transfer without compromise

Transcription

1 transfer without compromise

2 OVERVIEW INTRODUCTION Introduction alpha Ports alpha Port alpha Port 190 Removable Door alpha Port 190 Flushfloor Lowered alpha Port 190 Roto alpha Port 190 Rotating alpha Port 190 beta Parts beta Transfer Container 316L beta Transfer Container PE beta Single Use beta Liner PE - HD beta False Applications Complete pull - out - system Rail system Trolley Special designs Documentation Welcome to castus GmbH & Co. KG your specialist for a safe and uncompromising transfer with the highest standard. The core competence of our internationally active company is projecting, manufacturing and assembling Rapid Transfer Systems in the cleanroom technology sector. We offer: Double lid locks with safety interlocks (alpha Port) for a contamination-free loading and unloading regarding protection of people, environment and product Rotating Ports for better handling great quantities Transfer Containers (beta Parts) made of stainless steel or polyethylene, which safely contain the element for loading and unloading Complete pull-out-systems integrated within the beta Transfer Container, which facilitate the withdrawal of the elements Rail systems, which allow a transfer of process material over long distances within the installation in order to facilitate the process Trolleys with adjustable height for a safe transport of the beta Transfer Containers Special solutions in pharma equipment and transfer systems We are characterized by the longtime experience of our motivated staff in planning and realizing your requirements. Our vast vertical range of manufacture enables us to react promptly to the increasing demands.

3 FOR A SAFE WORK PROCESS our transfer systems ensure the separation of employee and process area ALPHA PORT The alpha Port is made of a stainless steel flange and a polyethylene door. This combination is integrated as real transfer opening into the system wall of an isolator. The safe seal between flange and door is created by a sealing. The patented Safety Interlock System prevents an improper transfer process and ensures a safe and non - compromising transfer. Usable diameter: mm Installation diameter: mm Material alpha door: PE - HD nature or PE - HD AST Main frame: 316L Seal: System: csis (castus safety interlock system)

4 ALPHA PORT 190 REMOVABLE DOOR ALPHA PORT 190 FLUSHFLOOR The alpha Port 190 Removable Door corresponds to the standard alpha Port but is usually installed if space at the workplace is limited, as it is possible to open the port entirely. The alpha Port 190 Flushfloor corresponds to the standard alpha Port. Due to its installation on ground level, it is easier to clean out, for example, pieces of broken glass. There is no overhanging edging, what makes a cleaning of the isolator easier. Usable diameter: 190 mm Installation diameter: 268 mm Material alpha door: PE - HD nature or PE - HD AST Main frame: 316L Seal: System: csis (castus safety interlock system) Usable diameter: 190 mm Material alpha door: PE - HD nature or PE - HD AST Main frame: 316L Seal: System: csis (castus safety interlock system)

5 LOWERED ALPHA PORT 190 ROTO ALPHA PORT 190 The Lowered alpha Port 190 is used to load containers within the isolator with parts in great quantities. As the containers are difficult to move, the entire docking process is executed from outside the cleanroom by the Lowered alpha Port. The hand grips are attached ergonomically to help the operator. The Roto alpha Port 190 makes the docking of a beta Transfer Container or another beta system possible, which cannot or should not be rotated. It is also used to connect two isolators. The necessary rotating movement during the docking process is executed by the Roto alpha Port. Compared with the Rotating alpha Port, the Roto alpha Port is not mounted floating (3D). Usable diameter: 190 mm Material alpha door: PE - HD Main frame: 316L Seal: System: csis (castus safety interlock system) Usable diameter: 190 mm Material alpha door: PE - HD Main frame: 316L Seal: System: csis (castus safety interlock system)

6 FOR A SMOOTH PROCESS our Rotating alpha Port for a reliable transfer of great quantities ROTATING ALPHA PORT 190 The Rotating alpha Port 190 is used if the rotating movement during docking cannot be executed by the beta part, for example stopper vessels, which are docked by lifting devices. The rotating movement of the alpha Port is carried out easily with the big hand wheel. An ingenious 3D-guide system adjusts inaccuracies of the lifting device. Optionally, sensors observe the ending position and release the lifting process. The patented Safety Interlock System guarantees a safe process. The Rotating alpha Port 190 was developed under the aspect of hygienic design; pivot bearing and springs are installed encapsulated, which makes the port easy and safe to clean. Usable diameter: 190 mm Installation diameter: see data sheet Material alpha door: PE - HD nature Main frame: 316L Seal: System: csis (castus safety interlock system) (optional sensors)

7 FLEXIBLE USAGE our beta products are available in different designs and sizes BETA TRANSFER CONTAINER 316L The beta Transfer Container is made of a flange and a lid, sealed by a lip seal, and a cask body. The docking process (rotating movement) of the beta Transfer Container and the alpha Port creates a mechanically connected unit, sealing the contact surfaces hermetically against each other. Opening the alpha door is only possible after having connected the beta part correctly, due to the patented Safety Interlock System. This system guarantees that the beta Transfer Container cannot be disconnected when the alpha door is open. The combination of the alpha Port and beta Transfer Container makes up the Rapid Transfer System (RTS). Size: Length: Material: Seal variable: Handles: Standing: mm up to 500 mm 316L or EPDM variable in position and design customized

8 BETA TRANSFER CONTAINER PE BETA SINGLE USE The beta Transfer Container is made of a flange and a lid, sealed by a lip seal, and a cask body. The docking process (rotating movement) of the beta Transfer Container and the alpha Port creates a mechanically connected unit, sealing the contact surfaces hermetically against each other. Opening the alpha door is only possible after having connected the beta part correctly, due to the patented Safety Interlock System. Beta Single Use products are designated for onetime use only. Products that are gamma sterilized in the bag can be inserted after the docking on the alpha Port. Waste can be removed from the cleanroom in the beta Single Use and disposed of afterwards. Beta Single Use can be used as a flexible option in combination with beta Transfer Containers. This system guarantees that the beta Transfer Container cannot be disconnected when the alpha door is open. The combination of the alpha Port and beta Transfer Container makes up the Rapid Transfer System (RTS). Size: Length: Material: Seal variable: Handles: mm variable PE - HD or PE - HD AST or EPDM variable in position and design Usable diameter: Flange: Seal variable: Filling quantity: Type: mm PE - HD or EPDM max. 100 l sterile or non - sterile

9 BETA LINER PE-HD BETA FALSE Beta Liners are used to remove contaminated waste, samples, toxic or highly reactive substances from the cleanroom and guarantee a high protection of people and products. The NBK - Folding - System of the foil cartridge offers a higher capacity. If requested, the Beta Liners are available in a gamma sterilized as well as an antistatic version. Beta False Containers are connected with the alpha Port during the decontamination with H 2 O 2. Thus the alpha door can be opened and the critical surface of the seal can be treated with gas safely. Usable diameter: 190, 270, 350 mm Bracket: PE - HD Seal variable: or EPDM Foil: PE 80 µm Foil length: 25 m Usable diameter: Material: Seal and cover: mm PE - HD

10 OUR SOLUTIONS FOR YOUR REQUIREMENTS PULL-OUT-SYSTEMS Complete pull-out-system for the beta Transfer Container In order to handle the equipment or product that is inserted in a more ergonomic way close to the place of usage, complete pull - out-systems are installed universally within the Transfer Container. The operator can remove the elements more easily. Insertions and fixations for sensitive components can be designed individually and integrated flexibly into the pull - out system.

11 RAIL SYSTEM TROLLEY A rail system is used if the transfer of process material within the isolator is executed over long distances. The fix installation of the rails within the container allows a transfer by means of a bridge and thus a further transport on rails leading to the desired place in the isolator. The trolley facilitates the transport and docking of heavy beta Transfer Containers. Four castors allow a comfortable shunting. The height of the trolley can be adjusted manually depending on the height of the installed alpha Port in the system wall. PEEKrollers on top and on the bracket guarantee an easy rotating movement while securing the container at the same time. Size: Total Lifting: Material: for beta Transfer Containers mm 150 mm autoclavable

12 plant expert Unterschrift D Erolzheim Leaktest-Protokoll Referenzbehälter 350_02 Prüfgegenstand Art.nr. Test item parts no. Seriennummer Serial no. castus GmbH Co. KG Daimlerstr. 6 Verwendete Prüf- und Messmittel Testing and measuring equipment used Bezeichnung Differenzdruckmessgerät ATEQ F620 designation Differential Pressure Gauge Seriennummer Serial no. Druckbereich bar pressure range Messbereich Pa SPECIAL DESIGNS DOCUMENTATION Measuring range 10/2014 Genauigkeit Precision Kalibriert 2,5% vom Messbereich calibrated until bis Hilfsmittel Referenzbehälter 350_01, castus auxiliary means used reference container Seriennummer Serial Kalibrier-Zertifikat S vom no Prüfmethode Druckhaltevermögen nach castus QS-VA018 Stand Jan.2014 ability pressure maintaining by castus QS-VA018 standing Jan.2014 Lage bei der Prüfung horizontal position during test horizontal Prüfort test Erolzheim location Prüfzeit (min) Test time(min) Programm-Nr. 1 Druckverlust Enddruck test pressure pressure Leckrate (max. 0,3) final pressure 6 10,5 programm no. Testdruck loss 1037 leak rate(max. 0,3) 1031 Ergebnis 0,03 result i.o. 0,00 i.o , ,01 i.o ,5 5 10, Prüfgegenstand erfüllt die Herstellerspezifikation ein ja / yes item perform the manufacturers specification ,02 0,01 0,00 i.o. i.o. i.o. nein / no X Werksachverständiger Herzhauser, Jürgen Together and flexible for an ideal solution Your individual requests and our longtime experience lead to the development of a customized solution in close cooperation, satisfying your technical and economical requirements. Packing specifications Drawings with parts list Operating and maintenance manual Welding report Leak test protocols Protocol of roughness measuring Calibration of critical measuring instruments (protocols, certificates) Material certificate for seals: Conformity certificate according to FDA Code 21 CFR Part 177/ USP Class VI Works certificate 2.1 according to DIN EN ISO Inspection certificate 3.1 according to DIN EN ISO Evaluation of the tightness based on microbial test of impermeability Evaluation of the tightness based on particulate test of Helium gas

13 castus GmbH & Co.KG transfersysteme Daimler Straße 6 D Erolzheim Tel Fax info@castus.pro