharma Date:
Executed Work aprroved by:: Customer Date:
Module Maintenance done? Date / Signature
Ja Nein
1) Compressor 1
2) Compressor 2
3) Compressor 3
4) Cooling Unit 1
5) Cooling Unit 2
6) Cooling Unit 3
7) Circulation fluid System
8) Heater
9) Jacket Cooling System
10) Chamber inner Parts
11) Exchange all wear Parts
12) Run short automatic cycle
service
Preventive Maintenance of the Freeze DryerKeeping stable processes up to date with regular maintenance intervals
Everything in sight: Preventive maintenance checks and
takes into account all components of the freeze dryer. New
and future needs are taken into consideration for upgrades.
spare Parts serviceSafety in every process step
Optima pharma commands a large spare parts stock and ofers fast
service. Individual concepts for stocking spare and wear parts are a
further cornerstone of equipment reliability.
scope of services
f Information on cost and delivery
of spare parts
f Personalized consultation for first
set of spare parts and of wear parts
f Parts catalog on CD-ROm
f Fast service for manufactured parts
f Guaranteed quality
scope of Delivery
f Equipment-specific documentation
for inspection and service
f Equipment specific documentation
for PC-Service
f Preventive exchange of defined
wear parts
f Identification of the most critical
replacement parts prior to
maintenance or inspection
f Standardized scope and
reproducible processing
f Re-qualification (calibration) of
measurement systems
f Assessment of electrical and
mechanical functions
f Identification and review of
required repair and maintenance
requirements
f Identification of deficiencies
and risks
f Consideration of „Lessons Learned“
f Shelf temperature distribution
measurements, sterility assurance
distribution measurements
Professional maintenance ensures that
your freeze dryer remains up to date for
current and future needs. Our team of
qualified and experienced service
personnel can make recommendations
for suggested and required modifications.
12 13
CIP/SIP
µbar
Modern building infrastructurefor the installation and operation of the
units under real conditions. Single floor
as well as dual floor units can be built
and installed to mimic the architecture
of the final site, thereby allowing
simulation of potential conflicts prior to
site installation. The installation /
de-installation as well as the transport
is fully prepared in the factory. The units
are shipped in sealed trucks. This
ensures optimal delivery at the
installation site and speeds the
installation on-site, saving valuable
time to commissioning and production.
Loading and Unloading Systems Isolator/RABS Freeze Dryer
system Integration – Closely Coordinated
Pharmaceutical Freeze Drying
14 15
OPTIMA pharma GmbH
Otto-Hahn-Str. 1
74523 Schwaebisch Hall
Tel.: +49 791 9495-0
Fax: +49 791 9495-2610
www.optima-pharma.com
OPTIMA pharma GmbH
Vor dem Langen Loh 8
35075 Gladenbach-mornshausen
Tel.: +49 6462 91576-0
Fax: +49 6462 91576-148
www.optima-pharma.com
MeTAll + PlAsTIC GmbH
Bodmaner Str. 2
78315 Radolfzell-Stahringen
Tel.: +49 7738 9280-0
Fax: +49 7738 9280-10
www.metall-plastic.de
OPTIMA Packaging Machinery PlC
7 Loader Close
Kings Worthy
Hampshire SO23 7TF, Great Britain
Tel.: +44 1962 620898
Fax: +49 791 506 6500
www.optima-gb.com
OPTIMA Packaging France s.A.R.l.
Zone d´Activités de l´Energie
4, rue Ampère B. P. 9
59559 Comines Cedex, France
Tel.: +33 320 6306-48
Fax: +33 320 6306-41
www.optima-fra.com
OPTIMA Machinery Corporation
1330 Contract Drive
Green Bay, WI 54304, USA
Tel.: +1 920 339-2222
Fax: +1 920 339-2233
www.optima-usa.com
OPTIMA packaging
machines, s.A. de C.V.
San Jorge 198
Col. Pedregal Santa Úrsula
Del. Coyoacán
C.P. 04600 méxico, D.F. méxico
Tel.: + 52 55 5421-0271
Fax: +52 55 5610-4452
www.optima-mex.com
OPTIMA do Brasil Máquinas de
embalagem ltda.
Rua Joana Foresto Storani, 500
13280-000 Vinhedo - SP, Brazil
Tel.: +55 19 3886-9800
Fax: +55 19 3886-9810
www.optima-bra.com
OPTIMA India packaging machines
Pvt. ltd.
Unit 110, 1st Floor, Brigade Rubix
Plot No. 20, HmT main Road
Bangalore – 560 013, India
Tel.: 91 80 29724090
www.optima-ind.com
OPTIMA Japan Co. ltd.
362 Shimizu-cho
Kawaramachi-dori
Nijio-agaru, Nakagyo-ku
Kyoto 6040911, Japan
Tel.: +81 75 223-1588
Fax: +81 75 223-1595
OPTIMA KOReA CO., lTD
SUITE 1107, 6 WIRYESEONG-DAERO,
SONGPA-GU, SEOUL, KOREA, 138-827
Tel.: +82 2 414 7105
Fax: +82 2 414 1908
www.optima-kr.com
OPTIMA Packaging Machines
(shanghai) Co., ltd.
No. 695 Fengmao Road
malu Town, Jiading District
Shanghai 201801, China
Tel.: +86 21 6707 0888
Fax: +86 21 6707 0889
www.optima-cn.com
OPTIMA PACKAGInG MACHInes
(M) sDn. BHD.
5008 A 1st Floor
Jalan Lunas, Batu 2.5
09000 Kulim, Kedah
malaysia
Tel.: +60 4 495 1619
Fax: +60 4 495 1697
www.optima-mal.com
OPTIMA pharma GmbH
Vor dem Langen Loh 8 | 35075 Gladenbach-mornshausen | Phone +49 6462 91576-0 | Fax: +49 6462 91576-148 | [email protected] | www.optima-pharma.com
more information:
www.optima-pharma.com
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