Process Systems Pharma
Welcome to the WALDNER Corporate Group For more than one century WALDNER has been setting standards. For the benefit of our customers our business divisions take advantage of our cross-border capabilities. With their size and their involvement 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 Machines Process Systems Water Technology WALDNER Labor- und Schuleinrichtungen GmbH 2
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 contamination-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 filters. 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 development and planning to the realization of turnkey 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 integration into your production process we consider a project as a success. Experienced engineers and technicians are at your disposal for the qualification 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. 3
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 installation of preparation and pressure vessels, pressure filters 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 according to your specifications. 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 finish of glass bead blasting, the coating with e.g. PTFE up to mechanical polishing or electropolishing 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 passivating 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 factory acceptance test with tests like e.g. non-destructive material testing with X-ray fluorescence, surface roughness test or CIP-cleaning certificate using riboflavin test. Our quality- and environmental management system is certified 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-certificate and are therefore optimally prepared for all markets. 4
Mobile preparation vessels Mobile preparation vessel with WALDNER port for docking at the isolator. 5
100 liters mixing vessel Pressure filter casing with WALDNER central locking Single-layer pressure filter / nutsche filters When handling expensive or toxic products in a pressure filter, 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 filter bottom and vessel shell without any leakage. Of course we also deliver our filters with standard locking systems. Both the filter bottom and head can be lowered or lifted and are laterally slewable. 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. Mobile preparation vessel at filling panel 6
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The shown In Process Control (IPC) isolator can be operated from two sides and offers place for the different test devices which are necessary in the tablet production. Isolators 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 filtration, drying and weighing, becomes difficult. For this reason isolators are more and more prevalent in production, laboratories and pilot plants. An isolator separates the active agent and its environment contamination-free and requiring a minimum of space and protects personnel and product to the same extent. The custom-made Process Systems isolators and full containment solutions enable safe, flexible 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 diversified 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 filter change H 2 O 2 sterilization for sterile isolators Locks with interlock function Monitored inflatable sealings for front glass panes and sliding doors WALDNER glove tester CIP / WIP cleaning systems Halar coating WALDNER inertization system 8
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. 9
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Preparation isolator with docking for pressure vessel This isolator with deco-chamber and with integrated freeze dryer offers highest operator protection during the work with highly active substances. Thanks to their excellent cleanability, Process Systems isolators can be applied for various products. Cross contamination is eliminated, and you remain flexible. Optimum, contamination-free product handling means avoiding interfaces. Combinations between isolators and other WALDNER Process Systems products as e.g. pressure- and preparation vessels, pressure filters or vacuum dryers provide new perspectives. WALDNER isolators verifiably reach an Occupational Exposure Limit (OEL) of far below 0,1 µg / m³. On request the complete qualification 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 sterilization 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. This isolator offers a contamination-free docking of pressure vessels, so that a WALDNER preparation vessel can perfectly be combined with the isolator. 11
Package Unit in cgmp-conform design with 1,0 m 2 -VTP-vacuum dryer for the gentle drying of pharmaceutical substances. Drying Technology Warmly recommended by numerous customers. Drying has established in the pharmaceutical and chemical industry as a versatilely applicable procedure for many decades. Above all in the pharmaceutics high GMP and FDA-demands have to be fulfilled 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 available 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 pharma design our vacuum dryers of the series VTP are the high-end-product among our vacuum tray dryers. The cgmp-conform construction is characterized by heated shelves, which are integrated seamless into the cabinet back wall. It is designed for small and mediumsized 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 12
Vacuum circulating air dryer for the intermittent drying of pharma products 13
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 mediumsized and large drying areas up to 30 m² they are above all predestinated for the use in production plants. The VTWvacuum 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 first 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 complete and flexible system, which enables the operator to carry out the process steps filling, drying, emptying and cleaning on locally independent stations. The mobile vacuum contact dryers with an operating volume of 10 350 liters have the following characteristics: Contamination-free product transfer from the centrifuge to the filling container cgmp-conform design according to the FDA-guidelines Gentle, effective drying with contemporaneous homogenizing by fixed 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 solventwet 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 HEPAfilters 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 flow over the trays In special construction also deliverable as vacuum circulating tray dryer Circulating air tray dryer HW-6 in hygienic design for the drying of highly active substances. Vacuum drying lines with VTW-vacuum dryer for the production drying with product temperature measurement and a surface of 15 m². 160 liters MVK substance container docked at the drying station 14
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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. 17
Stackable round container with manhole in the top bottom Mobile container with agitator, electric heating with temperature control and isolating jacket. Container 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 definitely. So for example the container 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 subjected to a standard immersion pickling bath. For quality reasons the container tank bodies are exclusively made of stainless chromium nickel steel. The frames and underframes are optionally made of stainless steel, special aluminum alloy and galvanized steel. Mixing- and turning KTC for mixer support. 18
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Hermann WALDNER GmbH & Co. KG Process Systems Anton-WALDNER-Straße 10 16 88239 Wangen im Allgäu Germany Tel. +49 7522 986-474 Fax +49 7522 986-595 www.processsystems.de processsystems@waldner.de www.inallermunde.de 0212 20