Process Systems

Pharma

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Welcome to the WALDNER Corporate Group

For more than one century WALDNER has been setting standards.

For the benefi t of our customers our business divisions take advantage of our cross-border capabilities. With their size and their involve-ment in the Corporate Group the three WALDNER companies represent stability, expertise and continuity.

Today the WALDNER Corporate Group consists of three independent companies:

WALDNER Laboreinrichtungen GmbH & Co. KG

Hermann WALDNER GmbH & Co. KG

Dosomat Filling and Closing MachinesProcess SystemsWater Technology

WALDNER Labor- und Schul-einrichtungen GmbH

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WALDNER Process Systems The complete production process from one source.

From the single unit up to complete systems WALDNER Process Systems as a business unit of the Hermann WALDNER GmbH & Co. KG offers customized procedural solutions for the pharmaceutical, chemical and food industry.

• Isolators and containments Full containment systems for the contami- nation-free handling of highly active and toxic substances (API) and isolators for sterile applications.

• Drying technology Mobile vacuum contact dryers for dust-free powder handling, vacuum tray dryers conform to GMP standards, intermittent and circulating air tray dryers.

• Vessels, skids and units Vessel technology, ranging from single preparation, pressure and reaction vessels to complete units and single-layer pressure fi lters.

• Cooking systems Batch cooking lines for the food industry, amongst others for the production of aseptic fruit preparations, jam and many more.

• Container systems Round and cubic returnable container systems in stainless steel.

Including the process measuring and control equipment our products can be combined on the basis of the modular design principle. From competent advisory service on the process devel-opment and planning to the realization of turn-key projects, we provide you with an individual service package.

A Process Systems line has an average service life of several decades and a successful, constant collaboration with our customers is our principal goal. Not after delivery of the line, but after a perfect integra-tion into your production process we consider a project as a success. Experienced engineers and technicians are at your disposal for the qualifi cation of the lines (DQ, IQ, OQ) and provide support with validation. The training of your staff, support and advisory service, as well as reliable supply of spare parts is a matter of course to us.

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Vessels, skids and units

Full of your ideas!

More than 25.000 realized projects in the world market give evidence of WALDNER Process Systems well-founded know-how in the planning, production and installa-tion of preparation and pressure vessels, pressure fi lters and special plants. A process vessel or bioreactor barely comes close to another in all its details. The optimal design is always an individual solution which is perfectly adapted to your production activities. If vertical, horizontal or suspended design, mobile or stationary – we build the vessel accord-ing to your specifi cations.

For the fabrication of our vessels and skids in addition to all stainless alloy steels we also apply the most different special alloy steels with a surface fi nish of glass bead blasting, the coating with e.g. PTFE up to mechanical polishing or electropo-lishing with a surface roughness of up to Ra < 0,2 µ. We offer you the latest welding and grinding technology, shielded arc welding, WIG / Argon-Arc or respectively Plasma and an own pickling and pas-sivating plant. We also comply with your requests regarding the size of the vessels, if fermenter in bench-scale or preparation vessel in tank scale – our production is perfectly equipped for all sizes!

Our engineers are responsible for your project from the engineering to the fac-tory acceptance test with tests like e.g. non-destructive material testing with X-ray fl uorescence, surface roughness test or CIP-cleaning certifi cate using ribofl avin test.Our quality- and environmental manage-ment system is certifi ed according to ISO 9001:2008 as well as ISO 14001:2004. We produce our vessels according to all current rules and standards like PED, AD2000, 13445, ASME, China Licence and the TR-certifi cate and are therefore optimally prepared for all markets.

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Mobile preparation vessel with WALDNER port for docking at the isolator.

Mobile preparation vessels

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Mobile preparation vessel at fi lling panel

Single-layer pressure fi lter / nutsche fi lters

When handling expensive or toxic prod-ucts in a pressure fi lter, the prevention of leakages is the principal goal.

We have the solution: WALDNER Process Systems well-proven automated central locking-system provides quick, pressure resistant sealing of the fi lter bottom and vessel shell without any leakage. Of course we also deliver our fi lters with standard locking systems.Both the fi lter bottom and head can be lowered or lifted and are laterally slew-able. According to your application we decide which is the suitable solution, if with manually operated lifting spindle, pneumatic / hydraulic or even with hinged opening-aid.

Pressure fi lter casing with WALDNER central locking

100 liters mixing vessel

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The clean solution for the pharmaceutical industry.

For many years Process Systems has been delivering isolators and containment systems for well-known companies in the pharmaceutical industry.

When it comes to the handling of highly active substances, routine work in the pharmaceutical R&D and production, like fi ltration, drying and weighing, becomes diffi cult. For this reason isolators are more and more prevalent in production, laboratories and pilot plants. An isolator separates the active agent and its environment contam-

ination-free and requiring a minimum of space and protects personnel and product to the same extent. The custom-made Process Systems isolators and full contain-ment solutions enable safe, fl exible and comfortable working.

Customized isolator systems can be composed of well proven and reliable elements.

Our isolators are ergonomically adjusted to your needs and by means of a mock-up model on a scale of 1:1 the handling in the isolator is simulated and tested before the start of production.

All modules and components are especially designed to meet the strictest GMP and

FDA requirements for the production of toxic and biologically active substances. A diversifi ed range of proven Process Systems components, including the corresponding automation is available:

• WALDNER vessel docking• WALDNER automatic Rapid-Transfer-Port• WALDNER continuous liner system• WALDNER Push-Push Filter for contamination free fi lter change• H

2O

2 sterilization for sterile isolators

• Locks with interlock function• Monitored infl atable sealings for front glass panes and sliding doors• WALDNER glove tester• CIP / WIP cleaning systems• Halar coating• WALDNER inertization system

Isolators

The shown In Process Control (IPC) isolator can be operated from two sides and offers place for the differ-ent test devices which are necessary in the tablet production.

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Isolator for the production of cytostatic. The chambers of the isolator are interconnected via sliding doors and have different pressure levels.

The WALDNER Rapid Transfer Container (RTC) can automatically and contamination-free be docked on an isolator. The containers are approved as hazardous material containers, so that they can be transported hazard-free on road, sea and in the air.

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Thanks to their excellent cleanability, Process Systems isolators can be applied for various products. Cross contamination is eliminated, and you remain fl exible.

Optimum, contamination-free product handling means avoiding interfaces. Combinations between isolators and other WALDNER Process Systems products as e.g. pressure- and preparation vessels, pres-sure fi lters or vacuum dryers provide new perspectives.

WALDNER isolators verifi ably reach an Occupational Exposure Limit (OEL) of far

below 0,1 µg / m³. On request the complete qualifi cation of the unit is planned and carried out with IQ and OQ from WALDNER. Also the execution of SMEPAC tests as proof of the OEL can be coordinated by WALDNER on request

Our sterile isolators offer perfect product protection through the integrated steriliza-tion with H2O2. Through the Laminar Flow ventilation system clean room class A is reached in the isolator. Give us a challenge: We built sterile isolators for you according to your demands.

Preparation isolator with docking for pressure vessel

This isolator offers a contamination-free dock-ing of pressure vessels, so that a WALDNER preparation vessel can perfectly be combined with the isolator.

This isolator with deco-chamber and with integrated freeze dryer offers highest operator protection during the work with highly active substances.

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Warmly recommended by numerous customers.

Drying has established in the pharmaceuti-cal and chemical industry as a versatilely applicable procedure for many decades. Above all in the pharmaceutics high GMP and FDA-demands have to be fulfi lled – this is a situation which is challenging for the technology of the drying systems.For this Process Systems offers innovative batch drying systems, which enable safe and contamination-free product handling of toxic and highly active substances.

We offer complete systems with the complete peripheral equipment such as temperature control system, vacuum pump, piping and process control. In many cases our drying units are also equipped

with WIP- or CIP-systems, which enable an automated and repeatable cleaning of the systems. The installation, the assembly and the start-up of the complete system is also included in our scope of services. Our high quality drying systems are avail-able in different stainless steel grades and special alloys like Hastelloy.

All Process Systems drying systems can be delivered in explosion-proof design according to the guideline 94 / 9 / EG (ATEX). This provides the safe drying operation with solvent based substances.

With its continuous and consequent phar-ma design our vacuum dryers of the series VTP are the high-end-product among our vacuum tray dryers. The cGMP-conform construction is char-acterized by heated shelves, which are

integrated seamless into the cabinet back wall. It is designed for small and medium-sized drying areas up to approx. 7 m² and above all is ideally suitable for the vacuum drying of API- and HAPI-products. The distinguished characteristics of the VTP-vacuum dryer-series are:

• Seamless welded construction with completely ground interior• Heated shelves welded into the back wall• All edges and corners rounded in the interior• Unlimited accessibility and optimum cleanability• Optional equipment: CIP-cleaning system, carrier gas lance • Combinable with our isolators for contamination-free product handling

Drying Technology

Package Unit in cGMP-conform de-sign with 1,0 m2 -VTP-vacuum dryer for the gentle drying of pharmaceu-tical substances.

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Vacuum circulating air dryer for the intermittent drying of pharma products

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Vacuum drying lines with VTW-vacuum dryer for the production drying with product tem-perature measurement and a surface of 15 m².

Our vacuum dryers of the series VTW are designed for high standards in the chemical and pharmaceutical industry. The heatable shelves spaces are welded into the side walls. Designed for medium-sized and large drying areas up to 30 m²they are above all predestinated for the use in production plants. The VTW-vacuum dryer-series has the following characteristics:

• Welded construction with minimal dead space • Good accessibility and cleanability of the interior• Optional equipment: WIP-cleaning system, carrier gas lance, tray carriage• Heatable shelves on request also removable separately

If the contamination-free drying of toxic and highly active substances is necessary, our mobile vacuum contact dryers of the series MVK are the fi rst choice. The core –the mobile, conical substance container with integrated agitator – is supplemented by the stationary drying station and

the lifting column. This provides a com-plete and fl exible system, which enables the operator to carry out the process steps fi lling, drying, emptying and cleaning on locally independent stations. The mobile vacuum contact dryers with an operatingvolume of 10 – 350 liters have the follow-ing characteristics:

• Contamination-free product transfer from the centrifuge to the fi lling container • cGMP-conform design according to the FDA-guidelines• Gentle, effective drying with contem- poraneous homogenizing by fi xed installed helical segment agitator• Unlimited accessibility by hinged top bottom• Excellent cleanability if required also with CIP-cleaning system

With our universally applicable circulating air tray dryers we give our customers the possibility, to dry water-wet and solvent-wet product batches convectively. They can be operated both in gas loop and in

partial fresh air operation. In the modularly designed dryers of the series HW and HC the components for the conditioning of the drying gas are integrated in the drying cabinet casing. The circulating air tray dryers with drying surfaces up to 24 m² offer the user the following advantages:

• HW-dryer in cGMP-conform design• HC-dryer can be equipped with HEPA- fi lters for supply air and exhaust air• Pharma-conform surface qualities• Tray carriages with „pickaback trolley“ for easy and comfortable handling of the product trays inside and outside of the dryer• Leak-proof door closing system with lever locks• Removable and pivoting air duct elements for optimal cleaning of the cabinet interior• Condensate recovery in the gas loop operation• Equal distribution of the horizontal gas fl ow over the trays• In special construction also deliverable as vacuum circulating tray dryer

160 liters MVK substance container docked at the drying station

Circulating air tray dryer HW-6 in hygienic design for the drying of highly active substances.

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Systems – our products combined cleverly

We deliver the made-to-measure complete lines from one source, as e.g.: preparation vessel for the production of sterile parenteralia with integrated CIP / SIP systems also with highly active agents. The control of the complete system offers high production safety and protection against misuse. Latest formalities and public authorities’ demands are considered.

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Mobile container with agitator, electric heating with tempera-ture control and isolating jacket.

Your product perfectly packed.

Safety you can rely on

You have the possibility to choose from our large range of standard products with a variety of different models. If the standard program does not offer you the requested container version, we quickly realize special solutions for you so that your special operating requirements are met defi nitely. So for example the contai-ner can be equipped with a heating jacket or also with an agitator.

In order to meet the high requirements of the pharmaceutical and the chemical industry, we offer our containers in all material and surface qualities.

In order to obtain a chemically neutral overall surface the containers are sub-jected to a standard immersion pickling bath. For quality reasons the container tank bodies are exclusively made of stain-less chromium nickel steel. The frames and underframes are optionally made of stainless steel, special aluminum alloy and galvanized steel.

Container

Mixing- and turning KTC for mixer support.

Stackable round container with manhole in the top bottom

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Hermann WALDNER GmbH & Co. KGProcess SystemsAnton-WALDNER-Straße 10 – 1688239 Wangen im Allgäu Germany

Tel. +49 7522 986-474Fax +49 7522 986-595

www.processsystems.deprocesssystems@waldner.de