cGMP-compliant cleaning equipment » Flexible machine design

» Validated cleaning processes

» Highest energy efficience

The specialists for cleaning equipment

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 equip-ment, their accessories and an extensive maintenance and service program. Internationally operating pharmaceutical companies trust in the high quality we provide.

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 over-head and staff cost. The high availability of the machines and the projectable cycle times help increase the productivity in your company.

Our experience – your competitive advantage

Thanks to more than 30 years of experience of our staff in the pro duction of special machinery for the pharmaceutical industry, we are able to offer cutting-edge, innovative, high-quality cleaning equipment.

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.

Experience | Knowledge | Expertise

alphaphoenix – the team with experience

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 high- quality materials for the manu facture of our products. For the components, only high-end products of renowned manufacturers such as Endress & Hauser, GEMÜ, Hilge (Grundfos), Mettler-Toledo 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 manu- factured in Germany. Also commissioning, service and after sales are ensured by our staff. Our products stand for long life-cycles, ease of maintenance and highest reliability.

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Under the designation ‘PW series’, alphaphoenix GmbH develops and produces washing machines for the pharma- ceutical 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 pharma ceutical production processes. They comply with national and international standards and regulations for quality assurance in the manu-facture 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.

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

Functionality | Efficiency | Profit

Our cleaning equipment

Fully cGMP compliant development and design

PLANNING

PQ

OQ

DQ

IQ

URSUser Requirements

SpecificationPerformance Qualification

VRValidation Report

FSFunctional

SpecificationOperational Qualification

DSDesign specification

Des

ign

Qua

lifica

tion

Installation Qualification

SBSystem Build

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

» 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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5 steps with alphaphoenix

Approval

Get reproducible, documented cleaning processes in just

| Design |

| Project planning |

| Installation |

| Qualification |

| Service |

| Maintenance |

You give us thespecifications of your

items to be washed

| Format parts | | Pipes | | Hoses | | Glassware | | Bulk containers | | Production components | | Filter housing |

Room dimensions

| Facilities || Single door | | Pass through system |

+

2.

3.

1. Competent advice Individual, holistic

Flexible design Machine, wash rack, software

Fast manufacturing / shipping Adherence to schedules

5 steps with alphaphoenix

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Approval

Get reproducible, documented cleaning processes in just

| Optimal settings || Many years of experience || Highest efficiency |

Use in production Under maximum daily strain

| Structured validation | | Long operating life || Competent service || Easy maintenance || Consistent wash results || Documented wash processes || Simple operation |

| Lower consumption of highly purified water | » Highest energy efficience

Fast ROIReturn on Invest

| Scalable, more efficient wash cycles | » Fewer staff required » Better planning » No downtime

4.

5.

Proper installation / configurationIndividual optimization of wash processes

Fast manufacturing / shipping Adherence to schedules

Individuality | Functionality | Reliability

alphaphoenix supplies solutions

» 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

Simple operation and progress display

New operating concept and interface design

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

Update your existing systems cost-effective now!

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

Individuality | Functionality | Reliability

Examples of wash racks:

Sorting bowlSorting bowl

Filter housing,pumps, pipes

Filter housing,cap, clamps

10L and20L carboys20L carboys

Small partsand cups

Matrices,tablet stampstablet stamps

Cap,Cap,drumsdrums

Feed unitFeed unitFilter, small partssmall parts

Filling-line

Filter tube,bottlesbottles

Basketsfor small parts

Customizedwash racks…

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Besides washers, alphaphoenix also develops and pro duces 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 in-dividually customize them by adapting them to your wash items. Thus, you receive a product which can be optimally integrated into your production environment.

Quality control and shipping

Mapping of wash items

Creation of a 3D rack layout

Detailed engineering

Approval of rack layout by the customer

Manufacturing of rack

Creation of documentation

Individuality | Functionality | Reliability

Examples of wash racks:

Bin,chute

BottlesBottles100ml, 500ml

Ball cleaner

Hosewash rack

Barrels,clampsclamps Sorting bowl Small parts

Pans,slidesslides Filling-lineFilling-line

Valves,clamps

Feed unitFeed unit

Hoses,bottles

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.

… for convincing wash results

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Suited for all kinds of wash items

Optimal wash zone W x D x H

Model Usable chamber size W x D x H

Overall dimensions W x D x H

Individuality | Functionality | Reliability

For your individual processes and wash items we offer you standard models with different-size wash chambers which we customize according to your needs.

S

AR

DS

PW 6474

PW 0695

PW 0795

PW 0995

PW 0995L

PW 1095

PW 1095 H (barrel cleaning)

PW 20 XL(Container cleaning)

640 x 640 x 740 mm 25 x 25 x 29 inches

720 x 800 x 740 mm 28 x 31 x 29 inches

1400 x 1000 x 2400 mm 55 x 39 x 94 inches

640 x 640 x 950 mm 25 x 25 x 37 inches

790 x 890 x 950 mm 30 x 34 x 37 inches

1700 x 1100 x 3000 mm 67 x 43 x 118 inches

700 x 1000 x 950 mm 27 x 39 x 37 inches

850 x 1190 x 950 mm 33 x 47 x 37 inches

1760 x 1400 x 3000 mm 69 x 55 x 118 inches

940 x 940 x 950 mm 37 x 37 x 37 inches

1090 x 1190 x 950 mm 42 x 46 x 37 inches

2000 x 1400 x 3000 mm 78 x 55 x 118 inches

940 x 1240 x 950 mm 37 x 48 x 37 inches

1090 x 1490 x 950 mm 42 x 58 x 37 inches

2000 x 1700 x 3000 mm 78 x 66 x 118 inches

1000 x 1600 x 950 mm 39 x 62 x 37 inches

1150 x 1800 x 950 mm 45 x 70 x 37 inches

2060 x 2000 x 3000 mm 81 x 78 x 118 inches

1000 x 1600 x 1150 mm 39 x 62 x 45 inches

1150 x 1800 x 1150 mm 45 x 70 x 45 inches

2060 x 2000 x 3000 mm (3400 mm glass door) 81 x 78 x 118 (125) inches

i.e. 1500 x 1800 x 2000 mm 59 x 70 x 78 inches

custom built

According to present

facilities; loading at ground-

level also possible

Individuality | Functionality | Reliability

All machines are available with a lateral sliding door; dimensions upon request

alphaphoenix – the team with experienceSafety » 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

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

nature friendly Economic

less:- water

- energy

- detergent

purified water

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0110

615E

N

alphaphoenix GmbHcGMP Pharma WashersMühlhauser Feld 5D - 85664 Hohenlinden, Germany

Phone: +49 (0) 8124 445 65-0Fax: +49 (0) 8124 445 65-99E-Mail: info@alphaphoenix.deInternet: www.alphaphoenix.de