cGMP-compliant cleaning equipment

cGMP-compliant cleaning equipment
» Flexible machine design
» Validated cleaning processes
» Highest energy efficience
alphaphoenix – the team with experience
The specialists for cleaning equipment
Our experience – your competitive advantage
alphaphoenix GmbH is one of the leading suppliers of cleaning
equipment for the pharmaceutical industry. Its portfolio includes
the development, manufacture and sales of cleaning equipment, their accessories and an extensive maintenance and
service program. Internationally operating pharmaceutical
companies trust in the high quality we provide.
Thanks to more than 30 years of experience of our staff in the
production of special machinery for the pharmaceutical industry,
we are able to offer cutting-edge, innovative, high-quality cleaning
equipment.
alphaphoenix cleaning equipment impress with quality and allow
full control of the complete cleaning process. Their consumption
of energy, detergents and high-purity water is economical. The
intuitive operation of the machines, as well as their simple
integration into your production processes reduce your overhead and staff cost. The high availability of the machines and
the projectable cycle times help increase the productivity in
your company.
Besides their professional qualifications in pharmaceutical
cleaning processes, the qualities of our specialized employees
and engineers include curiosity, willingness to learn, constant
professional training and flexibility. With their passion for design,
their know-how and their creativity they find efficient solutions to
increase your benefit.
Products and core competencies
» Planning, development, production and sales of
cleaning equipment for the pharmaceutical industry
» Development and production of custom-built wash racks
for cleaning machines of various manufacturers
» Many years of experience in optimization of cleaning processes
» Pharmaceutically compliant documentations
» Maintenance, service and trainings for operating and maintenance staff
Experience | Knowledge | Expertise
Highest quality as a standard
Highest quality is one of the central values of alphaphoenix,
as it stands for reliability and safety. Thus, we only use highquality materials for the manufacture of our products. For the
components, only high-end products of renowned manufacturers
such as Endress & Hauser, GEMÜ, Hilge (Grundfos), MettlerToledo or Siemens are used.
Furthermore, our staff put their personal performance under
the company’s guiding principle ‘quality’ as well. That includes
development, design and manufacture as well as various
services, such as installation, maintenance or after sales service.
The best, cutting-edge product possible for highest customer
satisfaction – that is their aspiration and goal.”
Quality – Made in Germany
“Made in Germany” is not an empty marketing phrase to us.
It stands for highest German engineering competency:
Development, design, engineering and, above all, production, as
well as quality assurance and documentation all take place in
Germany. This ensures highest production quality, long operating
life and little need for servicing and spare parts of all products.
alphaphoenix products – from washing machines to the single
accessory – all products are entirely developed and manufactured in Germany. Also commissioning, service and after
sales are ensured by our staff. Our products stand for long lifecycles, ease of maintenance and highest reliability.
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Our cleaning equipment
Fully cGMP compliant development and design
Under the designation ‘PW series’, alphaphoenix GmbH
develops and produces washing machines for the pharmaceutical industry. The requirements of our customers are our
guidelines. Hence we produce washers in different sizes, and
individually adapt them to the building conditions of your
company’s premises - from small-parts washers for labware over
barrel cleaning systems up to cleaning equipment for IBC’s.
Our washers are suitable for all pharmaceutical production
processes. They comply with national and international
standards and regulations for quality assurance in the manufacture of pharmaceutical products, such as DIN, EHEDG,
EN, VDE, IEC, cGMP, GAMP and FDA. This ensures that our
machines and systems always meet your requirements with
regard to hygiene and production safety.
VR
PLANNING
Validation Report
URS
PQ
Performance
Qualification
User Requirements
Specification
OQ
FS
Operational
Qualification
DQ
Design Qualification
Functional
Specification
IQ
DS
Installation Qualification
Design specification
SB
System Build
Functionality | Efficiency | Profit
Design
» Mirror-polished wash chambers (Ra ≤ 0,6 µm)
» Self-draining pipework
(granted slope of > 3% at any point)
» No crevices nor dead spots
(of entire system including wash racks)
» One-door machine design or pass through system
for separation of “clean” and “unclean” sides
(horizontal or vertical sliding door)
» Highly efficient drying system with HEPA filter
» Fully rounded heating elements
for residue-free self-cleaning
Functionality
» Auto-diagnosing PLC for qualified cleaning
of the wash items
» Individually configurable wash cycles
» Conductivity measurement during final rinse
» Reliable process monitoring and documentation
of pressure, temperature, conductivity, TOC, etc.
» Safe report generation via network or printer for validation
» Eco mode for the final rinse saves up to 80 % of highly
purified water
Simple operation
alphaphoenix washers are characterized by their user-friendly,
well-structured, and therefore simple operation. The entering of
machine commands as well as the rendering of functions occurs
intuitively, whereas users can start the desired wash programs
via touch-screen, or optimize the wash process my means of
special functions.
At the end of each washing process, an automatically generated
protocol is created, which can be either printed out or retrieved
via the network. Clear displays inform the user or service
technician about the current system parameters, the machine
status or outstanding maintenance or service work. In order
to further increase the ease of use for your staff, our accessories
program includes manual as well as automatic loading and
unloading aids and equipment.
In addition to their easy operation, alphaphoenix washers
are service friendly. Various works can be carried out during
operation without the necessity of dismantling any parts.
Additionally, our systems are always secured through several
password levels: only authorized staff can change settings. This
means constant safety and transparency for you.
At a glance
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cGMP-compliant wash processes
Simple operation via touch screen
Full control over the entire cleaning process
Low consumption of energy and highly purified water
Easy integration into production processes
Easy service and maintenance
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Get reproducible, documented
cleaning processes in just
5 steps
with alphaphoenix
1.
Competent advice
Individual, holistic
| Design |
| Project planning |
| Installation |
| Qualification |
| Service |
2.
Flexible design
Machine, wash rack, software
| Maintenance |
You give us the
specifications of your
items to be washed + Room dimensions
| Facilities |
| Format parts |
| Single door |
| Pipes |
| Pass through system |
| Hoses |
| Glassware |
| Bulk containers |
| Production components |
| Filter housing |
Approval
3.
Fast manufacturing / shipping
Adherence to schedules
Fast
ROI
Return on Invest
| Lower consumption of highly purified water |
» Highest energy efficience
| Scalable, more efficient wash cycles |
» Fewer staff required
» Better planning
» No downtime
5.
Use in production
Under maximum daily strain
| Structured validation |
| Long operating life |
| Competent service |
| Easy maintenance |
| Consistent wash results |
| Documented wash processes |
| Simple operation |
Approval
4.
Proper installation / configuration
Individual optimization of wash processes
| Optimal settings |
| Many years of experience |
| Highest efficiency |
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alphaphoenix supplies solutions
Alphaphoenix gives you the opportunity for flexible, individual and cost
efficient solutions – regardless of the brand of the washing machine. By
replacing the HMI we will update your package unit and guarantee the
compatibility to your existing systems, if possible without replacing
the CPU. Even your familiar, existing software layout can be reused.
Therefore you will be able to save on additional costs, e.g. for
unnecessary retraining. If required, we unlock new functions for
you with more efficient application for users and maintenance staff.
New alphaphoenix software
Simple operation and progress display
» Migration from old software to TIA portal
» Flexible design
» New applications
(e.g. pre-direct-rinsing in rejected water, pulsing, ...)
» More efficient washing programs available
(e.g. free phase selection with up to 15 wash steps)
» Communication with higher-level systems (OPC, UP, Scada)
» Monitoring by Office PC possible for a higher
level of reliability and time efficiency
» Training and instruction on site
New operating concept and interface design
Update your
existing systems
cost-effective now!
Individuality | Functionality | Reliability
alphaphoenix wash rack
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Production according to cGMP standards
Self-cleaning coupling system
Complete documentation
Individually adapted to different wash items
Production for washing machines of various manufacturersh
Automated loading und unloading possible
Wash racks with different loading possibilities
Different modules attachable to the base frame
More detailed views and wash racks at:
www.alphaphoenix.de
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Examples of wash racks:
Filter housing,
cap, clamps
Sorting bowl
Filter tube,
bottles
10L and
20L carboys
Filter housing,
pumps, pipes
Baskets
for small parts
Small parts
and cups
Matrices,
tablet stamps
Cap,
drums
Feed unit
Filter,
small parts
Filling-line
Individuality | Functionality | Reliability
Customized
wash racks…
Besides washers, alphaphoenix also develops and produces
wash racks that are built according to your requirements. Due to
our high flexibility and extensive experience, we not only design
and manufacture wash racks for various manufacturers, but individually customize them by adapting them to your wash items.
Thus, you receive a product which can be optimally integrated
into your production environment.
Mapping of wash items
Creation of a
3D rack layout
Approval of rack layout
by the customer
Detailed engineering
Manufacturing of rack
Creation of
documentation
Quality control and
shipping
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Examples of wash racks:
Ball cleaner
Bin,
chute
Feed unit
Hose
wash rack
Bottles
100ml, 500ml
Hoses,
bottles
Barrels,
clamps
Sorting bowl
Small parts
Pans,
slides
Filling-line
Valves,
clamps
Individuality | Functionality | Reliability
… for convincing
wash results
The wash racks are made from electro-polished stainless steel.
The piping system required for the internal cleaning (≥3 % slope
is connected to the machine’s pipe system via a self- cleaning
coupling device). All wash racks are delivered to you with a full
documentation and all certificates. Our cleaning systems as well
as our wash racks are manufactured in compliance with cGMP
and FDA standards.
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S
Suited for all kinds of wash items
AR
Model
DS
For your individual processes and wash items we offer you standard models with
different-size wash chambers which we customize according to your needs.
Optimal wash zone
Usable chamber size
Overall dimensions
WxDxH
WxDxH
WxDxH
640 x 640 x 740 mm
720 x 800 x 740 mm
1400 x 1000 x 2400 mm
25 x 25 x 29 inches
28 x 31 x 29 inches
55 x 39 x 94 inches
640 x 640 x 950 mm
790 x 890 x 950 mm
1700 x 1100 x 3000 mm
25 x 25 x 37 inches
30 x 34 x 37 inches
67 x 43 x 118 inches
700 x 1000 x 950 mm
850 x 1190 x 950 mm
1760 x 1400 x 3000 mm
27 x 39 x 37 inches
33 x 47 x 37 inches
69 x 55 x 118 inches
940 x 940 x 950 mm
1090 x 1190 x 950 mm
2000 x 1400 x 3000 mm
37 x 37 x 37 inches
42 x 46 x 37 inches
78 x 55 x 118 inches
940 x 1240 x 950 mm
1090 x 1490 x 950 mm
2000 x 1700 x 3000 mm
37 x 48 x 37 inches
42 x 58 x 37 inches
78 x 66 x 118 inches
1000 x 1600 x 950 mm
2060 x 2000 x 3000 mm
39 x 62 x 37 inches
1150 x 1800 x 950 mm
45 x 70 x 37 inches
PW 1095 H
1000 x 1600 x 1150 mm
1150 x 1800 x 1150 mm
(barrel cleaning)
39 x 62 x 45 inches
45 x 70 x 45 inches
PW 6474
PW 0695
PW 0795
PW 0995
PW 0995L
PW 1095
81 x 78 x 118 inches
2060 x 2000 x 3000 mm
(3400 mm glass door)
81 x 78 x 118 (125) inches
PW 20 XL
i.e. 1500 x 1800 x 2000 mm
(Container
cleaning)
59 x 70 x 78 inches
All machines are available with a lateral sliding door; dimensions upon request
Individuality | Functionality | Reliability
custom built
According to present
facilities; loading at groundlevel also possible
alphaphoenix –
the team with experience
Safety
» cGMP-compliance as a standard
» Software design according to latest GAMP standards
» Sliding doors made of reinforced safety glass
with sensing edge as anti-trap protection
» Full monitoring of the machine for the control and
validation of cleaning processes, temperature,
water quality, pressure, time and water volume
» Precise documentation including DQ package;
weldseam documentation; electrical documentation
according to EN/ISO 60204; IQ/OQ protocols for FAT and SAT
» FDA and 3.1 certificates
» Password protected operation
» Consistent and proper washing results
» High safety of investment; high ROI, low TCO
Reliability
» Exclusive utilization of high-end components
» Auto diagnosing PLC for qualified cleaning
» Safe report generation via network or printer for validation
nature friendly
Economic
less:
- water
- energy
- detergent
Flexibility
» Modular software for cleaning cycle control
» Customized wash racks
» Individually designed cleaning systems
Ergonomics
» Easy operation via touch panel
and well-structured software
» Easy insertion of the wash rack at an
ergonomically convenient loading height
» Easy access for service without the need of disassembly
» Electrical cabinet either stand-alone or integrated
Effectiveness
» Self-cleaning coupling system for the connection of the
wash rack to the machine
» Highly efficient drying system with HEPA filter
» Plannable, shorter, as well as configurable washing processes
» Eco mode for the final rinse saves up to 80 % of highly
purified water
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Phone:
Fax:
E-Mail:
Internet:
+49 (0) 8124 445 65-0
+49 (0) 8124 445 65-99
[email protected]
www.alphaphoenix.de
0110615EN
alphaphoenix GmbH
cGMP Pharma Washers
Mühlhauser Feld 5
D - 85664 Hohenlinden, Germany