The Hellenic manufacturer for solutions in the Laboratory & Industry ISO catalogue. V a

Transcription

1 The Hellenic manufacturer for solutions in the Laboratory & Industry ISO 9001 STABILITY TEST CHAMBERS catalogue V a DESIGNING, PRODUCTION, SUPPORT OF SCIENTIFIC & INDUSTRIAL LABORATORY EQUIPMENT

2 Our Company 55 YEARS OF EXPERIENCE-TWO GENERATIONS OF CONTINUOUS IMPROVEMENT. EM. E. CHRYSSAGIS was originally established in 1954 by Ev. Chryssagis initially servicing commercial refrigerators. Since 1988 it designs and manufactures environment controlled chambers and material testing appliances for scientific, industrial laboratories and horticulture producers under the trademark CDR. Today EM. E. CHRYSSAGIS is well known for the reliability and consistent support of its products. It is the only Hellenic company dedicated to the design and production of environment simulation chambers or appliances used exclusively in industrial quality control laboratories. The technical knowledge and manufacturing tradition of the company are firmly established by the large number of specialized products designed for scientific and industrial laboratories that are in the Hellenic and International market

3 Pharmaceutical Stability Test Rooms Modular and ready built rooms CDR E.CHRYSSAGIS is a Hellenic leader in the design, manufacture, installation and servicing of controlled environments, environmental test chambers and test rooms. Our combination of high quality components, design and manufacturing expertise enables us to offer outstanding control performance and reassurance of the integrity of temperature, humidity and atmospheric testing results. Developed through our 27 years of experience, this generation of Pharmaceutical stability test rooms represents leading edge technology. With the new ENVIMED models further consideration of all aspects of the incubation or stability testing process have been incorporated into the design. Our pre-fabricated walk-in incubator s modular or ready built construction, facilitates ease of move-in and setup and a competitive quality-price ration. CDR provides a range of Standard Walk-in Incubators, or alternatively we can design and build them to suit the customer's requirements. Walk-in ENVIMED series

4 CDR's ENVIMED room series has been specially developed to meet the test or production requirement in research and industrial laboratories. Any size to suit customer's needs. CDR is equipped with computer-aided design and manufacturing technology in order to conform to your specific needs. Optionally CDR offers an on-site service to establish exactly what is needed to meet customer requirements. Our modular incubation rooms are manufactured at any dimensions to meet particular room restrictions or to effectively accommodate any budget. They are designed for accurate, quick on-site assembly by our experienced technicians. Please contact our sales department for information on orders and local support of our products in your region. Modular walk-ins Ready-built walk-ins Modular Walk-ins. Every model has walls, ceiling and floor made of German origin prefab panels with pour-in-place polyurethane. This high-density (45Kgr/m3), fireproof and environment friendly insulation ensures low power consumption. Panel's skins are made of galvanized sheet metal, finished off in white baked enamel which assures long service life. All joints are perfectly sealed at both sides by double barreled NSF approved gaskets. The added raised surface pattern of the floor increase traction thus reduces the potential of slip-and-fall accidents, even in wet conditions. Ready-Built Walk-ins As an alternative to our modular chambers, factory pre-assembled models are available and ready to be installed. On site. Structures arrive at the site typically on a gooseneck truck and, depending on size and customer preference, lifted into place by crane, boom-lift or forklift and they are immediately fully operational. Tailor-made internal configuration. Rooms can be built to blend with architectural features of new or existing facilities. They can have adjustable or modular multilevel shelving, loading trolleys and any other furnishings available to enhance utilization. Every chamber is equipped with: A covered instrument entrance. Internal working light and a 45-minute emergency backup light. Full size mechanically lockable door with emergency opening facility. A double glazed observation window (optionally with a cover) allows for checking without disturbing the internal environment. Optionally the door is equipped with an electromagnetic locking system that supports password protection and access log record thought the CMP3 control system and/or CMP3/SCADA central management software. Tailor made shelves

5 Uniform, Stable and Accurate Conditioning. ENVIMED rooms have special wall plenums that offer excellent uniformity with a horizontal air distribution throughout the chamber. Variations in airflow pattern are available to meet requirements of any specific test type. NIKI CMP3 control system Our main control system NIKI CMP3 is a PLC base system, with 7 color LCD touch screen, capable of controlling in full PID mode temperature, relative humidity, and any other variable by request. Precision is achieved by the use of high quality sensors. Multiple level menu screens permit authorized users (code protected) to easily adjust set points alarm parameters, and other key data. Constant and secure temperature across the working space is measured using multi-point sensors. NIKI CMP3 control system features: 7 color touch-screen with graphical interface menus. Control menu with password protected access for authorized users only. Real- time chamber monitoring of all controlled parameters. Self-diagnostic menus for all electromechanical systems with warning screens for faulty condition. Temperature sensor protection with differential comparing measurement of two identical probes. Audible and visual alarms with alarm log for every parameter. Alarm logs record when limits are exceeded and corrected. Alarm connection capability to building's central alarm system. Integrated data logging facility. Data is optionally exportable for processing with Excel and other spreadsheet applications with a USB stick. Viewing archived data appears in list format. Access data-log file while continuing to log current data without disruption. Program reading rate is adjustable by the user. Ethernet connectivity (please see central management software). UPS protection of the control system for 45 minutes. CMP3 OPTIONAL FEATURES: Programming of any parameter with ramp, soak, and sequencing capability. Temperature uniformity protection with multi-point measurement. Alarm extension with GSM voice or SMS message. Door locking with an electromagnetic system that supports password protection and access log record. CMP3 control system with 7 color touch screen.

6 Multi password protection CMP3 on board data logging CMP3/SCADA alarm monitoring UPS protection for electromagnetic door locking (45 minutes). Controller redundancy ensures that if PLC control system fails, chamber continues to operate according to program retained in the controller memory. Multiple password protection at various levels of access. Central management software CMP3/SCADA central management software. CDR understands the convenience of managing your chambers right from your desktop or from any internet-enabled PC. We now offer the advanced SCADA based system with data communication support. CDR CSADA in conjunction with CMP3 is a powerful management system that allows you to precisely and effectively control, monitor and acquire data from your chamber. From your desktop computer with intranet access or from anywhere with internet connected laptop you can use the friendly graphical interface of our SCADA/CMP3 to master your chamber. The system Is capable of: 1. A supervisory dashboard view displaying the status of all CDR's chambers. 2. Alarms adjusting by setting critical control parameters and tolerances. 3. Immediate alert/alarm notification to your PC, on your mobile phone with voice or SMS message. 4. Risk Management by auto backup and restore including system protection, disaster recovery and file restoration. 5. Data Acquisition of all working parameters of your chambers. All history data is available: a) for viewing in graphical form. b) for viewing as tabular form c) for printing in real time or intervally. d) temperature is available also as mean kinetic temperature reading. 6. User Account Management of your chamber, user time tracking with accounting scheduling. 7. User chamber access controlling/data logging. 8. Our CMP3/SCADA software complies with FDA 21 CFR Part 11. DQ/IQ/OQ/PQ Validation Protocols We offer a high-level validation service combining security, assurance and exceptional value. A fully documented on-site validation package (DQ/IQ/OQ, PQ) is available for all models. On site work is carried out by our specialist engineers or fully trained local representatives. CMP3/SCADA on line monitoring

7 CDR E. CHRYSSAGIS can provide all protocols and documentation which are fully compliant with ICH, GMP guidelines. Our Validation Protocols are recognized and surpass even the most demanding requirements. Protocols are based upon a standard industry format. Every test contains the test objective, method, acceptance criteria, equipment reference, comments section, corrective action section and validation engineer and customer sign off sections. Initial and periodic validation allows the customer to build an auditable history for their equipment, therefore demonstrating compliance with ICH guidelines, GMP guidelines or stability guideline (Q1A). Customer's specific document numbers are incorporated in all protocols to conform with validation requirements. On site validation activities typically take 2-4 days (IQ-OQ-PQ). Within our standard price regime, two twenty four PQ tests are conducted. Tests are conducted at one temperature and humidity setpoint, loaded and unloaded or two temperature and humidity setpoint conditions loaded. Each PQ test has a five-minute intrusion test as standard. PQ/PV testing is conducted utilising 21 CFR part 11 compliant dataloggers. Therefore each customer has total assurance regarding the validity of data logged results, as all files are binary encrypted, secure, unalterable files. We are able to data log up to 12 temperature and 4 humidity points at a time. Air cooled condensing unit Machine highlights The refrigeration compressors are standard <<tropical>> hermetic or optionally semi-hermetic models which are universally available. Optionally special refrigeration systems are available by request. CDR offers the choice of air or water cooled refrigeration plant or use of local "chilled water" systems. This guarantees energy saving and reliability. Secure Rooms Our <<DX>>series models have two full sized identical conditioning plans. CMP3 control system that is continuously supervising both plans is auto-interchanging them every 4 hours so they are always <<ready>> to engage in case of an emergency. In case of malfunction of the actual primary plan CMP3's protection software isolates the problematic plan and permanently activates the <<backup>> system. The user is informed with a local audible and visual alarm. Furthermore for more protection NIKI CMP3 has two more options. It can be connected with the building's central alarm system or (optionally) can be equipped with a GSM emergency call system that automatically is sending Voice Alarm messages or sends SMS messages to three (3) preselected phone numbers. Modular heat exchanging compartment Easy access of the electrical panel Optional semi-hermetic refrigeration plan

8 ENVIMED Walk-in Specifications ENVIMED Internal Volume 2. Temperature range ENVIMED ENVIMED BR By request +10 C έως 45 C 3. Temperature resolution +/-0,1 C 4. Temperature accuracy +/-0,1 C (Pt100 sensors) 5. Temperature stability +/-0,2 C 6. Temperature uniformity +/-0,5 C 7. Relative humidity range (optional) 8. Relative humidity range with dehumidifier (optional) 9. Relative humidity resolution 10. Relative humidity stability 11. Relative humidity accuracy 12. Internal configuration 13. Door size 14. Insulation 15. Temperature protection 16. Humidifier type 17. Central management software 18. Working environment 19. Test points (ICH quidelines) 20. Power supply environment to 95% >35 έως 98% Limited by dew point +4 C 1% +/-3 % RH +/-2 % RH Tailor made upon request 0,80 X 1,90m polyourethane 42 Kgr/m3 / 60mm thickness Independent digital thermostat (high/low limit) Centrifugal Atomizing / optional Ultrasonic (ETHERNET connection) optional -20 έως +46 C (Tropical refrigerator) +25 C / 60% RH, + 30 C / 65% RH +40 C / 75% RH, + 30 C / 35-75% RH (other ranges upon request) 400VAC / 3 ph / 50Hz or 440VAC / 3 ph / 60Hz Other upon request Specifications are based on nominal voltages of 400 or 440V in ambients of 22C to 25C. Continuing research and improvments may result in specification changes at any time without previous notice.

9 ENVIMED Walk-in 5.3 Dimensions

10 Reach-in ENVIMED series Pharmaceutical Stability Test Chambers Climate reach-in chambers for Reliable Stability Testing of Pharmaceuticals. According to the ICH Guideline Q1A, stability tests have to be performed under defined climatic conditions in order to provide evidence of the stability of active substances and pharmaceuticals. In cooperation with the pharmaceutical industry, we have developed a specific ENVIMED 1000 CMP3/dx range of test cabinets and test chambers to meet these requirements. The ENVIMED series chambers are available in sizes to suit every need. From the smallest 500 liters when demand for test space is small, to the largest 2000 litres chamber. MEET THE QUALITY CRITERIA We have developed our ENVIMED test chambers to meet the following climate conditions according to the ICH Guideline Q1A. Long-term testing at +25 C / 60% RH or +30 C / 65% RH Accelerated testing at +40 C / 75% RH Intermediate testing at +30 C / 65% RH Construction Chambers have thinner wall construction that gives maximum space utilization due to the high quality polyurethane insulation. Foam in place CFC free polyurethane insulation binds inner and outer walls into single unit for greater strength. As standard, Optional wire mesh basket shelves with sliding out mechanism. body construction is all stainless steel. Special attention has been given so the working room is practical and easy adjustable to user s needs. Standard wire shelves made of stainless steel have a ladder rack system for shelf positions giving total flexibility of shelf spacing.they have supports that allow a choice of vertical positioning at 12mm intervals. (Optionally code \NET) Special pull out drawers made of stainless steel mesh, have a mechanism for sliding out smoothly. The user can quick and easily load and unload the samples even if the chamber is fully loaded. These wire mesh basket shelves are capable to hold even the smaller drag boxes and ensure 100% utilization of the chamber s working space. Standard wire shelves

11 ENVIMED-500/1000/1500/2000DG or CMP3 Special recirculation air flow ensures environment uniformity Standard models have energy efficient, CFC Free, air cooled selfcontained refrigeration systems. Refrigeration plan include hot gas bypass systems for high temperature stability and continuous compressor operation that last long. This guarantees economy, reliability and quiet operation. As standard all models are equipped with <<tropical>> refrigeration system that is designed to operate in ambient temperatures up to 46 C. The ENVIMED uni-flow system incorporates a technique for preconditioning the air before it enters the specimen area. Uniform airflow is introduced to the storage area in a vertical airflow pattern discharged ENVIMED 1000DG from a perforated rear wall plenum. This special air-conditioning system has an air flow velocity specifically targeted at Pharmaceuticals testing and distributes the pre-conditioned air uniformly across all shelves. With no defrost required, the test conditions remain well within ICH guidelines throughout the test period with no unexpected deviations from set point. Standard humidification system is a reliable centrifugal atomizing humidifier (optionally with electronic ultrasonic humidifier). These humidifiers produce very small water droplets (>7μm). Main advantages of atomizing humidifiers are easy servicing and that they are working without stopping unexpectedly due to the salt formation which is giving adequate time for service planning.atomizing ENVIMED-1600 humidifiers must be supplied with clean water to the following specification ph = 7.0 ± 0.5, filtration <2 microns ( in) and resistivity between 0.5 and 1.0 Meg Ohms.CDR can optionally supply the customer with an on line water deionizing system. Secure Stability Rooms (Option /DX) Our <<DX>>series models have two full sized identical conditioning plans. CMP3 control system that is continuously supervising both plans is auto-interchanging them every 4 hours so they are always <<ready>> to engage in case of an emergency. In case of malfunction of the actual primary plan CMP3's protection software isolates the problematic plan and permanently activates the <<backup>> system. Automatic water deionizer (option /WD) The user is informed with a local audible and visual alarm. Furthermore, for more protection NIKI CMP3 has two more options. It can be connected with the building's central alarm system or (optionally) can be equipped with a GSM emergency call system that automatically is sending Voice Alarm messages or sends SMS messages to three (3) preselected phone numbers. Information subject to change without written notice.

12 Selectable control system All models may be equipped with one of the following control systems: DG control system s panel DG control system is our economical solution. DG series chambers are equipped with microprocessor PID controllers, which offer dual set point (day-night temperature and humidity set point) and analog timer for the photo-period. Panel is equipped also with protection and alarm for high/low temperature and relative humidity. NIKI CMP3 control system CMP3 control system s panel with 7 color touch screen Our main control system NIKI CMP3 is a PLC base system, with 7 color LCD touch screen, capable of controlling in full PID mode temperature, relative humidity, and any other variable by request. Precision is achieved by the use of high quality sensors. Multiple level menu screens permit authorized users (code protected) to easily adjust set points alarm parameters, and other key data. Constant and secure temperature across the working space is measured using multipoint sensors. NIKI CMP3 control system features: 7 color touch-screen with graphical interface menus. Control menu with password protected access for authorized users only.. Real- time chamber monitoring of all controlled parameters. Self-diagnostic menus for all electromechanical systems with warning screens for faulty condition. Temperature sensor protection with differential comparing measurement of two identical probes. Audible and visual alarms with alarm log for every parameter. Alarm logs record when limits are exceeded and corrected. Alarm connection capability to building's central alarm system. Integrated data logging facility. Data is optionally exportable for processing with Excel and other spreadsheet applications with a USB stick. Viewing archived data appears in list format. Access data-log file while continuing to log current data without disruption. Program reading rate is adjustable by the user. Ethernet connectivity (please see central management software). UPS protection of the control system for 45 minutes. CMP3 on board data logging Multi password protection CMP3 Control optional features: Programming of any parameter with ramp, soak, and sequencing capability. Temperature uniformity protection with multi-point measurement. Alarm extension with GSM voice or SMS message. Door locking with an electromagnetic system that supports password protection and access log record. UPS protection for electromagnetic door locking (45 minutes).

13 Central management software. Controller redundancy ensures that if PLC control system fails, chamber continues to operate according to program retained in the controller memory. Multiple password protection at various levels of access. Central management software. CMP3/SCADA central management software. CDR understands the convenience of managing your chambers right from your desktop or from any internet-enabled PC. We now offer the advanced SCADA based system with data communication support. CDR CSADA in conjunction with CMP3 is a powerful management system that allows you to precisely and effectively control, monitor and acquire data from your chamber. From your desktop computer with intranet access or from anywhere with internet connected laptop you can use the friendly graphical interface of our SCADA/CMP3 to master your chamber. The system Is capable of: A supervisory dashboard view displaying the status of all CDR's chambers. Alarms adjusting by setting critical control parameters and tolerances. Immediate alert/alarm notification to your PC, on your mobile phone with voice or SMS message. Risk Management by auto backup and restore including system protection, disaster recovery and file restoration. Data Acquisition of all working parameters of your chambers. All history data is available: a) for viewing in graphical form. b) for viewing as tabular form c) for printing in real time or intervally. d) temperature is available also as mean kinetic temperature reading. User Account Management of your chamber, user time tracking with accounting scheduling. User chamber access controlling/data logging. Our CMP3/SCADA software complies with FDA 21 CFR Part 11. CMP3 control system with 7 color touch screen. CMP3/SCADA alarm monitoring DQ/IQ/OQ/PQ Validation Protocols We offer a high-level validation service combining security, assurance and exceptional value. A fully documented on-site validation package (DQ / IQ / OQ / PQ) is available for all models. On site work is carried out by our specialist engineers or fully trained local representatives. CMP3/SCADA on line monitoring

14 ENVIMED Reach-in series Specifications ENVIMED-500 ENVIMED-1000 ENVIMED-1600 ENVIMED-2300 External dimensions a) Single Refr. 815x705x x1396x x2097x2160 (DXWXHmm) 815x1453x x2144x x2845x x2097x x2845x b) DX Internal volume (liters) Number of shelves / total area 5pcs / 1,72 m2 Temperature range 0,2 C / 0,1 C Temperature uniformity 0,6 C Relative humidity range 25-95% over a min Dew Point temp. of +5 C % RH deviation standard ±3%, optional ±2% % RH accuracy standard ±2%, optional ±1% (capacitive type sensor) Humidification system/ consumption Recorder or data logger Stainless steel pull out drawers 16. Operating temperature 17. DX models 17. Power source 6pcs / 8,37 m2 0,5 C Temperature accuracy/ resolution Hi / Lo limit visual & audio Alarm 5pcs / 6,33 m2 + 5 to +45 C Temperature deviation Test points ( ICH guidelines) 5pcs / 3,77 m2 atomizing / max 20 Ltr per day +25 C / 60% RH, + 30 C / 65% RH, +40 C / 75% RH, + 30 C / 35-75% RH (other ranges upon request) Temperature & Humidity Optional Optional model \PD + 10 to +46 C (tropical refrigeration plan) Two auto interchangeable temperature & relative humidity control systems VAC /1ph / 50Hz (other upon request) Specifications are based on nominal voltages of or 240V in ambients of 22C to 25C. Continuing research and improvments may result in specification changes at any time without previous notice. OPTIONS CDR can customize stability rooms with the following optional accessories or to your specific requirements: 1) On screen paperless recorder with data logging facilities. Special scada type PC software ensures PC communication with RS-232 or optionally RS-485 or Ethernet for multi chamber controlling, real time monitoring and data printing. The paperless recorder, the scada software, user manuals and user education from CDR ensures that the system complies with CFR 21 Part 11. 2) Chart or paperless recorder that complies with CFR 21 Part ) Automatic deionizers for water or drain water recirculation. 4) Electronic ultrasonic humidifiers. 5) Special pull out drawers made of stainless steel mesh, that have a mechanism for sliding out smoothly.the user can quick and easily load and unload the samples even if the chamber is fully loaded.

15 ENVIMED reach-in series Dimensions

16 Support & Repair CDR E.CHRYSSAGIS can deliver and install your new equipment with our factory trained personnel. Quotations upon request. All service personnel are graduates of technical schools. Additionally, the technicians attend factory sponsored training seminars when available so that CDR can provide the best possible service. We have no limit in our area of coverage. At CDR E. CHRYSSAGIS we are committed to our customers not only at the initial installation but to increasing the life and limiting downtime of that unit. We have designed a Preventive Maintenance program and provide Calibration services to help you meet your test requirements and recording requirements. We recommend an Annual PM and Calibration to properly maintain your unit. The PM involves removal and replacement of all components that could fail within a year. This includes filters, float switches, orings, fans etc. This process usually takes one day and normally eliminates the need for further service calls. Don't hesitate to contact us with your questions or problems. CDR

17 Sales - Distributors EMMANUEL CHRYSSAGIS 8 Sahtouri Str, Athens, HELLAS Tel.: +30 (210) , Fax: +30 (210) sales@chryssagis.eu ALBANIA OLS-END sh.p.k Rr. Komuna e Parisit Pallatet TIRHINO Kulla D, Ap 7/3, Tirana Phone: +355 (67) viola.allka@gmail.com BANGLADESH MICRO ENGINEERING Co Dhaka Phone: +880 (2) Fax: +880 (2) micro@axisbd.net CYPRUS TASNI TRADING CO LTD 57 LIDRAS FLAT LEFKOSIA 0 NICOSIA Phone: +357 (22) Fax: +357 (23) Website: EGYPT FIRST MEDICAL INTERNATIONAL 19 Naser Al Thawra St., El Haram,Giza Postal Code: Phone : Fax : firstmedical_226@yahoo.com Website: INDIA JKG Bio Science Pvt Ltd 6D, MIG DDA Flats Shivam Enclave Delhi India Ph: Tel/Fax: Website: IRAQ Scientific apparatus Tatweer Group Amman Regional Office Phone: Fax: info@tatweer.us, tatweer.mail@gmail.com Website: KUWAIT Al-Arfaj Engineering Co WLL PO Box 391, Salmiya, 22004, Kuwait Tel : / Fax: / / sales@arfajengg.com Website : ISO 9001 OMAN AlAjmi Technical Supplies & Trading LLC (ATS Lab) Laboff Middle East Office PO Box 333, Al Maladda, Post Code 314 Sultanate of Oman Tel: Fax: laboff-me@atslaboman.com bmss4ats@omantel.net.om JORDAN Tatweer Group Amman Regional Office Phone: Fax: info@tatweer.us, tatweer.mail@gmail.com Website: PAKISTAN PROGRESSIVE TRADE COMPANY Rawalpindi Phone: +92 (51) , Fax: +92 (51) progressivetradeco@gmail.com HELLAS ANTISEL SA 61 P. Karatasiou Street , Thessaloniki, Greece Phone: Fax: antisel@antisel.gr Website: APEROTAN TECHNIKI Epictitou & ΖΥΓΟΥΡΗ Rd Joannina GREECE Phone: +30 (26510) Fax: +30 (26510) info@apeirotan.gr, diapost@otenet.gr Website: HELIODYNAMI 224, Syngrou Ave. Scientific Devices S.A GR Kallithea (Athens). Greece Phone: +30 (210) Fax +30 (210) info.vector@pertip.gr Website: LABOR SCIENCE SA 6, Aftokratoron Angelon Str. GR Athens, Greece P.O. Box Phone: +30 (210) Fax: +30 (210) info@laborscience.gr

18 EMMANUEL CHRYSSAGIS 8 Sahtouri St., Ayios Dimitrios, Athens, HELLAS tel.: +30 (210) , fax: +30 (210) sales@chryssagis.eu